showcasing india’s biopharma future · 2015-10-14 · managing director, indian immunologicals...
TRANSCRIPT
Showcasing India’s biopharma future
3-4 November 2015The Westin Mumbai Garden City
Mumbai, India
www.terrapinn.com/biopharmaindia
Managing Director, Indian Immunologicals
GREAT EXPOSURE TO THE DEVELOPMENTS IN BIOPHARMA INDUSTRY - BOTH TECHNICAL AND COMMERCIAL ASPECTS.”
“
India’s biotech industry is forecast to reach US $11.6 billion in turnover by 2017. Such growth is unsurprising, given its low manufacturing costs, large patient population, impressive pharma expertise and improving regulatory environment.
But despite this huge potential, there are challenges for you to overcome, if you want to build a biopharma business in India. You need to be able to navigate India’s sometimes complex regulatory framework, protect your IP and ensure the integrity of in-country biomanufacturing processes, to name just a few.
That’s where we can help. Together with leading biotech entrepreneurs, biopharma organizations and associations, and big pharma players from both within and outside India, BioPharma India Convention 2015 will offer you a 360o overview of how India is innovating to lead the race to Asia’s biopharma future. Across two jam packed days, we will cover:
India is one of Asia’s hottest biopharma destinations
Endorsed by an advisory panel of outstanding biopharma leaders, this is an event created by the industry, for the industry.
This is not just a trade show. This is not just a conference. This is where you plot the course of your lucrative future in India’s biopharma industry.
If you are part of India’s biopharma ecosystem, or want to be, then you need to join us at the BioPharma India Convention 2015.
How India is supporting biotech entrepreneurs
How to find in-country partners and which partnership model is right for you
Therapeutic innovation in India, including biosimilars, NBEs and gene therapy
New developments in India’s biotherapeutic manufacturing processes
How to navigate India’s regulatory regime effectively
Director, Advent Worldwide
EXCELLENT OPPORTUNITY TO MEET TOP DECISION MAKERS, WHO ARE NORMALLY IN-ACCESSIBLE.”
“
Keynote Speakers Keynote Speakers
Dr Cyrus KarkariaWith stints at Celldex Therapeutics and CuraGen before joining Lupin Pharmaceuticals, Dr. Karkaria’s biotech pedigree is impressive. Having been part of teams that have developed multi-billion dollar blockbuster drugs in neurology, immunology and oncology and developed commercial processes all the way from the bench to manufacturing scale, he is well-placed to comment on how India is driving biopharma innovation and what more we need to do to drive growth.
Raj MehtaPresident of Cadila Biotech, Mr. Mehta brings 25 years’ experience in vaccines, biotech and pharmaceutical industry to this opening session. Building on his prior experience with global MNCs including Novartis and GSK, he has developed an innovative vision for sales, marketing and new business across US, South East Asia and India, giving a truly international perspective to our biopharma innovation panel.
Dr Renu SwarupWinner of the “BioSpectrum Person of the Year Award” in 2012, Dr. Swarup heads the National Bioresource Development Board at the Department of Biotechnology (DBT), where she is involved in developing, funding and monitoring programmes in Energy Biosciences, Bioresource Development & Utilisation and more. She is also Managing Director of the Biotechnology Industry Research Assistance Council (BIRAC), a government-incorporated company that nurtures and promotes innovation research in the biotech space, with special focus on Start‐ups and SMEs. Don’t miss her insights on encouraging biotech entrepreneurship during the closing session on day one.
Dr Sanjeev KumarIn his decade-long tenure as the Senior Vice President of Biotechnology and Head of Biologics at Zydus Cadila for more than ten years. Dr Kumar and his team started an end-to-end biosimilars program from clone development to product manufacturing. Prior to this, he garnered additional experience working with Expression Genetics and Valentis, and also with renowned professors from India’s National Institute of Immonologicals and Harvard. Learn from this experience as he offers insights into launching the world’s first Humira biosimilar in India.
K V BalasubramaniamA 25-year pharmaceutical industry veteran, Mr Balasubramaniam is a major player in India’s vaccine industry. During his tenure at Indian Immunologicals, he has been instrumental in reviving the fledgling unit of the National Dairy Development Board and making it a professionally managed, performance driven and result oriented vaccine player. His expertise developing commercial processes and scaling up production, combined with Indian Immunologicals’ mission of making biotechnology in healthcare affordable and accessible make him a great addition to our opening biopharma innovation panel.
