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.
If you would like to share your thoughts
on this topic, we encourage you to contribute to the discussion
thread in the BioPharmNet forum.
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).
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