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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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 Dr Pablo Fernandez,
Senior Vice President, Medical Affairs PharmaNet Ltd After practicing Medical Oncology, Dr Fernandez joined the Pharmaceutical Industry in 1979 and has headed International clinical research departments at American Cyanamid, Wyeth, Wellcome and Bayer Biologicals before joining PharmaNet in 1999, where he heads the global Medical Department. Based in the UK since 1984, Dr Fernandez is an active member of several medical societies and Industry/Government working groups related to medicines research. For over 30 years, Dr Fernandez has been instrumental in the clinical development of medicines in a variety of therapeutic areas including cancer, infectious diseases, immunology, respiratory, cardiovascular, neurology and haematology. During the last 15 years, Dr Fernandez has been involved in the development of numerous biological compounds, from early stages to commercialisation. Together with colleagues in PharmaNets Regulatory Consulting, Clinical Operations, Early Stage Development and Bioanalytical Services, he advises clients on Clinical Development and registration of biological compounds, including biosimilars.Appearing: Day one - Wed 24 Feb 2010 4.45pm Practical overview of clinical development for biosimilars
- Are Biosimilar really just Biogenerics?
- The preclinical requirement for comparability. How does that differ from non-biological generics?
- How different is the clinical development plan of a Biosimilar?
- What are the regulatory hurdles for biosimilars in Europe and the US
- Practical aspects of selecting endpoints – are they different from efficacy studies for new molecules?
- Are the statistical approaches the same as in innovator clinical development?
- Are there particular differences in the safety and pharmacovigilance requirements?
- The spectrum of immunogenicity – Damocles sword or market opportunity?
- Is it possible to extend the number of indications beyond those covered in the clinical trials?
Dr Pablo Fernandez, Senior Vice President, Medical Affairs, PharmaNet Ltd Dr Pablo Fernandez, Senior Vice President, Medical Affairs,
PharmaNet Ltd Post-conference workshop - Fri 26 Feb 2010 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 Dr Pablo Fernandez, Senior Vice President, Medical Affairs,
PharmaNet Ltd 3.30pm Close of workshop and afternoon tea Dr Pablo Fernandez, 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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