Leena MenghaneyAs the South-Asia Head for MSF’s new Access Campaign, Ms. Menghaney specialises in public health, innovation and intellectual property. A keen advocate for affordable generic drugs, she worked extensively on the people’s campaign for the inclusion of public health safeguards in the Patent (Amendment) Bill 2005, as its provisions seriously affected their production. Ms. Menghaney will be sharing her experiences in striving for affordable healthcare initiatives in India, and directing the discussion at the start of day two.
2015 Speakers include:
ADVISOR
Dr. Ajith V. Kamath Head, External R&D Innovation, IndiaWorldwide Research & DevelopmentPfizer Inc., India
ADVISOR
Swapnil Ballal Senior Director, Quality Assurance, Biocon, India
Gouri Shankar Drug Inspector, CDSCO, India
Milind Ponde Global Head, Submission Publishing and Site Head Drug Regulatory Affairs, Novartis Healthcare, India
ADVISOR
Dr. Manjunath Ramarao Director and Head, Disease Sciences and Technology, Bristol-Myers Squibb, IndiaGovernment of India
Renu Swarup Senior Advisor, Department of Biotechnology, Ministry of Science and Technology, Government of India
Nipom Deka Regional Pharmacovigilance Manager - Asia, Africa & Middle East Global Pharmacovigilance (EPD), Abbott, India
Gaurav Gupta Head, Virology and biotechnology, Vaccine Technology Center, Zydus Cadila, India
ADVISOR
Dr. Mahalaxmi Andheria Vice President Intellectual Property Rights, Panacea Biotec, India
ADVISOR
Dr Craig Smith Vice President Development and R&D, Bioproduction Division, Thermo Fisher Scientific, USA
Shubhadeep Sinha Associate VP and Head, Clinical Affairs, Medical Affairs and Pharmacovigilance, Global Operations, Hetero Group, India
Sridhar Kottakota Principal Scientist, Lupin, India
B.N. Manohar Managing Director, Stempeutics Research Pvt Ltd, India
ADVISOR
Dr. Sandhya Kumaraswamy Associate Director, Quality Assurance, Dr Reddy’s Laboratories, India
Cyrus Krakaria President, Biotechnology Division, Lupin Limited
Narasimha Rao Nedunuri Managing Director & CEO, Clonz Biotech Pvt. Ltd., India
ADVISOR
Sanjay Desai Director, Supply Chain Asia, Thermo Fisher Scientific, Singapore
Ashwani Pandita Deputy General Manager and Head, Clinical Quality Management & Training ,Global Clinical Research Operations, Glenmark Research Centre, India
Shraddha Tawade General Manager, Quality and Training, Global Clinical Research, Wockhardt Ltd, India
Jyoti Iyer Principal Scientific Manager, Process Development, Monoclonal Antibodies, Biocon, India
Chandrakant Kathote Plant Head, Biotechnology Division, Lupin, India
Kaushik Deb Managing Director & CEO, Merisis Therapeutics, DiponEd Biointelligence, India
Anurag Rathore Professor, Department of Chemical Engineering, Indian Institute of Technology Delhi, India
Dilip Bandyopadhyay Head, Novel Biological Entity, Zydus Cadila
Nandan Pendsey Partner and Head of IP, AZB & Partners, India
Prasad Koka Chief Scientific Officer and Scientific Director, Merisis Therapeutics, DiponEd Biointelligence, India
Dulal PandaProfessor, Chair, BioSciences and BioEngineering, Indian Institute of Technology Bombay, India
Sunita K. SreedharanFounder and CEO, SKS Law Associates, India
Atul Kumar Senior Principal Scientist, Academy of Scientific and Innovative Research, Central Drug Research Institute (CDRI), India
Anup KarnikBusiness Solution Lead, COE, Life sciences and Healthcare, Capgemini, India
Sunny Kataria Senior Research Fellow, Institute for Stem Cells and Regenerative Medicine, India
Amulya Panda Staff Scientist VII (Scientist G), National Institute of Immunology, India
Murali NeelakantanFounder and Principal, Amicus, India
Arnaud LefevreManaging Director, UCB India, India
Takashi Shimada Manager, R&D, Life Science Research Center, SHIMADZU Corporation, Japan
Varun GuptaManager, Market Access, Novartis, India
Devi KalyanAssociate Director, Dr Reddy’s Laboratories, India
Gazala Khan-Koticha, Associate Director, Manufacturing technical services, Dr Reddy’s Laboratories, India
Raman GovindarajanHead, External Science and Partnering, Sanofi-Aventis, India
Monalisa Chatterji, Associate Director, Biocon, India
Clive FernandesPrincipal Consultant, Joint Commission International and Group Clinical Director, Wockhardt Group Hospital, India
Sheikh Raisuddin Professor, Head, Centre for Translational and Clinical Research, Jamia Hamdard, India
Organiser’s opening remarks
Chair’s opening remarks
Opening keynote session
Speed Networking
Networking refreshment break
Keynote Opening Panel: – How is India driving biopharma innovation?
