Business Roundtable
Managing Risk in Clinical Trials - Perspectives and Challenges
Wednesday, February 14, 2007
9:00 AM
Astor Salon
The cost of bringing a drug to market is quickly approaching one billion dollars and the costs of the clinical trials that support regulatory filings are estimated to be 40% of that total development budget. As a result, outsourcing global clinical trials is at an all-time high, with the CRO industry estimated at $11 billion in 2005. What are some of the hidden implications of outsourcing and the risks associated? Focusing on informed consent, protocol deviations, adverse event reporting, and others, this panel examines the legal and regulatory issues associated with innovations in clinical trial design and the role that insurance plays in process intervention and compliance.
Moderators
- Mary Beth Borgwing; Senior Vice President, NY Life Sciences Practice Leader, Willis Group Holdings
Panelists
- Theresa Podrebarac, M.D.; Vice President, Clinical Research, CombinatoRx, Incorporated
- Linda McLaughlin; Vice President, Products Liability Division, AIG HEALTHCARE
- Eileen Smith Ewing; Partner, K & L Gates
- Lorraine Marchand; Vice President, Project Management and Clinical Operations, Covance Inc.