iahi august volume 1 issue 1

Volume 1 Issue 1I International Animal Health Industry

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The Global Animal Health IndustryTrends, Challenges and Opportunities Total Project Management SolutionsFor Development of Veterinary Medicinal Products

Animal HealthR&D Functions and Externalisation Opportunities Introduction Of Electronic Data Capture Systems in Animal Health Clinical StudiesImpact of Change for the Animal Health Sector

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Volume 1 Issue 1II International Animal Health Industry

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Contents

06 FOREWORD

WATCH PAGES08 The Global Animal Health Industry – Trends, Challenges and Opportunities

The global animal health market is in the midst of a series of mergers, acquisitions, spin-offs and joint ventures. Carel du Marchie Sarvaas of IFAH sees this as reflecting the growing recognition of the importance of the animal health industry, and sums up in his article the trends that pose both challenges and opportunities for governments, industry, and stakeholders; and how the industry provides solutions and value.

12 One Health – One Mantra for Animal Health IndustryIn his editorial, Hemant K. Joshi of Nika Biochemicals explores the current landscape, key developments and trends in outsourcing. This is a “very exciting time” for the global animal health industry. Zoonotic diseases have made human and animal healthcare even more connected today than ever in the past.

14 Animal InstinctThere is significant investor interest in the area of animal health. In the last 12 months, the private equity press has reported a number of UK mid-market deals across a range of sub-sectors including veterinary services, online pharmacies, pet food, wearable technology for the animal health sector and diagnostics. David Lonsdale of August Equity explains why the animal health market continues to be a highly rated and highly sought after area for investors.

REGULATORY & MARKETPLACE

16 Vet Meds Legislation: How Far Will The Commission Go?Paul Cooper of Assentra reflects upon the review of the veterinary medicines legislation that has started in 2010. More than four years later, those with a stake in how veterinary medicines are regulated in Europe are still waiting for the Commission’s proposals to be published. The current regulatory framework is defective in some major areas and the animal health industry is labouring under a heavy administrative burden.

20 One Health – A Reality or Yet Another Utopian Overreach?

He believes in it and practises it in his business because “it is common sense”. Sam Al-Murrani of Babylon Bioconsulting discusses the “One Health” concept and the irony that, considering its fundamental importance, it has not been matched by a concerted effort to engender grassroots and popular support for it. Apart from a few professionals, professional organisations and some governmental agencies in a few countries, the effort has thus far been rather elitist, targeting the highly educated, and essentially preaching to the converted.

22 The Economics of Animal HealthAnimal health professionals need to have an understanding of the application of economics to animal health, and the current economic crisis makes the need for these skills all the more urgent. In their paper Elizabeth L. Jackson, Barbara Häsler & Jonathan Rushton of Department of Production & Population Health, Royal Veterinary College highlight how the best use of economics will improve decision-

MANAGING DIRECTOR Martin Wright

PUBLISHERMark A. Barker

PROJECT DIRECTORClive Baigent

EDITOR Cecilia Stroe

EDITORIAL MANAGEROrsolya Balogh

DESIGNER Fiona Cleland

BUSINESS DEVELOPMENTRichard Goodard

ADMINISTRATOR Barbara Lasco

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The opinions and views expressed by the authors in this magazine are not necessarily those of the Editor or the Publisher. Please note that although care is taken in preparation of this publication, the Editor and the Publisher are not responsible for opinions, views and inaccuracies in the articles. Great care is taken with regards to artwork supplied, the Publisher cannot be held responsible for any loss or damage incurred. This publication is protected by copyright. Volume 1 Issue 1 August 2014 PHARMA PUBLICATIONS

Volume 1 Issue 12 International Animal Health Industry

Contents

making on animal health on so many levels. Economics can add value to disease impact assessments, assisting understanding of people’s incentives to participate in animal health measures, and refining resource allocation of public and private animal health budgets.

26 Zoonotic Diseases – The Forgotten Ones?About 75% of the new diseases that have affected humans over the past 10 years have been caused by pathogens originating from an animal or from products of animal origin. Even though many of the zoonotic diseases have the means to spread over long distances and to become global problems, limited reliable qualitative and quantitative information on their burden is available at the moment. Cecilia Stroe, editor of IAHI, looks into those neglected zoonotic diseases which seem to have been almost forgotten, at least in terms of allocation of funding for research and collective action for control.

30 The Human-Animal Bond – The Cost of CareThis may be the biggest issue the veterinary community faces — how to help pet owners afford the care we are now able to provide as veterinarians, argues Kerry E. Marshall of Trupanion. In her article, she discusses medical insurance for pets: a powerful tool preventing “ethical exhaustion” by helping assist pet owners in affording the care their pet needs. The time to ACT is now — innovations in pet medical insurance are improving the value to pet owners, and veterinarians are the most important factor in determining whether pet medical insurance is a viable option.

RESEARCH & DEVELOPMENT

34 Animal Health: R&D Functions and Externalisation Opportunities

The last decade has witnessed a surge in the number of dedicated animal health CROs, labs and consulting organisations, pan-US and EU. In his paper, Vivek C of Beroe provides a cursory glance at the global animal health market, its chief constituents, R&D trends, outsourcing practices incorporated by large manufacturers and best sourcing approaches, across shared functions of human and animal health R&D divisions, such as toxicology and process-oriented functions such as data and project management.

38 Total Project Management Solutions for the Development of Veterinary Medicinal Products

The introduction of new pharmaceutical veterinary products is dependent on a wide range of activities, through development and manufacturing to clinical field trials and building the regulatory dossier. A key activity, and the focus of John W Banks of Triveritas`s article, is the transfer of the process development knowledge into a cGMP manufacturing facility to generate formulated products that can be used in either clinical or commercial supply.

42 Antibiotic Alternatives for AnimalsAntibiotics are needed in pets and food animals, just as in humans, but efficacy is compromised through antimicrobial resistance and no new antibiotic molecules. The key drivers to reduce consumption and preserve antibiotic efficacy are similar, although arguably stronger, in veterinary than in human medicine, particularly with respect to regulatory


Contents

hurdles and restrictions in use. Elinor McCartney of Pen & Tec Consulting points out that pressure to reduce antibiotic use, coupled with the EU ban on antimicrobial growth promoters and current debate in the USA, is driving innovation in alternative products that can help reduce, refine and replace antibiotics in farm and companion animals.

CLINICAL STUDIES

46 The Heart of the MatterThe central figure in any clinical trial is the investigator. But whilst every investigator is a veterinarian, not every veterinarian makes a good investigator. Denny O. Day of VetPharm emphasises the importance of finding the right team of investigators, and then supporting them in the right way. Because finding, training, and motivating veterinarians to be effective investigators will help ensure the success of those trials ... and the long-term health and wellbeing of our beloved pets.

IT & LOGISTICS

50 Introduction of Electronic Data Capture Systems (EDC) in Animal Health VICH GCP Clinical Studies – Impact of Change for the Animal Health Sector

Electronic data capture (EDC) has been in the human clinical study arena for a number of years; however, this technology has only recently been introduced to animal health clinical VICH GCP studies. In their paper, Janice Sarasola of Ondax Scientific, Jo McKelvie of EVITA Services and Iain McPhee of Novartis Animal Health discuss the fact that using EDC in animal health VICH GCP studies presents unique challenges based on the logistics of running small and large animal field studies, despite the numerous guidance documents and information available related to EDC for human GCP studies.

54 Protecting the Supply ChainIn the world of human health, the increased call for establishing a clear and traceable pedigree for pharmaceutical supply chain had driven the US government to take up legislation. Hotly debated by the California Board of Pharmacy and several times delayed, the issue of serialising medications has now been put into law by the federal government, making the issue unavoidable. As serialisation is one part packaging process, one part IT data management, Justin Schroeder of Packaging Coordinators Inc (PCI) explains what the handling of codes means to the process of successful serialisation and establishing a foundation for securing the supply chain.

MANUFACTURING & PACKAGING

56 Developing Products in the Animal Health IndustryThe animal health market has demonstrated a recession-proof nature uncommon to most industries. Given the attractiveness of the veterinary market, a number of innovators, entrepreneurs, and investors are being drawn to the space. While the financial hurdles and time to approval are lower in veterinary medicine than in human, it remains critically important to understand the market and the technical requirements expected in animal health. Tom Overbay of Expedite Animal Health addresses the importance of applying a disciplined approach to this process, fundamental to avoid errors in market expectations and forecasting, as well as to ensure an efficient approach to development of animal health products.

60 Waste Not, Want NotThe world has many problems producing enough food for the increasing population with decreasing farmland, flooding, environmental issues and fuel to produce electricity, and now disposal for unsold manufacturers and supermarket food – estimated to be 15 million tons annually in the UK alone. Paul Goddard of UKFarmFeeds tells us this “foodstuff” is a very valuable commodity and must not be wasted. Saving Landfill, Saving Waste, Saving Money!


Chapter Title


Editor’s Letter

Editorial Advisory Board

German Graff Veterinary Surgeon Consultant at Triveritas

Kimberly H. ChappellSenior Research Scientist & Companion Animal Product DevelopmentElanco Animal Health

Sven BuckinghamBuckingham QA Consultancy Ltd

Dr. Sam Al-Murrani Chief Executive Officer at Babylon Bioconsulting & Managing Director at Bimini LLC

Richard V. Myer Vice President, Global Business Development - Argenta, Ltd

I am delighted to introduce to you the first issue of IAHI. It is the missing piece of the jigsaw in the global animal health arena, a comprehensive journal for the entire outsourcing industry – accurate, clear and objective, as seen through the eyes of industry peers. And it`s “taking the bull by the horns”, bursting with timely analysis and opinions on what animal health professionals are most worried about.

To get answers, one needs to ask the right questions. For Carel du Marchie Sarvaas, The International Federation for Animal Health (IFAH) Executive Director, these are “How to ensure healthy food animals and greater efficiency in a sustainable manner? How to ensure healthy companion and working animals? How to avoid or recover from disease outbreaks that can impact entire economies?”

Elizabeth L. Jackson, Barbara Häsler and Jonathan Rushton of Department of Production & Population Health, Royal Veterinary College, look into the extensive research on animal health economics, and from their paper, we learn that the questions are the same when looking at an outbreak of avian influenza in a poultry flock or diagnosing a case of canine parvovirus: “What are the economic consequences of a disease, what is the value of diagnosis, of treatment or of prevention?” Apparently, putting aside the different emotional attachment to a companion animal, it is only a matter of scale: 3000 turkeys or one greyhound. The decisions are the same.

At this moment in time, the economic issues involved in animal health represent strategic challenges as never before, but despite the substantial amount of research on animal health economics, there is still further enquiry needed. According to the experts, questions still remain on how to measure animal disease impacts and the quality of existing data to prioritise disease management. But to answer all the key questions requires economists to work alongside animal health specialists, statisticians, sociologists and psychologists and anyone involved in the decision-making, from farm through to policy levels.

Once again, the challenges facing animal health overlap with those of public health and the environment, particularly concerning the use of xenobiotics and the development of antibiotic resistance. And just as in humans, the efficacy of antibiotics in pets and food animals is compromised through antimicrobial resistance and unavailability of new antibiotic molecules. Elinor McCartney of Pen & Tec Consulting tells us that the pressure to reduce antibiotic use, coupled with the EU ban on antimicrobial growth promoters and the current debate in the USA, is driving innovation in alternative products that can help reduce, refine and replace antibiotics in farm and companion animals.

The animal health industry is considered today to be more regulated than at any time in its history, and it seems that veterinary product manufacturers often face higher hurdles than human medical manufacturers. When it comes to the veterinary medicines legislation in Europe, it appears there is nothing as complicated as simplification. Paul Cooper of Assentra shares with us his considerations on the forthcoming veterinary medicines legislative proposals, “always just beyond the horizon, out of reach”. More than four years after the review started, the Commission’s proposals are yet to be published.

Discussing the “One Health” concept, Sam Al-Murrani of Babylon Bioconsulting warns us that time is of the essence; that humanity’s impact on other species and the environment is exponential, therefore any counter-measures must also be aggressive and exponential. It is a matter of urgency to involve the industry and educate the public in a coherent way, otherwise the “One World, One Health” concept may turn out to be “yet another Utopian overreach”.

Cecilia Stroe,Editor

And Finally....

I hope you enjoy the publication. I would like to personally thank all the companies and individuals who have participated in the launch of IAHI. I look forward to working closely on a long term business relationship.

After 20 years of working within the Life Sciences and Pharmaceutical Industry, it is a pleasure to be able to now work within the International Animal Health Industry, and look at the innovation and expertise in this area.

For those who are not involved yet with IAHI, feel free to contact us with your views, recommendation and support. We look forward to supporting the industry and ensuring that we bring you informative and topical articles for your reading.

As I promised at the start of this journey, IAHI will always be for the Industry, by the industry.

Please enjoy the 1st issue of the journal, and I hope to hear from you in the near future and build a concrete relationship between the industry and IAHI.

Clive BaigentProject Director

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The Global Animal Health Industry – Trends, Challenges and Opportunities

Introduction: A Changing WorldWe live in a rapidly changing world where the equilibrium between people, companion and food production animals and wildlife is changing rapidly. Nine major trends highlight the importance of healthy animals.

1. Growing demand for food and changing dietary patterns. Driven by population growth and a rise in per capita income, FAO projects a 70% increase in food demand by 2050. Since the 1960s, dietary patterns have been changing towards consumption of more livestock products and fish.

2. Changing food production systems. The livestock sector is among the fastest growers in agriculture and is a valuable source of wealth, generating food and rural income. Pig and poultry production continues to expand and is more integrated within global supply chains.

3. Increasing trade of food products. Trade of agricultural products is increasing as a result of better transport and fewer barriers. Poultry and pig meat exports have increased by 520% and 207% respectively over the last twenty years, with similar trends for beef and dairy products.1

4. Increasing animal-health and food-safety awareness and standards. There is evidence and awareness of the important link between animal health, food safety and public health. Consumers want risk-free food and so governments, farmers and veterinarians work towards ever better, science-based standards to improve animal and public health.

5. Increase and persistence of communicable diseases and zoonosis. Emerging and re-emerging communicable animal diseases will continue to lead to outbreaks with serious consequences. Being warm-blooded animals, humans share diseases with animals - three out of four emerging diseases are shared between humans through animals. Early detection of pathogens circulating or emerging in animal populations is a public and animal health priority.

6. Increased spread of vector-borne diseases due to climate change. 1 million people die annually from diseases like malaria, dengue, yellow fever and tick-borne encephalitis carried by mosquitoes, flies, ticks and other insects. Rising temperatures are leading to changes in the location and incidence of insect prevalence and disease outbreaks.

7. Increasingly constrained natural resources. There is increasing competition for agricultural land, water, marine fisheries and other resources. This constraint has created a need to produce more food with less resources.

8. Increasing importance of science/technology for productivity increases. With only a small percentage

of land available to produce the required extra food needed to feed the growing population, 70% of the necessary increase in food production will have to come from increased farming efficiency and innovations.

9. Increasing number of companion animals. With rising standards of living, ageing populations and an increasing desire for companionship, there is a rapid rise in the number of companion animals. Human-animal interactions bring many benefits, and pet owners constantly look for improved ways to care for their animals. There are also zoonotic risks from people and animals living in closer proximity.

The Global Animal Health IndustryGlobally, there are 20 billion chickens, 1.4 billion cattle, 1 billon sheep, 1 billion pigs, and hundreds of millions of companion and other animals. Like people, these animals can get sick and need medicines. No matter how animals are cared for, from pets living in comfortable apartments to high-tech livestock barns for turkeys, to open-range grazing for cattle, animals as well as people benefit from today’s veterinary medicines.The animal health market was worth US$23 billion in 2013.2 Globally, about 60% of the spend is on farm animal health, though this differs per country. Global sales are divided roughly between North America with a 47% share, Europe with 31%, and the rest of the world with 23%. Eleven global companies sell more than 80% of the world’s animal health products – Zoetis, Merck, Merial, Elanco, Novartis, Boehringer-Ingelheim, Bayer, Lohmann, Virbac, Vetoquinol and Ceva.

Source: Vetnosis

How the Industry Provides Solutions and Value These global trends pose both challenges and opportunities for governments, industry, and stakeholders. How to ensure healthy food animals to produce more with greater efficiency and in a sustainable manner? How to ensure healthy companion and working animals? How to


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avoid or recover from disease outbreaks that can impact entire economies? The animal health industry has become an important player in addressing these issues. One of the most important contributions of animal medicines is their role in helping ensure that only healthy animals are used for food production. Studies show the importance of healthy animals to the production of safe food, and the potential risks from consumption of food from sick animals. Animal health products help protect public health and the global food supply from unsafe foods. Much like safety, increasing the availability of nutritious foods is important too. The animal health industry plays an important role in helping provide an increasing amount of animal-sourced foods. By providing the tools to protect the health of animals, the co-benefit to society is that greater quantities of food are available for consumers – many of whom are moving into the middle class and increasing protein consumption. Protecting the health of animals with proper care, vaccines, and medicines also contributes to more sustainable production of food. Sick animals require more resources and are less able to convert nutrients to food. In these economic times, it is important to highlight the role of investment and belief in the future of the industry. The animal health industry is a significant global investor in the knowledge economy,

science jobs, and research. For the past 20 years, industry participants have consistently increased the amount of investment into research, development and manufacture of new products to address important challenges.

Lastly, the benefits of animal medicines for companion and working animals are incalculable: the reduction in animal suffering which allows animals to live longer lives, and the ensured safety of close contact with pets are prime examples.

Hurdles and ChallengesThe animal health sector faces five major challenges that limit its capacity to deliver innovative solutions for veterinarians, farmers and pet owners.

First is the lack of harmonisation in technical requirements for market authorisation. The industry supports the implementation of rigorous, proportionate, science-based regulatory standards, but there is a need for consistent application of guidelines and the development of global standards.

Second is the challenge of public acceptance of new technologies. Increased transparency and science-based decision-making are needed to build consumer confidence in animal health products, including the use of biotechnology.

Third is the challenge of further opening up trading. Trade is key to global food security - growing food where resources exist and productivity is high increases the food availability, keeps it more affordable, and makes production more sustainable.

Fourth is the growing concern about antibiotic resistance. The animal health sector promotes responsible use of antibiotics and subscribes to the principle “as little as possible, as much as necessary”. Antibiotics remain an invaluable part of a veterinarian’s toolkit, and their importance in protecting both consumers and animals should not be underestimated.

Fifth is the tendency to apply common regulations to human and veterinary medicines, ignoring major differences like product requirements and use conditions. Contrary to human medicines, veterinary drugs are not reimbursed - farmers and pet owners pay for them out of their own pockets.

Animal Health Looking Forward: Trends and Opportunities Looking ahead, a series of assumptions can be made.1. The trends identified earlier will continue and

intensify. There will be more demand for and more consumption of animal products; food production systems will continue to change and trade will increase; awareness and implementation of animal health standards will increase; diseases will emerge and re-emerge; vector-borne diseases will spread


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faster; new technology will be applied; there will be less natural resources available and there will be more pets.

2. Disease control and food security will continue to be of particular importance. Awareness of economic impacts of livestock diseases will grow. How global agriculture will maintain and optimise productivity with fewer resources is intrinsically linked to innovative solutions for animal health.

3. The ‘One Health’ approach, which the animal health industry supports, will bring more recognition that ‘healthy animals equal healthy people’, and will lend weight to closer partnerships between the human and animal health sectors.

4. The animal health market will continue to grow due to increasing animal populations. Two recent forecasts estimate that by 2018/19 the global animal health market is expected to grow at an annual rate of 7-8% to reach an estimated value of US$41-43 billion in 2019.3

5. Animal health expenditure on farms is increasing, due to the increasing number of animals and the growing concern for their health.

6. Companion animal spending will grow, as will the demand for innovations to improve pet care.

7. There is a growing demand for innovative solutions. Animal health products like vaccines, parasiticides, anti-infectives and feed additives are especially prominent.4 New regulations for the control of animal diseases to reduce food-borne diseases offer opportunities, as will the urgent need to develop new vaccines. Vaccines will be the fastest growing product segment in the future.

8. The global animal health market is in the midst of a series of mergers, acquisitions, spin-offs and joint ventures. This reflects a growing recognition of the importance of the animal health industry. Changing regulatory environments and the emergence of regional and country-specific companies will increase competition in the global market.

References 1. World Livestock 2013, Changing disease landscapes,

FAO 20132. Figures from Vetnosis3. Transparency Market Research “Animal Healthcare

Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast, 2014 - 2019,” and Global Industry Analysts, report on Animal Medication markets. Animal Medication: A Global Strategic Business Report

4. Global Industry Analysts, report on Animal Medication markets. Animal Medication: A Global Strategic Business Report

Carel du Marchie Sarvaas, Executive Director of the International Federation for Animal Health. IFAH represents international companies, as well as associations that comprise small and medium-sized enterprises, engaged in R&D, manufacturing and commercialisation of veterinary medicines, vaccines and other animal health products. IFAH

members represent approximately 80% of the global marketEmail: [email protected]


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One Health – One Mantra for Animal Health Industry

I am delighted to write this editorial for the first issue of International Animal Health Industry magazine covering the entire management of outsourcing for this industry. The global animal health industry broadly consists of pharmaceuticals, biological and medicinal feed additives. The importance of this industry can be put into perspective by the fact that sick food animals cannot produce food suitable for human consumption.

The global animal health market is projected to reach USD 42.9 billion by 2018, primarily driven by current unmet needs and growth of the industry. Geographically, North and Latin America (US, Argentina and Brazil) have accounted for half (47%) of the global animal health markets, with the rest accounted for by the European (31%) and Asian (21%) markets respectively. The animal health industry can be divided into production animals (livestock: cattle, poultry and sheep), companion animals (cats and dogs) and equine (horses). Overall, large animals have accounted for the majority (60%) of drug sales.

Traditionally, an animal health establishment has preferred to keep most of the drug production in-house. A total of less than 10% of total animal health manufacturing has been outsourced up to recent years. This trend, however, is now increasing, with outsourcing estimated to double in the next five years. Of the top ten animal health companies, Zoetis, Merck and Sanofi have managed to keep the majority of their production in-house. However, Boehringer Ingelheim Vetmedica (BIVI), and Eli Lilly (Elanco) have had both innovator as well as branded generics drugs outsourced. The majority of the future estimated outsourcing is attributed to the growth in vaccines, generic pharmaceuticals and protein therapeutic products. In recent years, patent expirations and high competition in human health have led manufacturers such as Pfizer (Zoetis) to convert their human health facilities to animal health, and provide an alternative to the outsourcing of these products.

As far as the dosage forms are concerned, the majority of animal health outsourcing has been in vials, tablets, caplets, oral solutions, topical and injectable and chewable tablet forms, including both innovator and dosage forms. Firms actively handling outsourcing in the animal health sector include Bayer, Vetpharm (now Ceva), Belcher, Cipla, Okasa, AAI, Norbrook, Nika Biochemicals and Vericore, among others. Usually pharmaceutical companies prefer regional outsourcing for quality and regulatory reasons.

Drugs in the therapeutic category like vaccines, antibiotics, and parasiticides involve higher-technology processes and expensive instrumentation (bioreactors, lyophilisers, BFS (blow, fill and seal), and quality control assays. These categories are likely to be outsourced to contract manufacturers. Current good manufacturing practices (cGMP) vary from region to region, e.g., the EU-GMP and US-GMP have many variations in their requirements for standard manufacturing practices including facilities and procedures. Continued new investment in facilities and equipment across the globe is modernizing the animal health manufacturing sector. There is, however, a need for an international harmonization of the manufacturing practices for this industry.

Animal health giants try to maintain their own sites for clinical trials. However, in recent years Merck has sold a few sites, for example its former clinical research site in Indiana was spun off as Midwest Compliance Laboratories. Boehringer Ingelheim Vetmedica, Inc.

purchased clinical and manufacturing sites of Pfizer (formerly Wyeth and Fort Dodge Animal Health) during the historical merger and acquisition in 2010.

The animal health industry has seen quite a bit in the way of mergers, acquisitions, spin-outs and new establishments in recent years. BIVI acquired divested products and manufacturing sites from Pfizer during the Pfizer and Wyeth merger in 2010. Wyeth had purchased Fort Dodge Animal Health not long before its merger with Pfizer. Schering Plough bought Intervet and was acquired by Merck. CEVA purchased Vetpharma and expanded its sites in Kansas. New entrants, such as Aratana in pharmaceuticals and Nika Biochemicals Inc. in veterinary biologics, have opened doors and established themselves in the animal health corridors in recent years. BIVI has a strong product portfolio for the pork industry, while both BIVI and Elanco are expanding and establishing into large animal (bovine) markets. Recent globalisation efforts like CEVA’s joint venture in China with Huadu - the Beijing Ceva Huadu Biological Company - expands its poultry manufacturing and marketing of poultry vaccines in emerging markets. CEVA has thus positioned itself strongly in poultry. Zoetis (Pfizer), Merck, Novartis and Sanofi (Merial) have been positioning and repositioning themselves in all species. The recent spin-off of Zoetis from Pfizer as an independent animal health company, and then its going for a successful IPO, has stirred quite a bit of interest.

This is very exciting time for the global animal health industry. Zoonotic diseases have made human and animal healthcare even more connected today than ever in the past. In order to keep animals healthy, increase yields and encourage economic sustainability, we need to keep the cost of livestock farming low, hence the rationale for an entire industry, and for this magazine dedicated to animal health.

With one mantra – one healthYours,

Hemant K. JoshiCEO, Nika Biochemicals Inc.Kansas, USA

Dr. Hemant K. Joshi is experienced in the animal health industry, early and late stage pharmaceutical and bioprocess development, technology transfer, assessment, acquisitions and mergers and cGMP manufacturing of biologics. He has worked in various capacities in the private sector at Boehringer-Ingelheim Vetmedica Inc. and Sachem Inc., and in academia at the Universities of Arizona and Nebraska. Hemant received his undergraduate degree from I.I.T.

