Conference on 7th Annual Biosimilars(Conference and Workshop)

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Bharatbook.com announces the inclusion of latest conference on "Conference on 7th Annual Biosimilars (Conference and Workshop)" Conference on 7th Annual Biosimilars Optimising commercial strategies to develop Biosimilars and Biobetters 5th - 7th October 2010, BsG Conference Centre, London, UK Key Speakers Dr Gillian Cannon, Executive Director - Commercial Operations, Merck Bioventures, Mohamed Oubihi, Senior Manager, International Regulatory Affairs, Biogen Idec, Jo Pisani, Partner Strategy, PricewaterhouseCoopers LLP, Mateja Urlep, Founder & CEO, Tikhe Pharma, Former Global Head of Marketing and Medical, Sandoz, Fernando de Mora, Chairman - Dept of Pharmacology, Universitat Autònoma de Barcelona, Robin Thorpe, Head - Biotherapeutics Group, National Institute for Biological Standards and Control, Dr David Goldsmith, Consultant Nephrologist, Guy’s Hospital and St Thomas’ NHS Foundation Hospital, UK, Michael Dilger, Senior Director, Simon-Kucher & Partner (http://www.bharatbook.com/detail.asp?id=144298&rt=Conference-on-7th-Annual-BiosimilarsConference-and-Workshop.html) Conference Introduction Key topics of discussion include: • Gaining insights of the competitive landscape in biosimilars: US, EU and emerging markets • Evaluating biobetters and differentiated biosimilars as practical alternatives to biosimilars for regulated markets • Implementing successful commercial models for biobetters and follow-on biological medicines • Reviewing the global pricing and reimbursement models in the biosimilars and generics market • Learning the impact on biosimilars product patenting • Leveraging licensing opportunities for biosimilars • Validation of biomarkers and comparative immunogenicity as surrogate endpoints • Exploring technologies for producing improved biologics: Drug delivery, half-life extension, cell production, and glycoengineering methods.

Who should attend?

Members of Board, Vice President, Directors, Heads and senior Managers involved in: • Follow-on Biologics/Follow-on Proteins/Biosimilars • Biologics/Biotechnology/ Biogenerics • Biopharmaceuticals/ Biotherapeutics • Clinical Immunology file:///C|/Documents%20and%20Settings/user29/Desktop/...Annual%20Biosimilars(Conference%20and%20Workshop).htm (1 of 7)7/27/2010 9:57:23 AM

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• Process Control and Analytical Technologies • Quality Affairs/ Quality Control • New Product Development • Process science • Analytical Characterisation • Research & Development • Quality Assurance • scientifi c Affairs • Commercial Affairs • Legal Affairs • Intellectual Property • Health Economics • Pricing and Reimbursement • Regulatory Compliance • Pharmacovigilance • Business Development • Marketing & sales - Branded and Generic Pharmaceuticals & Biotechnology Companies - CROs/CMOs - Drug Regulators, Academic & Government Bodies Pre-Conference Interactive Workshop 7th Annual Biosimilars Tuesday 5th October 2010, London UK Patent issues in the development of biosimilar medicines About the workshop: Biosimilar medicines are already a commercial reality in the European Union. The U.S. Healthcare Reform Bill, with its defined pathway for the regulatory approval of follow-on biologics, should open up the U.S. market in the coming years. However, the next wave of biosimilars faces other difficulties in reaching the market, both in the EU and in the USA, because many valuable second generation biological products are better protected by originator patent estates. The aim of this workshop is to examine and discuss the patent issues that may be confronted in developing biosimilar products for these markets. The discussion will be framed by reference to specific products. There will also be an analysis of the patent dispute procedure in the new U.S. legislation.

