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Leaping the Valley of Death: Keys to Successfully Going from the Lab to the Clinic for Pharmaceutical Products
Tuesday, June 26, 2012
1:30 PM to 3:00 PM
Michael Swit has solved vital FDA legal issues since 1984. Before joining Duane Morris, he was: VP at The Weinberg Group; with 3 major FDA law firms, general counsel of Par Pharmaceutical; and CEO of FDANews.com. He graduated magna cum laude from Bowdoin College and got his law degree at Emory U.
Gerald Yakatan, IriSys, Inc., United States
Nayan Nanavati, Jubilant Clinsys, United States
Heidi Kraus Politis is the V.P., General Counsel of Abon Pharmaceuticals, LLC. She has thirteen years of experience counseling pharmaceutical companies regarding U.S. intellectual property law. She was the Chief IP Counsel for Barr Laboratories, Inc., and was a director at the IP law firm SKGF.
Going from the lab to the clinic is the first huge leap in drug development. This session will explore how to ensure that the jump over the "valley of death" is smooth and avoids the sponsor falling into an abyss of bad decisions and poor results.
Discuss the crucial decisions to jump from lab to clinic and how those decisions can speed or derail drug development
Identify strategies to analyze unexpected challenges and minimize their impact on drug development
State how to use internal and external resources to succeed.
Audio Synchronized to PowerPoint