Kanpur, India and graduated from the University of Arizona, USA. Hemant is well published in peer-reviewed journals and an invited speaker at industry events. Most recently, he is CEO and Co-founder of Nika Biochemicals, a veterinary biologics company located in Kansas, USA, developing vaccines in the unmet area of infectious bovine keratoconjunctivitis and porcine epidemic diarrhea.Email: [email protected]

Corporate Profile

Prevtec microbia: Innovation and Expertise for Sustained Animal Health

Prevtec microbia is a Canadian biotechnology company specialising in developing and bringing to market products designed to help improve the health of food-producing animals in order to increase production, performance and food safety.

At Prevtec microbia, we believe in taking a proactive approach to animal health, focusing on disease prevention.

Our activities are founded on the universally-held values of health, safety and responsibility. The company’s mission is to be a world leader in the development and commercialisation of vaccines and other biologicals. From the laboratory to the global market, our in-depth understanding of animal health challenges and solutions has led to a portfolio of performance-proven products for commercialisation around the world.

As the world’s food ecology evolves as a result of limited resources and other realities that threaten animal health, it is now more important than ever to identify ways to optimise food production processes and output. Less waste, more food and efficiency-improving technologies: Prevtec microbia is working on ways to achieve all this – and more.

Innovation StrategyPrevtec microbia’s core strength lies in our strategic assets, namely, our track record, our technologies and our people.

At Prevtec microbia, we believe that research & development spells the future of the animal health industry. With R&D facilities and corporate headquarters located in the Greater Montreal area of Quebec – known as a Canadian pharmaceutical hub – the Prevtec microbia team is comprised of specialised veterinarians and industry experts.

As a testament to the company’s success, since 2008 Prevtec microbia has sold more than 8 million doses of its Coliprotec®F4 – an E.coli vaccine for swine – in Canada. This vaccine is also registered in Brazil, Russia and Kazakhstan with plans for

launch in other major markets. To that effect, Prevtec microbia recently submitted a dossier to European regulatory authorities for the approval of Coliprotec F4.

Our pipeline of future products is as exciting as our currently marketed entities and includes innovative solutions to animal health concerns. In this regard, Prevtec microbia has joined the ranks of thriving animal health companies with activities in various parts of the world. And we are privileged to count two of the top animal health companies in the world as our distributors.

Connectivity: Contributing to Future SuccessPrevtec microbia’s success in an increasingly competitive global market is due in large part to our belief in the power of synergistic partnerships. Our innovation strategy is based on connectivity. We feel strongly that pursuing dialogue with like-minded corporations will propel us to even greater heights.

We enjoy access to a worldwide network of scientists, university academics, manufacturers and distributors. These partners are well positioned to align with Prevtec microbia in generating new avenues of growth and distribution channels through the development and acquisition of new technologies and biologicals.

Our future plans include strengthening our presence in existing markets while making our products available in as yet untapped geographical areas. Leveraging our veterinary, scientific and management expertise, together with our commercial activities, will translate into new opportunities to make a practical difference in animal health.

We look forward to embracing new opportunities in a spirit of interaction and cooperation. In the coming years we expect to announce game-changing ways of approaching challenges in animal health, with technologies and products that will translate into tangible problem-solving solutions.

For more information about Prevtec microbia and how we contribute better ways to feed the planet, visit www.prevtecmicrobia.com.


Watch Pages

Animal Instinct

There continues to be significant investor interest in the area of animal health. In the last 12 months, the private equity press has reported a number of UK mid-market deals across a range of sub-sectors including veterinary services, online pharmacies, pet food, wearable technology for the animal health sector and diagnostics. There are a number of factors which make this market attractive for investors: Large and Highly Stable MarketPet ownership in the UK is both large and stable, with just under 50% of the UK’s 26 million homes owning a companion animal. It is estimated that Britons spend an astonishing £4 billion per annum on feeding, caring for and entertaining their pets. Recent research from the Pet Food Manufacturers Association estimated that there are around 16 million cats and dogs in the UK, and a further 3 million smaller animals such as birds, chickens, snakes and hamsters. Whilst propensity for pet ownership varies by region (the South West of the UK and Wales having the highest concentration), statistics point to a highly stable pet population over the last decade. The industry has proven remarkably resilient during the recession, with

UK spend on pet food outstripping GDP by 1.5%. Recent research found that families have cut back on expenditure on eating out, holidays and utilities, rather than reducing their spend on family pets.

“Humanisation” of the Family PetThe pet care industry increasingly refers to the “humanisation” of family pets, whereby the family dog and cat are now seen as companions / part of the family unit rather than just pets, and require “parenting” rather than “ownership”. This has manifested itself in a huge increase in the amount of pet accessories and toys purchased, with an estimated £145 million alone spent each year on Christmas presents for pets, and 15% of pet owners sending their pet a Christmas card. Reasons for this are complex but academic studies by the British Psychological Society point to the emergence of smaller families, single-person households, and a rise in the elderly population. In short, companion animals are filling the emotional and physical void left by people. There is now far more understanding and interest in areas such as animal psychology (several brands of dog anti-depressants are now on the market), preventative pet


Watch Pages

health plans and the nutritional content of food given to pets. In relation to food, whilst sales of pet food globally are growing by circa 4% per annum, growth of natural and organic pet food is expected to be three times this - over 12% per annum - between now and 2015, with many of the current products in the market having greater nutritional constituents than that of human food. The Protein Problem

Whilst much of the investment to date has been on companion animal care, the role of food producing animals has also come into sharp focus in recent years. With the global population expected to exceed nine billion by 2050 (seven billion currently) and an increasing desire from emerging markets for more Western based diets, analysts predict a 70% increase in protein output is required to meet demand. Such an increase in output is only achievable through agricultural yield efficiencies, improved veterinary provision and medicine innovation. Add to this significant public health concerns driving government, consumer and food producer focus on food security and traceability and the scene is set for a number of innovative businesses models to emerge which fundamentally challenge the status quo. In the UK context, the Governments re-organisation of the TB testing regime coupled with the end to milk quotas in 2016 looks set to reshape the structure of the domestic production animal landscape.

Advances in Veterinary CareOver recent years there has been significant innovation in the range of treatments and medicines available to the veterinary profession to treat animals. Some of this has been driven by the continued growth in pet insurance, which is now purchased by approximately 25-30% of pet owners according to Pet Plan, the UK market leader in pet insurance. Whilst older conditions such as rickets and distemper have now been largely eradicated, there has been significant growth in drugs and services which treat conditions such diabetes, arthritis and more acute conditions such as renal failure. Specialist referral centres are now able to offer a range of treatments across orthopaedic care, ophthalmology, soft tissue conditions and spinal injury, all of which are increasing the life expectancy of companion animals and indeed the lifetime cost to a pet owner. Whilst animal health represents just 2.5% of the global pharmaceutical market, consolidation in this market continues as the large players innovate in new drug development to offset the fall in the number of high-volume patented products which can be produced on a generic basis. This year has seen the industry consolidate further with the acquisition of Novartis by Eli Lilly for $5.4 billion, following quickly on the back of the Zoetis IPO in 2013. Such activity will also inevitably drive deal activity and deal flow for larger buy-out players as product portfolios are divested and the animal health pharmaceutical companies focus on a smaller and more concentrated portfolio of brands.

In summary, the animal health market continues to be

a highly rated and highly sought after area for investors. Whilst the defensive characteristics of the market are well documented and understood, changing demographics, global demand for protein, a consolidating supply chain and an increasingly scientific approach to animal health are leading to new opportunities and niche areas of growth for investors.

David Lonsdale is a partner at August Equity. He recently led the investment in Westpoint, the UK’s largest farm and production animal veterinary group. David also led the investment into Independent Vetcare, a consolidator of companion animal clinics in the UK which was recently sold to Summit Partners.Email: [email protected]


Regulatory & Marketplace

Vet Meds Legislation: How Far Will The Commission Go?

The review of the veterinary medicines legislation started in 2010. More than four years later all of us with a stake in how veterinary medicines are regulated in Europe are still waiting for the Commission’s proposals to be published. Some general images have emerged from the mists of the consultations, discussions and exchanges between the stakeholders and the Commission and gained some substance from the IFAH conference, but at the time of writing – and I suspect of publication – we are still left wondering.

It is widely believed that the legislation will be in the form of a Regulation rather than a Directive. This will enforce harmonisation and remove the scope for member states to nuance implementation to suit their interests. Industry in general supports a Regulation, but unless it is carefully written and properly scrutinised we may find ourselves strait-jacketed in unexpected areas that demand some flexibility and with no prospect for further change before 2030.

The current regulatory framework is defective in some major areas and we are labouring under a heavy administrative burden that is double that for human medicines. We have an internal market that is not free and far from harmonised, particularly with respect to medicines availability. On top of this, there is pressure on our use of antimicrobials which is, rightly or wrongly, perceived as a threat to public health. All of these aspects feature in the Commission’s objectives for the new legislation.

In my mind the central issue is improving veterinary medicines availability. Our industry exists to provide medicines to improve animal (and human) health and welfare and all of the other aspects affect how well this is achieved in Europe. There are around 160 products with European Marketing Authorisations (MAs) through the centralised procedure, but while veterinarians in France or the UK have access to almost all of these, smaller states such as Iceland have relatively few. There are 10 times this number of mutual recognition / decentralised MAs listed in the VMRI index, but of these around 10% list one to five concerned member states and only ~20% have 24 or over. The availability across the Community is far from uniform – one can only agree with the statement that farmers do not understand why a colleague on one side of the border can use a certain medicine and they can’t.

The Commission has stated that availability may be improved through reducing the administrative burden and stimulating innovation and competitiveness; both sides of industry consider the administrative burden as a factor in availability. There are currently four routes to obtain an MA. This is over-complex, highly administrative, costly and inefficient.

As the Commission has said, in the context of this regulatory

review, there is nothing as complicated as simplification. IFAH Europe has proposed the famous 1-1-1 concept, an ambitious plan where all current procedures are replaced by a single ‘one dossier, one assessment, one EU-wide authorisation’. While attractive in principle and well adapted to the larger companies, it is less well suited to the smaller and particularly local companies with limited financial and human resources and which are active in one or few member states. These are well adapted to meet local needs and niche markets. In response, EGGVP proposed an alternative, simpler 1-1-1 process with a single assessment leading to multiple separate MAs. The general expectation is that IFAH Europe’s 1-1-1 proposal will not see the light, but some of its principles may be adopted into a much wider extension of the centralised procedure, which would allow all-EU authorisation for more products.

But what of the smaller, single-market companies? It appears that the decentralised and national procedures may also be retained permanently, rather than for a transitional period. If so, have we really simplified the regulatory environment? Will the proposals allow a new, simplified DCP to lead to authorisations that will be effectively EU-wide, without the inevitable disagreements clogging the system with referrals as they do now? Decision by majority voting would go a long way towards this goal. Will retaining these routes in a simplified form tempt companies to apply for more MAs, in more countries – or will the right to choose the concerned member states be restricted?

Whatever the new routes for new products, we have a legacy of around 30,000 nationally-authorised existing products with SPCs that differ significantly between countries. Tentative attempts to harmonise a handful have been resource-consuming and less successful than hoped. Bringing these into some form of harmonised, EU-wide authorisation will significantly improve availability. However, unless the majority of well-established, safe and effective products can undergo some administrative (industry would say, voluntary) process, the administrative burden would be massive. Of course there are products, including antimicrobials, where a scientific assessment is necessary but assessment should be limited to where there is an identifiable serious risk to human or animal health.. Harmonisation must not be to the lowest common denominator – that would mean losing indications and species and our veterinarian clients are justifiably very nervous of such unintended consequences.

Currently, maintaining the existing authorisations is a significant drain on the MA holder’s resources. Product defence absorbs 35% of the EU R&D budgets, double that in the USA. The finance and resource costs of making variations are significant, and, according to industry, disproportionate to the work involved. Reducing – even removing – the



administrative burden of changes which do not affect quality, safety or efficacy and bringing back the ‘umbrella’ Type II concept (combining unrelated minor changes within a single process) are two ‘easy wins’ which could release resources without detriment.

One area in the variations envelope expected to be addressed is the disproportionate cost and effort of changing the pharmacovigilance system. Currently the described PV system DDPS is linked to each MA, so every minor change must be changed by variation for each product, in each country. The concept of a pharmacovigilance Master File has been widely discussed and must be adopted if the proposals are to have credibility.

Pharmacovigilance is the most rapidly growing administrative sector. The value of properly monitoring the safety and efficacy of veterinary medicines is recognised by all stakeholders, and the confidence that robust surveillance brings may even lead to completely removing the need to renew MAs. This may be facilitated by the completion of a single European product database covering all authorisation routes and maintaining full pharmacovigilance records, with appropriate public access. However, the current reporting system is overly complex and is driven by process, not risk. At least, the routine PSUR reporting in prescribed complex formats could be simplified and focussed on new and higher-risk products, and reduced or removed for established products with known, good safety records.

Several years of effort by industry and CMDv has reduced the requirements for labelling – and so for translation – as far as possible under current rules, and a simplified QRD template is now actively promoted. I’m confident that the Commission’s proposals will further facilitate availability through multi-country labels.

IFAH Europe has lobbied hard to increase data protection, to delay generic entry and so stimulate innovation. Cumulative data protection, where additional claims increase protection up to 20 years, has been floated. Unsurprisingly, the generic industry argues that data protection should also promote competition, through increased choice, reduced costs and better availability that they bring to the market. They argue that extensions may benefit from specific protection which would allow a generic authorisation of the original MA, but without the new species or indication. The Commission seems to have accepted the need to adapt data protection to encourage innovation, but will have to find a balance with competition to optimise availability. In any case, we all expect special provisions for the MUMS sector, especially bees and probably fish, where the lack of authorised medicines is so severe.

The traditional pharmaceutical market model has been seen to fail in human medicine in two very public areas; in the Ebola crisis unfolding in West Africa, and in the lack of new antibiotics to offset the relentless march of resistance in hospitals and the community. Governments are now openly discussing how big pharma can be incentivised to develop new antimicrobial molecules that will, by definition, only be used as a last resort. One thing is certain; we will not see these molecules allowed in a species under our care. How can the animal health industry be incentivised to develop new antibiotics when the major source (big pharma) will shut the door, and any relationship with a ‘critically important’ molecule for human treatment will significantly reduce the probability of regulatory success? I hope to see some innovation from the Commission in this vital area, but I’m not optimistic.

The pressure to reduce antimicrobial use in animal health is intensifying. While it is important we continue to defend



our corner, it is vital that the agricultural sector is seen to be taking action to responsibly use antimicrobials ‘as little as possible but as much as necessary’, and we can expect to be encouraged (more probably, mandated) in this by the Commission’s proposals. The delay in publishing the legislation is thought to be related, at least in part, to the measures on antimicrobial resistance. The EMA has just published its draft advice to the Commission on the impact on public health of the use of antibiotics in animals, with finalisation anticipated by the end of this year. Perhaps we won’t see the proposal until afterwards. At least, I expect the proposal to include enabling measures to restrict and even stop use of specific antimicrobial classes in animals following scientific advice and/or risk assessments, to tightly control or restrict off-label use and to collect detailed data on antimicrobial use and prescribing. I’m also anxious to see what is proposed around ‘preventive’ (prophylactic) use – will this be banned? If so, how will ‘prophylactic’ be defined? Will metaphylaxis become a legal concept?

There is pressure on in-feed administration of antibiotics, especially in intensive pigs and poultry, where it is viewed

by some as supporting poor husbandry. The Commission is believed to have recognised that it is a legitimate and important route of administration. In member states where in-feed medication is not allowed by local legislation, alternative practices such as top dressing lead to inconsistent dosing which may increase resistance pressures. It is hoped that the related proposals on feed legislation will make in-feed administered medicines available across the community under a clearer and tighter framework, and even allow developments of innovative in-feed medication in new areas, such as companion animals.

One area which has raised concerns with regard to feed medication is carry-over. A zero-tolerance policy on residues in following batches has been suggested. This is impractical, as analytical methods are capable of detecting nano-quantities. Such a policy will effectively stop feed medication overnight as feed manufacturers withdraw from the market. Carry-over might be reduced if pre-manufacture were allowed, with supply only on a responsible and appropriate prescription from a veterinarian for animals under his care. I would expect common sense to prevail in the Commission proposal, but I’m nervous about the European Parliament’s amendments.

Veterinarians are rightly nervous about their ability to continue to prescribe off-label. The ‘Cascade’ currently permits a prescribing hierarchy where there is no authorised medicine for the clinical condition. In most circumstances this is a reasonable and controlled approach that protects animal welfare, human health and the veterinarian’s clinical freedom, but there are fears that this may be restricted, particularly with respect to antimicrobials in food animals. In some species (goats and turkeys come to mind) the choice of authorised medicines is so limited that their welfare is dependent on the Cascade. Even if the new Regulation is successful in improving availability, the Cascade or something very like it will be needed to fill in the gaps.

We have been promised these proposals for revised veterinary medicines and feed legislation for so long now, but they are always just beyond the horizon, out of reach. The Commission has said it should be within 2014, but has not given guarantees. My final hope is that they are published soon. There are limits to our patience!

The views expressed in this article are my own and not necessarily those of any organisation with which I am associated.

Paul Cooper is an independent consultant in Veterinary Regulatory Affairs. Paul is currently Vice President of the Association of Veterinary Consultants and Chair of the British Veterinary Association’s Medicines Group. Paul has previously held senior regulatory roles in Merial and was an active member of IFAH Europe regulatory and safety committees.

Email: [email protected]

Corporate Profile

Kingfisher International Inc. (KFI) is a Canadian veterinary contract research organisation (CRO) whose sole purpose is to improve the lives of companion animals. We do this by exclusively specialising in product development and regulatory studies (GLP/GCP) for dogs and cats. We pride ourselves on our vigour, our teamwork, our study quality, and our ability to meet or exceed our sponsor’s timelines. We are good listeners and we strive to understand our sponsors’ expectations. Maintaining the highest standards of animal welfare is critical to what we do.

Our company was incorporated in 2004 and since then, we have conducted both GLP and non-GLP studies on behalf of eight of the top ten companion animal health companies. Our exclusive dedication to the animal health industry means that we are very familiar with regulatory agency requirements and guidelines (CVM/EPA/VDD/EMEA). Working in this industry allows us to engage with like-minded professionals who see dogs and cats as the target client, and are just as committed as we are to ensuring animal welfare is at the forefront of our research. We are acutely aware that the research we do and our findings have a direct impact on final labelling.

Our staff of 25 people include: veterinarians, PhDs, registered veterinary technicians, quality assurance professionals, study co-ordinators, laboratory technicians, and animal care attendants.

We have a full-time archivist, and in-house information technology support. Our staff are active in many professional organisations and we actively encourage and support the pursuit of continuing education opportunities.

We have two facilities, totalling 15,000 sq. ft., both of which have been purpose-built to our specifications since 2010. In addition to vivarium space (we have room for approximately 100 dogs and 120 cats) we have a fully-validated clinical pathology laboratory, gross post-mortem suite, surgery suite, and treadmill lab. Our facilities are accredited in Good Animal Practice® by the Canadian Council on Animal Care.

Kingfisher International Inc. has conducted GLP target animal safety studies for FDA, EPA, and EMEA submission. We have a solid track record of regulatory acceptance, typically on first pass review. We take pride in ensuring concise, comprehensive, quality submissions that smoothly negotiate the regulatory process.

While not all of our studies are GLP, we nonetheless maintain a GLP environment every day. We do, however, routinely conduct non-GLP pilot studies in areas such as pharmacokinetics, bioequivalence, tolerance, and surgical and non-surgical models. At KFI we believe that pilot studies are crucial to establishing appropriate endpoints and determining estimates of statistical variability.

Our bioequivalence studies are conducted in compliance with GLP regulations and CVM bioequivalence guidelines to support abbreviated new animal drug applications. While we do not have in-house bioanalytical capability, we manage all aspects of bioequivalence studies including, but not limited to: in-vivo phase; bioanalytical method development; validation and sample analysis; pharmacokinetics and statistical analysis; final study report; and archiving.

At Kingfisher International Inc., we take seriously the “single point of control” maxim of GLP. We strive to take complete ownership over our studies and provide the sponsor a “turnkey” approach to study management. We do not like surprises and ensure that the sponsor’s experience is as stress-free as possible. We are large enough that we have sufficient resource for complex study designs, yet small enough to ensure that study directors and test facility management are intimately aware of study activities. We understand how sponsors can sometimes feel “out of the loop” when their studies are outsourced and we strive to ensure they are kept fully abreast of study activities.

We encourage sponsor audits and value the constructive feedback we receive. Since we are located close to Toronto, Canada we are readily accessible to North American and overseas travel. We are close to several major hotels and many fine restaurants in one of the world’s most multicultural cities.

Please contact us to discuss your animal health product development needs!

Contact Info:Jonathan Hare, DVM, PhDVP, ResearchKingfisher International Inc.165 Mostar Street, Unit 8, Stouffville, Ontario, Canada L4A 0Y2Phone: (905) 642-3712Email: [email protected]



One Health – A Reality or Yet Another Utopian Overreach?

Relationships among species and their environments have existed from the beginning of time. It is those relationships that make our earth habitable. Going back several thousand years, humans and animals have lived together, cooperated and depended on each other for almost every basic need imaginable for the emergence of a civilised society.

However, the rapid evolution of human society over the past few hundred years has created gaps between humans, animals and the environment. In this relatively short period of time, humans have changed so much that in many cases animals and the environment that we depend on have been left behind.

In essence, we as humans have created a bubble. This bubble, however, unlike the economic bubbles that we have grown accustomed to over the past few years, will eventually be detrimental to our lives and our planet as a whole.

The One Health concept recognises that the health of humans is inextricably linked to the health of animals and the environment. The One Health umbrella covers wide-ranging disciplines including environmental health, ecology, veterinary medicine, public health, human medicine, molecular biology, microbiology and health economics.

The origins of the One Health movement can be found as early as the early 19th century. However, it wasn’t until 1964 that Calvin Schwabe, DVM, ScD, MPH proposed that human and veterinary health professionals collaborate to combat zoonotic diseases. He then coined the term “One Medicine” in his textbook “Veterinary Medicine and Human Health”, published by The Williams & Wilkins Company, Baltimore.

The One Medicine concept eventually became One Health in 2007 through an official collaboration between the American Veterinary Medical Association and the American Medical Association. The One Health Joint Steering Committee (OHJSC) held its first meeting on December 3, 2008, in Washington, D.C. to discuss, among other issues, the development of a national One Health Commission. The One Health Commission (OHC), was chartered as a 501(c)3 non-profit organisation on June 29, 2009.

In late 2008, representatives from more than 120 countries and 26 international and regional organisations endorsed the first One Health-based strategy for fighting avian influenza and other infectious diseases at the International Ministerial Conference on Avian and Pandemic Influenza in Egypt. This strategy directed efforts towards controlling infectious diseases in areas where animals, humans and ecosystems meet.

We have known for a long time that if we keep our animals healthy and take care of our environment, we as humans will be healthier. Scientific breakthroughs and technological advances have merely enforced this knowledge and helped demonstrate just how closely connected human health is to animal health and the overall health of the environment.

There are many factors that are evident to us every day that highlight the importance of One Health. One major factor is the world population. The annual world population growth

rate, although declining, is currently just over 1%. The world population is expected to reach 8 billion from the current 7 billion in the next ten years, and will be over 10 billion in 2100. As the population continues to increase and expand, contact between human and wild animal habitats will increase, increasing the risk of exposure to new viruses, bacteria and other disease-causing pathogens. In fact, a large majority of the most devastating emerging and re-emerging diseases are either spread directly between humans and animals, or are carried across animal populations from infected animals by intermediate species like insects and bats.

And it’s not just wild animals we need to be concerned about. As human society has become more advanced, changes have occurred in how humans view and interact with animals. In many parts of the world, animals are viewed as companions and family members. In many of those societies we are not animal owners but pet parents, and our pets share our living rooms, beds and many other aspects of our lives.

Another factor is our food supply, which has been shown to be vulnerable, and thus human food and animal feed safety has become a hot item high on the lists of governments worldwide. Recent legislative developments in many parts of the globe, and most noticeably in the United States through the Food Safety Modernization Act, underscore how important and visible a factor this has become.

Finally, one cannot ignore water safety. Our waters are regularly contaminated by industrial by-products and chemicals manufactured for our daily use. In a recent example, an accidental leak released an estimated 7500 gallons of 4-methylcyclohexane methanol into the Elk River, in the State of West Virginia. The site of release was about two miles upstream from the intake at West Virginia American Water’s treatment plant that provides drinking water for some 300,000 residents of nine counties in the Charleston area. The residents were ordered to stop using tapwater for anything besides flushing toilets for several days.

I can, and I’m sure others can, given some time, go on and on to give example after example of why this concept is important to us. But considering the “obviousness” of all of this to many, and the fundamental importance of this “One Health movement”, if one can call it that, it’s ironic that it has not been matched by a concerted effort to engender grassroots and popular support for it. Apart from a few professionals, professional organisations and some governmental agencies in a few countries the effort has thus far been rather elitist, targeting the highly educated, and essentially preaching to the converted. Of course, involving organisations such as the American Veterinary Medical Association and the American Medical Association, and government agencies such as the Center for Disease Control, the Food and Drug Administration and a handful of universities in the United States, is very important and efforts there should continue. Realistically, however, without involving industry and educating the public in a meaningful way, the concept may remain just that … a concept or a fad. To be clear, humanity’s impact on other species and the environment is exponential and therefore any countermeasure effort must also be aggressive and exponential.



Let’s take food, for example, because it touches every soul, human or otherwise, on this planet on a daily basis. In the past several years, food safety for both humans and animals has been reported on frequently and has captured the public’s attention. We don’t have to look too far back to find some reports about E. coli- or Salmonella-tainted human foods or food ingredients. Similarly, pet food has been in the public eye, starting with the melamine disaster back in 2006/2007, which was followed a year later by another melamine-related disaster, this time with Chinese infants given contaminated baby formula. More recently, jerky treats for pets in the United States have been linked to the deaths and illness of thousands of animals in recent months, with the cause still unknown.

While we always talk about healthy eating, avoiding processed food, eating fresh and sourcing ingredients from reputable suppliers in the human world, when we go to look at what we feed our animals, the vast majority are still fed “animal-grade” foods made with ingredients that humans themselves will not eat.

Common animal feeding practices, including the heavy use of antibiotics as growth promoters in cattle and other animals destined for the human food chain, are also bound to backfire in the not too distant future, and while it’s easy to blame greed and the industry, one must not forget the essential driver behind those practices, the one and only “market”.

