Raymond L. Woosley, MD, PhD - 2012 AZBio Pioneer

SUMMARY

Raymond L. Woosley earned a Ph.D. in Pharmacology from the University of Louisville and an M.D. from the University of Miami. He began his career as the first scientist in the US operations for Glaxo, now known as GlaxoSmithKline. Dr. Woosley specialized in Internal Medicine and Clinical Pharmacology at Vanderbilt University where he rose to the rank of Professor of Medicine. At Georgetown University he served as Chairman of the Department of Pharmacology and in 2000 was appointed Associate Dean for Clinical Research. In 2001 he became Vice President for Health Sciences at the University of Arizona and Dean of the College of Medicine. In January of 2005 he assumed the position of President of The Critical Path Institute (C-Path), a non-profit corporation formed by the Food and Drug Administration, SRI, International and the University of Arizona to accelerate the development of safe innovative medicines. Since 1999, he has directed one of seven federally-funded (Agency for Healthcare Research and Quality) Centers for Education and Research on Therapeutics (CERT).Under Dr. Woosley’s leadership,  C-Path (the Critical Path Institute) orchestrated the  acceleration of medical product development through a unique collaborative process among industry, academia, and the FDA. Our collaborations among 6 global consortia, 1000+scientists, and 41 companies has already produced these notable successes:

• First preclinical safety biomarkers (7) qualified by the FDA, EMA, and PMDA (the Japanese counterpart)
• First CDISC (Clinical Data Interchange Standards Consortium) therapeutic area data standard
• First and largest open database of CDISC aggregated clinical trial data for Alzheimer’s disease (6,100 patients and 22 clinical trials) Read more
• First drug-disease trial model & clinical trial simulation tool submitted and under review by the FDA
• First imaging biomarker for trial enrichment qualified by the EMA