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Adaptive designs: Opportunities, challenges and scope in drug development
A PhRMA-sponsored workshop "Adaptive Designs: Opportunities, Challenges and Scope in Drug Development" was held at the Marriott Bethesda North Hotel and Conference Center (North Bethesda, MD) on November 13-14, 2006. The workshop was chaired by Michael Krams (Wyeth) and Walt Offen (Eli Lilly).
Program Committee
Dennis Erb, Merck; Brenda Gaydos, Eli Lilly; Michael Krams, Wyeth; Walt Offen, Eli Lilly; Frank Shen, BMS; Luc Truyen, Johnson and Johnson; Greg Campbell, FDA CDRH; Shirley Murphy, FDA CDER; Robert O'Neill, FDA CDER; Robert Powell, FDA CDER; Marc Walton, FDA CDER; Sue Jane Wang, FDA CDER.
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The workshop was attended by more than 350 people with more than 20 talks given by clinicians and statisticians from the industry, FDA and academia.
Presentation slides can be found on the PhRMA sponsored Innovation.org web site.
Several members of the PhRMA adaptive design working group presented at the workshop, including Vlad Dragalin (Wyeth), Paul Gallo (Novartis), Brenda Gaydos (Eli Lilly), Michael Krams (Wyeth), Jeff Maca (Novartis).
Several members of the PhRMA adaptive dose-ranging design working group presented or chaired a session at the workshop, including Alex Dmitrienko (Eli Lilly), Greg Enas (Eli Lilly), Qing Liu (Johnson and Johnson), Jose Pinheiro (Novartis), Rick Sax (AstraZeneca).