The reality is that because markets are made of, and indeed, by “us” the people, who look for value for money and, for the most part, pay without asking too many questions about how the food eventually arrives at our tables, the driving force for such practices will exist for a long time to come. It is, therefore, essential to educate the people to help nurture a grassroots change that would be more effective and longer-lasting than an alternative top-down approach.

Of course, it’s easy for me to sit in my ivory tower and preach about this, because words are cheap and the facts on the ground are complex, but the examples above are simply given to illustrate the reality that we live. In the food example above,

without meaningful partnerships with pet food and animal feed manufacturers, backed by strong regulatory requirements that have teeth and the political will to enforce them, there will be no incentive for any change in any meaningful way.

I am by no means singling out the pet food and animal feed industries, nor do I have any intention of painting them as villains. The fact is that every industry that touches humans, animals or the environment in any way has some responsibility towards the overall health and wellbeing of all of us. It is well documented in history that single-minded approaches to things even as simple as farming could turn into unmitigated disasters that affect humans, animals and the environment that they live in. One only needs to mention the words “dust bowl” to remind many amongst us of the disproportionate impact that human practices can have on our lives and livelihoods.

More importantly, without educating the public, who in the end have the power to put pressure for meaningful change on industry and governments alike, the effort may simply fizzle out and be relegated to the archives of the “also-ran” social movements that never made it.

Call it what you may - a concept, idea, mission or movement, I personally believe in “One Health” innately and I practice it in my business because it is common sense. I also believe that eventually all the moving parts will catch up with each other to make meaningful change. But time is of the essence, and as someone, somewhere said well over 2000 years ago, we should most definitely “seize the day”.

Dr. Sam Al-Murrani Chief Executive Officer Babylon BioConsulting LLC, a human and animal health-based business consultancy firm. He is also Managing Director for Bimini LLC, a privately owned pet health company manufacturing pet dose-form health supplements and a newly introduced line of pet health treatsEmail: [email protected]



The Economics Of Animal Health

The world economic crisis has highlighted a need to reassess public resource allocation for animal health services, and to question the balance of cost-sharing with the private sector. Added to this general economic context, animal diseases are emerging with increasing frequency (BSE, influenza viruses, blue tongue, Schmallenberg virus) and several known diseases have re-emerged.. Therefore animal health professionals need to have an understanding of the application of economics to animal health, and the current economic crisis makes the need for these skills all the more urgent. In fact, the need for economic skills in animal health has never been greater. Economics can add value to disease impact assessments, assisting understanding of people’s incentives to participate in animal health measures, and refining resource allocation of public and private animal health budgets. In general, the best use of economics will improve decision-making on animal health at a number of levels.

Economics applied to animal health is a relatively young field in relation to other fields of study (Howe and Christiansen, 2004; Rushton et al., 2007). It is concerned with “making rational choices and decisions in the allocation of scarce resources for the achievement of competing goals”, thereby providing the greatest benefit to society (Morris, 1999; Rushton, 2009). The need for economic skills in animal health appears to have never been greater. In the international livestock industry indeed, there is an increasing demand for disease impact assessments and improvements in the allocation of resources for disease surveillance and control for which economics can add value. Discussions are intensified on who should bear the costs of animal health (and disease), and cost-sharing frameworks, which require economic expertise, are being developed to redistribute the financial burden of disease (Rich and Perry, 2011; Schwabenbauer, 2012). Moreover, emergence and re-emergence of animal diseases is strongly related to people’s behaviour, and an understanding of incentives through the use of economics allows more refined approaches to disease management. After all, farming is a human activity that interacts with numerous biological systems and therefore provides an ideal platform for social science to aid in addressing problems in natural science.

Are ‘Economics of Animal Health’ and ‘Economics for the Veterinary Practice’ Different?There are interesting discussions about the divergent nature of animal health economics and the economics of veterinary practice. We offer an alternative view to the bilateral relationship that is often proposed. First, animal health economics and the economics of veterinary practice fall under the same umbrella and second, that economics is a small, but essential, part of understanding the veterinary practice as a business. Are the questions not the same when looking at an outbreak of avian influenza in a poultry flock or diagnosing a case of canine parvovirus? What are the economic consequences of

a disease, what is the value of diagnosis, of treatment or of prevention? Aside from the different emotional attachment to a companion animal, this is nothing more than a matter of scale: 3000 turkeys or one greyhound. I think decisions are different, but the decision “problem” /”question”, etc are the same.

In terms of veterinary practice economics, running a veterinary practice goes far beyond mere economics and finance. There is concern that there is an over-simplification of the softer needs of the veterinary business as it is not an inanimate object; it is a living, breathing, changing entity that is highly responsive to attitudes and decisions of its stakeholders. To add complexity to the argument, these stakeholders (be they owners, staff, clients, suppliers or government regulators) have increasing demands which this entity must a) be cognisant of and b) be capable of providing a response to. For example, staff may want new facilities such as a new lunch room or gymnasium or perhaps a different roster system, clients may be demanding new communications strategies (e.g. on-line booking, tweets, text reminders of consultations), owners may see the need for new high-cost equipment, government regulators may demand higher animal welfare or food safety standards than ever before or higher business tax rates. Thus, veterinary practitioners are in the challenging position of having a dual role, namely being a civil servant operating under government regulations to promote animal health and welfare, while at the same time providing a service to clients with varied needs and demands. There are human resources (including leadership) to consider, the psychology of the vet-patient-client competing values triad, the marketing of the veterinary practice, the financial management of the veterinary practice and, above all, the business strategy of the practice which paves the way for the business’ future direction (need we use the cliché of the cargo ship setting sail into uncharted waters?). This is all about the allocation of scarce resources, but it is infinitely more complicated than book-keeping and investment analysis.

To ensure that animal health professionals are adequately equipped with knowledge on addressing economic and business issues within their industry, the NEAT project (“Networking to enhance the use of Economics in Animal Health Education, Research and Policy Making in Europe and beyond”) was developed (http://www.neat-network.eu/). Funded by the the EU’s Lifelong Learning Programme, it aims at developing and strengthening educational materials and delivery methods to animal health professionals at undergraduate university level and beyond. It is a community of animal health economists or professionals with a particular interest in the field; all 60 partners (mainly from European countries) of the project have strong links through training, research and consultancies to the animal health services and livestock sectors of member states. The project runs 2012-2015 and will also disseminate key knowledge of animal health economics and business to a wide range of animal health professionals.



The Major Questions for Animal Health Economics and ProductionBased on their experiences with trans-boundary, food-borne and endemic diseases, Rushton et al. (2007) identified several avenues of enquiry that are necessary for the future development of a robust animal health industry. In brief, these questions are:

• How can one guarantee not just reasonably priced livestock products (food security), but also food that has low or almost no risk in terms of spreading disease (food safety) and from farming and processing systems that guarantee that animals are treated humanely (animal welfare)?

• What is the optimal level of resource allocation to the detection and prevention of exotic and emerging diseases?

• Is there a justification to allocate public resources for campaigns to control and eradicate endemic diseases?

• What methodologies can improve the implementation of animal disease control programmes that are assessed to be nationally economically profitable?

• In an animal health system, what roles should the public veterinary services and the private sector play to improve the welfare benefits from animal disease control investments?

• At the international level, where do responsibilities lie for the control of trans-boundary disease? This is particularly relevant for countries that are poor and have the potential to export livestock products, but have difficulties in achieving OIE/WHO regulations to enter into attractive export markets.

In an effort to address some of these questions, knowledge is being created by consortia of researchers in groups like the LCIRAH project (Leverhulme Centre for Integrative Research on Agriculture and Health, see: http://www.lcirah.ac.uk/) which aims to better address complex global issues surrounding the need to feed nine billion people healthily by 2050, by bringing together agri-health researchers from various disciplines (e.g. economics, epidemiology, nutrition science, veterinary science, anthropology, etc.). Further to this, the Network for the Evaluation of One Health (NEOH) Action (http://www.cost.eu/domains_actions/TDP/Actions/TD1404) aims to enable future quantitative evaluations of “One Health” activities. The “One Health” concept addresses complex challenges affecting human health and wellbeing, such as malnutrition, emerging and endemic zoonotic diseases, antimicrobial resistance and climate change through the integration of relevant sciences at systems level. The network plans to develop a science-based evaluation protocol for One Health activities and to coordinate and compare evaluations of existing One Health initiatives at the international level in a networked community of experts.

The Direction of Animal Health Economics EnquiryAn historical overview of animal health economics thinking reveals the major theoretical work by John McInerney, Clem Tisdell and David Leonard. There were also practical applications of economics to animal health by a number of

authors including Richard Bennett and Tim Carpenter; and at the International Livestock Research Institute, Kenya. More recently there has been work by the Pro-Poor Livestock Policy Initiative at the Food and Agriculture Organisation of the United Nations (FAO).

With regard to the future, more work has been requested in the area of value chain analysis to reflect the increasing complexity of livestock value chains and the influence of these complex chains on animal health risks within society. New institutional economics was also highlighted as the basis of a more flexible and all-encompassing approach than other theoretical frameworks to understanding the motivations of people living and working in these chains. The responses from the research funders and major research centres has so far been encouraging, such as the EU-funded COMPETE project (http://www.iamo.de/compete/home.html); more work is being funded by the British Research Councils on livestock value chains and on understanding how people involved in these systems behave.

The challenge is how such research is to be used in decision-making from farm to policy-making. With this in mind, an international seminar was held in London in December 2010 (http://www.rvc.ac.uk/Meetings/AHE/Objectives.cfm) supported by Royal Veterinary College, Defra and FAO to discuss how economics can add value to animal health decision-making. One outcome of the meeting was a decision to better disseminate knowledge on the use of economics in animal health, with the aim of making it more of a talking point amongst animal health professionals (with particular emphasis on decision-makers and economists).

The animal health industry covers a range of important areas that constantly challenge us in decision-making processes. Richard Bennett (Reading University) clearly states the case for public intervention to improve resource allocation in animal disease management. Leading thinkers have conducted research on the various aspects of animal health economics. For example, Tim Carpenter (Massey University) and Karl Rich (Norwegian Institute of International Affairs) provide an explanation of risk; Jesus Anton (Organisation for Economic Co-operation and Development) has overviewed the use of compensation in animal disease control and Bob Burden (Serecon Management Consulting) has suggested practical means of designing and implementing compensation with mixed models of funding. An area of increasing importance is the economics of animal disease surveillance, which focuses on the elimination of contagious pathogens from livestock populations kept in expensive facilities. Barbara Häsler (Royal Veterinary College), Keith Howe (Exeter University and Royal Veterinary College) and Katharina Stärk (Safoso and Royal Veterinary College) have attempted to address this issue by proposing a theoretical framework to approach resource allocation decisions for surveillance. In terms of the evaluation of animal health programmes Jonathan Rushton (Royal Veterinary College) et al. have examined available methods with examples of their application in The Netherlands and France. Ian Mitchell et al. (from Defra) have worked to understand how economics can be used in a policy-making



environment. Karin Schwabenbauer (Federal Ministry of Food, Agriculture and Consumer Protection, Germany) and Michael Seals (Chairman of the Animal Health and Welfare Board for England) have considered the importance of economics in decision-making through the perspective of a chief veterinary officer and farmers involved in government policy-making, respectively.

Despite this extensive research work on animal health economics, there is still further enquiry needed. Research questions still remain on how to measure animal disease impacts and the quality of existing data to prioritise disease management. Is there sufficient analysis of how control methods are selected for epidemic and endemic diseases? To answer these and other key questions requires economists to work alongside animal health specialists, statisticians, sociologists and psychologists and the people involved in the decision-making from farm through to policy levels. Even though the call for interdisciplinary integration is nothing new, it is difficult to implement due to training, thinking and working in uni-disciplinary environments that are often separated physically or administratively. Heady (1952) advocated inter-disciplinary research by observing that “agricultural production economics must necessarily be integrated with that of other physical and social sciences”. Putt et al. (1988) stated that disease control policy needs an “inter-disciplinary approach involving the close and continuous cooperation of the various disciplines concerned”. Perry and Randolph (2004) made a case for a more standardised approach to integrated economic and epidemiological modelling. Interdisciplinary work does not only require an understanding of the basic concepts and terminology of the other discipline(s), but also a willingness to share, exchange and collaborate. This process can be promoted by providing relevant basic training at undergraduate and postgraduate level (as for example done in the NEAT project), awareness-raising in the different professions, networking, the establishment of mentoring schemes, and – particularly at the academic level – the creation of appropriate reward and support structures.

To truly add value with economics it is suggested that the aim is for a better balance between how research is conducted and how it is translated into the policy-making environment.

References

1. Heady, E.O. (1952) Economics of Agricultural Production and

Resource Use. Prentice-Hall, Inc., N.J.

2. Howe, K.S. and Christiansen, K.H. (2004) The state of animal health

economics: A review, Proceedings of the Society for Veterinary

Epidemiology and Preventive Medicine, Martigny, 24-26 March, pp.

68-80.

3. Morris, R.S. (1999) The application of economics in animal health

programs: A practical guide, World Organisation for Animal Health

Scientific and Technical Review, 18(2), pp. 305-314.

4. Perry, B.D. and Randolph, T.F. (2004) Integrated epidemiology and

economics modelling for the management of animal health. Journal

of Developmental Biology (Basel), 119, pp. 389-402.

5. Putt, S.N.H., Shaw, A.P.M., Woods, A.J., Tyler, L. and James, A.D.

(1988) Veterinary Epidemiology and Economics in Africa - A manual

for use in the design and appraisal of livestock health policy,

Veterinary Epidemiology and Economics Research Unit, University

of Reading, accessed on 8 July, 2014, available: http://www.fao.org/

wairdocs/ilri/x5436e/x5436e00.htm#Contents

6. Rich, K.M. and Perry B.D. (2011) The Economic and Poverty Impacts

of Animal Diseases in Developing Countries: New Roles, New

Demands for Economics and Epidemiology, Preventative Veterinary

Medicine, 101(3-4), pp. 133–47.

7. Rushton, J. (2009) The Economics of Animal Health and Production,

Cabi Publishing, Wallington, UK.

8. Rushton, J., Viscarra, R.E., Otte, J., McLeod, A. and Taylor, N. (2007)

Animal Health Economics. Where have we come from and where

do we go next?, in Perspectives in Agriculture, Veterinary Science,

Nutrition and Natural Resources, CABI., 1 No. 031.

9. Schwabenbauer, K. (2012) The role of economics for animal health

policy makers, EuroChoices, 11(2), pp. 18-21

Dr Elizabeth Jackson is a lecturer in business with research interests in agricultural systems, agribusiness management, food supply chains and food marketing using both quantitative and qualitative methodologies. She also has pedagogical research interests in internationalisation of the curriculum, peer observation, e-learning and distance learning. Elizabeth has practical experience in Australian grain, sheep and cattle farming systems and professional experience in the Australian grain and biotechnology

industries. She is an active committee member of the Logistics Research Network Committee and runs its annual workshop for PhD students.Email: [email protected]

Professor Jonathan Rushton is an agricultural economist who specialises in the economics of animal health and livestock production and food systems – interests that grew from living and working on the family dairy farm. He is involved in research in the UK and Europe, and has extensive international experience of livestock production and the control of animal diseases in South America, Africa and Asia. During the global avian influenza response he worked at the Food and Agriculture Organization of the United

Nations (FAO). His recent research focus has been on the use of economics in understanding the emergence of pathogens from food systems and the more general impacts of disease at individual level and across society. He is currently the professor in animal health economics at the Royal Veterinary College, a member of the Leverhulme Centre for Integrative Research on Agriculture and Health and a non-executive member of the Animal Health and Welfare Board for England.Email: [email protected]

Dr Barbara Häsler graduated in veterinary medicine from the School of Veterinary Medicine, University of Bern, in 2002. Her doctoral thesis undertaken at the Swiss Federal Veterinary Office was on the ‘Economic and epidemiological aspects of bovine neosporosis in Switzerland’. After working as a border veterinary inspector at the border inspection post in Basel, she joined the Royal Veterinary College as a research assistant in Veterinary Public Health. From 2008 to 2011 she undertook research for a PhD on the economics

of animal health surveillance while simultaneously studying for a Certificate of Higher Education in Economics, both of London University. From 2011-2013 Barbara Häsler worked as a Post-Doctoral Fellow in the Leverhulme Centre for Integrative Research on Agriculture and Health (LCIRAH), London University, developing frameworks to assess the impact of foodborne and zoonotic diseases and their mitigation. In 2013 she became a lecturer in Agrihealth at the same centre. She has a strong interest in applying One Health or Ecohealth approaches to better understand food systems and how changes in those impact on food safety and food security and to improve the wellbeing of people and animals through better resource allocation.Email: [email protected]

Corporate Profile

The global animal health industry is large, complex and dynamic, offering great opportunities and significant risks to animal health companies that compete in the sector. In 2013, the market was valued at $23 billion and has shown robust growth in the last decade.

The global animal health industry can be segmented by product group into medicinal feed additives, biologicals and pharmaceuticals, which can be further segmented into anti-infectives, parasiticides and other pharmaceuticals.This is a global industry with important country markets in the

Americas, Europe and other regions.

The market can be segmented into food animals and companion

animals, which have very different needs and drivers.

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Zoonotic Diseases: The Forgotten Ones?

About 75% of the new diseases that have affected humans over the past 10 years have been caused by pathogens originating from an animal or from products of animal origin. Even though many of the zoonotic diseases have the means to spread over long distances and to become global problems (there is nowhere to hide as a result of international trade and travel), limited reliable qualitative and quantitative information on the burden of zoonotic diseases is available at the moment. There are `high profile` diseases such as AIDS, tuberculosis and malaria – and “the others”, some neglected zoonotic diseases which seem to have been almost forgotten, at least in terms of allocation of funding for research and collective action for control. But, as the experts say, one needs a problem to be quantified, otherwise it is difficult to ask the policy-makers for attention and, more importantly, funding. And as the largest outbreak of Ebola virus ever recorded has proven, when there isn’t a global threat, there are no licensed drugs and vaccines.

According to WHO`s `Technical report of the TDR Disease Reference Group on Zoonoses and Marginalized Infectious Diseases of Poverty`, of some 1400 species of infectious disease pathogens of humans, nearly 60% are derived from animal sources, hence the importance of recognising the role of livestock, companion animals and wildlife in the interactions between animals and humans. The WHO report represents the output of the Disease Reference Group on Zoonoses and Marginalized Infectious Diseases of Poverty (DRG6), which is part of an independent think tank of international experts, established and funded by the Special Programme for Research and Training in Tropical Diseases (TDR) in order to identify key research priorities through review of research evidence and input from stakeholder consultation.

The review points out that zoonotic diseases, although biologically diverse, share common characteristics associated with the conditions under which people live in the world`s poorer countries. The number of people who are directly dependent on livestock is estimated at somewhere around 600 million, which accounts for nearly a tenth of the world`s population. Furthermore, exactly in those environments where zoonotic diseases represent the highest burden, health systems are weak, fragmented or not accessible to populations; there is inadequate surveillance and reporting of disease outbreaks, a situation exacerbated by inadequate diagnostic and therapeutic services. The efficacy of drugs for both humans and animals is not effectively monitored as a result of lack of control of imports and the widespread sale of ineffective or counterfeit products through an unregulated private sector.

It has become clear now that effective disease control for zoonotic diseases requires multisectoral collaboration between the human and veterinary health, agricultural, and water and sanitation sectors. Interventions are generally directed at both the human and the animal host, and the

approaches may be biomedical (drugs or vaccines), vector or intermediate host control, environmental, legislative (inspections) or educational. Integration must also happen across the human health and animal health sectors. The WHO report draws attention to the fact that control measures are already in place for diseases such as rabies, anthrax, echinococcosis, cysticercosis and brucellosis. There are several examples of major successful control programmes indicating that national, regional or even global control is (at least theoretically) possible; unfortunately, the effectiveness of these interventions in reducing human infection for some of the diseases is still unknown.

It is acknowledged that more research should be conducted to improve and develop new disease control tools. However, a tough problem seems to be adapting the diagnostic, curative, preventive and monitoring tools to the condition prevailing in developing countries and recognising the constraints of financing, affordability and delivery. And whilst there is unprecedented interest in research on diseases of the poor, the appeal of the research on zoonoses is considered still disproportionately small. Over and above the report, the needed research should be undertaken cooperatively at the international level, be multidisciplinary, involve both human and animal health research groups, and engage relevant stakeholders.

Apparently, for most diseases there is a need for development of affordable, rapid and reliable diagnostic tools, which should also be considered in the context of surveillance and monitoring and evaluation tools; a need for development of innovative strategies for disease surveillance, including the use of sentinel populations, both human and animal, adopting new approaches in communication technology and analytical tools (e.g text/data mining such as the USDA livestock disease alerts), participatory approaches such as the use of abattoir workers for surveillance and mobile phone reporting.

No doubt, there is a need for stronger advocacy and for a focused research agenda directed at improved approaches to control zoonotic diseases. In a review paper published recently in PLoS Neglected Tropical Diseases, a team of researchers from the Centre for Infectious Diseases and Division of Pathway Medicine, School of Biomedical Sciences, College of Medicine and Veterinary Medicine, The University of Edinburgh, Edinburgh, United Kingdom examined the extent of high-level political advocacy that has taken place for the NZDs since the inception of the WHO in 1948.

According to the researchers, years of advocacy for the neglected tropical diseases (NTDs) have succeeded in focusing the world’s attention on these diseases of the poor, resulting in the 2012 “London Declaration” and more recently, the World Health Assembly Resolution WHA66.12 on NTDs in May 2013. Control of the endemic neglected zoonotic diseases



(NZDs) would certainly benefit from such a campaign, which needs the support of a global community. As to the perception that the NTDs and NZDs have been historically “neglected” by decision-makers in terms of their political profile and allocation of funding for research, the study shows that such neglect is largely driven by the fact that their burden is often solely found in developing countries, where the majority of effort in recent years has focused on HIV/AIDs, tuberculosis, and malaria. Then again, it is also difficult to gather information about the extent and impact of these diseases of the poor due to ineffective diagnostic capacity and poor health delivery systems, hence the underestimation of disease burden. Well, unless a problem can be quantified, it is difficult to argue for funding and attention by policy-makers.

The passing of the recent World Health Assembly Resolution WHA66.12 is seen as a key step in the advocacy process for the neglected tropical diseases, acknowledging the research and efforts of those involved in their control. Five of the eight neglected zoonotic diseases — cysticercosis, rabies, echinococcus, human African trypanosomiasis, and leishmaniasis — are now included in the list of NTDs identified by Resolution WHA66.12. However, anthrax, bovine tuberculosis, and brucellosis are still lacking the high-level advocacy required to rally political support for their control in endemic countries. Global advocacy for control of the NZDs as a whole would similarly benefit from adoption of a One Health approach as is promoted for the NTDs under WHA66.12.

The priority is … to prioritiseAt the Centre for Public Health and Zoonoses, Department of Population Medicine, Ontario Veterinary College, University

of Guelph, Guelph, Canada, Victoria Ng and Jan M. Sargeant used a well-established quantitative method in market research (CA), to identify the relative importance of 21 key characteristics of zoonotic diseases for their prioritisation in Canada and the US. As their study shows, although zoonotic outbreaks are a significant burden of disease in North America (for example, outbreaks of West Nile virus, SARS, H1N1 influenza and Lyme disease in the past decade), there are limited resources available for their control and prevention, making the development of a scientifically driven framework for the prioritisation of zoonoses essential.

Apparently, everyone agrees on the need to prioritise zoonoses, to establish a universally accepted priority list, but there are a lot of challenges to the process: it is not easy to compare the overall public health impact of zoonoses when they vary so significantly in incidence, clinical manifestations, control measures, transmission potential and socio-economic impact in humans and animals. Additionally, there are multiple stakeholders involved, each with their own prioritisation objectives and beliefs, and there is even a lack of agreement concerning prioritisation methodologies .

The principle behind the novel quantitative approached used by the researchers, Conjoint Analysis (CA), is that a product (goods or service) can be described by a set of characteristics and the extent to which an individual values a product is determined by the level of each of those characteristics and the combination of those characteristics together. A CA study presents individuals with competing products containing both desirable and undesirable characteristics and forces them to state a preference, usually as a choice between products. In doing so, they make a trade-off between the desirable and undesirable characteristics in



the products through their choices, revealing the true value of each characteristic relative to each other.

In the context of zoonoses, a disease can be treated as a product described by a set of disease criteria (characteristics), and the value of the disease can be determined by the level and the combination of those criteria.

For their study, the researchers recruited 707 participants from Canada and 764 from the US from relevant professional disciplines that would provide some prior knowledge of infectious diseases: epidemiologists, public health practitioners and policy-makers in the human and animal health disciplines at the local, provincial/state and national level, academic and practising physicians and veterinarians, infectious disease researchers, human and animal health laboratory microbiologists, pathologists and technicians and registered nurses. This study represents the first zoonoses prioritisation exercise involving public health, veterinary and medical professionals in North America, and the results illustrate that CA can indeed be used as a tool for the prioritisation of zoonoses, particularly as a method to overcome subjective weighting and scoring of disease criteria.

Although differences were observed between countries, both groups considered incidence of the disease in the last five years in humans and case-fatality in humans to be the most influential criteria in the decision to prioritise zoonoses. Similarly, both groups judged high-risk groups in animals to be the least influential criteria in the decision to prioritise zoonoses.

Canadian professionals were more strongly influenced by severity of disease in humans, economic burden in humans, duration of illness in humans, case-fatality in animals and high-risk groups in animals. US professionals were more strongly influenced by incidence of the disease in the last five years in humans, incidence of the disease in the last five years in animals, disease trend in the last five years, and economic and social burden on trade in animals.

Canadians deemed rabies to be the most important of the zoonoses to prioritise, followed by Nipah virus encephalitis, H1N1 influenza, variant Creutzfeldt-Jakob disease and listeriosis. These were also the top five priority diseases in the US, ranked in a different order. There was also consensus between the bottom five diseases on the priority list with three of the five least important diseases appearing in both priority lists.