About the workshop leader: Dr Duncan Curley qualified as a solicitor in 1995. He became a partner in the intellectual property (IP) department of an international law firm in 2003 and he founded the boutique London-based IP law practice, Innovate Legal, in 2007. Duncan is a life sciences specialist and he acts for a number of file:///C|/Documents%20and%20Settings/user29/Desktop/...Annual%20Biosimilars(Conference%20and%20Workshop).htm (2 of 7)7/27/2010 9:57:23 AM

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multinational pharmaceutical companies on freedom to operate, patent clearance and litigation issues.

He has worked on many high profile cases, including Lenzing v Courtaulds (fibre technology), Bespak v 3M (metered dose inhalers for asthma), Pliva v Eli Lilly (gemcitabine) and two of the major UK cases on antitrust ‘Eurodefences’ to IP claims (Sandvik v Pfiffner, patents and Sportswear v Stonestyle, trade marks). He is the author of numerous published articles on IP issues, the textbook “Intellectual Property Licences and Technology Transfer” (on the European Technology Transfer Block Exemption) and “Extending Rewards for Innovative Drug Development”, a Report on Supplementary Protection Certificates, published in December 2007 by the Intellectual Property Institute.

Workshop agenda: 09:30 Registration and Refreshments 10:00 PART 1 – A EUROPEAN PERSPECTIVE 10:10 Patent issues in the development of biosimilars – an introduction 10:30 Insulin analogues • Commercial overview • Rapid and long-acting insulin analogues 11:30 Morning Refreshments 11:45 Pegylation • PEG-interferon • PEG-filgrastim 12:30 Monoclonal antibodies – the EU guidelines 13:00 Lunch PART 2 – A U.S. PERSPECTIVE 14:00 The U.S. approval pathway for Biosimilars – An update • Terminology: “highly similar” and “interchangeable” • Data exclusivity • The patent dispute procedure 14:45 Discussions and questions 15:00 Close.

Day 1 Wednesday 6th October 2010, London UK 09:00 Registration and refreshments file:///C|/Documents%20and%20Settings/user29/Desktop/...Annual%20Biosimilars(Conference%20and%20Workshop).htm (3 of 7)7/27/2010 9:57:23 AM

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09:30 Opening address from the chair 09:40 Understanding the competitive landscape in biosimilars • Exploring the biosimilars opportunity • Exploring obstacles to entry: Strategic, pricing, sales & marketing • Assessing the major markets for biosimilars: US, EU and emerging markets • Identifying current and potential players and business models Jo Pisani Partner, PricewaterhouseCoopers 10:20 Overview of Japanese regulatory framework on biosimilars: Trends, opportunities and challenges • Introduction of Japanese regulatory environment and biosimilars market • PMDA’s new guidelines on follow-on biologics • Opportunities and challenges Mohamed Oubihi, Senior Manager, International Regulatory Affairs, Biogen Idec, 11:00 Morning refreshments 11:20 Impact of healthcare reform on biosimilars in global biosimilars development • Anti-trust aspects (comparing FTC latest reactions as well as its June 2009 report) ? • Patent aspects and the creation of new “Orange book-like system” ? • Regulations promulgated pursuant thereto Liz Fuller, Director, Life Sciences Regulatory (US qualified), Wragge & Co, 12:00 Biosimilar erythropoietin: Uptake in Europe • Rationale for biosimilar epoetins • Epoetin market factors • EMEA regulatory environment • Clinical considerations Dr David Goldsmith, Consultant Nephrologist, Guy’s Hospital and St Thomas’ NHS, Foundation Hospital 12:40 Networking lunch 13:40 Biosimilars: Between innovator biomedicines and classical generics • The rationale behind the EMA regulation on biosimilars • Answering payers, patients and prescribers concerns about biosimilars • Biosimilar vs. the generic market ? • Need for a specific strategic approach to the biosimilar market file:///C|/Documents%20and%20Settings/user29/Desktop/...Annual%20Biosimilars(Conference%20and%20Workshop).htm (4 of 7)7/27/2010 9:57:23 AM

