Clinical Trials: Managing the Risk, Managing Expectations


Clinical trials are the life blood of the biotech industry. Given the growing trend for life sciences companies conducting clinical trials overseas, it is more critical than ever to respond to the unique risk management challenges
Wednesday, November 28, 2007
The Harvard Club of Boston (Back Bay location)
374 Commonwealth Avenue, Boston MA 02215

This session will look at the design and management of a successful clinical trial program, both domestic and foreign, by examining such logistics as local regulations, analysis of consent content including cultural considerations, and determining the possible need for separate insurance policies for each country. Other discussion topics will include:


  • Responsibilities of the key players in a clinical trial (sponsor, investigator, site, IRB, ethics committee and CRO)
  • The business risk of litigation and exposures faced by the various players
  • Best practices to help minimize litigation – from both domestic and foreign clinical trials claimants
  • Managing expectations – from the boardroom to business partners

Our featured panelists include:

Kelly Blackburn, Clinical Development Operations, Vertex Pharmaceuticals Inc.
Fran Miller, Of Counsel practicing in the healthcare practice, Nutter McClennen & Fish LLP
and Professor, BU School of Law
Lee Farrow, Senior Vice President, ACE Medical Risks
Jeffrey L. Quillen, Partner, Foley Hoag LLP
Lyn Rossano, Senior Vice President, William Gallagher Associates
and will be moderated by Amy Sinclair, Senior Vice President, William Gallagher Associates

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