Canadians considered leishmaniasis, Hendra virus, salmonellosis, cryptosporidiosis and Crimean-Congo hemorrhagic fever of higher priority than Americans. Conversely, Americans considered babesiosis, anaplasmosis, paralytic shellfish poisoning, coccidioidomycosis, cysticercosis and Rocky Mountain spotted fever of higher priority than Canadians. According to the researchers, this can be explained by regional differences in both human and animal disease incidence: for example, babesiosis does not occur naturally in Canada but is endemic in the US, anaplasmosis is extremely rare in Canada but endemic in the US, and Rocky

Mountain spotted fever is found only in Western Canada but is distributed throughout the US. Regional differences in disease trend also likely contributed to different rankings, for example, paralytic shellfish poisoning has been increasing in the US but is stable in Canada.

Seven of the top ten diseases were common across all groups (rabies, Nipah virus encephalitis, Ebola virus hemorrhagic fever, Marburg hemorrhagic fever, H1N1 influenza, variant Creutzfeldt-Jakob disease and listeriosis) while five of the bottom ten diseases were common across all groups (bovine tuberculosis, cyclosporiasis, Dengue fever, La Crosse encephalitis and St Louis encephalitis). Despite more similarities in demographics, model fit, disease criteria importance scores and part-worth utility values between the two public and the two professional groups, there was more uniformity across priority lists between the Canadian public and Canadian professionals and between the US public and US professionals than between the Canadian and US public groups and between the Canadian and US professional groups.

Cecilia Stroe Editor

References1. WHO — “Research Priorities for Zoonoses and

Marginalized Infections – Technical report of the TDR Disease Reference Group on Zoonoses and Marginalized Infectious Diseases of Poverty”

2. `Neglected Zoonotic Diseases — The Long and Winding Road to Advocacy` - Hayley E. Mableson, Anna Okello, Kim Picozzi, and Susan Christina Welburn*, Centre for Infectious Diseases and Division of Pathway Medicine, School of Biomedical Sciences, College of Medicine and Veterinary Medicine, The University of Edinburgh, Edinburgh, United Kingdom. PLoS Negl Trop Dis. Jun 2014; 8(6): e2800. Published online Jun 5, 2014. doi: 10.1371/journal.pntd.0002800 PMCID: PMC4046968

3. `Quantitative Approach to the Prioritization of Zoonotic Diseases in North America: A Health Professionals’ Perspective`, by Victoria Ng and Jan M. Sargeant. Centre for Public Health and Zoonoses, Department of Population Medicine, Ontario Veterinary College, University of Guelph, Guelph, Canada and Université Catholique de Louvain, Belgium. PLoS One. 2013; 8(8): e72172. Published online Aug 21, 2013. doi: 10.1371/journal.pone.0072172 PMCID: PMC3749166


Advancing Animal Health

BRIEF HISTORYMoredun Scientific is a contract research organisation with over 25 years of experience in conducting efficacy and safety studies in livestock for the global animal health industry to GLP/VICH-GCP standards.

Our company is the commercial arm of the Moredun Group supported by world leading scientists at the Moredun Research Institute who have a research focus on the prevention and control of infectious diseases of livestock.

SERVICES OFFEREDOur range of services includes:

Efficacy StudiesWe offer an extensive portfolio of experimental and field infectious disease models for use in client studies, Table 1 details our areas of expertise. We also develop new models and protocols as required to meet the needs of our clients.

We can deliver short- and long-term studies (e.g.onset of immunity, dose determination, dose confirmation, duration of immunity, foetal

protection) and work with a broad range of product types including vaccines, antimicrobials, anthelmintics, and anti-inflammatories.Studies are conducted in our GLP accredited laboratories and in our extensive, flexible animal facilities. Our integrated complex incorporates purpose built farm animal accommodation, an operating theatre and a post mortem suite. A high containment facility is also available that provides optimal controlled environmental conditions for large and small animal species and facilitates research on specified pathogens up to Category 3.

Safety StudiesWe conduct safety and tolerance studies in compliance with relevant international guidelines for pharmaceuticals, biologicals and feed additives.

These include:

• Reproductive performance.• Spread of vaccine strain.• Local and systemic tolerance following single, repeat and

overdose administrations.• Dissemination in the vaccinated animals• Reversion to virulence• Potency and safety of vaccines for batch release.• Environmental safety, especially grazing studies.• Biosafety testing including adventitious agent testing,

biodistribution, etc

Field TrialsWe offer field trials to veterinary good clinical practice (VICH-GCP) to animal health companies requiring UK field trial data from cattle or sheep studies.

Our offering ranges from complete management and delivery of studies to provision of specific elements to meet client requirements including:

• Study design and set up• Protocol development• Site selection• Study monitoring• Study close out

Biological MaterialsCustom preparation of a range of biological materials including antisera, viruses, bacteria and other material for research or commercial use.

Quality AssuranceOur quality systems are a key element of the service we offer to our clients. Our independent quality assurance department has expertise in GMP, GLP and VICH-GCP. We are a member of the UK GLP compliance programme and are accredited for GMP (Testing).We are regularly audited and inspected by both our clients and regulatory bodies to ensure ongoing compliance.

CONTACT DETAILSFind out more about how we can support you:Moredun ScientificPentlands Science ParkBush Loan, Penicuik,EH26 0PZ , UKTel: +44 131 445 6206Email: [email protected]

Respiratory Diseases

Mammary Gland Diseases

Reproductive Diseases

Diseases of the Gut

Parasitic Diseases

Systemic Diseases

Bovine Virus Diarrhoea Virus (BVDV)Bovine Herpesvirus-Type 1 (BHV-1)Parainfluenza Virus Type 3 (PI3)Bovine Respiratory Syncytial Virus (BRSV)Mannhaemia (Pasteurella) haemolytica (Bovine,ovine)Pasteurella multocida (bovine)Mycoplasma bovisActinobacillus pleuropneumoniae (porcine)

Staphylococcus aureus mastitis (bovine)Streptococcus uberis mastitis (bovine)

Bovine Virus Diarrhoea Virus (BVDV)Porcine Reproductive & Respiratory Syndrome Virus (PRRSV)Neospora caninum (bovine)Chlamydophila abortus (ovine)Toxoplasma gondii (ovine)

Escherichia coli (bovine, ovine)Rotavirus G6 & G10 (bovine)Coronavirus (bovine)Salmonella spp. (porcine)

Endo and ecto Parasitic Disease (Bovine, ovine, equine, avian, natural and experimental infections)

Pasteurella trehalosi (ovine)Streptococcus suis (porcine)

Corporate Profile

Table 1: Disease models & areas of expertise



The bond between pets and people started thousands of years ago. The history of the partnership between dogs (Canis lupus familiaris) and humans is a long and rich history resulting in a lasting and deep bond between the species. The partnership is based on human needs for help with herding and hunting, an early alarm system, and a source of food in addition to the companionship many of us today know and love. Domestication was a long process, first starting with the genetic divergence of dogs from the wolf.1

Mitochondrial DNA studies put the split between wolves and dogs as early as 135,000 years ago.2 Based on evidence from Goyet Cave in Belgium, Chauvet cave in France, and Predmosti in the Czech Republic, the dog domestication process began as long ago as 35,000 years, although the oldest evidence for a broader working relationship is at the Bonn-Oberkassel site, 14,000 years ago.1 The story of dog domestication is still in transition itself. According to the most recent evidence presented in Science in 2013, the geographic and temporal origins of the domestic dog remain controversial, as genetic data suggest that domestication may have begun in East Asia beginning 15,000 years ago, whereas the oldest dog-like fossils are found in Europe and Siberia and date to >30,000 years ago. Mitochondrial genomes of 18 prehistoric canids from Eurasia and the New World were analysed, along with a comprehensive panel of modern dogs and wolves. From molecular dating findings, it appears that domestic dogs are the culmination of a process that initiated with European hunter-gatherers and the canids with whom they interacted 18,800 to 32,100 years ago.6

To further create a picture of the relationship between dogs and humans, we have evidence that people have been burying or ritually disposing of dead dogs for about the past 12,000–14,000 years. Such practices directly reflect the domestic relationship and the social compatibility between people and dogs. That compatibility is directly signified by the burial of dogs, with people often responding to the deaths of individual dogs much as they usually respond to the death of a family member.3

Not only has the relationship been developing for a long time, but there is new evidence that dogs have much the same capacity to experience pleasure from the companionship as we do. Gregory Berns, in his new book, How Dogs Love Us, writes that “… many of the same things that activate the human caudate, which are associated with positive emotions, also activate the dog caudate… The ability to experience positive emotions, like love and attachment, would mean that dogs have a level of sentience comparable to that of a human child. And this ability suggests a rethinking of how we treat dogs.”5 This should make us think about how we help protect this relationship and how veterinarians have the responsibility to understand how to better protect the dog by preventing the most common causes of dissolution of this long-evolving bond.

“I think recently, that animals — dogs and cats — are seen more as persons in our home, and I think we’re realising how incredibly adaptive they are,” Feuerbacher said. That’s not by accident, according to Brian Hare, who teaches evolutionary anthropology at Duke University. “In a word it’s because of domestication,” he said. “Dogs have been selected not to be smarter in the way we normally think about it; they’ve been selected to be emotionally smarter. They like humans and they want to be with humans more than they want to be with other dogs. They really see us emotionally as partners.”7

Besides the emotional and functional aspects of the bond we have with pets, pets also help us physically. Heart disease is the leading cause of death in the United States. But a new study says having a pet, especially a dog, could lower your risk of heart disease. High blood pressure, high cholesterol and diabetes are risk factors for heart disease. Previous studies have linked having a pet to having lower blood pressure. There is even a study that found that men who had dogs had lower cholesterol levels.12,13,14

Regardless, dogs and people have been working on this physical and emotional relationship a very long time and it is a very deep and mutual relationship.

Thus it is surprising that practices such as “economic euthanasia”, situations in which families surrender their beloved pets to shelters because of illness or injury,11 and the inability to cover its cost of care exist. In the past, veterinarians have helped strengthen the bond between pets and people by providing advanced care at a reasonable price or even free, to the detriment of their own financial and emotional wellbeing. As medical care for pets has advanced, this practice has put a huge stress on the system of veterinarians subsidising care or feeling forced to perform “economic euthanasia” because of a client’s lack of financial preparation for the cost of care, which goes against their ethics.

The human-animal bond is greatly affected when people cannot afford the care their pets deserve, and that they want to be able to provide for them. In fact, the impact to the bond between their pets and their veterinarians is impacted when the pet owner cannot afford care their veterinarian has offered. Because the pet owner has to compromise or face financial difficulty, a series of cascading impacts result. This may be the biggest issue the veterinary community faces - how to help pet owners afford the care we are now able to provide as veterinarians. Financial preparation for pet care is essential. This impact is not only on the human-animal bond as the pet owner feels guilt about compromising care, or even having to euthanise their beloved pet because of a hard financial decision, but it also affects veterinarians. Veterinarians experience a deep “ethical exhaustion” when they are continually forced to offer less care than they want to provide for their patients. When a veterinarian, who went into the profession because they love animals, is forced to euthanise a pet unnecessarily, the impact to their morale and their love of their profession is compromised, sometimes beyond repair. Some veterinarians leave the profession because of their frustration at not being able to deliver the care they are trained for, and not being able to make the living they dreamed of for themselves and their family because of clients not being financially prepared for the unexpected illnesses and injuries their pet may experience.

The bond is affected when pet owners feel guilty about having to euthanise their pet due to lack of financial resources, and then never get a pet again, or they take their pet to an animal shelter. Either way, the human-pet bond is destroyed. In fact, this may be the real elephant in the room for veterinary medicine.

Undoubtedly people feel a deep love for their pets and their pets return the love. Veterinarians also love animals, and dedicate their lives to keeping this bond between people and their animals strong

The Human/Animal Bond - The Cost Of Care



by taking care of the health of these important partners in our lives. We have all experienced the deep guilt and grief our clients go through when they cannot say yes to the best care for their pet, even though they want to. Even if they do say yes, it sometimes leaves them in much more financial risk than it should. When you repeatedly make yourself do things not in line with your moral compass, the resulting syndrome is called “ethical exhaustion” and is the third of three maladies of veterinary medicine, alongside burnout and compassion fatigue.9

At the 2013 Veterinary Social Work Summit, Sonnya Dennis, DVM, DABVP, presented a session on Ethics Exhaustion, and Katherine Dobbs did an excellent summary of this newly emerging issue for veterinarians.9 Dennis defined “ethics” as a code of moral conduct or rules, following duty and not convenience, and doing the thing that “I should do.” Ethics exhaustion is fatigue, emotional distress, and lack of will to continue to act in a way that is consistent with what you believe is the ethical thing to do. It is having failed to square behaviour with belief so often that you no longer care to try. At times, ethical exhaustion can be having trouble defining what that right thing is, or can be a mismatch between your ethical belief and your actual behaviour. “Ethics exhaustion is not a loss of compassion, but being prevented from acting on what you believe is the compassionate, caring thing to do,” Dr Dennis explained.9

In order to explore your personal ethics, consider the range of possibilities when a client decides upon euthanasia. How do you feel, and what does your practice do, about the 17-year-old poodle

with end-stage heart failure, as compared to an otherwise healthy animal whose family cannot financially bear the burden of the surgery to fix a broken leg? What about the client who can’t be “bothered” to give insulin to a newly-diagnosed diabetic pet, as compared to the family that is moving and can’t take the pet with them? What you would like to do, and what you are asked to do by the practice owner, can be two very different things.9

In dealing with ethical exhaustion, one of the four steps is to ACT. Medical insurance for pets is a powerful tool preventing “ethical exhaustion” by helping assist pet owners in affording the care their pet needs and you are trained to provide, thus helping to prevent being faced with compromising care with “plan B” or worse, “plan E” – economic euthanasia because the client and the veterinarian did not understand the value of pet medical insurance.

The time to ACT is now — innovations in pet medical insurance are improving the value to pet owners, and veterinarians are the most important factor in determining whether pet medical insurance is a viable option. Both pet owners and veterinarians should be careful, as the choice impacts their future as much as it does the future of our pets.

Pet insurance has been around for over 50 years, starting in Sweden followed by the UK. It’s a little newer in the US and has been in the country for 30 years, yet less than 2% of US pet owners have medical insurance for their pets. Other countries have 20-30 times the penetration rates for pet insurance than the US does,



thus their veterinary community and pet owners are much closer to ending economic euthanasia and pet abandonment because of the cost of an illness or injury. Pet medical insurance providers in the US have been trying to copy human healthcare in a property insurance model, and this has resulted in a less than optimum value proposition for the pet owner, and the veterinarian is impacted if they have referred a less than optimum solution. The solution has been slow in coming as pet insurance companies struggled to develop a model that worked for pet owners and veterinarians in a highly regulated environment. In other countries, pet insurance has become an accepted practice associated with responsible pet ownership. For instance, Sweden has about 50% of their pets covered by medical insurance, and the UK has over 25% of their pets insured. Veterinarians in the US have become frustrated with early experiences with pet insurance, and thus have been slow to recommend pet insurance as the solution it can really be. With new models emerging, there are three areas medical insurance for pets can make a difference:

1. Positive customer experience with pet insurance will help end economic euthanasia: The value proposition of pet medical insurance has changed. The client experience associated with the current reimbursement model has also changed — how does this affect both pet owners and veterinarians? What happens when you remove the financial burden for clients and don’t require them to come up with the payment for care upfront? Instead they pay their small copayment and you receive the rest upfront not from the pet owner, but from the provider? Besides a proven uplift in client loyalty, there is also a reduction in the credit card fees charged to veterinary practices with this improved model, which helps your bottom line so you can reinvest in your practice and your team.

2. Pet medical insurance providers that do not dictate veterinary care results in better care and less disruption to the bond: The impacts of pet medical insurance on veterinary practice and the concern about insurance dictating care are real if the insurance is modelled after human healthcare. Veterinarians need to understand and advocate for pet insurance that doesn’t dictate care, so they are free to practice the quality of medicine that pets deserve and free to make the best decision for each pet. This is important for our future and the future of the human-pet bond.10

3. Healthy sustainable veterinary practices are good for the human-animal bond: Medical insurance for pets will play a big role – and veterinary practices will thrive. Hospital data shows that insured pets visit veterinary practices 61-130% more often than uninsured pets, and that 90-170% more care is delivered (as measured by revenue per pet per year).8

The bond between pets and people is too special and too longstanding to support tolerance of practices such as economic euthanasia and continual compromising of care delivered to these special members of our family. Clients benefit from having pets, and deserve the best recommendations to help them afford the incredible range of care veterinarians are trained to deliver.

References1. Hirst KK, Dog History, How were Dogs Domesticated? Ask.com/

archaeology, 2014.2. Akey JM, Ruhe AL, Akey DT, Wong AK, Connelly CF, Madeoy

J, Nicholas TJ, and Neff MW. 2010. Tracking footprints of artificial selection in the dog genome. Proceedings of the National Academy of Sciences 107(3):1160-1165.

3. Morey DF, Burying key evidence: the social bond between dogs

and people Original Research Article, Journal of Archaeological Science, Volume 33, Issue 2, February 2006, Pages 158-175

4. Carles V et al, “Multiple and Ancient Origins of the Domestic Dog” Science 13, vol. 276 (13 June 1997) 1687-1689. (From “Merle’s Door, Lessons from a Freethinking Dog”, Ted Karasote, Harcourt Publishing, 2007)

5. Berns G, How Dogs Love Us, A Neuroscientist and His Dog Decode the Canine Brain, Scribe Publications, 2013.

6. Thalmann O et al, Complete Mitochondrial Genomes of Ancient Canids Suggest a European Origin of Domestic Dogs, Science 2013, 342 (6160) 871-874

7. Weir W, “What’s your dog thinking? Yale researchers want to know”, The Hartford Courant, March 17, 2014

8. Marshall K, data from Trupanion Practice Value Models, 2012-2014.

9. Dobbs K RVT, DVPM, PHR: Behind Door #3: Ethics Exhaustion, Henry Schein ImproMed E-newsletter (quoting Sonnya Dennis, DVM, DABPV), Issue: 56- Aug 15, 2013

10. Christensen C, Grossman J MD, Hwang J MD, The Innovator’s Prescription, A Disruptive Solution for Health Care, McGraw Hill, 2009.

11. Solman MD, Human and Animal Factors Related to the Relinquishment of Dogs and Cats in 12 Selected Animal Shelters in the USA. JAAWS, Vol 1, No 3, pp 207-226.

12. Fryhofer S MD, Are Pet Owners Healthier? A new study suggests that pet owners are at lower risk for cardiovascular disease. What are the reasons? Medscape Internal Medicine, December 2013

13. Levine GN, Allen K, Braun LT et al; American Heart Association Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing. Pet ownership and cardiovascular risk: a scientific statement from the American Heart Association. Circulation. 2013;127:2353-2363. December 9, 2013

14. Anderson WP, Reid CM, Jennings GL. Pet ownership and risk factors for cardiovascular disease. Med J Aust. 1992;157:298-301. Abstract

Kerri Marshall, DVM joined Trupanion in June of 2011 as Chief Veterinary Officer. Dr Marshall develops strategies, systems and teams to leverage technology to improve the customer experience for pet owners and veterinarians with pet insurance.

Prior to joining Trupanion, Dr Marshall worked for 16 years at Banfield Pet Hospitals, and prior

to Banfield, she worked in private practice and at University of California, Davis. During her career at Banfield, she gained experience from the start-up phase of the rapidly growing business and held leadership roles in medicine, operations, and IT as Banfield grew from 30 hospitals to almost 800 hospitals nationwide.

During the last eight years at Banfield, Dr Marshall built and grew teams and led design and testing processes supporting the proprietary electronic health record and practice management system, PetWare® and the client portal.

Dr Marshall graduated with her doctorate in veterinary medicine from Washington State University. She also completed an executive programme and received a Masters in Business Administration from the University of Oregon. Dr Marshall lives in Seattle with her husband, Andrew Muray, a physicist and the founder of Nanoport Technologies, and their four four-legged children: Rudy Einstein (a terrier/dachshund mix), Maya and Popo (10-year-old Chihuahuas), and Mona Montana (a rescue cat).

Pets take us places. Better places than we could ever go by ourselves. To help protect

that human-animal bond, we’re passionately committed to helping you help pets live

longer, healthier, higher-quality lives. Providing trusted solutions that promote

well-being – so they can keep taking us places.

To learn more, visit elancovet.com.

©2012 Elanco, a division of Eli Lilly and Company Limited.WECACMIS00059

Longer. Healthier. Higher-Quality.


Research & Development

Animal Health: R&D Functions & Externalisation

Opportunities

IntroductionOver the last two decades the costs and time of developing an animal health product have both increased by >100% and six years, respectively. R&D investment across the top manufacturers, which account for 10 -12% of sales, is slated to reach the $3 billion mark in next 2-3 years. Outsourcing in key regions such as the EU has increased from the average 25% to 40% and the last decade has witnessed a surge in the number of dedicated animal health CROs, labs & consulting organisations, pan-US and EU. Given such market developments, it is in the best interest of category/sourcing managers to have actionable insights, in order to grasp cost savings opportunities and streamline their R&D functions via taking informed decisions concerning externalising functions.This paper attempts to provide a cursory glance at the global animal health market, its chief constituents, R&D trends, outsourcing practices incorporated by large manufacturers and best sourcing approaches, across shared functions of human and animal health R&D divisions, such as toxicology and process-oriented functions such as data and project management, to name but a few.

RecommendationsLeverage outsourcing, for the cost and time benefits that accrue to a manufacturer, by virtue of externalising functions based on an objective assessment of each spend category/

micro-market/function. Revisit existing sourcing practices and seek to consolidate spend among a preferred list of suppliers for two-pronged benefits of A. vendor management through reduced number of transactions and B. cost benefits through volume bundling and qualifying for discounts.

In stark contrast to the competitive dynamics witnessed in the human health pharmaceutical market, which is close to 40x the market size of animal health products and pegged at a massive $ 856 billion, the fragmented and intricate animal health industry faces its own set of challenges. The two major product segments, namely, companion animal and farm animal products, albeit having shorter, less expensive R&D cycles, are taxed with stringent regulatory demands, formulation and medicine administration complexities and competition for resources with the human health divisions. Furthermore, insofar as the market potential is concerned, it is critical that manufacturers target significant unmet needs across product types (anti-microbial, vaccines and parasiticides) and species segments, whilst challenges relating to compound scouting and escalating costs are efficiently managed. The aforementioned phenomena are expected to prompt newer business models to emerge alongside a hitherto unobserved greater reliance on the third-party R&D partners.

Source: Primary Interviews and secondary document http://www.ifaheurope.org/about/about-the-industry/facts-and-figures.html, (http://www.ifahsec.org/ifah-reveals-outcome-of-global-benchmarking-survey-on-animalhealth-industry/)

Current Industry Trends:



“Considering the significant increase in costs of diseases and the rise in ownership of companion animals, R&D focus in the next few years would be ‘NextGen’ parasiticides and anti-virals, across livestock and companion animals”

Global Sales Set to Grow at a CAGR of 6%The US and EU currently account for close to three-quarters of the $22 billion global animal market. In the EU, France, Germany, Italy, Spain, and the United Kingdom are the markets expected to drive sales in the product segments companion and livestock. The top-selling animal health products are anti-parasitic for companion animals, and generate annual sales of almost $1 billion a year. Zoetis is the leading firm, with sales close to $4.2 billion and a healthy pipeline of products. The emerging markets, including India and China, have been predominantly farm-animal-driven markets as opposed to companion animals. However, this trend is likely to change, as the overall economic outlook in these regions will drive adoption of pets, especially among the growing middle classes. Research & DevelopmentThe average R&D spending among mid-size pharmaceutical firms (revenue of $200-800 million) and large animal health companies (>$800million), is 7-8% and 10-12% of sales, respectively. R&D facilities of large pharmaceuticals are primarily concentrated in the major markets the US and EU. A marked difference in spending within various functions of

the value chain is the fact that ~35% of the R&D budget is directed towards existing brands’ life-cycle management. Key product segments and species of spend include parasiticides, vaccines for cats, dogs and cattle. R&D would also seek to tap opportunities in ectoparasitic, osteoarthritis, cardiac, renal, cancer, analgesia, anaesthesia and reproductive area.

Animal Health - Outsourced Services MarketThe average outsourcing rate hovers at 40% of the R&D budget. A large portion of the functions are outsourced to functional CROs, who specialise in various phases such as field studies and discovery R&D. Off-shoring to emerging markets, unlike human health R&D, is restricted, owing to that fact that field studies ought to be done in the target commercial markets and the poor track record of discovery/innovation in developing markets. Hence, the US and EU would be the leading destinations for contracted work and are likely to account for over 50% of the animal health CRO market.

“The CROs offering animal health services are well poised to address greater volumes of contracted work, partly owing to consolidations, competition for finite resources and an inherent dearth of expertise in the animal health sector. Large pharmaceuticals including Zoetis, Merck, Elanco, and Bayer engage with multiple service providers. Outsourcing in silos as opposed to an integrated approach is largely due to higher process & cost efficiencies gained through functional engagements especially in functions such as regulatory submissions and project management.”

Companion Animal Development: Toxicology AdvantageThere are virtually no toxicology tests required for companion animals, and therefore the chief driver for TOX is the livestock segment, for which studies are conducted on rodents to determine safety factors and continue till the development phase. Toxicology is also done in conjunction with residue testing for human food safety in the development phase. Three- and six-month toxicology programmes are mandated by the regulatory agencies and usually overlap between discovery and development phases. Therefore, the low requirement of the toxicology for companion animals allows slashing significant amount of development time and the associated costs. Furthermore, DMPK is optional for companion animals; however, in the case of livestock the same is mandatory.

Source: Primary Interviews and secondary documents http://www.

ifahsec.org/ifah-reveals-outcome-of-global-benchmarking-survey-on-

animal-health-industry/, please refer to the research methodology)



In-licensing CompoundsMost animal health companies, especially the mid- and small-sized, do not have their own discovery organisations. Some firms like Aratama and Kinread Biosciences outsource 100% of the development work. “Seekers” zero in on potential compounds to be in-licensed from the human health parent organisation, and the same are developed for various target species. This is seen as a highly pragmatic approach as products suitable for cats can be suitable for dogs, and extension to other species is possible. Commonly Outsourced Functions and Preferred Regions Formulation: Heavily outsourced to vendors like ARGENTA, CEBIPHAR, PIEDMONT

Regulatory: Regulatory dossier preparation, submission and support are outsourced often to specialist animal health regulatory CROs or consultants. In the EU, each technical section requires a “Detailed and Critical Summary” (also called an expert report) that is highly outsourced. Outsourcing of the DACS is always within the EU. Outsourcing of regulatory dossiers is in the US for US submissions and the EU for EU submissions. Pharmacovigilance: Clinical trial PV is largely outsourced; however, pharmacovigilance for post-marketed drugs has

been retained. Zoetis and Bayer have invested in training PV resources for managing post-marketed drugs’ PV.

