A: Practical Steps for Delivering HPAPI Projects 08.30 - 12.30

Workshop Leader: Justin Mason-Home, Director, HPAPI Project Services Limited

B: Preventing Cross Contamination & Employee Exposures in the context of HPAPIs – What you may not know

13.30 - 17.30Workshop Leader:

Dean Calhoun, President/ CEO, Affygility Solutions LLC

PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPS | WEDNESDAY 23RD MAY 2018, HOLIDAY INN KENSINGTON FORUM, LONDON, UK

CHAIR FOR 2018:

• Justin Mason-Home, Director, HPAPI Project

Services Limited

KEY SPEAKERS INCLUDE:

• Ildikó Zeigler, Validation Expert, Gedeon Richter

• Ulrich Ruemenapp, Head of Launch Preparation

and Coordination, Bayer

• Vincenzo De Sio, HPAPI Specialist, Cristália

• Pascal Drago, Principal Technical Manager, Roche

• Henri Motte, Head of Pilot Plant, UCB Pharma

• Jeff Parry, Senior Scientist Manufacturability,

AstraZeneca

• Greg Sowell, Principal Scientific Manager,

Genentech

HIGHLIGHTS IN 2018:

• Discover practical approaches to HPAPI manufacturing in a controlled and efficient manner

• Explore different containment methods and learn about which strategy best suits your needs

• Evaluate the use of containment risk mitigation tools in early phase development

• Learn how to manage and effectively and safely dispose of HPAPI, post-production waste

• Discuss the most important regulations surrounding potent ingredients

CONFERENCE: 21ST-22ND

WORKSHOPS: 23RD

MAY 2018

HOLIDAY INN KENSINGTON FORUM, LONDON, UK

SMi Presents the 2nd Annual Conference on…

Highly Potent Active Pharmaceutical IngredientsFinding the balance between safety, quality and cost-effectiveness

by addressing containment and cross-contamination issues

BOOK BY 31ST JANUARY AND SAVE £400 BOOK BY 28TH FEBRUARY AND SAVE £200 BOOK BY 29TH MARCH AND SAVE £100

SPONSORED BY

A TR IN ITY CONSULTANTS COMPANY

www.highlypotentapi.comRegister online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711

SMi Pharma

#SMiPharm

Highly Potent Active Pharmaceutical Ingredients Day One | Monday 21st May 2018 www.highlypotentapi.com

8.30 Registration & Coffee

9.00 Chairman’s Opening RemarksJustin Mason-Home, Director, HPAPI Project Services Limited

MANAGING HPAPI PROJECTS AND RISK ASSESSMENTS

9.10 Strategic Management of HPAPI projects• Key stages of an HPAPI project• Stakeholder Engagement and Learning for HPAPI projects• Benefits of a Systematic and Scientific Approach• Pot Pourri; Risk Assessment, QA and H&S conflicts, Pitfalls

and More!Justin Mason-Home, Director, HPAPI Project Services Limited

9.50 Practical Approach to HPAPI Manufacturing in Early Development• Designing, building and working in a multiproduct kilo lab

environment• Risk analysis of entire synthetic process based on factors

including process safety and industrial hygiene• Important link between surrogate testing of equipment,

training staff and process specific equipment needs• Ensuring proper transfer of safety information to CMOs

Gregory Sowell, Principal Scientific Manager, Small Molecule Process Chemistry, Genentech

10.30 Morning Coffee

11.00 The manufacturing of an oncological product by a CDMO• The different approaches via which oncological products

can be produced/ manufactured by a CDMO• Case studies of the different approaches• A summary, with industry perspective, of the best way

through which the manufacturing of these products should be approached

Fabio Zenobi, EHS Director, BSP Pharmaceuticals Srl

11.40 Things about OELs and ADEs that your toxicologist never told you• Frequently asked questions about OELs and ADEs from

clients and end-users• Common misconceptions on how these are applied in the

field• Steps you can take to ensure that these values are properly

appliedDean Calhoun, President / CEO, Affygility Solutions

12.20 Networking Lunch

CONTAINMENT STRATEGIES

13.30 Use of a containment Risk Mitigation Tool in early phase development at UCB Pharma• Risk Mitigation and its necessity within early development• Leveraging of non-traditional data in order to assess risks/

hazards• The benefits and disadvantages of using a Risk Mitigation

Tool• Case study of application for the use of it within UCB

PharmaHenri Motte, Head of Pilot Plant, Drug Delivery Design & Development, UCB Pharma

