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- 130+ participants
- In excess of 75 individual organisations represented
- 33 hours of presentations
- Over 10 hours of networking
- 91% of our attendees ranked the congress as good or excellent
- 30 different countries
› Benefits of sponsoring
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Conference:
Pre-conference workshop
23 Feb 9am - 5pm
Day 1
24 Feb 8.30am - 6:00pm
Day 2
25 Feb 8.30am - 5:30pm
Post-conference workshop
26 Feb 9am - 5pm
Venue:
The Royal Horseguards Hotel, London, United Kingdom
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Post-conference workshop - Fri 26 Feb 2010 Post-conference workshop - Fri 26 Feb 2010
Development and commercialization framework for biosimilars
Objectives:
Biologics have outperformed the pharmaceutical market as since they address areas of clinical need that are unmanageable with conventional therapeutics and they command a premium price. Consequently one would expect biosimilars to be commercially attractive. However, we have seen very few companies enter this field and for those who have they have been limited to the “easier” products to launch. This workshop will examine the challenges to be addressed and identify strategies to enter this potentially lucrative market building on the themes of the conference.
9.25am Opening Remarks from the Chair
Dr Jeffrey J. Freitag, Senior Vice President, PharmaNet Consulting, PharmaNet Development Group, Inc
9.30am Biosimilars - Evolution or Revolution for the Pharmaceuticals Market
- Exploring the biosimilars opportunity
- Exploring obstacles to entry such as strategic obstacles, pricing obstacles, sales & marketing obstacles
- Identifying potential players and business models
Partner, Strategy, PricewaterhouseCoopers LLP
11am Biosimilars - Evolution or Revolution for the Pharmaceuticals Market continued1pm Biosimilars - Important Concepts for Regulatory Approval
- Global challenges
- Demonstrating physico-chemical comparability
- The importance and challenges of biological testing
- How valuable is non -clinical testing?
- The role of PK and PD data
- Key considerations for demonstrating therapeutic equivalence?
- How much clinical safety data?
Vice President, PAREXEL Consulting
2pm Creating a strategy
- What are the clinical requirements?
- Lessons learned from recently approved biosimilars in Europe
- Thoughts for more complex protein entries: clinical challenges—e.g., monoclonal antibodies
- Sales and marketing obstacles and strategy
- Where is the U.S. regarding biosimilar drug development?
Senior Vice President, PharmaNet Consulting Senior Vice President, Medical Affairs, PharmaNet Ltd
3.30pm Close of workshop and afternoon tea
Senior Vice President, Medical Affairs, PharmaNet Ltd Senior Vice President, PharmaNet Consulting
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Robert Wessman
Executive Chairman
Alvogen
Petra Danielsohn-Weil
European President, Established Brands
Pfizer
Satish Reddy
Chief Operating Officer & Managing Director
Dr Reddy's Laboratories
Gerard van Odijk
President & Chief Executive Officer
Teva Pharmaceuticals Europe
Honorable Henry A Waxman
Member of Congress
United States of Americas
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