Contract Management: Cursory Adoption Trends

Outsourced Functions and Preferred Regions

ConclusionIn conclusion, the supply market for outsourced animal health services will likely witness consolidations at functional levels in different regions. Academic institutions would also play an integral part in early innovation and discovery. The US and EU, which adhere to the VICH guidelines, will continue to remain major markets in terms of sales and R&D spending. Investments would also be directed at diseases for which there haven’t been treatments, like the feline viral diseases; however, they will remain at moderate levels as incidences have been low. Time and costs to gain registrations have increased significantly and therefore sponsors/manufacturers are expected to rely on third-party specialised regulatory consultants. Competitive positions of the leading animal health manufacturers such as Zoetis, Merck and Merial will be closely monitored, and one could expect stern competition from the likes of Elanco and Novartis, adding to the dynamism of the animal health market.

Research Methodology and ReferencesThe contents of this paper were derived from secondary literature and primary interviews with suppliers based in the US and EU (sample size - 21). Comments of key opinion leader with animal health experience of over 25 years in R&D management and outsourcing auditing have also been captured.

Source: Primary Interview



Secondary Sources1. “IFAH reveals outcome of Global Benchmarking Survey

on Animal Health Industry” -PDF2. “Facts & Figures of the European animal health industry”3. “Animal Health: Market & Opportunities: Companion

animal landscape” by Linda J.I. Horspool4. “Facts and Figures About the Animal Health Industry -

NOAH”5. “Promoting a positive environment for veterinary

medicines: A case for separate regulation for the animal medicine sector

6. Financial statements of companies and other press releases

h t t p : / / w w w . s e c . g o v / A r c h i v e s / e d g a r /data/1555280/000155528013000008/zoetis20121231-10k.htmhttp : / /www.merckgroup.com/company.merck .de/en/images/Q4_2012_Annual_Report2_EN_tcm1612_105641.pdf?Version=http://annualreview2012.sanofi.com/animal_health.htmlh t t p : / / f i l e s . s h a r e h o l d e r . c o m / d o w n l o a d s /LLY/3397753031x0x648089/D3A84E25-2AE1-4E41-8E25-A1AE41DA09BB/English.PDFhttp://www.annualreport2012.bayer.com/en/bayer-annual-report-2012.pdfxhttp://www.boehringeringelheim.com/content/dam/internet/opu/com_EN/document/01_news/08_APC/APC_2013/BoehringerIngelheim_Summary_Report_2012.pdf http://www.novartis.be/downloads/nl/teaser/novartis-annual-report-2012-en.pdfhttp://www.virbac.com/files/live/sites/corp-public/files/contributed/05-investors/05-regulated-information/01-financial-reports/2012/01-annual-financial-reports/Annual_Financial_Report_2012.pdf

C.Vivek is a Senior Domain Lead – Pre-clinical services, with Beroe Inc., a global provider of customized procurement services specializing in sourcing, supply chain visibility, financial risk analysis and environmental impact to Fortune 500 organizations. Vivek specializes in tracking various core- spending categories such as Discovery and Pre-

clinical research & development. He has worked on multiple projects for many Fortune 500 clients involving categories such as screening, research model and services, bioinformatics, etc Vivek, earned his degree in MBA from the Bangalore University.



Total Project Management Solutions for Development of Veterinary Medicinal Products

Development, Scale-up, Validation and Marketing Authorisation The introduction of new pharmaceutical veterinary products is dependent on a wide range of activities, through development and manufacturing to clinical field trials and building the regulatory dossier. This requires the support of multiple teams working in a coordinated approach.

A key activity, and the focus of this article, is the transfer of the process development knowledge into a cGMP manufacturing facility (likely to be a contract manufacturing organisation, CMO) to generate formulated products that can be used in either clinical or commercial supply. The data produced is used to generate a compliant Part II/ CMC for inclusion in the submission for a marketing authorisation.

Current ModelProject management in pharmaceutical medicinal product development and registration is vital in ensuring the overall aims of the project are met. All too frequently, this responsibility resides with a single person at the innovator company who has too little time available to do it justice.The current model for project management concerning the introduction of new pharmaceutical products to market follows the premise of a centralised project leader being the coordinator, decision-maker, planner and tracker for all aspects of the project.

A project will typically cross functions such as active pharmaceutical ingredient (API), drug product (DP) and supply chain (SC) in the development, scale-up and commercialisation phases in the life cycle.

There is an extensive list of potential activities the project leader can be responsible for:

In pictorial terms this approach can be represented as per the diagram below.

Keeping tabs on what the marketing team need, what the

development scientists are producing, and when the supplies are required in the clinic / warehouse, considering these are in-house activities, is challenge enough without having to consider what is required externally by contract development / manufacturing / regulatory support teams.

The project depicted above covers the whole range of activities, including requests for proposals; site assessments; negotiating contracts; planning activities (API and DP – probably separate organisations); regulatory standard technical packages; dossier preparation and submission to authorities.

There will also be multiple points of contact to consider as each of the key activities will have a pseudo project manager identified, looking after a particular area of responsibilities (e.g. at a CMO). This could be a benefit to the project leader, but frequently the CMO is more focussed on juggling the CMO resources to cover multiple projects in their facility rather than making sure any individual project runs to plan. Also, the CMO very rarely has access to the full project requirements and will therefore not be in the best position to make informed decisions.

The need for an independent project manager who has a full understanding of what is to be delivered, and is not protecting the interests of a CMO, is clear. The regulatory project manager is in an ideal role to satisfy this need, having full project oversight. The regulatory project manager would Table 1: Project Leader Responsibility List

Figure 1: Current Project Support Structure



also have the knowledge of what needs to be done during development, scale-up and manufacture to generate the quality of documents to support a regulatory dossier.

A Better WayThere is clearly a need for two very important roles within the project delivery team.

Firstly there is the project leader, who is the person with the overall responsibility for project delivery. The project leader will be an employee of the innovator who initiated the activity. The project leader will need to manage his company’s needs and resources as the project unfolds.

Secondly there is the regulatory project manager, who is responsible for driving the detailed actions of the project. This role could be either internal or external to the innovator company, but in essence is responsible for ensuring good communication flow to the project leader, as well as the detailed management of the external resources required for delivery.

It is obvious that the project leader cannot satisfy both roles and needs plenty of support and assistance, and in many cases an external project manager with a focus on regulatory outcomes makes a sensible addition to the team.

The concept that a regulatory project manager is directly responsible for the external coordination of support functions and in direct communication with the project leader at all stages would address the above issue of having a single person at the hub of everything, and all decision-making going through a single person. The project leader should be responsible only for the strategic and financial decisions for the project.

Responsibilities would be broadly divided as follows:

An example of how this would look is depicted in figure 2.

All communications have to be two-way, accurate and timely, which is pivotal if the subject matter experts are to be kept aligned with the project goals. The key communication link is between the project leader and the regulatory project manager, and both need to be fully aligned with the project goals at all times.

The benefit of splitting the decision-making workload in this way is that the decisions are being taken not only by people who are aware of the overall aims of the project, but also aware of the specialist areas they are responsible for. This approach gives a real-time control of the compliance aspects of the projects, leading to the decisions being made with the end goal in sight and reducing the risk that a downstream regulatory gap analysis would uncover a deficiency.

An example of how this approach improves the information flow is the transfer of technology from the innovator R&D to the CMO.

Figure 2: Improved Project Support Structure

Table 2: Shared Responsibility / Awareness in Improved Project Structure

Figure 3: Example Information Flow



Instead of the information flow, as originally depicted, passing from R&D to the project leader to the CMO, the regulatory project manager will now have full visibility. This small section of a project demonstrates clearly how the load on the project leader can be reduced, but still ensures availability of full information, and the approval decisions (in this case around document transfer and delivery plan) will be the responsibility of the regulatory project manager.

Having this combined approach between the project leader and the regulatory project manager will have several benefits, such as:

• Removing the project leader as the hub of all communications

• Debottlenecking information flow• Compliance, technical and scientific review happening in

parallel• Risks identified and mitigation strategies developed• Compliance assured going forward• CMO has full understanding of requirements• Enables detailed plan to be developed and agreed• All parties committed to plan and held to account• Tracking to plan becomes transparent• Project leader kept fully informed

A similar scenario and communication pathway could be envisaged for many other aspects of project delivery, and all would provide similar benefits to the innovator organisation. The generation of free capacity in their internal resources will mean they will be able to accommodate internal challenges / needs as required.

Selection of a Regulatory Project ManagerThe key in this strategy is the selection of the regulatory

project manager. The main prerequisites for being able to fulfil this role will be:

• •Regulatory experience in multiple markets (US, EU, Japan)

• CMO exposure in requests for proposals and negotiating contracts

• Hands-on experience of manufacturing at all levels (lab, pilot plant, full commercial)

• Breadth of understanding of the pharmaceutical operation (API > DP > packaged product formats)

• Scientific understanding of various disciplines (chemistry, analysis, formulations)

• Commercial acumen and understanding how to deliver marketing requests in the most cost-effective manner

• Strategic thinker• Good communicator • Overview of all aspects of medicinal product development

in addition to Part II / CMC requirements (e.g. clinical trial management, safety and efficacy studies).

Dr John W Banks is a Project Manager Part 2/CMC Veterinary Pharmaceuticals with Triveritas Ltd, a global veterinary product development consultancy with operations in Europe and North America. Dr Banks role focuses on the development, technology transfer and clinical supply of veterinary medicinal products. Dr Banks also provides expert support with the assembly of the quality section of Marketing Authorisation applications to EU and US standards. Dr

Banks’ 20 years experience in development operations includes positions at Dr Reddy’s Laboratories, Piramidal Healthcare, Pfizer and Searle (Monsanto).Email: [email protected]

UK • GERMANY • FRANCE • USA • POLAND

Triveritas is a dynamic international veterinary product development consultancy offering a vast range of services to support clients in the development and registration of

veterinary pharmaceuticals, vaccines and biologicals through skills built upon over 350 years of experience in the Animal Health industry

in depth expertise in all veterinary species and products

Triveritas has worked on a wide variety of veterinary therapeutic areas such as:

ANTIBACTERIALSintramammarieswater solubles

injectablesin-feedstabletstopicals

ANTI-INFECTIVESbiocidesteat dips

antifungalsantiparasiticsanticoccidialsantiprotozoals

BIOLOGICALSgenetically modified

serum productscombinationinactivated

live

othersNSAID’S

SEDATIVESANALGESICS

ANAESTHETICSCANCER TREATMENTS

START-TO-FINISH SERVICEWith our breadth of knowledge we can help you take projects from proof of concept to international approval swiftly and efficiently.

SPECIALIST PRODUCT DEVELOPMENTUnrivalled experience in veterinary pharmaceutical and biological product development. We offer a full range of project management services.

IN-HOUSE TRAININGOur tailor-made courses are a cost effective way to train your staff using real examples from your own product portfolio.

VETERINARY CLINICAL STUDIESIn-depth veterinary clinical study expertise, specialist in-house and EU and US veterinary Investigators committed to delivering quality clinical trials.

REGULATORY AFFAIRSFrom strategic advice to MA maintenance, with our up-to-date knowledge of legislation we can help you through the regulatory maze.

CONTRACT QUALITY ASSURANCEWith excellence in QA, we provide contract QA to current quality standards to the principles of VICH GCP, GLP and GMP.

SCIENTIFIC WRITINGOur scientific and clinical experts offer a specialist document writing service for expert technical reports or articles for scientific publication.

PHARMACOVIGILANCELet our veterinary and regulatory team help you keep compliant with the legislation relating to the monitoring of the safety of veterinary medicines.

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www.triveritas.com your expert partner in Animal Health

Triveritas Limited Bank Barn How Mill Brampton Cumbria CA8 9JY UK • t +44 (0) 845 123 28 88 • f +44 (0) 845 123 28 89



Antibiotic Alternatives for Animals

Pressure to reduce antibiotic use, coupled with the EU ban on antimicrobial growth promoters and current debate in the USA, is driving innovation in alternative products that can help reduce, refine and replace antibiotics in farm and companion animals. Market opportunities and regulatory hurdles are highlighted.

Uses of Antibiotics in AnimalsAntibiotics are needed in pets and food animals, just as in humans, but efficacy is compromised through antimicrobial resistance and no new antibiotic molecules. The key drivers to reduce consumption and preserve antibiotic efficacy are similar, although arguably stronger, in veterinary than in human medicine, particularly with respect to regulatory hurdles and restrictions in use (Table 1).

The animal health world differs from human health scenarios in the way that antibiotics are used, and typical patient profiles. In food animals, whole herd health approaches are the norm. When infectious disease strikes, it is common to medicate the drinking water of the whole herd, to treat affected animals, and prevent healthy animals from contagion. In modern food production systems, typical patients are relatively young, rarely kept beyond adolescence or early adulthood, whereas human antibiotics are used from paediatrics to geriatrics. The relative youth of livestock kept for food has implications for the most common indications of antibiotics. Gut and respiratory infections are common problems in pigs, poultry and cattle. Joint infections are also frequent in farm animals, and skin infections are not uncommon in both pigs and pets. Infectious mastitis is a major problem in dairy herds.

Food animal production systems, whether intensive, extensive, and/or organic, are subjected to stronger market pressures in comparison with human or companion animal medicines. There is a limit on food production costs, largely imposed by supermarket buyers. The cheapest foods tend to arise from the most intensive production systems, with the most economical inputs (e.g. feed, labour, air space, air and water quality). Feed costs may be up to 70% of total food animal production costs, depending on the species, in contrast to the 7% of income that US citizens spend on food. Low-cost generic antibiotics in feed or drinking water have been used for decades to treat farm animals, and indeed most problems, including sub-optimal hygiene and husbandry, improve after

antibiotics. In many cases, antibiotics have been an easy substitute, used instead of better farm management. But now, antibiotics are not welcome any more, and there are opportunities for alternatives.

Nutritional Alternatives to AntibioticsNutritional products such as feed additives, feed materials, and complementary and dietetic feeds can support animal health and welfare, and, directly or indirectly, contribute to reducing or replacing veterinary antibiotics. However, no veterinary claims can be made to “prevent, treat or cure” disease. Product positioning and claims strategies are therefore important considerations to be addressed early in new product development, especially where product registration is required. Protection of intellectual property is another important issue requiring appropriate expert advice.

Market OpportunitiesNutritional approaches can be considered as anything given by mouth. An old adage in the feed additive business is “If you can put it in the feed, put it in the feed. If you can’t put it in the feed, put it in the feed”. Today, application via drinking water may be preferred as a fast, convenient way to administer essential nutritional support, especially in food animals. Nutritional supplements are increasingly applied by spray to newly-hatched chicks or incorporated into gels or granules in chick boxes. Such enriched products improve chick viability and vigour in the crucial hours from hatching through packing and transport to farms for rearing. Innovative coating systems have been developed to protect delicate probiotics during feed processing, and to deliver functional nutrients at target gut sites, bypassing the fore-stomachs in ruminants or offering slow-release in the lower small intestine and large gut of monogastrics. Example of innovations in animal nutrition that contribute to sparing antibiotic therapy are summarised in Table 2.

Better Quality FeedsPiglets and calves are weaned much earlier in modern than traditional systems and are susceptible to enteric infections, commonly treated with antibiotics. However, improving



quality and innovation in feed ingredients can reduce antibiotic use significantly, by improving feed digestibility and thus the dynamic morphology and physiology of the gut. Examples are the use of colostrum or egg derivatives, high in natural or vaccinal antibodies that help protect the delicate gut mucosa of young mammals. Enzymatic processing of soybean meal to remove anti-nutritional factors enables feeding to a wide variety of young animals, including farmed fish and pets. The resulting soybean meal also has improved mouth feel and palatability, plus a prebiotic effect, since the anti-nutritional factors are converted to beneficial fibres that help develop the right type of hind gut fermentation

ProbioticsProbiotics offer versatile and varied benefits. Robust, spore-forming probiotics survive tough feed processing, whereas more traditional lactic acid bacteria may be applied in drinking water and milk-replacers, or be bound up in complex matrices that improve stability. Presentations miscible in liquid fats and oils can be sprayed on feeds after extrusion, to preserve probiotic viability. Under farm conditions probiotics give consistent improvements in zootechnical performance (growth, feed efficiency), in the order of 2-3% in chickens, and 5-10% in young monogastrics. Probiotics support animal welfare and health by stabilising the gut microflora, improving the quality of gut microbial fermentation (fewer putrefactive micro-organisms and enteropathogens), enhancing faecal consistency (lower water content), and ameliorating adverse environmental effects (reduced excretion of enteropathogens and less ammonia). Hence probiotics may be used in poultry to improve litter quality, and in intensive production systems the reduction in faecal E. coli is translated to reduced respiratory infections. Benefits in companion animals include improved faecal consistency, facilitating collection of faeces in urban areas (much appreciated by owners!), and a reduction in veterinary interventions for gastro-enteritis, especially notable in puppies.

PrebioticsA variety of prebiotic fibres and oligosaccharides are used in animal nutrition, particularly in extruded pet foods. Prebiotics are valued for their stability to harsh feed processing conditions, and their bulking and laxative actions. There is increased interest in developing “dream team” prebiotic-probiotic combinations, to enhance gut health through synergistic actions on the gut flora and faecal quality. EnzymesThe first feed enzymes arrived in the 1980s and were mostly targeted at digestion of “difficult” carbohydrates in cereals and oilseeds. These exogenous enzymes allowed incorporation of a larger variety of ingredients (e.g. rape, sunflower, triticale, rye) and/or a higher content of cereals in feeds (e.g. barley, wheat). Subsequent enzymatic waves targeted support of endogenous enzymes, such as proteases and amylases, at critical points in development, for example, piglets at weaning. Enzymes, like probiotics, improve the gut environment, but by different mechanisms. Probiotics suppress enteropathogens, and so enhance positive gut microbial fermentation, whereas enzymes achieve a similar effect by rapid and complete

digestion of fermentable substrates, thus preventing adverse fermentation by putrefactive or pathogenic bacteria. A third enzymatic wave, derived from genetically modified producer strains, includes heat-tolerant carbohydrases and phytases. Heat-tolerant enzymes are more stable during feed processing. Phytases improve phosphorus utilisation, and hence increase skeletal strength, with positive environmental effects derived from reduced phosphorus excretion. Recently developed phytases also offer significant improvements in zootechnical performance. A fourth enzymatic wave is expected to target enteric problems by novel, non-antibiotic mechanisms.

Organic Trace MineralsOrganic trace minerals such as chelated copper, iron, manganese, and zinc, or selenium yeasts, offer essential minerals in highly protected and bioavailable forms. Hence absorption and distribution are enhanced with fewer anti-nutritional cross-reactions in the gut. Trace minerals are important in myriads of biochemical processes, and play key roles in supporting the nutritional needs of today’s fast-growing, fast-metabolising food animals. Put simply, inorganic minerals may not supply the needs of such animals to achieve their genetic potential for growth and feed conversion. Skeletal strength is a key attribute in poultry and pigs. For example, high culling rates in breeding sows and boars are often associated with joint and leg problems. More dramatically in broiler chickens and turkeys, bred for “big breast” meat yields, weak leg bones cause lack of mobility and recumbency, leading to breast and skin burns, and bacterial infections of the skin, feet and joints, complicated by poor litter quality (high moisture and ammonia).

Natural Immune ModulatorsA number of immune modulators are used, especially in pets and aquaculture. Beta-glucans and nucleotides are two examples from aquaculture. Young farmed fish are subject to many stresses during handling, vaccination, and transfer from freshwater to seawater cages. Nucleotide immunomodulators exert positive effects on gut morphology and function, resulting in higher viability and improved growth rates. Inactivated microbes such as Lactobacillus spp. have shown good effects in skin inflammation, atopic dermatitis and seasonal allergies of people and pets. In a study with an inactivated Lactobacillus acidophilus strain, dietary supplementation of 4-8 weeks duration in dogs with atopic dermatitis resulted in reduced area and severity of skin lesions, reductions in T cells with type 4-positive C-C chemokine receptors, and reductions in allergen-specific IgE antibodies (Shinji et al 2014).

Organic Acids/SaltsOrganic acids and their salts have been successfully used for several decades to improve gut hygiene in food animals, More recent developments include fat-based coating systems that reduce handling hazards in feed mills, reduce corrosion of equipment, and deliver effective dosages to target gut sites. The total dose required is also reduced due to the synergism between the protective coating and slow-release micro-granules.



BacteriophagesBacteriophages targeting specific enteropathogens have aroused interest over past decades, but successful use in animal feeds or drinking water has been challenging. Improved delivery systems and final product stability will help resolve major obstacles to market.

BotanicalsDevelopment of botanicals as alternatives to antibiotics in animal nutrition began in the EU in the 1980s. Since 2010 a few “flagship” products have achieved, or are undergoing, EU registration as zootechnical feed additives, an attractive legal status for investors, resulting in an authorisation linked to the applicant with resulting protection of intellectual property. A zootechnical approval also serves to differentiate the product, as successful evaluation by EFSA (European Food Safety Authority) is viewed globally as an independent guarantee of quality, safety and efficacy. Natural botanicals are complex (Figures 1 and 2), with large variations in quality

and activity of components due to many factors, for example the part/s of plant/s used, type/s of processes applied, as well as geographical origin, harvesting conditions, etc. In the EU there are also borderline issues on the legal status of botanical extracts (or the related terms absolute, essential oil, tincture), classed as feed additives (flavours, colours or zootechnical), and plant derivatives subject to simple processing (e.g. drying/crushing herbs and spices) considered as feed materials. Additionally EFSA and member states have sometimes divergent views on potential toxicity of certain botanicals. Some botanical preparations are based on nature-identical components, which have the advantage of high purity, but the disadvantage in marketing terms of being less “natural”. As with other products destined for in-feed use, a variety of coatings may be used to improve stability of volatile aromatic substances, and to deliver active components to target gut sites. Good quality botanical preparations deliver expected and surprising benefits, Expected benefits, perhaps related to aromatic and appetent properties, include improved feed intake, feed digestibility and animal growth. More unexpected benefits are related to better gut hygiene, reduced enteric problems, faster gut maturation, and improved skeletal strength. Some botanicals are targeted at diseases such as coccidiosis and necrotic enteritis in poultry.

Registration Costs and Time to MarketFeed additive registration costs for antibiotic alternatives can vary considerably, depending on the safety package required, the target species, and other regulatory challenges. Generally speaking, the safety package is considerably less than that required for a new molecule, since many of the active components have a safe history of use in the food chain. As a rough guide, the minimum EU registration cost for a new feed additive preparation destined for broilers is around €250,000, with increments of approximately €150,000 per additional target animal category. Time to market, assuming zero data at project start is three to five years, for generation of data, preparation and submission of an EFSA-compliant dossier, and guidance through EFSA evaluation and EU approval.

ConclusionsThe global feed additive market, including feed antibiotics, is estimated to grow at around 4% per annum, and to be worth in excess of €15 billion by 2018. Experience in Europe suggests that there are opportunities to develop innovative alternatives, and it is likely that “antibiotic-free” demands from consumers and supermarkets will drive product development towards nutritional solutions in preference to traditional antimicrobials.

Dr Elinor McCartney, Pen & Tec Consulting Ltd. Elinor McCartney is an expert in EU food chain legislation, with over 30 years experience in development and registration of veterinary, animal health and nutrition products. In 2000 she founded Pen & Tec Consulting, dedicated to strategic and regulatory support of companies wishing fast access the EU market with innovative, non-antibiotic products.Email: [email protected]

Figure 1

Figure 2

WHY RISK IT?On-time, accurate study data. Dependable communication. Optimized study designs. Some study outcomes you

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Clinical Studies

The Heart of the Matter

The central figure in any clinical trial is the investigator. Everything they do, and how they do it, can affect the outcome of the trial. So, finding the right team of investigators, and then supporting them in the right way, can spell success or failure for the new therapy being evaluated.

While every investigator is a veterinarian, not every veterinarian makes a good investigator. Good investigators are not a homogeneous group, but they do share certain characteristics, like organisation, perseverance, and integrity.

Finding Study InvestigatorsThere are multiple ways to recruit investigators. Some sponsors compile a database of veterinarians to whom they mail or fax study invitations. This method may often generate a high number of responses, but selecting from such a pool can be time-consuming and relatively risky. Even veterinarians who appear to satisfy all of the requirements may falter under the burdens of protocols and regulatory standards.

That may be why certain sponsors rely on a roster of trusted investigators to whom they return for every study. Even if one of these investigators is not interested in participating in a particular trial, they often can refer the sponsor to one of their colleagues. Reliance on familiar investigators can yield more predictable results but, over time, may also lead to complacency. When the sponsor-investigator relationship gets too cozy, data quality usually suffers. It should never be blindly assumed that an investigator who performed well during one study will automatically deliver the same results in a subsequent trial.

Another approach is to search the summary of an approved drug that is similar to the compound being evaluated in a planned field trial. Listed investigators may be interested in participating in another trial and could bring useful experience and relevant perspective to the planned study. These summaries are available at http://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/FOIADrugSummaries/. However, the same caution applies to these investigators. Experience in a previous trial does not guarantee superior performance in the planned study.

Clinical research organisations (CROs) are another source of experienced investigators. Many CROs have databases of investigators with clinical trial experience in one or more therapeutic areas, and large patient populations with the corresponding indications. Some CROs will identify and qualify a team of investigators for a sponsor as a stand-alone service.

Some CROs, and even some sponsors, are in perpetual recruiting mode, always searching for new and better investigators. They use a variety of techniques, from

advertising to trade shows, to identify potential investigators. They then invest the time to thoroughly vet each candidate before adding them to their roster. This regular investment pays healthy dividends when future studies must get up and running quickly.

