Challenges of Clinical Trials and Product Approval
Location: Room 4.02/4.03

(L-R): Mary Dwight, Vice President, Government Affairs, Cystic Fibrosis Foundation, Vicki Seyfert-Margolis, Advisor to Chief Scientist, Food and Drug Administration, and Haroon Hashmi, Director, Drug Development Asia Pacific, Biogen Idec

Moderator:
Wendy Diller, Co-Chief, Business Bureau, Biopharma Group, Elsevier Business Intelligence

Speakers:
Joel Braunstein, Managing Partner of Life Tech Development
Mary Dwight, Vice President, Government Affairs, Cystic Fibrosis Foundation
Haroon Hashmi, Director, Drug Development Asia Pacific, Biogen Idec
Vicki Seyfert-Margolis, Advisor to Chief Scientist, Food and Drug Administration

The cost in time and dollars of clinical trials is crushing the discovery enterprise. What are some of the new approaches that might help streamline the process? What challenges does the FDA face in reviewing and approving the new, more targeted/personalized treatments? What role can patient-oriented groups play in revolutionizing the system?

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