Emerging Opportunities to Streamline Cancer Drug Development
Agenda
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8:30 |
Registration |
|
8:30 |
Welcome and Introductions |
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9:10 |
Session 1, Part 1: Bringing Drugs that Add Value to Market Faster Presentation: Richard Pazdur, MD, Acting Director, Oncology Center of Excellence, U.S. Food and Drug Administration (15 min) Moderated Discussion (40 min) |
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10:10 |
Break |
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10:25 |
Session 1, Part 2: Bringing Drugs that Add Value to Market Faster |
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11:25 |
Session 2, Part 1: Accelerating Throughput and Learning from Clinical Trials Presentation: Lisa LaVange, PhD, Director, Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration (10 min) |
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11:40 |
Public Comment |
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11:45 |
Lunch |
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12:45 |
Session 2, Part 2: Accelerating Throughput and Learning from Clinical Trials Presentation: James Zwiebel, MD, Chief, Investigational Drug Branch, Cancer Therapy Evaluation Program, National Cancer Institute (10 min) Moderated Discussion (60 min) |
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1:55 |
Break |
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2:10 |
Session 3: Evaluating and Approving Combination Therapies Presentation: Gary Gilliland, MD, PhD, President and Director, Fred Hutchinson Cancer Research Center (10 min) Presentation: Roy Baynes, MD, PhD, Senior Vice President and Head, Global Clinical Development, and Chief Medical Officer, Merck Research Laboratories (10 min) Moderated Discussion (60 min) |
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3:30 |
Conclusions and Cross-Cutting Recommendations |
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3:45 |
Public Comment |
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3:50 |
Wrap-Up and Next Steps |
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4:00 |
Adjourn |