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Keynote Address(es)
Session Chair(s)
Dionne Price, PhD
Deputy Director, Office of Biostatistics, OTS, CDER, FDA, United States
Speaker(s)
Session Co-Chair
Jerald Schindler, DrPH
Chief Executive Officer, Strategic Statistics, United States
The 21st Century Vision for New Drug Review at CDER and the Role of Statisticians
Janet Woodcock, MD
Retired, Principal Deputy Commissioner, FDA , United States
The Times They Are A-Changin': How Economic Demands and Drug Development Challenges are Altering the Face of Pharmaceutical R&D
Kenneth I. Kaitin, PhD
Professor and Senior Fellow, Tufts Center for the Study of Drug Development, United States
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