14.10 Pre-reconstruction risk evaluation for an active substance development pilot plant • A cross contamination/containment assessment• EU and ISPE guidelines regarding cross contamination and

containment• Technical aspects and complexity in risk analysis• The case study: Comparing more approaches for the

reconstructionIldiko Ziegler, Distinguished Validation Expert, Gedeon Richter Plc.

14.50 Afternoon Tea

15.20 Containment design to enable existing equipment to handle HPAPIs – a journey• How to contain complex production equipment – solutions

considered• Other operator considerations• How to contain complex production equipment – solutions

trialed• Challenges, solutions and adaptations

Jeff Parry, Senior Formulation Scientist, AstraZeneca

16.00 Levels of containment depending on equipment & configurations• Type of occupational measurements• Tested configurations & equipment• Improvement & conclusionsElise Laperdrix Fanonnel, Manager Environmental, Oril Industries

16.40 Chairman’s Closing Remarks and Close of Day One

Register online at www.highlypotentapi.com

SPONSORSHIP AND EXHIBITION OPPORTUNITIESSMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement your company’s marketing strategy. Prime networking opportunities exist to entertain, enhance and expand your client base within the context of an independent discussion specific to your

industry. Should you wish to join the increasing number of companies benefiting from sponsoring our conferences please call: Alia Malick on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk

*Subject to Final Confirmation

SPONSORED BY BSP is focused on the development and manufacturing of anticancer drugs with high potency and cytotoxic characteristics for the pharmaceutical industry. With its state-of-the-art technology and highly skilled personnel, BSP sets out to be a valuable point of reference to serve the principal actors of the pharmaceutical field involved in research on new generation anticancer therapies. BSP has been at the forefront in the fight against cancer since 2006. Innovation is the hallmark of BSP with investments in new technologies and production methods in a high containment plant. The BSP industrial building covers an area of 30,000 m2 in a campus of approximately 20 hectares, 60 km to the south of Rome, ranking it in the world today as one of the most important Contract Development and Manufacturing Organization (CDMOs) for anticancer drugs. www.bsppharmaceuticals.com

SafeBridge Consultants, Inc. is the premier resource for high level safety, health and environmental support to the pharmaceutical and biotechnology industries. We provide services in occupational and environmental toxicology, risk assessment, product safety, industrial hygiene and analytical chemistry to clients worldwide from offices in California, New York and Liverpool, UK. www.safebridge.comA TR IN ITY CONSULTANTS COMPANY

Highly Potent Active Pharmaceutical Ingredientswww.highlypotentapi.com Day Two | Tuesday 22nd May 2018

Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711

SUPPORTED BY

Want to know how you can get involved? Interested in promoting your services to this market? Contact Pav Solanki, SMi Marketing on +44 (0) 20 7827 6048 or

