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Managing Drug Development Portfolios in a Safety-heightened Environment
Program Code:
402
Date:
Thursday, June 28, 2012
Time:
9:00 AM to 10:30 AM
EST
CHAIR
:
VP, US Regulatory Strategy, Consulting, & Submissions at INC and Adjunct Professor of Pharmaceutical Sciences at the University of Cincinnati. He is known for publishing books on regulatory strategy and was recently recognized by R&D Directions as one of the top 20 clinical research scientists.
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PRESENTER
(S):
VP, US Regulatory Strategy, Consulting, & Submissions at INC and Adjunct Professor of Pharmaceutical Sciences at the University of Cincinnati. He is known for publishing books on regulatory strategy and was recently recognized by R&D Directions as one of the top 20 clinical research scientists.
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Keith Ruark, Avos Consulting, United States
Patrick Frey, FDA, United States
Description
Portfolio management is changing to place more emphasis on the risk/benefit ratio. Since most new molecular entities can treat more than one disease, companies may select for initial development diseases which have a greater tolerance for potential risks.
Learning Objectives:
Describe a risk/reward approach to portfolio management
Discuss how recent changes in risk/benefit perceptions by regulators are changing portfolio strategies
Assess how greater expectations for safety data may influence choice of indication for new molecular entities.