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Pre-conference briefing Tuesday 25 September
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| ETHICAL MEDICINE: THE FUTURE OF THE PHARMACEUTICAL INDUSTRY? |
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| 08.00 | Registration and coffee
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| 09.00 | Chairman’s opening remarks
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| | Dinesh Dua, former President of the International and Biotechnology Strategic Unit, Wockhardt
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| 09.15 | Keynote address: Prospecting for ‘ethical pharmaceuticals’
- Provision of new medicines for poor patients in developing countries
- New opportunities to make patented cost-affordable medicines
- Improved health and financial profits as yardsticks for measuring new product success
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| | Sunil Shaunak, Professor of Infectious Diseases, Faculty of Medicine, Imperial College London
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| 09.45 | Reengineering the value chain of research and development for global health
- Gaps in market-driven pharmaceutical innovation
- Follow-on pharmaceutical innovation can be hindered by patents on research tools
- The need for reengineering the value chain of R&D to meet the priorities of global health
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| | Anthony So, Director, Program on Global Health and Technology Access, Terry Sanford Institute of Public Policy, Duke University
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| 10.15 | The varying models for addressing disease in developing countries
- Using intellectual property and strategic collaborations to address developing world disease
- The role of biosimilars and generics
- Understanding pharmaceutical needs in developing countries
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| | Katherine Woo, Senior Director, Corporate Partnering and Portfolio Development, Institute for OneWorld Health
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| 10.30 | How is the TRIPS agreement being interpreted by governments and pharmaceutical companies?
- What is the intention of the TRIPS agreement?
- The success of generic medicines in developing countries
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| | Precious Matsoso, Director of Technical Cooperation for Essential Drugs, World Health Organisation, Switzerland
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| 10.45 | Morning coffee
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| 12.00 | Panel session: the relationship between generics manufacturers and traditional pharmaceutical companies
- Does an increase in generics correlate with a reduction in research and development?
- Generics companies and traditional pharmaceutical companies working together
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| | Moderator: Dinesh Dua, former President of the International and Biotechnology Strategic Unit, Wockhardt Confirmed: Salah Ahmed, Executive Vice President and Head of Global Research and Development, Barr Laboratories, Inc Confirmed: Jo Pisani, Director, Pricewaterhousecoopers Llp
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| 12.45 | Lunch
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| ADAPTING BUSINESS MODELS IN RESPONSE TO THE GENERICS AND BIOSIMILARS BOOM |
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| 14.15 | Keynote address: Biologics opportunities and challenges for the Generics industry
- Market landscape for future biologics
- Scientific and technological challenges in the development of biogenerics
- Regulatory and compliance issues for the approval process
- Biosimilar (interchangeable or comparable) requirements
- Economical and marketing concerns for generic biologics
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| | Salah Ahmed, Executive Vice President and Head of Global Research and Development, Barr Laboratories, Inc
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| 14.15 | Opportunities and barriers in the biosimilars market
- Obstacles to overcome when entering the biosimilars market
- What changes must generics companies make to their business models to capitalise?
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| | Jo Pisani, Director, Pricewaterhousecoopers Llp
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| 15.15 | Afternoon tea
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| 16.00 | How are pharmaceutical companies adapting business models in response to the generics boom?
- Acquiring generics manufacturers – the Novartis business model
- Selling a generics – the Merck KgaG business model
- The degree to which new models will evolve following the introduction of biosimilars
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| 16.30 | What does innovation really mean in the pharmaceutical sector?
- Innovation in the biopharmaceutical sector
- Marketing as a part of the innovation process
- Distinguishing between radical, incremental and imitative products
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| 17.00 | Chairman’s closing remarks
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Day one Wednesday 26 September
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| THE IMPORTANCE OF GENERICS AND BIOSIMILARS IN REDUCING THE GLOBAL COST OF HEALTHCARE |
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| 08.00 | Registration and coffee
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| 09.00 | Chairman’s opening remarks
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| | Patrick Vink, Independent Consultant Life Sciences, Former Head of Global Biopharmaceuticals at Sandoz
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| 09.15 | Keynote address: the role of generics in reducing the cost of healthcare
- Becoming a global leader in generics
- Innovation, partnerships & alliances with Indian and Chinese companies
- The future crystal ball
- Case study: challenges to the Indian scenario
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| | Brian Tempest, Chief Mentor & Executive Vice Chairman of the Board, Ranbaxy Laboratories
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| REGULATORY GUIDELINES FOR BIOSIMILARS IN EUROPE AND THE USA |
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| 09.45 | Keynote address: biosimilar regulation in the USA and beyond
- Current FDA guidelines on biosimilar regulation
- What level of clinical trails is likely to be required in the biosimilar manufacturing process?
- Future outlook for biosimilars and key areas of opportunity
- The link between biotech in Europe and the USA
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| | William Haddad, Chairman and Chief Executive Officer, Biogenerics, Inc.
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| 10.15 | Regulatory guidelines for biosimilars in Europe
- Regulatory considerations for biosimilars manufacturing
- Regulatory guidelines at the EMEA
- Key complexities in biosimilars manufacturing
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| | Christopher Bravery, Pharmaceutical Assessor, Biologicals and Biotechnology Unit, Medicines and Healthcare Products Regulatory Agency
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| 10.45 | Morning coffee
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| 11.30 | Video link with the FDA: current regulatory guidelines for generics and biosimilars
- Regulatory consideration for generics and biosimilar submissions in North America
- Latest guidelines on biosimilar regulation at the FDA
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| | Keith Webber, Deputy Director of the Office of Pharmaceutical Science, Center for Biologics Evaluation and Research, FDA
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| 12.00 | Case study: How to get a successful biosimilar product
- The first examples of a successful biosimilar submission and registration
- Evolution of the biosimilars market
- What is the market outlook for the next three to four years?
