Conference on 7th Annual Biosimilars

Conference on 7th Annual Biosimilars
Optimising commercial strategies to develop Biosimilars and Biobetters
5th 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 & Partners.

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
• 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 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.


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