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DoubleTree by Hilton Washington DC - Crystal City

Feb 11, 2015 8:00 AM - Feb 12, 2015 4:30 PM

300 Army Navy Drive, Arlington, VA 22202

Joint Adaptive Design and Bayesian Statistics Conference: Drivers of Efficiency in Modern Medical Product Development

Concurrent Breakout Session 1A: Adaptive Design Case Studies

Session Chair(s)

Yili   Pritchett, PhD

Yili Pritchett, PhD

Senior Director, Global Development

Astellas Pharma Inc., United States

Speaker(s)

Chia-Wen  Ko, PhD

Sequential Stage Design in the Gazyva Registration Trial

Chia-Wen Ko, PhD

FDA, United States

Mathematical Statistician

M. Scott  Harris, MD, MS, FACP

2-Stage Design in the Crofelemer Pivotal Program

M. Scott Harris, MD, MS, FACP

Lyric Pharmaceuticals, United States

Principal

Brenda L. Gaydos, PhD

Moving Drugs from Phase 2 into Phase 3

Brenda L. Gaydos, PhD

United States

Sue-Jane  Wang, PhD, MA, MS

Q&A Panel Discussion

Sue-Jane Wang, PhD, MA, MS

FDA, United States

Mathematician Statistician

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