• Is India innovative or falling behind innovation?
• Realising the potential of India as a global innovative biopharmaceutical hub
• Encouraging infrastructure investment and building capacity in administration to encourage India to innovate
• Exploring current Modi’s policies and initiatives in encouraging FDI in India’s biopharma market
• Building a biotechnology hub in India by utilising the strength of India’s market in availability of affordable, English speaking talent
• Establishing supportive policies to encourage innovation in India
Panellists include:Cyrus Karkaria, President, Biotechnology Division, LupinRaj Mehta, President, Cadila Pharma BiotechnologyK V Balasubramaniam, Managing Director, Indian Immunologicals Ltd
09:00
09:05
10:00
10:15
10:50
11:10
10:45
09:15
Therapeutic & research innovations Partnering & regulatory modelsBiotherapeutic manufacturing
Biosimilars & biobetters development
New Biological Entities (NBE) & New Chemical Entities (NCE)
Launching the first Humira biosimilar: A case studySanjeev Kumar, Senior Vice President, Biotechnology, Head, Biologics, Zydus Cadila, India
Pharmacovigilance and drug safety in biosimilars and biobetters development
• Pharmacovigilance and studies in ensuring biosimilars product safety
• Understanding and overcoming the commonly encountered safety related risks with the development of biosimilars and biobetters
• Overcoming drug safety risk with proper Developmental risk management plan
Nipom Deka, Regional Pharmacovigilance Manager - Asia, Africa & Middle EastGlobal Pharmacovigilance (EPD), Abbott, India
Chair’s openingDr Craig Smith, Vice President Development and R&D, BioProduction Division, Thermo Fisher Scientific, USA
Improvising bulk biologic manufacturing with OPEX initiativesChandrakant Kathote, Plant Head, Biotechnology Division, Lupin, India
Designing a flexible antibody manufacturing processJyoti Iyer, Principal Scientific Manager, Process Development, Monoclonal Antibodies, Biocon, India
Chair’s openingAnurag Rathore, Professor, Department of Chemical Engineering, Indian Institute of Technology Delhi, India
Regulatory requirements for marketing of Biosimilars and Biobetters in India
• Applicable regulations, guidelines and competent authority in marketing of biosimilars
• Preclinical studies, clinical trial application and post-market data requirement for biosimilars and biobetters approval
• Understanding data required for market authorization application.
Gouri Shankar, Drug Inspector, CDSCO, India
Protecting human rights and clinical ethics in trialsSanjeev Hegde, Head, Clinical Development, Reliance Life Sciences, India
11:30
11:50
12:10
12:30
12:50
Developing CLONZAb, a biosimilar MAb to treat Non Hodgkins Lymphoma
• Early challenges in the development of CLOZAb.
• Establishing the analytical methods to test for biosimilarity
• Process innovation in creating an affordable therapy for Non Hodgkins Lymphoma
Narasimha Rao Nedunuri, Managing Director & CEO, Clonz Biotech Pvt. Ltd., India
Coping with osteoporosis with CDRI 99/373 (Centhank)
• Strategies in discovering new chemical entities
• Designing target-specific drugs in treating osteoporosis
• Performing ADME and toxicity studies for CDRI 99/373
Atul Kumar, Senior Principal Scientist, Academy of Scientific and Innovative Research, Central Drug Research Institute (CDRI), India
Design, synthesize and evaluate potent microtubule-targeted anticancer agents
• Recognising microtubules as successful anticancer drug targets
• Strategies in delivering of microtubule targeted drugs
• Highlighting the progress and challenges for developing microtubule targeted anticancer drugs
Dulal Panda, Professor, Chair, BioSciences and BioEngineering, Indian Institute of Technology Bombay, India
High throughput, sensitivity, and resolution in glycan analysis for characterisation & comparability studiesDr Craig Smith, Vice President Development and R&D, BioProduction Division, Thermo Fisher Scientific, USA
Protein recovery from inclusion bodies using mild solubilisation processes
• Nature of protein affect its solubility and aggregation process
• Develop novel solubilization method by understanding the dominant force that cause aggregation of protein into inclusion bodies
• Protecting the native-like protein structure during solubilisation as the key for high throughput recovery of bio active protein from inclusion bodies
Amulya Panda, Staff Scientist VII (Scientist G), National Institute of Immunology, India
Enabling continuous processing of biotech therapeutics: Case studies
• Elucidating the concept of continuous processing with case studies
• Creating novel experimental setup for continuous refolding of granulocyte colony stimulating factor (GCSF)
• Using of a novel, two-stage chromatographic purification process consisting of ion-exchange and hydrophobic interaction modes for effective and efficient control of aggregates for a mAb therapeutic
Anurag Rathore, Professor, Department of Chemical Engineering, Indian Institute of Technology Delhi, India