email: psolanki@smi-online.co.uk

8.30 Registration & Coffee

9.00 Chairman’s Opening Remarks

Justin Mason-Home, Director, HPAPI Project Services Limited

WASTE MANAGEMENT AND CONTAINMENT CONSIDERATIONS

9.10 Waste management for Highly Potent APIs

• Risks after manufacturing processes: Liquid and solid

residues of HPAPIs and related risk of contamination

• Waste disposal and waste treatment: How to handle

a hazardous residue and how to avoid environmental

contaminations

• Deactivation systems and procedures: Why and how to

transform a hazardous compound in less toxic substances

Vincenzo de Sio, Especialista, Cristalia Produtos Quimicos

Farmaceuticos

9.50 Conceptual Design of new HPAPI facilities: From lab to

production scale

• How to define our target

• Which strategy of containment

• Next steps before building these new facilities

Aurore Perzyna, Head, Production Plant, Oril Industries

10.30 Morning Coffee

11.00 Demonstrating that exposure controls are effective

• Analytical and assessment procedures

• Recognising and analysing data variables

• Revision to EN689 - guidance on data interpretation

Martin Axon, Principal Occupational Hygienist, SafeBridge

Europe Ltd

11.40 High Containment Compounds and Occupational Hygiene

Long Range Targets in AbbVie

• Potent (high containment) compounds in AbbVie

• Containment targets and long-range plan

• Risk assessment and improvements projects

• New product introduction and tech transfer

• OH exposure assessment metrics

Olindo Lazarro, Director Global EHS Technical Operations,

AbbVie

12.20 Networking Lunch

REGULATION AND HPAPI APPLICATIONS

13.30 Regulatory aspects of high potency APIs• Regulations of high potency drugs• High potency drugs as an investigational medicinal

products and its challenges• Guidelines for selection criteria of HPAPI manufacturing

facilityAnna Song, Director and Regulatory Manager Pharmaceuticals, Cortex Consultancy

14.10 Verifying containment performance in pharmaceutical multi product facilities: Providing evidence of absence of cross contamination• Containment concept• Dealing with airborne particles• Dealing with mechanical transferPascal Drago, Principal Technical Manager, Roche Pharma Research & Early Development

14.50 Afternoon Tea

15.20 The balance between regulatory quality guidelines and EHS considerations• The comparison between regulatory guidelines and EHS

considerations; the similarities and differences• How to effectively balance and consider integral aspects of

both regulation and EHS considerations• The common pitfalls and setbacks which are encountered

during attempted implementation of both• The discrepancies which could arise as a consequence of

improper implementation of both aspectsSpeaker To Be Confirmed

16.00 Antibody Drug Conjugates (ADCs) – antibodies meeting HPAPIs for specific and efficient bio-pharmaceutical drugs• Conjugation of small molecule toxins with antibodies• The overlap between ADCs and HPAPIs• In-house strategies for handling potent ingredients• Manufacturing of ADCs using HPAPIs - challenges and

solutionsUlrich Ruemenapp, Head of Launch Preparation and Coordination, Bayer Pharma

16.40 Chairman’s Closing Remarks and Close of Day Two

*Subject to Final Confirmation

HALF DAY POST-CONFERENCE WORKSHOP AWednesday 23rd May 2018

Holiday Inn Kensington Forum, London, UK8.30 - 12.30

Practical Steps for Delivering HPAPI Projects

Workshop Leader: Justin Mason-Home, Director, HPAPI Project Services Limited

Workshop overview:

Biopharmaceutical companies embody application of the scientific method to identify and deliver new patient therapies. The same systematic, scientific principles should be used to develop and deliver research, development and production facilities that are fit for purpose and which protect healthy workers. This workshop will explore key HPAPI project elements in a stepwise manner, helping define and deliver HPAPI projects that are technically sound, based on justifiable data which can underpin robust and defensible investment.

Why you should attend:

Learn key HPAPI project elements, what factors are important and how to build information designed to underpin HPAPI project investments. All too often companies and their advisors, design and deliver HPAPI facilities based on “emotion” and guesswork. This workshop will try to ditch the emotion and provide a pathway to systematic and scientific project design. The objective will be the delivery of efficient facilities with process matters at the centre and suitable and defensible worker protection measures integrated into and set around the process.

Agenda

8.30 Registration and Coffee9:00 Opening Remarks and Introductions9.10 Strategic HPAPI Project Considerations

• Legal matters and liability• Hazard assessment – it all starts with the

hazard• Process is primary

9.50 Real Risk Assessment• Risk to product• Risk to workers• Exposure potential and mass transport more

generally10.30 Morning Coffee11.00 Facility Design and Containment

• Features of facility design• Containment for higher risk activities• Control for lower risk activities• Procuring control and containment solutions• Verification of control and containment

performance11.40 Importance of SOPs and Worker Practices

• HPAPI awareness training• Medical surveillance

12.20 End of Workshop

About the Workshop Leader:

Justin Mason-Home is an organic chemist with extensive health, safety, environmental and chemical engineering experience in senior technical, legal and commercial aspects of the pharmaceutical, biochemical, chemical and other industries. He has held senior positions and worked globally in potent biopharmaceutical occupational health and safety global environmental consulting, board level positions in a biotechnology company and corporate environmental management. Mr Mason-Home has worked on many HPAPI projects, contributing potent compound project support advice for many years. He specialises in technically complex and strategic projects, including unique experience in managing sensitive highly potent and toxic biopharmaceutical compound matters.

