Therapeutic Workshop
Clinical Development and Regulatory Trends In the Era of Targeted Cancer Therapies
Thursday, October 20
8:15 a.m. - 9:15 a.m.
Twin Peaks North
A panel of clinical development, regulatory, and industry executives discussed: Clinical trial design considerations in the context of continuous new drug approvals and evolving standards of care; Use of survival versus clinical response trial endpoints; Evaluating efficacy standards and verifying clinical benefit for drugs approved under Subpart H.
Moderator:
- Adam A. Walsh, MD, Senior Vice President, Biotechnology Equity Research, Jefferies & Company, Inc.
Panelists:
- Craig Henderson, MD, President, Keryx Biopharmaceuticals, Inc.
- Herbert I. Hurwitz, MD, Associate Professor, Hematology/Oncology, Duke University Medical Center
- Leonard E. Post, PhD, Senior Vice President, Research and Development, Onyx Pharmaceuticals, Inc.
- William J. Slichenmyer, MD, ScM, Vice President and Head of Oncology Drug Development, Pfizer Global Research and Development