Best aseptic transfer techniques for preventing contamination
• Drafting SOPs in sterile manufacturing
• Crafting the best training for aseptic fill and finish process
• Critical steps and procedures in preventing contamination
Exploring the potential of disposable and automated downstream processingReserved for sponsor
Strategies for achieving favourable clinical trial inspection outcomes in India
• Overview of clinical trials market and FDA inspections within APAC region
• Comparing inspection outcomes of India with other members of APAC
• Strategies in achieving favourable inspection outcomes for successful clinical development
Ashwani Pandita, Deputy General Manager and Head, Clinical Quality Management & Training , Global Clinical Research Operations, Glenmark Research Centre, India
Biosimilar clinical development- Regulatory and clinical strategies in emerging markets
• Regulatory considerations in conducting biosimilar trials in India
• Strategies in overcoming challenges to obtain approval for biosimilar trials in India
• Biosimilar regulatory strategies in global developing markets, such as India, LATAM, ASEAN and middle east
Shubhadeep Sinha, Associate VP and Head, Clinical Affairs, Medical Affairs and Pharmacovigilance, Global Operations, Hetero Group, India
IND submission and filling for orphan drug biosimilars in India
• Regulatory requirements for research & production of orphan drugs in India\
• Procedures for IND submission and filing in India’s current regulatory framework
• Exploring the potential of orphan drug biosimilars for treating rare diseases in India
Protecting regulatory data and confidential submissions
• Comparison between India, Europe and USA: What can India learn from the west?
• Navigating through regulatory framework in India
• Strategies in ensuring confidentiality of documents submitted
Milind Ponde, Global Head, Submission Publishing and Site Head Drug Regulatory Affairs, Novartis Healthcare, India
Chair’s openingMahalaxmi Andheria, Vice President Intellectual Property Rights, Panacea Biotec
Obtaining central regulatory approval for vaccine products Reserved for sponsor
Case study: Single use technology in downstream processingReserved for sponsor
Efficient data management in NBE discoveryReserved for sponsor
IND & clinical approvalProcess development
Manufacturing technology showcase
DAY ONE Tuesday, 3rd November, 2015 1 of 4 DAY ONE Tuesday, 3rd November, 2015 2 of 4
Networking Luncheon
Roundtable Discussions
13:10 Afternoon Refreshments16:10
14:10
14:30
14:50
Cell & gene therapy
Overcoming challenges in treating peripheral arterial disease (PAD) with stem cellsB.N. Manohar, Managing Director, Stempeutics Research Pvt Ltd, India
Intervening in chronic disease development: A novel pathway for myofibroblast recruitment in fibrotic tissue
• Mediating epithelial to mesenchymal interaction in a mouse model of fibrosis
• Stimulating dermal fibroblasts migration and myofibroblast differentiation
• Facilitating fibroblast migration through Src family of kinases
Sunny Kataria, Senior Research Fellow, Institute for Stem Cells and Regenerative Medicine, India
Immunotherapies and immunomodulation using stem cells
• Alleviation of haematological disorders with stem cells
• Gene expression and profiling with immunohistology and flow cytometry
• Using humanised immunodeficient mouse models for investigating applications of stem cells in treating cancer
Prasad Koka, Chief Scientific Officer and Scientific Director, Merisis Therapeutics, DiponEd Biointelligence, India
Upstream process characterisation and validation with QbD Subhra Ranjan Chakrabarti, Associate Vice President, Shantha Biotechnics- a Sanofi Company, India
Managing the quality of high expression E.coli & CHO cell lines in vaccine production
• Mastering the art of managing cell lines of mammalian and bacteria cell cultures in biologic production
• Comparing methodologies for growing cell cultures with fed batch, continuous or batch processes
• Maximising yield with E.coli and CHO Cell lines
Case study: Overcoming challenges in expressing recombinant protein with Pichia pastoris systems
• Overcoming the inherent properties of recombinant proteins which challenges for its expression from typical bacterial cell lines
• Adopting yeast expressing system to mass produce recombinant complex mammalian protein
• Exploring alternative cell lines to express recombinant protein
Overcoming the impact of IP on access to vaccine technologies in India
• Overcoming challenges of IP for India’s companies in accessing vaccine technologies
• Case study: Gaining access to vaccine technology via licensing
• Strategies in preventing infringement of IPR
Mahalaxmi Andheria, Vice President Intellectual Property Rights, Panacea Biotec, India
IP protection in cross nation out-licensing
• Anticipating legal challenges in out-licensing technologies
• Strategies in overcoming IP and contractual challenges
• Case study on cross nation out- licensing stories
Sunita K. Sreedharan, Founder and CEO, SKS Law Associates, India
IP beyond patent: What’s next for India?