- Emerging capabilities in both India and China
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| | Patrick Vink, Independent Consultant Life Sciences, Former Head of Global Biopharmaceuticals at Sandoz
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| 12.30 | Speed networking
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| 13.15 | Lunch
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| EFFECTIVE STRATEGIES FOR MANUFACTURING A BIOSIMILAR |
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| 14.30 | Manufacturing industrial quantities of a biosimilar
- Single use technologies and their applications
- Scale and performance limitations of disposable technologies
- Scaling up to industrial quantities
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| 15.00 | Achieving correct glycosylation in your biosimilar
- The role of glycosylation in biosimilar manufacturing
- Selection of clones and manufacturing conditions according to glycosylation requirements
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| 15.30 | Afternoon tea
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| 16.15 | The European biotech perspective of biosimilars as an opportunity rather than a threat
- Complexities of manufacturing a biosimilar and the increased regulation and costs involved
- Current opinion on how the biosimilars markets will impact the biologics industry
- The European and Asian biotech view on opportunities available in the biosimilars market
- The contrasting views in the USA
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| 16.45 | Panel session: biosimilars: is the process really the product?
- How can small changes in manufacturing alter a biological product?
- What needs to be considered when manufacturing a biosimilar to ensure that there are no changes to effect and safety of the final product
- What level of clinical trials is required when developing a biosimilar?
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| | Moderator: Patrick Vink, Independent Consultant Life Sciences, Former Head of Global Biopharmaceuticals at Sandoz Confirmed: William Haddad, Chairman and Chief Executive Officer, Biogenerics, Inc. Confirmed: Bruce Rawlings, Product Manager, BioPharmaceutical Division, Pall Life Sciences
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| 17.30 | Chairman’s closing remarks
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Day two Thursday 27 September
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| GENERIC MEDICINES IN EUROPE: REGIONAL CONSIDERATIONS IN A GLOBAL MARKETPLACE |
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| 08.00 | Registration and coffee
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| 09.00 | Chairman’s opening remarks
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| | Kate Kuhrt, Director of Industry Research, Newport Strategies, Thomson Scientific
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| 09.15 | Keynote address: CEE as a key driver of the European generics market
- The booming CEE generics market
- The key expertise on offer in this region; generics and biosimilars manufacturing, gylcosylation expertise
- The future outlook for this market
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| | Jonas Tryggvason, Executive Vice President Marketing and Sales, CEE and Asia, Actavis
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| 09.45 | Accessing drug substances as a key competitive advantage in the generic pharmaceutical industry
- Drug substance (API) as a key driver of the generic pharmaceutical industry
- Vertical integration vs. external sourcing
- The importance of vertical integration and how M&A and partnerships can be of assistance
- India and China as one of the key markets for accessing drug substances
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| 10.15 | Morning coffee
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| 11.00 | Tools for launching a successful generic pharmaceutical in today’s ultra-competitive environment
- Current market pressures: price erosion, diminishing margins, and authorised generics
- Paragraph IV patent challenges in the USA
- Coping strategies, including consolidation and diversification, backward integration and sourcing from low cost countries
- Need for global information, excellent competitive intelligence, and disciplined product selection strategies
- The importance of API
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| | Kate Kuhrt, Director of Industry Research, Newport Strategies, Thomson Scientific
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| 11.30 | India: the life sciences destination: a hype or a reality?
- The emerging force of generics in regulated markets and the expertise available in India
- The global API structure story
- Can the same be replicated for biosimilars?
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| | Dinesh Dua, former President of the International and Biotechnology Strategic Unit, Wockhardt
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| 12.00 | Developing super biogenerics
- Time has run out for the development of classic biogenerics
- New ways have to be found to develop biologics with edge
- Development of a super biogeneric involves significant investment of time, finance and IP
- However this is the best way to make a worthwhile investment and survive against the competitors
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| 12.30 | Lunch
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| 14.00 | Panel session: establishing a successful generics business strategy
- Partnering and M&A in the generics sector
- Working with manufacturers in low cost counties
- Overcoming diminishing API sales margins and accessing API in emerging markets
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| | Moderator: Kate Kuhrt, Director of Industry Research, Newport Strategies, Thomson Scientific Confirmed: Dinesh Dua, former President of the International and Biotechnology Strategic Unit, Wockhardt Confirmed: Peter Kalinka, Managing Director, Accelsiors Group International
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| MANAGING PATENT LITIGATIONS AND INTELLECTUAL PROPERTY |
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| 14.45 | Implications of recent developments in European patent litigation and pharmaceutical legislation for the generics sector
- European pharmaceutical legislation and regulation update;
- Update on the Community Patent; European Patent Litigation Agreement and forum shopping in Europe
- Recent cases in the generics sector
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| 15.15 | Afternoon tea
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| 16.00 | New European guidelines on paediatric legislation
- New European legislation on paediatric medicine
- The resulting impact on intellectual property and patent extensions
- Strategies to ensure that generic pharmaceutical companies remain competitive
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| 16.30 | Launch strategies and the impact of ‘authorised generics’
- Patent considerations for launching a new generic pharmaceutical
- The need for robust product launch strategies
- How are ‘authorised generics’ impacting generic pharmaceutical companies?
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| 17.00 | Chairman’s closing remarks and close of conference
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