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Fernando de Mora, Chairman, Dept of Pharmacology, Universitat Autònoma de Barcelona, 14:20 Developing biosimilars of monoclonal antibodies • Patent expiry dates for the first generation of therapeutic MAbs • Barrier to entry to the biosimilar MAbs market • What does the future hold: Next gen branded MAbs-based products 15:00 Afternoon refreshments 15:20 Comparability evaluation of biological products • Evaluation: Biochemical characterisation, non-clinical and clinical characterisation • Elements to successful biosimilar comparability ? • Process & product comparability Robin Thorpe, Head, Biotherapeutics Group, National Institute for Biological Standards and Control, 16:00 Immunogenicity of biosimilars and biobetters • Product related risk factors of immunogenicity ? • Consequences on pharmacokinetics of the product • Product related risk factors of immunogenicity 16:40 Closing remarks from the chair 16:50 Networking drinks Take your discussions further and build new relationships in a relaxed and informal setting.

Day 2 Thursday 7th October 2010, London UK, 09:00 Registration and refreshments 09:30 Opening address from the chair 09:40 Developing a long-term commercial strategy for biosimilars • Challenges in commercialisation of biosimilars • Competitive advantage of unique yeast technology platform for the cost-effective production of followon biologics • Meeting the standards defined by the EMEA and US Dr Gillian Cannon, Executive Director - Commercial Operations, Merck Bioventures,

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10:20 Revolutionising biosimilar development in the EU market • Are current regulations adequate? ? • Navigating the complexity: Review of the EU guidelines • Indentifying the risks and benefits for successful development Mateja Urlep, Founder & CEO, Tikhe Pharma, Former Global Head of Marketing and Medical, Sandoz, 11:00 Morning refreshments 11:20 Overcoming CMC challenges for successful biosimilars development • CMC: Effective process development & biologics manufacturing • Establish knowledge-based process strategy early using QbD & PAT • Development capabilities and infrastructure requirements 12:00 Development of biosimilar medicines: Intellectual property issues • Originator patent landscapes for biologicals • The importance of process patents -method of use patents -supplementary protection certificates -upcoming patent and SPC expiries Michael Dilger, Senior Director, Simon-Kucher & Partners, 12:40 Networking lunch 13:40 Believing in biobetters: Half-life and antigenicity • Global market overview for protein drugs • Future of biosimilars/biobetters • Extending the half-life/duration of action of biologics • Efficacy and safety of PEGylated products Keith Powell, CEO, Polytherics, 14:20 Global P&R models for the biosimilars and generics market • Health economic challenges of R&D, registration, P&R of biopharmaceuticals and biosimilars • Identifying inherent differences in safety, effectiveness and costs • Adopting innovative mechanisms such as risk-sharing arrangements 15:00 Afternoon refreshments 15:20 Panel Discussion: Are the generic companies prepared for the competition?

Our expert panel will discuss various strategies to indentify opportunities and overcome barriers for the file:///C|/Documents%20and%20Settings/user29/Desktop/...Annual%20Biosimilars(Conference%20and%20Workshop).htm (6 of 7)7/27/2010 9:57:23 AM

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growth and profitability of generics companies in the current times.

Some of the key points include: • Pricing competition • Cost effectiveness • Adopting new business models Panel members will be drawn from the speakers who take part on day one or day two.

If you would like to submit a question to the panel, please email it to: maninder.paul@visiongainglobal. com 16: 00 Emerging markets: A spotlight on Asia • Understanding the dynamics of the Asian markets • Benefits and risks of outsourcing the development of biosimilars • Explore partnership opportunities 16:40 Chair’s closing remarks 16:50 End of Conference.

For more information kindly visit http://www.bharatbook.com/detail.asp?id=144298&rt=Conference-on-7th-Annual-BiosimilarsConference-and-Workshop.html OR Contact us at 207, Hermes Atrium, Sector 11, CBD Belapur, Navi Mumbai - 400 614, India.

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