• Gaining competitive advantage with brand names, trademarks, copy right, trade secret and data exclusivity
• Future of competition law analysis in India healthcare market
• Crafting the next business model: Venturing into a brand new market resulting from compulsory and other licensing method in India
Murali Neelakantan, Founder and Principal, Amicus, India
Licensing & IP ProtectionManaging fermentation and upstream
processes
DAY ONE Tuesday, 3rd November, 2015 3 of 4 DAY ONE Tuesday, 3rd November, 2015 4 of 4
15:10
15:30
Branding your technology for out-licensing Reserved for sponsor
Best cell banking methods for high expression upstream bioproductionReserved for sponsor
Exploring gene delivery strategies as vaccination toolsReserved for sponsor
Therapeutic table A:
Biosimilar and biobetter developmentSenior Representative, Thermo Fisher Scientific
Regulatory table A:
Searching for the right tech transfer partnerAnup Karnik, Business Solution Lead, COE, Life sciences and Healthcare, Capgemini, India
Manufacturing table A:
Process optimisation in biomanufacturingAnurag Rathore, Professor, Department of Chemical Engineering, Indian Institute of Technology Delhi, India
Therapeutic table B:
Commercialising NBEs
Regulatory table B:
Necessary regulation amendments of required to enforcing IPR protectionNandan Pendsey, Partner and Head of IP, AZB & Partners, India
Manufacturing table B:
Raw material testing for quality production
Closing keynote session: Starting a biotech in India
Keynote - Competing in India’s biotech market: Evolution, needs and challenges
• Protecting invention with proper IPR enforcement
• Realising the full potential of India’s biotech market by overcoming regulatory hurdles
• In-licensing useful technologies to heads up R&D effort
Closing panel – Encouraging biotech entrepreneurship in India
• Growing India’s biotech business via strategic partnerships in Asia Pacific
• Funds, regulatory approvals and infrastructure equipment requirements for building an accessible, affordable and high-quality healthcare system in India
• Empowering emerging biotech enterprise to encourage R&D efforts in coping with increasing needs of therapeutic products.Moderator:Renu Swarup, Senior Advisor, Department of Biotechnology, Ministry of Science and Technology, Government of India
Panellists:Narasimha Rao Nedunuri, Managing Director & CEO, Clonz Biotech Pvt. Ltd., IndiaB.N. Manohar, Managing Director, Stempeutics Research Pvt Ltd, IndiaKaushik Deb, Managing Director & CEO, Merisis Therapeutics, DiponEd Biointelligence, India
16:40
17:00
Chair’s closing remarks
End of Conference Day 1
17:40
17:50
Do you provide solutions to India’s biopharma market?
We have limited speaking opportunities available for first-class solution providers.
Contact Soo Min Lee for more information on [email protected]
nSMOL: Limited proteolysis on the Fab & accelerating mAb bioanalysis using LC/MS/MS
• Limitation of ELISA and conventional proteolysis for mAb quantitation using LC/MS/MS
• Novel and simple protocol for Fab-selective proteolysis
• Bioanalytical application for several different mAbs like Trastuzumab, Bevacizumab etc.
Takashi Shimada, Manager, R&D, Life Science Research Center, SHIMADZU Corporation, Japan
DAY TWO Wednesday, 4th November, 2015 1 of 3 DAY TWO Wednesday, 4th November, 2015 2 of 3
Organiser’s opening remarks
Chair’s opening remarks
Keynote session
Quality and affordability: Jan Aushadhi initiatives
• Why is Jan Aushandhi needed for India’s healthcare system?• Strategies for ensuring quality generics drug provided to the public • Influencing pricing of generics drug and their regulation in India Shri Kuldeep Chopra, Director of Operations, Jan Aushadhi, Bureau of Pharma PSUs of India (BPPI), Government of India
Keynote Panel: Developing affordable and quality healthcare access in India
• Promoting product quality, efficacy and safety
• Balancing market demand, patent protection, affordability with profit margins
• How can branded generics manufacturers differentiate themselves in India’s highly competitive market?
