CHAIR
:
SPEAKER
(S):
Royce A. Morrison, MD,MS (SPKNON), Executive Vice-Chair, Quorum Review, Inc., United States
Mary L Westrick,
PhD (SPKNON), Vice President, US Phase I,
Quintiles Inc., United States
Dr. Mary Westrick serves as VP US Phase I, & Site Head for Quintiles in Overland Park, KS and held similar positions at both Astellas and Covance. Dr. Westrick holds a BS in Chem, and MS & PhD degrees in pharmacology from Purdue University where she also sits on the Dean's Industrial Advisory Board.
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Stacie J. Bell,
PhD (SPKNON), Director, Clinical and Translational Research,
Questcor Pharmaceuticals, United States
A biochemist by training and a clinical pharmacologist/scientist by evolution. 18+ years of diverse experience in biotech and pharma. PhD-Vanderbilt Univ.; Postdoctoral -Univ. of Colorado, Thomas Cech, PhD. Currently with Questcor serving as Director of Clinical and Translational Research.
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William B. Smith, MD (SPKNON), Principal, New Orleans Center For Clinical Research, United States
Description
On the first-in-human (FIH) fast track, what defines "just right" design? Join us to hear experience of sponsor development teams, CROs, investigators and regulatory agencies, and best practice guidance on appropriate limits for FIH study complexity.
This session has been developed by the Clinical Pharmacology Community.