Once a potential investigator has been identified, they should be evaluated for participation in the upcoming field trial. Their file should contain a current resumé, a copy of their registration (and DEA licence, if necessary for the planned trial), and information about their practice and staff. After the candidate has reviewed the protocol, the sponsor or CRO should reconfirm their interest in and availability for the trial, answer any questions they might have, and verify that they have the requisite patient population. They also should review the study’s investigator budget and get the candidate’s agreement to that.

If the potential investigator passes all of these hurdles, the next step is the site qualification visit. This inspection will determine whether the potential investigator has a modern facility, adequate and properly-calibrated equipment, secure storage, organised medical records, and a friendly and professional staff. This visit also will give the sponsor or CRO another opportunity to confirm that the clinic has enough potential study subjects to meet their enrolment target quickly. Potential investigators who meet all of the study parameters then can be formally admitted as study investigators and be invited to study training.

Training Study InvestigatorsThe US Code of Federal Regulations (Title 21), Section 312.50, requires that study sponsors provide investigators with the information they need to conduct an investigation properly “...ensuring that the investigation(s) is conducted in accordance with the general investigational plan and protocols contained in the IND.” Like many regulations, this directive sets the objective but leaves the specifics to the regulated. Suffice it to say that, at the conclusion of study training, the investigators should know what they are required to do, how to do it, when and in what order they will do it, and what to do if something unexpected happens.

Sponsors and CROs differ on the most effective way to train investigators and, to some extent, the choice may depend on the total number of investigators and/or the complexity of the protocol. For some sponsors, budget constraints may dictate the training format. In the final analysis, though, the decision should be based on which format is expected to best prepare the investigators to produce superior results.

Training via webinar is often the least expensive and most flexible format. It allows the sponsor to train each investigator separately, small groups of investigators, or all


Clinical Studies

of the investigators at once. When multiple investigators are trained in the same webinar, they have the opportunity to interact and benefit from each other’s questions and comments. If the webinar is recorded on a DVD, copies can be sent to each investigator to share with other clinic staff and to refer to whenever they have questions during the study. Webinar training also may be the only option when tight timelines necessitate rapid study initiation.

The biggest disadvantage to webinar training is the lack of a controlled environment. There is no reliable way for the sponsor to determine whether each investigator is actually watching the webinar or has muted their phone and gone back to their clinic activities. It also is difficult to assess each investigator’s absorption of the training material and virtually impossible to role-play potential study situations.

On-site training is preferred by some pharmaceutical companies because it allows the project manager to qualify the site and train all of the staff in one visit. It also is an opportunity to see the clinic in action, assess their organisation and veterinary skills, and check the medical records for potential study subjects. However, since this training format is conducted in active veterinary clinics, it is subject to staff schedules and frequent interruption by pressing client issues, pet emergencies, and other clinic activities. Such distractions may hinder the investigator’s and/or clinic staff’s understanding of important protocol details, thus compromising the overall effectiveness of training and, perhaps, site performance during the trial.

Centralised training often is touted as both the most effective and most costly method. Having all study participants – sponsor, investigators, site technicians, clinical supplies distributor, laboratory representatives, biostatisticians, medical writers, electronic data capture administrators (for EDC studies), and the CRO project team (if involved) – together in one room, away from ringing phones, office responsibilities, and other distractions facilitates better interaction among all attendees, more consistent instruction of the protocol, deeper understanding of the pharmacology, and faster problem resolution. While the upfront cost of centralised training may seem high, it is almost always offset by faster enrolment, fewer queries, and better data. The value of shorter timelines and quicker regulatory approvals is far greater than the cost of plane tickets and hotel rooms.

Whatever training method is used, it may be worthwhile to periodically review certain key elements to correct misunderstandings, catch errors, and retrain the investigator and participating site personnel as needed to ensure protocol compliance and enhance site performance.

Investigator SupportOnce formal study training has been completed, initiation

visits can be scheduled for each investigative site. Under certain circumstances, a site may be ready to enroll their first study subject immediately after training has been completed. As appealing as this may be to the study’s project manager, it may be advisable to delay enrolment until the study monitor can schedule a site initiation visit. This will give


Clinical Studies

the monitor an opportunity to review all of the topics that were discussed during the training meeting, identify any gaps in understanding, and provide whatever refresher training may be needed. If training was conducted on-site, the study monitor can initiate the site right away and, perhaps, observe the first enrolments. If the site has not yet scheduled any subject screening visits, the monitor might advise the staff as they search the clinic’s medical records for likely candidates and also suggest various recruitment strategies.

As the study progresses, the monitor’s attention should shift to the three critical determinants of a successful study: enrolment, test article accountability, and data quality. Depending on the complexity of the protocol’s inclusion/exclusion criteria, enrolment can be relatively easy or extremely challenging. It is important to set realistic enrolment targets for each site and then to provide strong support to keep site staff focused and enthusiastic. Close tracking of each site’s progress against their target will help identify which ones need additional assistance or, in certain instances, when additional sites should be initiated to meet the overall enrolment goal.

One of the monitor’s responsibilities during each site visit is verification of each enrolled subject against the protocol’s inclusion/exclusion criteria. A frequent contributor to study budget overruns is the disqualification of completed cases that should not have been enrolled. Another important monitoring task is the reconciliation of test article inventory, which should be completed at every visit. Delaying it to the end of the study only increases the risk of discrepancies. The monitor also should confirm that test article is consistently stored in a separate, secure location, especially if the test article includes a controlled substance.

How often a monitor schedules their site visits depends on each site’s level of enrolment, number and frequency of protocol deviations, and number of queries issued and resolved. At every visit, study communication records and other site documentation should be reviewed for organisation and completeness. Outstanding queries also should be addressed, and remedial training provided when warranted. And, while not every investigative site is audited by the FDA, a call announcing an audit can come at any time. Therefore, it might be advisable to prepare the site personnel for that event in advance. Monitor travel cost usually is an important consideration when scheduling site visits but, in the context of an entire study, one additional monitoring visit at the right time often can result in a significant improvement in data quality from the respective site.

Bonus: Ten Tips for Tremendous Trials1. Before the study starts, set clear expectations for every

member of the project team, including the sponsor, investigators and other site personnel, CRO (if involved), monitors, laboratory, electronic data capture provider (if data will be collected electronically instead of on paper case report forms), biostatistician(s), and medical writer(s).

2. Include only those investigators who are truly interested

in, and committed to, the study. It is better to delay study initiation until the right investigators have been recruited than to proceed with study investigators who are not fully dedicated to a quality study.

3. Design and execute study training so that everyone involved understands the requirements of the protocol, accepts their responsibilities, and is committed to superior results.

4. Establish a project team communication plan, including what will be communicated to whom, by whom, when, and how.

5. Create a study team communication plan so that personnel at each investigative site know whom to contact for questions and problems, what communications they can expect and from whom, and the frequency and format of such communications.

6. Develop a monitoring plan and a projected site visit schedule. Regular monitoring prevents most end-of-study surprises.

7. Assign enrolment targets to each investigative site, but do not assume that they will always be met. Prepare a contingency plan.

8. Whether the study is paper- or EDC-based, review case report forms as quickly as possible. This will help catch errors early and indicate where remedial training might be needed or if a protocol amendment is warranted.

9. Reconcile test article inventory frequently and resolve discrepancies as soon as possible.

10. Don’t wait for the inevitable problems. Anticipate them and design solutions.

Our pets are not just animals. They are loyal companions, treasured members of our families, and, in certain instances, valuable assets. As such, they deserve the very best care available. That care will come from the new therapies being developed by veterinary pharmaceutical companies, and those therapies must be proven in clinical field trials. Finding, training, and motivating veterinarians to be effective investigators will help ensure the success of those trials ... and the long-term health and wellbeing of our beloved pets. And that is the heart of the matter!

Denni O. Day, BS, BSN, RN, MSPH is the founder, President, and CEO of VetPharm, Inc., a leading contract research organisation dedicated exclusively to animal health. VetPharm offers a complete menu of clinical trial support services including protocol development, data form design, investigator recruitment, site qualification, enrolment enhancement, study administration, site

monitoring, data management, biostatistics, medical writing, and regulatory support in the United States and Europe. VetPharm employs a comprehensive study management system comprising more than 1500 documented steps, a consortium of study-ready investigators, and an animal conditions database which facilitate rapid study initiation, accelerated enrolment, and superior results. For more information, please visit www.vetpharm.com or contact Denni Day at (585) 249-1090 ext. 209 or Email: [email protected].

HEAL,boy

VetPharm is the leading contract research organization dedicated exclusively to animal health. We treat your clinical trial as if it were our own. We believe in hard work, honest communication, and timely delivery of error-free data. Because, when the science of animal welfare is on the line, integrity counts beyond measure. Contact Denni Day directly at +1-585-249-1090 ext. 209 or [email protected] to learn more about VetPharm’s complete offering of clinical trial support services. Data delivered. Integrity found.

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IT & Logistics

Introduction of Electronic Data Capture Systems (EDC) in Animal Health VICH GCP Clinical Studies – Impact of Change for the Animal Health SectorThe last few years have seen some dramatic changes in the method of collecting data in animal health VICH GCP clinical studies. Electronic data capture (EDC) has been in the human clinical study arena for a number of years; however, this technology has only recently been introduced to animal health clinical VICH GCP studies. EDC has been a constant learning curve for all the individuals affected by the changes in using an EDC system. Although there are numerous guidance documents and information available related to EDC for human GCP studies, using EDC in animal health VICH GCP studies does have unique challenges based on the logistics of running small and large animal field studies.

Introduction of EDC impacts on all levels across an organisation and in the investigator study sites. These include organisational decisions on choosing an EDC vendor, to provide a study-specific database or to build the EDC database in-house, the training of industry professionals in the related disciplines i.e. data management, quality assurance and monitoring roles, and the way in which we select and train study site personnel at the veterinary clinics or on farms. It is a fundamental change to how we have worked up to now, and the key is to adapt as smoothly as possible with the overall goal of maintaining data integrity and compliance with the study protocol and relevant guidelines.

Change always has an impact, and what we are seeing is how animal health professionals are rising to the challenge of this change. We have “interviewed” three of the roles that have been impacted directly by the introduction of EDC in animal health and asked for their opinions on any positives and negatives, and any comments related to using EDC systems. The implementation of EDC has many advantages; however there is a cost to these “potential” advantages in terms of organisation restructuring, development of new procedures, staff re-training, time required prior to study start, etc. Is it all worthwhile? Well, read on and see some of the opinions to date!

Interview with a Study Monitor - by Jo McKelvie, Evita Services

1. What concerned you most about EDC before you had an opportunity to use it to capture data?My biggest concern was the availability of reliable connectivity in the field and being able to find ‘computer-literate’ investigators. In fact, I was pleasantly surprised to realise that most veterinary practices, even those in rural areas, now have some form of internet connection. Admittedly, connectivity can still be an issue: on occasions internet connections have been lost or are frustratingly slow. However, this has been the exception, and providing that a paper alternative is available, it has not greatly hampered the conduct of a study. Also, despite the occasional ‘older’

veterinarian who is uncomfortable with recording their data electronically, most investigators actually embrace this form of technology, and find it easy to use!

2. What are the key planning differences in comparison to using a paper-based system?The first time with any new process is the most challenging! Further, if you are using an external vendor to provide the system, you will have an additional member of your team. The biggest difference when comparing EDC and paper-based systems is the need for more up-front planning when using EDC to allow for the design and testing of the system. I would recommend that a data management plan and the database are developed in tandem with the study protocol, rather than subsequent to the protocol, and that CRFs are designed primarily as electronic, with paper intended to be only a back-up version. Therefore, enough time must be available to prepare adequately for the EDC study, bearing in mind that significant time will be saved at study close-out.

3. How has EDC changed your study site selection criteria?Admittedly, I think EDC is currently more suited to the set-up of small animal practice-based studies rather than for farm-based studies. However for companion animal studies, it has not changed my site selection criteria too much! Finding an enthusiastic and conscientious investigator with the right clinical expertise, time and access to the suitable cases is still most important. Ideally the practice will already have a secure and reliable internet connection wherever the study investigations will occur. However, there are solutions to many potential issues, such as providing tablet computers for mobility within the practice.

4. How has EDC changed the way you monitor studies?For me, the positives definitely outweigh the negatives! With EDC I can monitor the data almost in real time, and quickly provide feedback to the investigator. It also allows me to rapidly identify and report the adverse events, although there is a temptation to be constantly online, just in case! This can be managed if email alerts are set up to inform you of relevant events within the system (e.g. randomisation or AEs). As most of the data review can be conducted from the office, site visits have a different dynamic. I find I can be more prepared for what I want to review in advance (e.g. owner consent forms and drug accountability). This allows for more face-to-face time to discuss the study with the investigator and facilitate the management of any other non-data-related study issues (e.g. increasing case recruitment).

Interview with Study Investigators – by Janice Sarasola, Ondax ScientificA selection of Spanish investigators and dispensers were interviewed recently with regards to the hands-on use of EDC systems at their clinics. They were asked to comment on


IT & Logistics

the perceived advantages and disadvantages of EDC versus paper-based data recording systems. These investigators/dispensers had recently completed VICH GCP small animal studies using three different EDC systems. Computer expertise at the study sites ranged from minimum to competent users.

1. What were the main advantages you found when using EDC systems compared to paper when recording the study data?

• The lack of paper!!! Also the reduction in the number of folders to store the study documentation.

• NOT having to fax all the completed CRFs to the monitors on each study day.

• Data entry much easier than on paper and more difficult to forget to add data or enter incorrect format of data (obviously this depends on the level of edit checks that have been built into the system!).

• Data corrections and answering queries are much easier on EDC as the system clearly documents when all the corrections are made and by whom. Less “messy” than paper-based CRFs.

• Randomisation and dosing calculations on EDC saves time and potential errors.

• Receiving notifications of study activities, i.e. queries pending etc., really helps keep on top of all the study activities to be performed.

2. What would you say were the some of the disadvantages of an EDC system versus paper systems?

• Having to learn how to use the different EDC systems for different studies.

• Although the EDC systems have the CRFs translated into the local language, in certain cases the menus are in English, therefore we need to have a clear understanding of what they actually mean.

• Remembering to “save” the data, as some systems used do not save automatically after each field is entered and the page has to be manually saved – and if the system gets “stuck” before the page has been saved, then potentially you can lose the data entered on that page.

• Remembering to NEVER use the internet browser back arrow as data will be lost if the page had not been saved.

• When more than one animal has to be enrolled, for example when enrolling several dogs within one household, then it can take longer than using the paper CRFs.

• It does take longer to review electronic data than on paper as there are several electronic “clicks” required for the equivalent of turning a paper page.

3. What would you say has helped you make the transition from performing clinical studies using EDC compared to paper systems?Without any doubt, being able to contact the monitor at any time with any query on how to use the EDC system, and who can explain it in the local language. Veterinary practices are open routinely until 8 or 9pm and therefore being able to talk

to the monitor at any time is a huge advantage.

4. Given the choice, what method of collecting study data would you like to use in future clinical studies and what improvements would you make to the systems?

Definitely EDC; the overall experience of recording data on an EDC system rather than paper appears much more straightforward and less time-consuming.

Improvements could be made in the design of the systems, for example to clearly identify the animal name together with the animal study ID, as we remember animals’ names easily, however animal study IDs are more difficult to associate with the animal. In addition the ability to “view” several pages of the same animal at the same time would also be a nice optional feature.

Interview with Quality Assurance - EDC for Animal Health Applications - a QA perspective on validation by Iain McPhee, Novartis Animal Health

The recent explosion of interest in EDC within animal health for the collection and management of clinical study data has meant that EDC vendor companies are showing interest in the animal health market and its unique challenges. Some of these animal health-specific challenges include lack of computer bandwidth during a sheep study in rural Northumbria, or coping with hardware that cannot withstand the driving rain on a hillside while recording clinical assessment scores. The movement from paper to e-records is also a challenge for the QA unit. How to effectively focus resources in a changing environment? The QA challenge starts with the introduction of the system to the sponsor company. QA in this context may be a specialist department within the quality department of a company depending on company size and structure.VICH GL9 GCP expects that the computer systems we use in clinical studies are validated. How else can there be a comparable level of confidence to a paper record?

8.3.6. ……….. A computerized system should ensure that the methods for record keeping and retention afford at least the same degree of confidence as that provided with paper systems. For example, each entry, including any change, should be made under the electronic signature of the individual making the entry, and any changes that are made to data stored on electronic media should be maintained in an audit trail to protect the authenticity and integrity of the electronic records.

For EDC systems there are at least three configurations of sponsor and vendor software that can be considered:

1. Outright purchase of an EDC system and internal sponsor validation with or without leveraging the vendor’s information for the validation

2. Software as a service (SAAS): the system is owned and run by the service provider, data are captured at the vendor’s data centres, and the vendor carries the system risk


IT & Logistics

3. Some hybrid of the two above; variations on purchase, siting of software and computer servers, data capture and validation responsibility

Each has different challenges for QA’s assessment of systems compliance. Outright purchase of EDC software to run on the sponsor company’s computer infrastructure is a traditional option. QA may audit the vendor company to ensure their systems and processes for software development are adequate; the audit outcome will moderate the depth of in-house validation. QA will be involved in the validation, reviewing and approving the high-level validation document deliverables and the validation plans and reports, and approving test scripts for the installation, operational and performance qualification steps (IQ, OQ & PQ), etc., in the development of a validated system.

Because of internal resource and computer systems expertise constraints, SAAS may appear to be an obvious choice. The vendor has responsibility for the system and system validation, but remember, ‘the ultimate responsibility for the quality and integrity of the study data always resides with the sponsor’. Sponsor QA resource requirement may be lower, but greater care is required in assurance of the vendor, their systems, processes and system validation. Computer vendors do not work to the quality systems of the pharmaceutical industry, though many are ISO certified. Carefully structured vendor audit is required during vendor selection to provide the assurance that the vendor can provide a validated system within a secured environment. The vendor will need to be on the sponsor’s routine audit programme as a qualified supplier.

The third choice of a hybrid system is perhaps the most difficult from the QA viewpoint. There must be absolute clarity in the contractual agreements with regard to who is responsible for what parts of the system and its validation. QA can then develop an auditing plan to adequately test the compliance of the system during procurement and installation. QA should be involved at an early stage. Hybrid systems most readily fail at the interface between the sponsor and vendor.

QA need to reflect on their study-related activities. The database design by skilled IT staff, including study-specific user requirements, design of e-CRFs, security and data controls etc., all require structured testing (PQ), and QA oversight will also be required for these activities. On the other hand, the many issues that may occur with paper CRF are removed, e.g., no transcription errors, hence saving QA audit time. The requirements for investigator site audits will not change significantly; a minor adjustment to the new technology is needed. At final study reporting, QA can have greater confidence in the data sets provided, assessment of CRF against the database provides no added value, leaving time to concentrate on risk areas like adverse event reporting when IVP is a medicinal product.

With an EDC system, QA has an important role to assure compliance and validation of the system that will protect the

sponsor’s technology investment. The QA practitioners study-related activities in Animal Health will change, and the focus of study-related review, particularly at the beginning and end of a clinical study, will change.

Janice Sarasola: Born and bred in Glasgow, Janice graduated with a BSc. in Biology followed by a PhD in Veterinary Medicine at Glasgow University (1993). Janice continued her post doctoral research at Glasgow in swine diseases. On completion of her postdoctoral studies Janice joined Pfizer Research at Sandwich where she held different positions within Human Clinical Development (R&D) involved mainly

in European Phase III anti-infective clinical trials.Following her career in the pharmaceutical industry, Janice jointly set-up ONDAX Scientific, a contract research organisation (CRO) located in the UK and Northern Spain. Since the year 2000, ONDAX has been providing clinical development services to the pharmaceutical industry including set-up and monitoring of multinational VICH GCP clinical trials in livestock and companion animals, Data Management, Statistics, Quality Assurance and Training in VICH GCP. Janice is responsible for the Quality Assurance department within ONDAX Scientific whose activities include the auditing of the VICH GCP clinical trials and the related Data Management activities including database design and validation audits for both paper and Electronic Data Capture (EDC) database systems. Janice has been a member of RQA since 2000, becoming a member of the Animal Health Committee in 2008.

Jo McKelvie: After graduating from Glasgow Vet School (1992), Jo started her career as a clinician in mixed veterinary practice in Scotland before moving south to the RVC, London. There she studied for her PhD on veterinary immunopharmacology and enhanced her clinical skills whilst working in the equine hospital. Upon completion of her PhD in 1998, Jo joined Pfizer Animal Health, Kent. As

an Associate Director, Jo’s duties at Pfizer Animal Health included Global Team Leadership for multifunctional product development teams and the design and execution of clinical trials compliant with predominantly VICH GCP. Jo has contributed significantly to several successful novel product marketing authorisations for both farm and companion animals. Currently, Jo is based in Ireland providing independent consultancy services in the field of clinical trials, technical and medical writing, project management and quality assurance, as EVITA Services. Jo has been a member of RQA since 2007.

Iain McPhee: From a nutrition/biochemistry background as Study Director developing trace element medications for ruminants, he became involved in quality with the impending EU requirement for GLP in veterinary pre-clinical safety studies. The facility in which he became Quality Manager was the first exclusively veterinary medicinal development laboratory to come into

the GLP compliance programme. He was a member of QAG, the precursor to RQA, and a founder member of the RQA Scottish and Northern Regional Group. Iain has sat on a number of committees both in RQA and allied areas to promote veterinary research quality assurance. Currently working for Novartis Animal Health as a specialist in Quality Assurance he is concerned with Veterinary GCP and GMP, having been involved in the globalisation of VICH GCP throughout the company.


• Testo data loggers are delivered with a calibration certificate traceable according to ISO 17025• With testo data loggers, the well being of the livestock can be monitored during transportation and on arrival• Comprehensive alarm management, allows the setting of multiple alarm limits• The Saveris system, measures the temperature and humidity values of goods in processes and during transportation.

temperature, humidity & shock monitoring


IT & Logistics

Protecting the Supply Chain

In the world of human health, the increased call for establishing a clear and traceable pedigree for pharmaceutical supply chain had driven the US government to take up legislation. Hotly debated by the California Board of Pharmacy and several times delayed, the issue of serialising medications has now been put into law by the federal government, making the issue unavoidable. Globally, the European Union is debating its own legislation, and countries in emerging markets such as South Korea and Turkey, are more rapidly bringing laws to legislate that product is serialised as a precursor for sale in their country.

Estimates vary, but a World Health Organization report dating back more than a decade conservatively estimated that the revenue generated by substandard or counterfeit medications exceeded $32 billion dollars. Given the rapid growth in the market for animal health products, its attractiveness for supply chain diversion and counterfeiting is also on the rise. The global market for animal health medications is estimated at $22 billion dollars. Spending specifically on companion animals is expected to rise 3.3 per cent annually in the United States, and more than 10.2 per cent in emerging economies such as Latin America.

Using SerialisationA major pharmaceutical and animal health client recently came looking for a solution to their challenge in

authenticating the supply chain for their product. They were looking for a multi-tiered anti-counterfeiting and product authentication solution, allowing them to identify product in the supply chain, confirm its authenticity, and affirm its pedigree through their sales channels. Their goal was to protect the valued relationship they maintain directly with veterinarians for sale of their products and avoid the grey-market sale of their products. This is what is referred to in the industry as diversion, whereby veterinarians resell animal health medications to third-party resellers. This resale dilutes the value of their products and the important role of the veterinarian, while at the same time introducing opportunities for adulterated and potentially counterfeit products to enter the supply chain.

Working with the client, a serialisation solution was developed, that met their multi-tiered needs – a strategy where they employ overt and covert technologies and serialised coding to provide a unique identifier on each and every pack. The solution must include aggregation of coded cartons (the saleable unit) with its parent display and its associated code, as well as aggregation of the displays into the unit corrugate shipping container (also serialised), and ultimately the shipper to the pallet. This association reflects all the parent-child relationships as the product is built for sale. Completed batches would be accompanied by an electronic file of all commissioned codes, provided through


IT & Logistics

an XML file to allow the client to confirm codes in the field. Also provided is an inventory of any codes that had not been commissioned or had been removed in the batch, thereby keeping accountability of all live codes and any that had been obsoleted from the system.

Creating a Multi-tiered SolutionOne of the keys of this packaging solution is providing both overt and covert coding, namely a visible code identifier, whereby veterinarian professionals can readily identify that the product contains a code and can themselves verify its authenticity as valid product by means of an authentication system. This methodology is further supported by a covert coding system. This system employs the use of ultraviolet (UV) inks to apply codes, effectively invisible to the naked eye. Furthermore, the UV code is applied as a two-dimensional barcode, thereby effectively blinded to the laymen viewer should it be detected. These barcodes represent a serialised numeric code, which is assigned to specific sales channels in their downstream supply chain. When product is unearthed in the undesirable grey markets for sale, the client is able to identify to which veterinarian it was originally sold, by means of identification using these hidden codes and their assignments.

The ProcessEffectively employing serialisation in a packaging operation requires many levels of verification and data capture. The primary packaging is done and loaded into blister-packs. The blisters are loaded with leaflets and ancillary components into the unit cartons, which are the saleable unit in the market. After the application of the lot and expiration code, the overt (black) serialisation code is applied with a two-dimensional barcode and a human-readable code. Upon application of the codes, an automated vision inspection looks for the presence, correctness, and legibility of the code. Any code deemed to be of a lesser grade of readability is rejected off the line and captured as a rejected code. Likewise, codes deemed acceptable are taken up into the stream of acceptable codes. In this process, cartons also receive the covert UV code and similar inspection verification process. Coded cartons will then travel to the next station, whereby they are loaded into displays. In this process a discreet code is applied to the tray. Upon completion of loading the ten cartons, a vision system will confirm the codes and capture the relationship of the unit cartons and the display, thereby creating the first of the aggregation steps. Displays are then packed into the corrugated shipper. A serialised code is placed on the shipper’s label, scanned, and then married to the codes of the individual displays held within. The second level of aggregation is then captured. Successfully completing this step, each shipper is then loaded onto the pallet and logged. Upon completion of the palletisation, the pallet is issued its own discreet serialised code and married to its contents, completing the aggregation of the overall pallet load. These aggregated units are then rolled up in the reporting of the overall batch and its associated commissioned codes.