• Strategies in decreasing manufacturing cost in healthcare access
Moderator:Leena Menghaney, Regional Head, South Asia, Médecins Sans Frontières (MSF)Access Campaign, Doctors without Borders, India
Confirmed Panellists:Arnaud Lefevre, Managing Director, UCB India, IndiaClive Fernandes, Principal Consultant, Joint Commission International and Group Clinical Director, Wockhardt Group Hospital, India
09:00
09:05
09:10
09:30
Morning Refreshments
Networking Luncheon
10:10
13:10
10:40
10:50
11:10
Therapeutic & research innovations Partnering & regulatory modelsBiotherapeutic manufacturing
Chair’s openingDr. Manjunath Ramarao, Director and Head, Disease Sciences and Technology, Bristol-Myers Squibb
Therapeutic vaccines for oncology studyGaurav Gupta, Head, Virology and biotechnology, Vaccine Technology Center, Zydus Cadila, India
The role of bioinformatics in speeding drug development
• Speeding the search for leads in vaccine development
• Accurately predicting the structure-activity relationship between lead and targeted receptor to create high potency drug
• Predicting the pharmacodynamics and pharmacokinetic properties with bioinformatics before pre-clinical trials
Chair’s openingSenior Representative, Thermo Fisher Scientific
Overcoming challenges in upscaling the production of Exemptia, the first Humira biosimilarVibhor Saraswat, Vice President and Head of Manufacturing, Zydus Biologics, India
Upscaling and technology transfer in antibody manufacturing
• Exploring current trends in upscaling and technology transfer in India
• Overcoming challenges and mitigation of upscaling and technology transfer
• Case study: Strategies in upscaling of antibody manufacturing
Gazala Khan-Koticha, Associate Director, Manufacturing technical services, Dr Reddy’s Laboratories, India
Chair’s opening
Overcoming price control challenges on MNCs
• Understanding pricing challenges in India
• Exploring commonly used tactics by MNC to cope with pricing challenges
• Winning the game by overcoming limitations of the most optimal strategies
Rahul Chauhan, Associate Director, Regulatory Affairs and Pharmacovigilance, Eli Lilly, India
Improving healthcare access without increasing costs
• Periodic portfolio optimization during drug development to minimize cost burden
• Early Integration & alignment of commercial strategies to maximize reach
• Proactive partnering with stakeholders to enhance access and affordability
Varun Gupta, Manager, Market Access, Novartis, India
Vaccines
Antibody
Drug delivery & translational research
Pricing
Generics
Outsourcing relationship management
Upscaling production and flexible manufacturing
Bioassay validation
GMP Compliance and Quality assurance
11:50
11:30
12:30
12:10
14:10
12:50
Resolving ethical issues with pricing policies Reserved for sponsor
Driving generics drug selection with proper pricingD M Tripathi, Managing Director, Medicare Remedies Private Limited, India
Pharmacodynamic and clinical equivalence requirements for complex generic products
• Understanding current complex generics regulations for proper filling procedures
• Determining the right parameters for measuring the clinical equivalence of generic products
• Using pharmacodynamics and pharmacokinetics studies to qualify drug as complex generics
ANDA filing for generic peptides in India’s biopharma market
• Exploring the potential of global Peptide Therapeutics market
• Understanding ANDA as a simplified marketing authorization process for generic peptides launch.
• Discussing scientific considerations of ANDA filing for generic peptides.
