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Tuesday, 12/05/2017 5:52:30 PM

Tuesday, December 05, 2017 5:52:30 PM

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Any doubts about Dr. M being in the front end of the new paradigm on clinical trials? He will have plenty of first-hand experience to discuss.

BIO CEO Investor Conference Feb. 12th.
Designing Clinical Trials in a 21st Century Cures Paradigm

The passage by Congress of the 21st Century Cures Act in late 2016 has opened up new opportunities and expectations for the design of clinical trials that the FDA will consider for regulatory review. Real world evidence and the stronger inclusion of patient perspectives on endpoints are two examples of the shifts that will impact therapy development. This session will explain the advantages and complications that drug developers and investors should be aware of as the Cures Act gets implemented.

Moderator: Wade Ackerman, Partner, Covington & Burling LLP

Speakers:

Jeff Allen, PhD, President & Chief Executive Officer, Friends of Cancer Research
Gregory W. Daniel, PhD, MPH, RPh, Deputy Director, Duke-Margolis Center for Health Policy
Steven Kaminsky, PhD, Chief Science Officer, Rettsyndrome.org
Christopher U. Missling, PhD, President and Chief Executive Officer, Anavex Life Sciences Corp.
Raghuram Selvaraju, PhD, Managing Director, Senior Healthcare Analyst, Rodman & Renshaw, a unit of H.C. Wainwright & Co., LLC
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