Executing for SuccessSerialisation is one part packaging process, one part IT data

management. The handling of codes, both inbound and outbound, is critical to the process of successful serialisation and establishing a foundation for securing the supply chain. Establishing a serialisation process takes thorough planning to ensure proper execution. The key to success is working with the client to truly understand their needs and goals for the programme. If done properly, it can be a very effective tool in ensuring that the product on the market is effective and provides consumers the confidence they can expect.

Justin Schroeder is the Executive Director, Marketing, Business Development & Design at Packaging Coordinators Inc. (PCI). Mr Schroeder is responsible for new account development, global marketing, and creative package design with a focus on the development and commercialisation of unit-dose and compliance-prompting packaging. He holds a Bachelor of Science from the School of Packaging at Michigan State University,

and a Master of Business Administration in Marketing from Northern Illinois University. Mr Schroeder has been at PCI/Anderson since 2000, holding positions including Process Development / Packaging Engineer, Customer Project Manager, Director of Project Management and Planning, and most recently Senior Director, Marketing & Development Services. Previously, Mr Schroeder held package engineering positions with Hershey Foods Corp and at the J.M. Smucker Co. (Smucker’s). Mr Schroeder is a Certified Packaging Professional from the Institute of Packaging Professionals (IoPP) and is the Vice Chairman of the US Healthcare Compliance Packaging Council (HCPC). Email: [email protected]


Manufacturing & Packaging

Developing Products in the Animal Health IndustryThe animal health industry has seen a transformation over the past few years in terms of investment dollars flowing into the industry, as investors see this space as a previously untapped area of growth. Even so, there is a great deal of unfamiliarity with the space, leading investors to either take chances with what they believe to be the facts, or to undergo a long evaluation process in which no investment takes place due to uncertainty around the field.

The animal health market is a very different market than that of human health. There are few third-party payers as insurance is still embryonic, and there are no transactional government programmes. Veterinarians sell and dispense medications, vaccines, and other products so the value of products versus services becomes blurred at the consumer level. The value of the overall market also gets confounded by the inclusion or exclusion of foods, feed, treats, toys, “nutraceuticals” and veterinary pharmaceuticals as constituents of both value and growth.

If one focuses purely on veterinary products defined as packaged goods sold at the manufacturer level, the value of the global veterinary industry is approximately US$23 billion. These products include the various pharmaceutical products (antibiotics, analgesics, parasiticides, etc.), biologicals (vaccines, antisera, etc.), and medicated feed additives (the 50# bag not the ton of feed into which it is dispersed). Looking at the various categories comprising this $23 billion market, parasiticides comprise approximately 30%, biologicals 25%, antimicrobials and other pharmaceuticals make up 35%, and medicated feed additives make up the remaining 10%.

It is also important to understand that while there are large categories, there are very few “home runs” in animal health. Other than certain parasite control products, especially flea and tick products, and a few antibiotics, the animal health industry is made up of a collection of singles and doubles with $50 to $100 million products being considered blockbusters. Even the animal health companies follow this same formula, as, while the top five companies comprise 80% of the global market, there is a very long tail with companies having sales of $5 million being profitable and successful in niche markets.

So, with this backdrop of animal health, why the interest in investing in the space and how are the right choices made?

The animal health market has demonstrated a recession-proof nature uncommon to most industries. Though certain segments may suffer from a transient downturn, this is generally offset by concurrent growth in other sectors. For example, if market conditions cause products for livestock to suffer in sales, it is not unusual for companion animal products to flourish, or vice versa. This trait has led to the consistent year-on-year growth of roughly 6% to be widely accepted by most industry experts.

There is an increasing demand for animal protein, with no foreseeable change in this trend. As the global population of people increases, there is a linear demand for increased protein. In addition, as economic power increases, there is a demand for protein perceived to be of higher quality or value — the beneficiaries of this increased demand extending to fish, poultry, pork, beef, and milk, in addition to others.

The pet market has also seen substantial growth as people expect the same quality of care for their pets as they expect for themselves. While stories of extraordinary and heroic expenditure on individual pets abound, the reality is that these are the exception, however reasonable spending for improved care and quality of life is increasing. Products for parasite control, pain relief, and quality of life continue to be in high demand and growing for the pet market.

An additional benefit is the relatively low cost and short timeline to develop animal health products. Once a formulation is known, development time is measured in 4-6 years for companion animal projects, and total development costs, in many cases, are less than a single human study. The key to these savings is, however, dependent upon having a sound strategy and an experienced team in place to execute that strategy. Additionally, being able to submit pharmaceuticals in a phased manner on a section-by-section basis enables developers to make numerous go/no-go decisions ahead of doing all the work required for a full submission. This, along with concurrence, allows investors, both independent or within animal health companies, to make informed decisions with regard to costs and timelines, initially and throughout the project.

Given the attractiveness of the veterinary market, a number of innovators, entrepreneurs, and investors are being drawn to the space. While the financial hurdles and time to approval are lower in veterinary medicine than in human, it remains critically important to understand the market and the technical requirements expected in animal health. Applying a disciplined approach to this process is fundamental to avoid errors in market expectations and forecasting, as well as to ensure an efficient approach to development of animal health products.

The initial step of an animal health development programme is an understanding of the market and a cursory review of need. A key step is simply answering the question, “who will write the cheque?” This evaluation forces the discussion of perception of need by the final user — pet owner, livestock owner, or veterinarian. If the purchaser of the technology is unclear, or if there is question as to the willingness to spend money for the benefit offered, there is reason to reconsider the opportunity. Finding a perfect solution for a problem that does not exist is less attractive than an adequate solution for a well-recognised need.



Once the question of who will write the cheque has been answered, three questions need to be answered at the outset in order to determine if the opportunity for an asset to become a viable animal health product is real or not. First, the question of scientific merit must be answered. Are the fundamentals sound and do they withstand technical scrutiny? This evaluation also must contemplate if the science is applicable to the targeted veterinary species. Dogs and cats are very different from one another and both differ from humans. Simply because a product has utility in one species does not make it the right choice, or maybe not even a safe choice, in another. While it is popular today to espouse the repurposing of human health products for use in animals, this has been the case throughout the history of veterinary medicine from penicillin and sulfa drugs onwards. Most animal health products on the market today have their origin in either human health or the crop chemical industry. Still, products for humans may not be effective in veterinary species (such as Type II diabetes products when used for cats), or they may be unsafe (Acetaminophen).

The second question that requires attention is the “fit” with the practice of veterinary medicine. While new technologies tout to be disruptive, it is important that the use of the technology aligns with the routine and management practices of veterinary clinics, livestock operations, and pet owners. For example, a product that offers a solution for a pressing need is unlikely to be adopted if administration is too frequent or technical. As veterinary species present their own challenges in dosing and administration, attention to formulation that enables compliance often leads to adoption and market share. As veterinary medicine relies on owner administration to complete the course of therapy, failure to comply would be expected to limit sales and share more than a competitor. Fulfilling the recommended course of treatment is also more apt to result in better efficacy, which will further encourage its use.

The last key point to consider in determining the viability of a novel technology is a reasonable assessment of the financial circumstances. While everyone has heard the stories of heroic expenditures in order treat an animal, these are then exceptions and not the basis for product development. Recent economic events have sent a clear message regarding the amount of money which the animal-owning public is willing to spend. Even should there be an expectation of a premium value to the pet owner, the margins to veterinarians and distribution must be taken into account. At that point, if the product is to have optimal value to an acquiring animal health company, it should carry sufficient margins to align with that company’s financial requirements.

When considering the companion animal health market, it is readily acknowledged as the area in which value and margins are most easily achieved. However, while these markets are attractive, the per animal expenditure at the manufacturer level offers sobering insight. In the United States, for example, there are an estimated 150 million dogs and cats. The United States market for veterinary products at the manufacturer level is estimated at $7.7 billion USD with 46% of that market being attributable to the companion animal market (source: Brakke Consulting). While conceding that not all of these animals seek veterinary care, the $3.5 billion USD market when distributed over 150 million animals is less than $24/annually. This should add caution to the exuberance of value of a single treatment; it also illustrates the value that can be realised by easily-administered medications that address the pet health issues of interest to pet owners.

Production animals continue to hold financial opportunity for novel products. The benefit to financial assessment in these species is the ability to calculate benefit based on the performance in light of established market prices. Recognition that producers expect a return on their investment,



improvement to performance or from disease treatment should be a multiple of treatment cost. Additionally, given the handling challenges of livestock, convenient delivery systems will enhance adoption and, therefore, market value.

Once a technology has been identified whose science is solid, whose use is easily incorporated into a veterinary practice, household, or livestock operation, and whose financial performance can be forecast to fall within industry expectations, the next steps involve target determination. The target is defined as the desired label in the desired territory. This will dictate the regulatory body, if any, which will have jurisdiction over the approval of the product. At this point, the development plan should be single-minded in generating the data necessary to convince that regulatory body to say “yes.”

Knowing the governing regulatory body, or bodies, in the event of a global development programme, will dictate the specific criteria for product approval. The constituents of the development programme include regulatory guidance, bench science, clinical science, manufacturing, and legal. It is highly desirable that these various development units be involved and coordinated from the very beginning of the project. It is this coordination that enables the development programme to be efficient in terms of both time and money.

The governing regulatory body will also dictate the expertise and assets required for approval. For example, the skills required for development of biological products are fundamentally different from those required for pharmaceutical products. This also extends to facilities, as USDA and FDA products have very different requirements. Knowledge of these differences at the outset of a project will result in proper treatment of the asset and improve the odds for successful development.

It is also advisable to include business input to insure the development programme incorporates any changes in the market, including, but not limited to, competitive products entering or exiting and views relative to disease, treatment, or prevention. Attention should be given to the label required to be successful in the market. Are there minimal label claims necessary for a product to achieve commercial justification for the cost of development? Conversely, are the cost and time required to get the optimal label result in a market justified commercially? Having a definitive label target will further serve to keep the team focused on the goal of development, which is an approved product.

Novel technology is understandably accompanied by claims of patent protection. Perhaps more important is the issue of freedom to operate. While patents offer the benefit of protecting a technology, patents do not equate to the ability to practice the art without objection. Dealing with any real or potential infringements early in the development process puts the developing entity in a better position to negotiate a favourable licensing arrangement or realisation that the path to market must be navigated to avoid infringement.

Following a disciplined approach to technology assessment and design of a development programme is the most predictable path to gaining product approval. Veterinary product development shares many similarities with the development of products for humans, though there are important and meaningful differences. Engagement of individuals experienced in animal health is recommended to assist in navigation of these differences.

The adage of “plan your work, then work your plan” certainly applies to successful development of animal health products.

Dr. Tom Overbay is one of the founders of Expedite Animal Health, a company formed to assist with the commercialization of products in the veterinary industry. Dr. Overbay has successfully brought to market a number of products arising from universities, government agencies, human hospitals, start-up, and multinational pharmaceutical and chemical companies.Email: [email protected]


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Waste Not, Want Not

The need to save where possible and not to waste was instilled in me from an early age.

Born on a smallholding in Glossop, to say I have pigs in my blood is almost, but not quite, true. My first introduction to pigs, so I am told, was the hot summer of 1955. My mother was feeling the strain of childbirth, looking after my siblings and the house and helping on the farm, so she thought she would have two minutes in the sun, laying me in the grass in the field whilst she had a nap. Unbeknown to her, father was cleaning out pig-pens and had put a sow into another pen out of his way, but he had failed to shut the gate properly and the sow wandered into the field where mother lay. The sow took a shine to me, and as my mother dozed, decided she could look after me better than my mother, so started to carry me off in her mouth. Fortunately for me, my father had decided to check on us and discovered my predicament - had he not, I probably wouldn’t be writing this article today! I was involved with pigs from then on. We had a round where we would collect the waste food from shops.

In the winter of 1962, during the extremely snowy and cold weather in Old Glossop in the Peak District, the temperature was -30⁰F, freezing the river. Father had some sow and weaner mash in stock, and to make it last we needed to mix it with hot water. Due to the mains water being frozen, we melted snow in buckets on our Rayburn. Mother provided me with mittens she had knitted herself; these proved to be a liability rather than an asset as they got wet and froze, giving me mild frostbite in my fingers, and this took years to right as my fingers would split in the ensuing winters.

Our smallholding was only a sideline to father’s building company. He got the chance to buy the adjoining field and allotments together with the sheds which were on the opposite side of the river to where there had been a WW2 munitions store Nick (my brother) and I were tasked with tidying up the allotments and sheds. Under one of the sheds I discovered a box of ammunition and a machine gun as well as some grenades. Being the inquisitive person that I am, I thought I would find out how the grenades worked and decided that I would remove the pin. Fortunately for me and my brother, the pin had rusted and proved difficult to remove, and again father came to my rescue as he had returned from work early that day. Finding me messing with my new toys, he picked me up and carried me to the house; having been a sergeant throughout the war, he did not seem fazed at all but rang the local police, who then sent the Army bomb disposal team out – could you imagine what would happen today! Time moved on and my circumstances changed; I decided not to farm but to go into mechanical engineering, and developed my career in that field.

The feeding of swill was banned in 2001 due to an outbreak

of foot and mouth, which was blamed on pig swill – although I have my doubts. This meant that a valuable food source was directed to anaerobic digestion (AD) and landfill, putting a further strain on world resources.

During my early years I was very interested in the natural world, especially bird-watching, and spent all my spare time on the moors above Old Glossop noting the arrivals back from wintering at the coast of curlews, lapwings and my favourite, the golden plover. All of these birds returned to the moor to breed in their hundreds. Sitting still, dressed in camouflage I found it easy to watch the chicks running around the peat bogs catching insects. Another joy when walking back from the moor top through the valley (Mossy Lea), which had woodland on both sides, during May and June, was listening to and watching as many as 20 cuckoos flying across the valley. Only the male makes the famous call - the female cuckoo calls back a much quieter, gurgling noise. I liked to tape the birdsong, especially the cuckoo, which was not easy due to the distance. Seeing a sound recordist on a TV programme using a parabolic reflector, I made one out of an old heat lamp to add to my battery-powered tape recorder, which worked amazingly well.

On leaving school, work took up most of my time, but weekends and holidays we spent rock climbing, going to Wales and Scotland on a regular basis. Some 20 years passed before I retraced my steps up the valley (Mossy Lea) where I had watched and listened to the cuckoos, and now there were none to be seen or heard, I carried on up to the moor, and to my horror, there was not one pair of golden plover to be found. Where once it had been easy to see a hundred curlew, the day’s walk revealed that 30 other species like skylark and pipit were much fewer in number. I went back nearly every Sunday for two or three years, and the bird life did not get any better - what on earth had happened? The only thing that I had noticed was a great increase in the number of people walking, running and mountain-biking on the moor, and also a clay pigeon shoot had been set up at Mossy Lea. Still I did not think these were the only causes of the disappearing bird life, having watched documentaries about how rainforests disappearing at an unbelievable rate of three acres per minute, climate change, melting ice caps, and all the other pressures we put on the earth is affecting natural life. This was obviously affecting bird life here, which is very worrying.During the 20 years of failing to go onto the moor above Old Glossop, I had built up a business in road transport and engineering, enabling me to purchase a smallholding for myself. Still being obsessed with pigs, I had always wanted to keep wild boar, which can be a little challenging. They are very slow-growing so standard cereal pig feed, being so expensive (reaching £350 per ton in 2013), was not an economical food. A friend had just got a job as a store manager for Sainsburys in Manchester, and in 2007 he got approval from head office



for me to collect their unsold food from the store; it was really amazing, the quality and quantity of the assorted, discarded food, and it was spot-on for my herd of wild boar. Sainsburys thought it was a much better end use for their food. Obviously this created the sustainable, green circle of pork production. I set up a round collecting from the five Sainsburys superstores three times per week, bringing in tons of wonderful food. This became too much to de-package by hand, so I looked on the internet for a machine, but being frightened off by the price I decided to build one in my engineering shop. The machine worked very well, meaning that we could now start to sell some of my excess product.

I thought I should check with the authorities, who I discovered were Trading Standards and Animal Health. I rang them both to inform them what I was doing and gave them the address. The gentleman I spoke to was very good and said he would come to see me. Four hours later, two cars arrived in the yard, making an entrance like something out of The Sweeney! The four people that had arrived in the cars soon told me that I could not collect the unsold food as there may be animal by-products in the bin, which there were. I showed them how we checked the bins by tipping each one individually into a hopper which led down to a conveyor; we stood at the side and picked out any meat, fish, eggs, glass and tins. If any meat was found it was placed into a small bin which I took home each night, as I bred black labradors - quite often having as many as 24 puppies and parents, the meat helped

with the food bill. My visitors said that even though the food was in sealed packs and still fresh (we collected every two days) there was a possibility of foot and mouth virus in the sausage and bacon, and that the packages may leak this out, causing another outbreak in the UK. I do not think that Labrokes bookies would give good odds on that line of ‘ifs and maybes’! That afternoon, Trading Standards stopped Sainsburys and all my other shops from supplying me. After many emails from October 2009 to July 2010, Trading Standards accepted my plan of collecting from supermarkets as long as the store does not put meat, fish or eggs in the bin, and a HACCP (Hazard Analysis and Critical Control Point) plan was implemented. Stickers were put onto the lid of the bins as a reminder, and back at the farm each bin is checked on the conveyor picking line, as before. The system works well; we resumed animal feed production in August 2010 and were very surprised to receive an invitation in November 2011 to attend a meeting at the House of Lords to discuss food waste and our project. There we met many interesting people, one of whom was Tristram Stuart (author of Waste – Uncovering the Global Food Scandal), who has travelled the world investigating the horrific waste of natural resources. In November 2013, he held an event in Trafalgar Square called The Pig Idea; he reared six pigs in Stepney Park on unsold food, then had them slaughtered, and served thousands of people at the event, using every part of the pig – some of the food being cooked by Hugh Fearnley-Whittingstall. The event was designed not only to show how unsold food can



go to a good use, but also to highlight how climate change is affecting crop production.

Since making the first machine, I have redesigned and redeveloped the machine (Super Separator) and it is now capable of de-packaging and recovery of more than 95% of most food. The wrappers leave the machine very clean, ready to be recycled. From the operator’s point of view, the fact that the machine is practically self-cleaning as it runs is a bonus!

Animal Health state that the accepted limit for inclusion of plastic in feed is 0.15%. This equates to 66g per ton – our de-packaging machine achieves a much lesser amount.

I have another device which removes even more of the minute amount of plastic. Paper, being a natural material, is digestible and is accepted at a high level, but again the Super Separator achieves an extremely good level of removal. There is only one manufacturer who wraps bread in waxed paper, but this is not an issue.

The world has many problems producing enough food for the increasing population with decreasing farmland, flooding, environmental issues and fuel to produce electricity, and now disposal for unsold manufacturers and supermarket food – estimated to be 15 million tons annually in the UK. This foodstuff is a very valuable commodity and must not be wasted.

DEFRA’s favoured route for all food waste is to anaerobic digestion plants, saying there is a bigger risk of a foot and mouth outbreak even when the HACCP plan is put into place for food to be processed into animal feed. This is hard to believe when the spent AD effluent is spread onto farmland as a fertiliser. I would be much more concerned about this being a risk. DEFRA have supported ADs with large grants and subsidies for ‘on tariff’, paid for many years, also helping with

the technology. One such project was set up at Harper Adams Agriculture University in Shropshire at a cost of £3million two years ago; the AD facility there has burst vessels twice in the last 18 months, spilling millions of litres of contaminated, unpasteurised waste into the environment. How many more similar incidents have happened at premises less in the spotlight? I know we need electricity, but there are many things that can be done, such as:

• not wasting it on road lighting (I drove on the M3 and M27 from Newbury to the outskirts of Southampton, a stretch of motorway with no lights, and did not find it a problem)

• not using illuminated advertising boards – especially during the day!

And there are many more. We could develop better ways of power generation - using the tide must be feasible.

On 1st January, 2014, the law changed in Scotland, so that anyone who produces more than 50kg of food waste must register and declare which recycling route their waste is being sent to, with the fine for not adhering to the law being up to £10,000 - making the collection of unsold shop and manufacturer food even more viable.

The Farmers Guardian reports weekly on what is happening. On 6th June 2014, it reported a change in Government thinking, as in the same week as the Harper Adams disaster it was announced that there will be no more grant money or subsidised tariff available. The Farmers Guardian has previously reported that antibiotics used in pigs are getting through to us, causing hospital treatments to fail.

We now have a few farmers collecting from manufacturers in London and Sheffield; our aim is to duplicate this throughout the UK, which may bring back some of the 65% of pig farmers who have left the industry, causing the UK to import 60 million pounds worth of pork annually.

Obviously the non-profitability of pig farming is why young people are not joining agriculture, leaving us with the average age of the UK farmer at 60. If we could restart UK farming, this would tick lots of boxes, including:

• cutting carbon footprint – less importing of food• reducing pressure on the rainforests of Brazil and Borneo

where soya is grown – we can grow oilseed rape to obtain the protein needed to add to pig feed

• creating thousands of jobs here • improving our food security

Paul Goddard, born in Glossop in 1955, his professional life has included owning a building company, motor repair garage and is very involved in the food recycling business. Mr Goddard is passionate about wildlife and natural habitat. Email: [email protected]

Exhibitor success at VetME 2O14

Now in its 7th edition, VET Middle East is the region’s

leading platform for veterinary suppliers and

manufacturers to showcase their latest products and

services.

Running alongside AgraME & AquaME the event

continues to grow at a tremendous rate with over

5O% of the exhibition space already sold.

'VetME is the only meeting place in the region for

veterinary professionals'.

To book your stand visit www.vetmiddleeast.comor contact [email protected]

Media PartnersSupported by Organised byPartner Events

16-18 March 2O15Dubai International Convention and Exhibition Centre

97%

87% 43%

84% of the exhibitors consider VETme to be crucially important to their marketing activity in the region

of the visitors will returnto the event in 2O15

of the exhibitors weresuccessful in establishingcontacts for future sales

of the exhibitors securedbusiness deals worthUS$ 1OO,OOO or above

Full page 297x210-PRINT.pdf 3 11/8/14 8:56 AM


Exhibition & Conferences

Vet, Agra and Aqua Middle EastHis Excellency Dr. Rashid Ahmad Bin Fahad, Minister of Environment and Water, opened Agra and Vet Middle East on the 25thof March 2014, the regions specialist veterinary and agribusiness trade events.

With regional animal health on the agenda, the Veterinary Outlook Forum was addressed by leading regional and international veterinary experts as they discussed various topics including diagnostics, therapy, and treatment of domestic, farm and exotic animals.The forum provides an excellent opportunity to learn and network with regional peers and colleagues.

While more than 4,500 visitors passed through the halls of Vet and Agra Middle East, the remarkable success has meant that more than 40% of the floor space has already been occupied for Vet and Agra Middle East 2015.

The fast-growing event for the burgeoning Veterinary industry has witnessed a 71 per cent growth in visitors since 2010, with the 2014 edition bringing more than 50 international manufacturers and suppliers of veterinary products and services.

Organised by Informa Exhibitions, Agra and Vet Middle East are held under the patronage of His Excellency Dr. Rashid Ahmad Bin Fahad, with a continued support from the UAE Ministry of Environment and Water.

Awards eveningIn 2015 we will see the launch of the Veterinary awards being held alongside the Agra Middle East awards.The 2014 edition of the Agra Middle East Awards celebrated agricultural innovations from around the world at a glittering ceremony and gala dinner at the Dubai International Convention and Exhibition Centre.

The awards were judged by an expert panel who selected the winners from a shortlist of 14 projects across five categories.Richard Pavitt, Agra Middle East Exhibition Director praised this year’s finalists and winners for the achievements they’ve made in their businesses and their contribution to agribusiness in the Middle East.

We’ve had an exciting year for the Agra Middle East Awards, given the diversity of industries represented across the five categories. All of this year’ nominations illustrated the diverse challenges and innovative solutions in implementing good agricultural practices on their farms, at their production facilities, and in the management of their business.

Informa Exhibitions is proud to have received so many entries for our second edition of the AgraME Awards and expects continued growth for 2015. Congratulations to the winners and all those shortlisted.