Devi Kalyan, Associate Director, Dr Reddy’s Laboratories, India
The checklist of to-do, not-to-do, and why it should be done when working with CRO, RI and academic institutionsAjith Kamath, Senior Director, Head, External R&D Innovation, India, Worldwide Research & Development, Pfizer India
Accelerating approvals with drug pharmacokinetics studies Reserved for sponsor
Sustainable disposable and single use technology in upscaling biomanufacturing Senior Representative, Thermo Fisher Scientific
Scaling up biosimilars production: Processes and challenges Sridhar Kottakota, Principal Scientist, Lupin, India
Effect of matrix composition in influencing bioproductivity
Standardizing criteria for bioanalytical assay development and pre-validation
• Overview of the expectation from the guideline for an bioanalytical assay
• Taking ELISA for HCP as an example – discuss development process and challenges
• Reviewing criteria assessed during pre-validation
Monalisa Chatterji, Associate Director, Biocon, India
Implementing QbD in India’s manufacturing plants
• Adopting QbD principles to increase manufacturing efficiencies
• Post approval change minimization with QbD approaches
• Higher early stage efforts Vs changes in filed and approved processes
• Designing manufacturing plants to achieve “Regulatory flexibility”
Swapnil Ballal, Senior Director, Quality Assurance, Biocon, India
Designing cell lines for low cost, high quality vaccines productionReserved for sponsor
Cutting edge technology in vaccines production
Minimised targeted cancer treatment toxicity with ADCs
• Novel combinations of antibodies with anticancer drugs for targeted treatment
• Investigating novel linkers for successful delivery of drug to the correct targets
• Increasing the specificity of ADC by adopting EGFR targeted antibodies
Discovery platform for developing novel therapeutic antibody
• Discovery of novel human antibody from naïve human phage display library
• Humanization of monoclonal antibody
• Development of antibody drug conjugates
Dilip Bandyopadhyay, Head, New Chemical Entity, Zydus Cadila, India
Overcoming side effects of cancer treatment with innovative immunotherapeutic methodsManjunath Ramarao, Director and Head, Disease Sciences and Technology, Bristol-Myers Squibb, India
Crafting manufacturable, low immunogenicity risk ADCsReserved for sponsor
DAY TWO Wednesday, 4th November, 2015 3 of 3
14:30
14:50
Understanding the role of natural products in preventing anti-cancer drug toxicity
• Learning the toxic effect of anticancer drugs on the host’s defence system to onslaught of other chemicals and immunological defence to infections.
• Exploring conventional approaches of reducing the toxic side effects of anticancer drugs are not very effective.
• Adopting natural products to enhance host’s defence to toxic onslaught and infection challenge while treating cancer
Sheikh Raisuddin, Professor, Head, Centre for Translational and Clinical Research, Jamia Hamdard, India
Improving efficacy of biopharmaceutical substances with nanotechnology drug delivery platformRinti Banerjee, Madhuri Sinha Chair Professor, Department of Biosciences and Bioengineering, Indian Institute of Technology Bombay, India
Data integrity essentials in biomanufacturing
• Learning the importance and necessity of data integrity in quality assurance
• Understanding changes in the regulatory environment around data integrity and what the increased surveillance entails for the industry
• Discuss and obtain key learning points from case studies
Sandhya Kumaraswamy, Associate Director, Quality Assurance, Dr Reddy’s Laboratories, India
Achieving quality manufacturing with proper metrics evaluation
• Strategizing a more quantitative and objective measure of quality at the product, site and systems level.
• Promoting positive firm behaviour and a corporate culture of responsibility for improving product quality.
• Applying continuous improvement process to achieve high quality product, systems and control on site in achieving competitiveness.
Narendira Kumar, Senior Manager, Quality Assurance, Formulations, Orchid Healthcare, India
Crafting good working relationship with strategic partners
• Defining internal need, capabilities and the need for external partners
• Choosing the right partner and building the right relationship with them.
• Overcoming potential partnership failures and introducing mid-course correction measurements
Raman Govindarajan, Head, External Science and Partnering, Sanofi-Aventis, India
Managing the quality of clinical data
• Implementing QbD in clinical trials
• Quality risk management in clinical research studies
• Exploring the importance of vendor oversight in quality management in successful trials
Shraddha Tawade, General Manager, Quality and Training, Global Clinical Research, Wockhardt Ltd, India
15:10 Ensuring product integrity when using 3PLs Reserved for sponsor
End-to-end validation in sterile operation Reserved for sponsor
Case study: Image guided drug deliveryReserved for sponsor
Roundtable Discussions 15:30
Therapeutic table A:
Designing affordable vaccines for mass production
Regulatory table A:
Generics pricing schemes
Manufacturing table A:
Strategies for upscaling biosimilar productionSenior Representative, Thermo Fisher Scientific
Therapeutic table B:
Increasing the specificity of antibody-drug conjugates
Regulatory table B:
Managing strategic partners
Manufacturing table B:
Quality assurance and control of biologic products
Close of BioPharma India Convention 201516:10
WHO ATTENDS?
AcademicsBioprocess solution providers
Governments
MNC BiopharmasAnalytical instrument manufacturers
Consultants
CROs/CMOsCold Chain Packaging & Cargo
Clinical trial supply chain providers
Biotechs & Startups Lab consumablesLegal Counsels
WHERE FROM?
JOB TITLES
Who attends?