About Affygility Solutions:HPAPI Project Services Limited is a new company formed by Justin Mason-Home, following over 11 years heading up the European operations of a well-known potent compound safety consulting firm. Core objectives of the company are to support companies design, invest and deliver better.

Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711

SUPPORTED BY

HALF DAY POST-CONFERENCE WORKSHOP BWednesday 23rd May 2018

Holiday Inn Kensington Forum, London, UK13.30 - 17.30

Preventing Cross Contamination & Employee Exposures in the context of HPAPIs

– What you may not knowWorkshop Leader:

Dean Calhoun, President/ CEO, Affygility Solutions LLC

Workshop overview:

This workshop will provide an overview of the regulatory basis for ADEs and PDEs, will discuss how they are determined and present the basics of preventing cross-contamination.

Why you should attend:Since June of 2015, the EMA’s requirements for developing and implementing health-based exposure limits in multi-product pharmaceutical manufacturing facilities has been in effect. Unfortunately, there is still much confusion and misunderstandings on how these health-based limits are to be implemented. If your company handles multiple products in the same facility, this workshop is for you.

Agenda

13.30 Registration & Coffee

14.00 Opening remarks and introductions

14.10 Session 1 – Regulatory factors to consider • Basis for ADEs/PDEs • Preventing Cross-Contamination• Discusses the regulatory requirements in

both the U.S. and E.U.

14.50 Session 2 – Determination of ADEs and PDEs• How ADEs and PDEs are determined• Common mistakes • Updates to the basic equation

15.30 Afternoon Tea

16.10 Session 3 – Basic Elements of a Cross-contamination Risk Assessment• Review of the elements of a risk assessment• Risk identification and risk analysis• Risk evaluation and risk reduction

16:50 Session 4 – Frequently asked questions • OELs, ADEs/PDEs• Things you may not know

16:50 Closing Remarks

17:30 Close of Workshop

About the Workshop Leader:

Dean Calhoun is an American Board of Industrial Hygiene Certified Industrial Hygienist (CIH). He has been an environmental health and safety professional for over 32 years. Prior to starting Affygility Solutions, Dean was the Associate Director of Environmental Health and Safety for Gilead Sciences, Inc., a biopharmaceutical company focused on developing pharmaceuticals for infectious, viral, and oncology applications. His experiences including development and implementation of global EHS guidelines, implementation and coordination of an executive management EHS Steering Committee, establishment of occupational exposure limits for pharmaceutical active ingredients, industrial hygiene program management and EH&S auditing of research, manufacturing and contract manufacturing facilities. Dean graduated with a B.Sc. degree in Engineering from the University of Wyoming and has dual master degrees in Environmental Policy and Management, and Technology Management from the University of Denver.

About the organisation:

Since 2002, Affygility Solutions has provided environmental, health and safety services to the biotechnology, pharmaceutical and medical device industry. Our services include the Affytrac EHS management tool, online training seminars, potent compound safety and categorization, occupational exposure limits, toxicology services and more. We’ve provided these services to small, midsize and large companies throughout the United States, Canada and Europe. All of the environmental, health and safety professionals at Affygility Solutions have many years of professional and hands-on life science industry experience. Affygility Solutions has offices in Broomfield, Colorado, and in Dubai, United Arab Emirates.

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HIGHLY POTENT ACTIVE PHARMACEUTICAL INGREDIENTSConference: 21st -22nd May 2018, Holiday Inn Kensington Forum, London, UK Workshops: 23rd May 2018, London

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