Biologics - Opportunities and Challenges of the $34 Billion Industry
Moderators: Peter Luo, PhD; Laura Hong, MD, PhD
Expert speakers from Merck, New Jersey BIO, Novartis Biologics, and
MedImmune, the major players in biologics industry, will discuss
opportunities and challenges in the $34.2 billion biologics market. Experts
in healthcare economics and policy will examine the impact of the
Obama administration’s new healthcare policies on the pharmaceutical
industry; the proposal to speed the availability of generic versions of
biologic drugs or "biosimilars" will be highlighted. Regulatory experts will
analyze FDA and EMEA requirements in developing novel biologics
and biosimilars.
- Biopharmaceutical Industry – Strategy & Vision
- Healthcare Reform and its Impact on Biologics
- R&D of “Bio-Similar” and “Bio-Better” Biologics
- Clinical Development & Regulatory Considerations
- Manufacturing & Commercialization

Featured Speakers

1:00 -1:30 PM
Preventing HPV-Related Epithelial Cancers by Vaccination
Eliav Barr, MD
Vice President, Oncology Clinical Research – Scientific Operations at Merck
Research Laboratories
2009 PhRMA Discoverers Award Recipient -for his contribution in the
development of GardasilTM

1:30 - 2:00 PM
The Development of Follow-on Biologics: A perspective based on actual
experience
Hillel Cohen, PhD
Head, Regulatory Affairs for the Americas
& Head, Regulatory Affairs for Early Development
Novartis Vaccines & Diagnostics, Inc.

2:00 -2:30 PM
Challenges and Opportunities for the Biopharmaceutical Industry
David Robinson, PhD
Vice President, Bioprocess, Merck & Co., Inc.

2:30 -3:00 PM
Accelerated Growth Markets - Wyeth Approach to Maximizing Potentials in
Emerging Markets
Mr. Mark Larsen
President, Asia Pacific and Global Nutrition, Wyeth Pharmaceuticals

3:00 - 3:30 PM
Immunoprophylaxis of RSV Infection: Advancing from RSV IGIV to Palivizumab
and Motavizumab
Herren Wu, PhD
Vice President, Global Head of Technology and Lead Generation, Head of
Antibody Discovery & Protein Engineering, MedImmune

3:30 - 4:00 PM
Biosimilars: Sense and Non-Sense
Geert Cauwenbergh, Dr. Med. Sci.
Chairman, New Jersey Bio; CEO & Chairman, RHEI Pharmaceuticals; Founder &
CEO, Phases123 LLC
Founder, Barrier Therapeutics Inc.