70%
India
15%
Rest of Asia
10%
US & UK
5%
ROW
Directors30%
Managerial Level 23%
Heads of Department 22%
Executive Level 8% Top Management (Managing Directors, Presidents, VPs, CEOs)
17%
Some of our previous attendeesAbbott Healthcare Pvt. Ltd. Astrazeneca Pharma India Ltd Bayer
Healthcare Bharat Serums And Vaccines Ltd Biocon Research
Limited Biological E Ltd Boehringer Ingelheim Pharma G.M.B.H.
and Company K.G. Bristol-Myers Squibb Cadila Pharmaceuticals
Ltd Central Drugs Standard Control Organization (West Zone)
Centre for Cellular and Molecular Platforms Cipla Ltd Clonz Biotech
Pvt Ltd DGHS , Dhaka , Bngladesh Dr. Reddys Laboratories Limited
Eisai Pharmaceuticals India Pte Ltd Eli Lilly And Company India
Ltd Glenmark Pharmaceuticals Ltd Haffkine Bio-Pharma Corp Ltd
Hospira Indian Immunologicals Limited Intas Pharmaceuticals Ltd
Abbott Healthcare Pvt. Ltd. Astrazeneca Pharma India Ltd Bayer
Healthcare Bharat Serums And Vaccines Ltd Biocon Research
Limited Biological E Ltd Boehringer Ingelheim Pharma G.M.B.H.
and Company K.G. Bristol-Myers Squibb Cadila Pharmaceuticals
Ltd Central Drugs Standard Control Organization (West Zone)
Centre for Cellular and Molecular Platforms Cipla Ltd Clonz Biotech
Pvt Ltd DGHS , Dhaka , Bngladesh Dr. Reddys Laboratories Limited
Eisai Pharmaceuticals India Pte Ltd Eli Lilly And Company India
Ltd Glenmark Pharmaceuticals Ltd Haffkine Bio-Pharma Corp Ltd
Hospira Indian Immunologicals Limited Intas Pharmaceuticals Ltd
Floorplan
Current sponsors & exhibitors:
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Partner with us: The BioPharma India Opportunity
You’ve got goals? We can help you achieve them. We can work with you to achieve your targets in 2015 by positioning your brand in front of the Asia Pacific biopharmaceutical industry. Join us as a sponsor to:
Meet, interact and network with senior level decision makers from India’s biopharma industry
Generate qualified and targeted leads for your sales team
Showcase your solutions to an audience keen to explore new technology
Extend your marketing footprint within India’s biopharma space
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Booth Organisation
1 Finesse Solutions
2 CPC Worldwide
3 Malvern Instruments
4 Thermo Fisher Scientific
5 BioClinica
6 RESERVED
7 RESERVED
8 AVAILABLE
9 AVAILABLE
10 AVAILABLE
11 RESERVED
12 AVAILABLE
13 AVAILABLE
Pod-stands
A AVAILABLE G AVAILABLE
B AVAILABLE H RESERVED
C AVAILABLE I RESERVED
D Kaneka J AVAILABLE
E Shimadzu K AVAILABLE
F AVAILABLE L RESERVED
SOLD RESERVED AVAILABLE
Benefits Platinum Gold Silver Roundtable Exhibitor Pod-stands
Chairperson 1 1
Keynote Presentation Day One Day Two
Conference Presentation 1 1 1
Roundtable discussion host 4 2 1 1
Pre-arranged onsite meetings
10 5
Lead Generation via Content E-Book
1 1
Lead Generation via Total Biopharma
3 2 1
Exhibition BoothTable-top
BoothTable-top
BoothTable-top
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BoothTable-top
BoothPod-stand
Conference Passes 7 5 4 2 1 1
Access to networking app Unlimited Unlimited Unlimited Unlimited Unlimited Unlimited
Your Marketing Footprint
Backed by esteemed industry associations and scientific publications, Terrapinn Life Sciences gets its additional boost in outreach through a sound network of supporting partners.
300+Industry Stakeholders
70+Speakers
200+Meetings
20+Networking hours
100+Companies
Supporting association:
Media Partners
Awarded the “Best Marketing Team - 2014” in the annual Conference Awards, this speaks volumes of how aggressive we are with what we do best. To top it off, Terrapinn Life Sciences run the TotalBioPharma community as well as a weekly newsletter that reaches out to more than 110,000 industry professionals in the world.
North America
38%Asia
29%Europe
21%Australia
7%
Sou
th A
merica/Caribbean2%Middle East
2%
36,500 20,000 110,000
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