Veterinary Outlook Forum Agenda from 2014Chairmen’s Opening RemarksDr.AzzamMahmood Al Wathaifi, Integrative Veterinarian, FEI Official Veterinarian, Endurance, UAE

EQUINE AND EXOTIC ANIMALS PresentationUpdate on Diagnostic Tests and Vaccines for Horses in Use Around the WorldHorses are the most travelling animals in the world and the level of infectious diseases’ control as well as harmonisation and standardisation of internationally used tests and vaccines for horses are of the greatest value. This presentation will give information about diagnostic tests for equine infectious diseases and equine vaccines commercially used worldwide as well as recommendations of Animal Health Organisation (OIE) on these important issues.Dr. Ekaterina F.Zabegina,President, Russian Equine Veterinary Association, Russia

PresentationNew Techniques to Improve Equine ReproductionDr. Guy Khoury, Veterinary Medicine, Al Arabia Equine Clinic, UAE

Open Discussion on Equine Veterinary PracticesThis session will be opened to all speakers and delegates to discuss current limitations, opportunities and future prospects for equine practitioners. DAIRY ANIMALS AND RUMINANTS PresentationInfertility in Dairy Cows and Treatment MethodsThis session will showcase how to increase farm incomes by reducing calving interval and finding the optimum reproductive management that will improve milk production and, reducing replacement rate. Hear how farms that have tighter calving pattern are financially different than farms that have longer calving interval.Bob Abband, Dairy Nutrition Consultant, Louvic Pharmaceutical L.L.C, UAE


Exhibition & Conferences

PresentationHeat Stress Control and Cow ComfortRami is a pioneer in using cooling system that has pushed temperature from 50 degrees to 25 degrees, shading all passages and implementing showers that are supported by movement sensors. Rami’s initiative was documented by BBC World News, and responsible for the expanding number of milking cows from 3500 to 6000 by January 2013.Dr. Rami Hamad, Farm Manager, Al Rawabi, UAE

WILDLIFE, ZOOS, AND PETS Introduction by ChairpersonDr.Majid Al Qassimi, Acting Director, Terrestrial Biodiversity at Environment Agency, UAE

PresentationDisease Management at the Wildlife-Livestock InterfaceThis session will discuss the importance of animal health for the agricultural industries as well as wildlife conservationists. Here, an attempt is made to define the wildlife or livestock interface in the Middle-East, in relation to pathogenic infections, economically important and, or zoonotic diseases and wildlife conservation. Diseases are frequently bi-directional at the interface and require vigilance of all stakeholders.Dr. Anne-LiseChaber, Veterinary Managing Director, Wildlife Consultant, UAE

PresentationPopulation Control and Monitoring of AnimalsThis session will give a brief description on population control, its importance, the techniques and methods used. It will give examples of different applications in different species and discuss monitoring of species with more focus on zoo animals, and free-ranging wildlife species.Stephen Chege, Senior Veterinarian, Al Ain Zoo, UAE

Panel DiscussionThe Big Discussion onthe Future of MENA’s ZoosDiscussion topics include:-Internationalperspective of zoos, the future roles and responsibility for animal welfare-Regulations, standards and policies to support zoo activities and expansion-New trends and Innovation in Zoo management excellence

Chaired by: Dr.Majid Al Qassimi, Acting Director, Terrestrial Biodiversity at Environment Agency, UAE

Panellists:Dr. Gerald Dick, Executive Director, World Association of Zoos and Aquariums, Switzerland Dr. Reza Khan, Specialist, Wildlife and Zoo Management, Dubai Municipality, UAEDr. Mark Craig, Director Life Sciences,Al Ain Zoo, UAE

PresentationBringing Regenerative Medicine to Your Practice: Applications of Therapeutic Laser and the Administration of Stem Cells to Optimize Clinical Outcomes and PerformanceThis session will help give a deeper understanding to both laser and stem cell therapy and technology. It will also show the use of regenerative medicine to optimize clinical outcomes. Through the use of these drug free modalities, Dr. Ron will show how it willoptimise athletic performance.Dr. Ron Riegel DVM, Co-founder, American Institute of Medical Laser Application- AIMLA, USA

PresentationWhat are the Next Steps for Progressive and Independent Veterinary Growth Here for the Middle East?This session will discuss the necessary actions needed to be taken to enhance veterinary practices in both business and research perspectives.

Chaired by:Dr.Majid Al Qassimi, Acting Director, Terrestrial Biodiversity at Environment Agency, UAE

Panellists:Dr. Martin Wyness, Founder, The British Veterinary Centre,UAEDr.Essam Al Hashimi, Manager, Agriculture Policy Section, ADFCA, UAEDr.AzzamMahmood Al Wathaifi, Integrative Veterinarian, FEI Official Veterinarian,Endurance,UAEDr. Roberto Ragni-Alunni, Marketing &Technical Manager, Equine, MENA, BoehringerIngelheim, UAE

Above is the itinerary from the 2014 Outlook Forum with the list of the previous speakers, The speakers for 2015 have not all been confirmed as of yet so we would not include them into the preview just yet.


CPhI Preview

CPhI Worldwide Event PreviewOverviewCPhI Worldwide will see senior decision-makers and innovators from the world of pharma descend upon Paris (Paris Nord Villepinte) for three days of networking, informative conferencing and meetings that will help shape the industry over the next year.With more than 35,000 visitors and over 2200 exhibitors, this year’s edition provides the opportunity for attendees from more than 140 countries to meet under one roof. There will be 20 dedicated zones covering ingredients, APIs, excipients, finished dosage, contract services, packaging, biopharma, machinery and more. Running alongside the pharmaceutical ingredients halls are three other sister brands, which help visitors to quickly identify the right halls for their needs. ICSE is an outsourcing-focussed area designed to connect the pharmaceutical community with contract providers from clinical trials, CROs, logistics providers, data management firms and CMOs. InnoPack brings together buyers and specifiers from the packaging and pharmaceutical industries. Finally, P-Mec Europe features exhibitors from traditional large-scale capital equipment to companies focussed on instrumental analysis, measuring and testing technologies, materials testing, quality control and laboratory.

Celebrating 25 Years of CPhICPhI has been instrumental in bringing together businesses in order to advance the pharmaceutical industry and initiate business growth. This year marks 25 years of CPhI Worldwide’s success in fostering innovation and partnerships. To mark this special anniversary, CPhI invited past participants to submit their success stories, demonstrating how CPhI was a catalyst for initiating growth and achieving business goals.

Highlighting exhibitors and attendees who made valuable connections through CPhI Worldwide, 25 success stories will be featured in a special anniversary publication available after the event. During the exhibition, the winning success stories will be on display through CPhI TV, while additional success stories will be filmed at the exhibition on 7th October. These short videos will be on display at www.cphi.com after the event.

Other Event Highlights:• Womens Networking Breakfast - 7:30am 8th October

@ Villepinte, Networking with fellow female pharma colleagues, inspirational speeches from pharma execs and charitable partners. Tickets available in online registration

• 25th Anniversary Networking Party - 8:00pm 8th October in Downtown Paris at the InterContinental Paris Le Grand. A networking and cocktail reception for the pharma industry, to celebrate 25 years of CPhI Worldwide. Tickets available in online registration

• Innovation Gallery - the latest innovations and product launches from companies at the forefront of the pharma industry

• Pharma Insight briefings, providing regional market updates and specialist topics from ‘Animal Health’ and ‘Orphan Drugs’ to ‘Ingredient Sourcing’ and ‘Innovation in Pharma’

When visiting CPhI Worldwide, make sure you also factor in attending the CPhI Pre-Connect Congress, on 6th October. The conference is an exclusive opportunity to join senior executives and influential speakers from across the pharma industry. Joined by esteemed representatives from Novartis, Catalent and Biocad, to name a few, this year’s congress will feature modules including Drug Delivery Systems and New Trends in Oncology.

Additionally, the show will feature the 11th annual CPhI Pharma Innovation Awards (winners will be announced at a ceremony on the show floor in the afternoon of 7th October). Furthermore, the show features a constant stream of informative content on the latest key developments via the free sessions in the Speaker’s Corners. Here, attendees have the opportunity to hear first-hand from exhibitors across the globe about the latest trends within the pharma industry, whilst also finding out about their latest products, innovations, services and more!

Exhibitors will also be able to take advantage of CPhI’s unique matchmaking programme, allowing direct access to potential customers. Held across three days of the event, this is a customised programme to facilitate high quality meetings, which will be invaluable in delivering a huge return on investment.

CPhI Worldwide, co-located alongside ICSE, InnoPack and P-MEC, brings together the global pharma community and creates a unique environment where leading industry pharma professionals can meet to learn, exchange ideas, and most crucially, drive business growth for their businesses year round.

Register now for CPhI Worldwide 2014 at: http://www.cphi.com/europe/visit

Pharma insights topic: Animal Health (10:15-11:30 Wednesday 8th October)Speaker: Daniel Peizer, Director-Animal Health, Catalent Pharma Solutions (USA)

Mr Peizer joined Catalent Pharma Solutions from Bayer HealthCare Animal Health, where he was most recently the Head of Trade Marketing for the Pet Specialty Division in the US. Prior to this, he held management roles of increasing responsibility within the Marketing Department for Bayer HealthCare’s Animal Health division in the US. Mr Peizer’s experience also includes roles as a professional technical sales representative. Mr Peizer is a graduate of Cornell University with a BS in Animal Science.


Chapter Title

7-9 October 2014 Paris Norde Villepinte • France

Co-located with

Mix with the world of pharma, products, people and solutionsJoin the world’s leading pharmaceutical event

Pharma contract services

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Organised By:

CPhI Worldwide hosts over 34,000 visiting pharma professionals, 2,200 exhibitors from 140 countries and more than 100 free industry seminars, covering every pharmaceutical sector under one roof. Attending CPhI Worldwide is the most cost effective way to establish new business relationships, meet with global partners and stay updated on the latest industry trends.

APIs Generic APIs Custom Manufacturing

Fine Chemicals Intermediates Finished Dosage Excipients/Formulation

Biopharma Ingredients

www.cphi.com/registerRegister today for freeUse media code: NDWW1878

“ We had plenty of opportunity to make new contacts. We’ve made an excellent start in terms of beginning conversations with new partners about potential agreements, and we’re now looking at several new products. ”Evi Economou Regulatory & Pharmacovigilance Affairs Manager, Ariti S.A.

#cphiww


Market Intelligence

A Growing Phenomenon – Animal Health Companies pursuing IPOs, by Chuck ZimmermanAccording to the folks at Husch Blackwell we’re seeing a growing phenomenon of animal health companies pursuing IPOs. Chuck Zimmerman visited with Jim Ash and Stan Baker about this largely unnoticed trend. Husch Blackwell is a national legal firm with a Food & Agribusiness team. They even have a D.V.M. on the staff – Stan Baker! According to these guys, animal health IPOs didn’t even exist 18 months ago. However, since when Pfizer spun off Zoetis first of last year there have been several more and there are more in the works. Apparently the type of public information provided by a deal like the Zoetis one has helped provide the industry with valuable data to help potential investors gauge the potential value of an investment.

Here are a few reasons they say have caused this increased activity:

• Animal health companies’ valuations have increased• Increased news coverage of animal health issues• A belief among investors that the regulatory process

for bringing animal health products to market is easier, which is actually incorrect in many instances

• Additional funding needs not met by “angel” investors• Improving market has led to more companies being

willing to step into the space

Husch Blackwell has been involved with two animal health IPOs to date, serving as licensing counsel in one and as regulatory counsel in both. So Stan and Jim have experience to speak about the differences in the filing process that have emerged, including regulatory schemes and the adjustments between human and animal medicine. They say these differences are subtle but extremely important.

Right to Farm Laws Necessary, by Jamie JohansenNew Holland ZimmPoll asked the question, “What do you think of Right to Farm laws?”This ZimmPoll struck very close to home for me. As a Missouri farmer, I did what I could to help educate everyone I knew on the truths about the Right to Farm amendment that took a narrow victory earlier this month. I was excited to see that the majority of pollers thought laws such as these were needed to ensure the right to farm for generations to come. I believe we will see more and more states taking action to protect farmers. In my opinion it is a necessity.

Here are the poll results:

Necessary to save farming – 47%Not necessary – 16%Too dangerous – 14%Maybe some states- 5%Should be federal law – 8%no opinion – 10%

Organic & Conventional Dairies Show Few Differences, by Jamie Johansen Cows raised on organic and conventional dairy farms in three

regions of the United States show no significant differences in health or in the nutritional content of their milk, according to a new study by Oregon State University researchers and their collaborators. Many organic and conventional dairies in the study also did not meet standards set by three commonly used cattle welfare programs.

“While there are differences in how cows are treated on organic farms, health outcomes are similar to conventional dairies,” said Mike Gamroth, co-author of the study and professor emeritus in OSU’s College of Agricultural Sciences. “Few dairies in this study performed well in formal criteria used to measure the health and well-being of cows.” Nearly 300 small dairy farms—192 organic and 100 conventional—in New York, Oregon and Wisconsin participated in the study, which was funded by a $1 million grant from the National Institute of Food and Agriculture in the U.S. Department of Agriculture (USDA).

The five-year project looked at many aspects of dairy cow health, including nutrition, lameness, udder cleanliness, and other conditions. Milk samples were screened for bacteria and common diseases, and farmers were asked about their operations, including the use of veterinarians and pain relief when removing horns from cattle.

Researchers found the following:

• One in five herds met standards for hygiene, a measure of animal cleanliness;

• 30 percent of herds met criteria for body condition, which measures size and weight of cows;

• Only 26 percent of organic and 18 percent of conventional farms met recommendations for pain relief during dehorning;

• Four percent of farms fed calves recommended doses of colostrum, which helps boost their limited immune systems after birth;

• 88 percent of farms did not have an integrated plan to control mastitis, a common disease in dairy cattle;

• 42 percent of conventional farms met standards for treating lameness;

• Cows on organic farms produced 43 percent less milk per day than conventional non-grazing cattle, the study found, and 25 percent less than conventional grazing herds.

Milk from organic and non-organic herds also showed few nutritional differences, researchers found. Organic milk can occasionally contain more omega-3 fatty acids, which may improve heart health. However, those increases come from seasonal grazing and are not present when cattle are fed stored forage, according to Gamroth.

Combination Vaccine Gives Swine Industry Options, by Jamie Johansen PfizerFostera™ PCV MH — the porcine circovirus (PCV) and Mycoplasma hyopneumoniae (M. hyo) combination vaccine that was built from the ground up by Zoetis — now has


Market Intelligence

the longest demonstrated duration of immunity (DOI) to help protect pigs from porcine circovirus-associated disease (PCVAD) caused by PCV Type 2 (PCV2). The U.S. Department of Agriculture has granted the combination vaccine the extended label claim of at least 23 weeks of protection against PCV2, which is three weeks longer than any other PCV2 vaccine on the market.

“PCVAD continues to be one of the most economically harmful swine diseases. Affected pigs suffer from progressive weight loss, increased mortality and other clinical impacts, which takes a toll on producers’ productivity and profitability,” said Darrell Neuberger, DVM, Pork Technical Services, Zoetis. “Now, with a vaccine that offers at least 23 weeks of immunity, producers have another tool to help their pigs realize the full market potential with convenience and flexibility.” Introduced in November 2013, Fostera PCV MH was developed to help protect pigs from PCVAD and enzootic pneumonia caused by M. hyo.

In clinical research studies of the flexible one- and two-dose protocols, Fostera PCV MH has been demonstrated to aid in preventing viremia, lymphoid depletion and colonization of lymphoid tissue caused by PCV2; and as an aid in reducing PCV2 virus shedding and enzootic pneumonia caused by M. hyo.

Unlike other combination vaccines that require field mixing, the one-bottle formulation of Fostera PCV MH allows the convenience of a one-dose program or the flexibility of a two-dose program. Fostera PCV MH is licensed for administration of pigs 3 weeks of age or older by a single 2 mL intramuscular dose or two 1 mL intramuscular doses spaced two weeks apart. “We strive to bring solutions to producers and veterinarians through innovative techniques and continued research,” Dr. Neuberger said. “We will continue to invest in our existing products as well as new technology and research to continue that commitment for our customers.”

Listening to What PEDv is Saying, by Cindy ZimmermanPorcine Epidemic Diarrhea virus (PEDv) is a wake up call for the United States swine industry and we better listen, according to Dr. Dale Polson with Boehringer Ingelheim Vetmedica (BIVI) who spoke to producers meeting last week in North Carolina for a swine health seminar. “We’ve got some things we’ve got to get in order in terms of risk of introduction of disease,” said Polson. “It’s a wake up call that we’ve got to plug some holes in terms of what could get in to this country.” In addition, Polson says PEDv is telling the industry to take a closer look at its structure. “We’ve captured efficiencies, we’ve improved performance, but at the same time we’ve put ourselves at risk that we didn’t have 20-30 years ago.” Polson thinks the industry is getting the message that PEDv is sending because he believes the future depends on it. “It could have been much, much worse,” he concluded.

Impact of Stress on Gut Health in Swine, by Cindy Zimmerman Stress is an important factor which it comes to gastrointestinal (GI) diseases in both animals and humans, as anyone with ulcers can attest. Dr. Adam Moeser with North Carolina State University spoke at the Boehringer Ingelheim Vetmedica (BIVI) Swine Health Seminar last week about how stress factors can specifically have an influence on how swine react to pathogens. “We know that the GI tract is one of the most important organ systems in the animal,” he said. “The gut represents a very large interface between the animal and the outside world.”

How the gut maintains its integrity in the face of disease can be influenced by stress. “We know that stressers in the environment always precede the onset of many diseases,” says Moeser. “But we really don’t understand much beyond that…when we know more we’ll be able to develop preventative strategies.” Moeser says his research has found a potential link between stress and a breakdown of intestinal integrity in swine. “The gut becomes leaky and the animals are more susceptible to disease,” he explained. “Management factors such as weaning age can have a dramatic impact on how that animal is going to be able to defend itself against pathogens later in life.”


Chapter Title

New Veterinary Vaccinology Network will help Tackle Threat of Animal Diseases, including those Spreading to HumansThe Pirbright Institute is to coordinate a new multidisciplinary network of veterinary vaccinology experts to help in the fight against animal diseases, some of which have the potential to spread to humans. Funded by the Biotechnology and Biological Sciences Research Council (BBSRC), the UK Veterinary Vaccinology Network will draw together major UK research players to enhance the uptake of new technologies in order to design, develop and deliver safe and effective next-generation vaccines against new and (re)-emerging diseases.

Building on the UK strength in veterinary science, advances in biotechnology, and the biological revolution in new technologies (such as next generation DNA sequencing and synthetic biology), there are opportunities for researchers to create new veterinary vaccines and increase efficient development pathways for them. Dr Bryan Charleston, head of the Livestock Viral Diseases Programme at The Pirbright Institute, and Network Coordinator, said: “There is huge potential to improve animal welfare, human health, and the economic performance of the UK livestock industries by developing new vaccines for widespread infectious diseases caused by parasites, bacteria and viruses. The network will facilitate and promote coordination of research in this important field to generate the scientific knowledge and discoveries needed for a step change in veterinary vaccinology.”Source: The Pirbright Institute

WVA – WMA Global Conference on One Health Concept On 15th July 2014, the World Veterinary Association (WVA) had a meeting with representatives of the World Medical Association (WMA), the Spanish Medical and the Spanish Veterinary Associations. The four organizations agreed to organize a Global Conference on One Health Concept to be held on 21-22 May 2015 in Madrid, Spain. The conference will mainly focus on zoonotic diseases, antimicrobial resistance, natural disaster management and environmental hazards exposure to humans and animals. The Global Conference aims in bringing together Veterinarians,

Physicians, Students, Public Health Officials, NGOs and others from the different world regions to learn, discuss and to address critical aspects of the ‘One health’ Concept. The main objectives of the conference is to strengthen the links and communications and to achieve closer collaboration between physicians, veterinarians and all relevant stakeholders to improve different aspects of the health and welfare of humans, animals and the environment.Source: World Veterinary Association

New Law for Veterinarians and Animal care In August 2014, President Barack Obama signed into law a crucial bill that makes it legal for veterinarians to provide complete medical care to their animal patients beyond their clinics and across state lines. The Veterinary Medicine Mobility Act (H.R. 1528) amends a restrictive provision within the Controlled Substances Act, which previously barred veterinarians from carrying and using controlled substances - necessary for pain management, anaesthesia and euthanasia - beyond their registered locations, often their clinics. “By passing and signing this legislation, the president and our legislators recognize the critical role veterinarians play in treating sick animals and relieving their pain and suffering. The health and welfare of our nation’s wildlife, food animals, and even our companion animals depend on veterinarians being allowed to do their jobs wherever the need arises,” said Dr. Ted Cohn, president of the American Veterinary Medical Association (AVMA).

Closing the loophole on this regulation has been particularly important for veterinarians who provide care in rural areas, respond to emergencies in the field, provide “house call” services for their clients, remove dangerous wild animals or rescue them from traps, conduct research and disease control efforts in the field, and provide routine medical care across state lines when they live on a state’s border. AVMA’s advocacy efforts led to more than 27,000 letters sent to members of Congress in support of this bill and the endorsement by over 130 veterinary medical and other organizations.Source: MedicalNewsToday

Coming soon - WVA Global Online Education PortalThe World Veterinary Association (WVA) has entered into Partnership with Verified Learning Company to create one central online resource of Veterinary Education. The aim is to provide a network of Learning Management Systems to WVA members that include training from Veterinary Associations, Veterinary Training Organizations, Veterinary industry and individual experts in an area of veterinary or related fields from all over the world. Training can be studied for vocational purposes and may also conform to legislated Continuing Education requirements.Source: World Veterinary Association

FDA finds Positive and Negative trends in Antimicrobial Resistance in Bacteria Isolated from Humans, Retail meats and Food animalsThe FDA`s National Antimicrobial Resistance Monitoring System (NARMS) 2011 Executive Report released on 11th of August 2014, shows both increasing and decreasing antimicrobial resistance trends. NARMS was established in 1996 as a partnership between the FDA, the Centers for Disease Control and Prevention (CDC), and the U.S. Department of Agriculture (USDA) to track antibiotic resistance in foodborne bacteria. NARMS is critically important for monitoring trends in antimicrobial resistance among foodborne bacteria collected from humans, retail meats, and food animals. In particular, it assists FDA in making data-driven decisions on the approval of safe and effective antimicrobial drugs for animals.

News


News

Key findings from the NARMS 2011 Executive Report include: in people, the five-drug resistance pattern “ACSSuT” (resistance to ampicillin, chloramphenicol, streptomycin, sulfonamide, and tetracycline) in Salmonella Typhimurium has declined to 19.5% in 2011 from its peak in 1997 at 35.1%; during its 16-year history, NARMS has found Salmonella resistance to ciprofloxacin, one of the most common antibiotics to treat Salmonella infections in humans, to be very low (less than 0.5% in humans, less than 3% in retail meat, and less than 1% in animals at slaughter); multi-drug resistance in Salmonella from humans, slaughtered chickens and slaughtered swine was the lowest since NARMS testing began (however, multi-drug resistance in Salmonella from retail poultry meats generally increased); erythromycin resistance in Campylobacter jejuni has remained at less than 4% in isolates obtained from humans, retail chicken and slaughtered chicken since testing began; Campylobacter resistance to the fluoroquinolone ciprofloxacin has increased slightly in isolates from humans since 2005; resistance to third-generation cephalosporins, another important drug class for the treatment of Salmonella infections, rose among isolates from retail ground turkey between 2008 and 2011 and among certain Salmonella serotypes in cattle between 2009 and 2011 (in April 2012, FDA prohibited certain uses of cephalosporin drugs in cattle, swine, chickens, and turkeys). Source: www.fda.gov

Scientists Develop the First Cancer Immunotherapy for DogsScientists at the inter-university Messerli Research Institute of the Vetmeduni Vienna, the Medical University of Vienna, and the University of Vienna have developed, for the first time, antibodies to treat cancer in dogs. Josef Singer and Judith Fazekas, both lead authors of the study, discovered that a receptor frequently found on human tumor cells (epidermal growth factor receptor or EGFR) is nearly 100 percent identical with the EGF receptor in dogs. In human medicine EGFR is frequently used as the target of cancer immunotherapy because many cancer cells bear this receptor on their surface. The so-called anti-EGFR antibody binds to cancer cells and thus triggers the destruction of the cells. The head of the study, Professor Erika Jensen-Jarolim, explained: “We expect dogs to tolerate these anti-cancer antibodies well. This will be investigated in clinical studies in the future and is expected to greatly improve the treatment as well as the diagnosis of cancer in dogs.”Source: MedicalNewsToday

Draft Guidance for Industry: Use of Nanomaterials in Food for Animals“Draft Guidance for Industry: Use of Nanomaterials in Food for Animals” addresses issues related to the use of nanotechnology in food ingredients intended for use in food for animals. Public comments on this draft guidance are requested by September 10, 2014. The FDA will continue to pursue ongoing scientific research and regulatory efforts and will consider new studies and data, as they become available, to determine future actions. As science is a critical component of the agency’s ongoing review of products, FDA has invested in a nanotechnology regulatory science program that will enhance the agency’s scientific capabilities. Additional guidelines for industry will be developed as needed. “Our goal remains to ensure transparent and predictable regulatory pathways, grounded in the best available science, in support of the responsible development of nanotechnology products,” said FDA Commissioner Margaret A. Hamburg, M.D. “We are taking a prudent scientific approach to assess each product on its own merits and are not making broad, general assumptions about the safety of nanotechnology products.”Source: MedicalNewsToday

Combined Agency to Safeguard Animal and Plant Health in UKThe Animal and Plant Health Agency will begin on 1 October 2014 to better equip the government to prevent the spread of animal and plant diseases, and to respond to emergencies. Chris Hadkiss, currently Chief Executive of Animal Health and Veterinary Laboratories Agency (AHVLA), has been appointed as the Chief Executive of the combined agency.

Animal and plant health inspectors have a strong history of working together in times of disease emergency, and this will be made easier when they are part of the same organisation. The Animal and Plant Health Agency will also play a vital role in stopping pests, diseases, and invasive non-native species entering the UK.

Environment Minister Lord de Mauley said: “Bringing together animal and plant health inspection functions in the Animal and Plant Health Agency makes very good sense. It will enable joined up working on plant and animal diseases and pests, and will increase our resilience and flexibility to respond to emergencies”. AHVLA Chief Executive Chris Hadkiss said: “I am really looking forward to building on the excellent reputation of both the Fera Inspectorates and AHVLA. Together as one agency we will be working for a healthier environment and economy.” Further work is being carried out on the future of the Cefas including on whether or not it should form part of this agency. A decision will be made in the autumn of 2014.Source: www.gov.uk

Companion Animals Harbour the same types of MRSA Infections as HumansA shared population of methicillin-resistant Staphylococcus aureus (MRSA) bacteria circulates both in humans and companion animals, according to a study published in the online open-access journal of the American Society for Microbiology. “Our study demonstrates that humans and companion animals readily exchange and share MRSA bacteria from the same population,” said senior author Mark Holmes, senior lecturer in Preventive Veterinary Medicine at the University of Cambridge in England. Holmes and colleagues sequenced the genomes of 46 MRSA samples from cats and dogs, collected over a period of four years from two large veterinary hospitals and several smaller veterinary practices throughout the United Kingdom.

The investigators found that all animal infections fell in the same family: Epidemic MRSA 15 (EMRSA-15) (sequence type ST22), a common strain of MRSA first detected in the United Kingdom in the 1990s that spread throughout Europe. Nearly all samples were genetically similar to human bacteria and researchers think that the companion animal bacteria most likely originated in humans. Researchers also observed that samples from the same veterinary hospitals clustered together genetically, suggesting that as in human hospitals, MRSA can be readily transmitted in veterinary hospital settings. Analysis of the genomes showed very little genetic discrimination between bacteria samples from humans and animals, indicating that the MRSA from cats and dogs had not undergone extensive adaptation to the companion animals, suggesting this type of MRSA has a broad host range. But the animal MRSA were significantly less likely than those from humans to have resistance to the antibiotic erythromycin, used rarely in English veterinary practices. Instead, these MRSA from animals were more likely to contain mutations making them resistant to the antibiotic clindamycin, used widely in veterinary medicine in the United Kingdom.Source: MedicalNewsToday


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