Pharmaceutical & Drug Policy
Incorporating information on therapeutic alternatives into the IRA prescription drug negotiations
To address critical issues in the development of new oncology drugs, Friends of Cancer Research and the Engelberg Center for Health Care Reform will co-host the seventh annual Conference on Clinical Cancer Research. This annual conference brings together leaders in cancer drug development from federal health and regulatory agencies, academic research, and the private sector for focused discussions on key issues surrounding the development and regulation of cancer drugs and therapies. This year’s conference will feature three panels that will propose unique approaches toward current challenges in drug development.
Agenda
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November 21
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Panel One: Potential Strategies for Non-Randomized Evaluation of New Drugs
9:00 am - 10:30 am
DADeborah Armstrong Professor of Oncology - Johns Hopkins Kimmel Cancer CenterMRMace Rothenberg Senior Vice President, Clinical Development/Medical Affairs - PfizerRSRich Simon Chief, Biometric Research Branch - National Cancer InstituteJSJosh Sommer Executive Director - Chordoma FoundationGBGideon Blumenthal Clinical Team Leader - U.S. Food and Drug AdministrationRPRichard Pazdur Director, Office of Oncology Products - U.S. Food and Drug Administration -
Panel Two: Improving Evidence Developed From Population-Level Experience with Targeted Agents
10:45 am - 12:15 pm
RSRichard Schilsky Chief Medical Officer - American Society of Clinical OncologyJPJane Perlmutter Founder and President - Gemini GroupVMVincent Miller Chief Medical Officer - Foundation Medicine, Inc.SNSam Nussbaum Executive Vice President, Clinical Health Policy and Chief Medical Officer - WellPoint, Inc.DDDane Dickson Director of Clinical Science - MoIDX, Palmetto GBARPRichard Pazdur Director, Office of Oncology Products - U.S. Food and Drug Administration -
Panel Three: Consideration of Summary Review of Supplemental NDA/BLA Submissions in Oncology
1:45 pm - 3:15 pm
RSRachel Sherman Principal, Drug and Biological Drug Products - Greenleaf Health LLCTPTatiana Prowell Breast Cancer Scientific Lead, Division of Oncology Products 1, Office of Hematology & Oncology Products - U.S. Food and Drug AdministrationKSKatherine Sugarman Senior Director, Global Regulatory Affairs, Oncology - Eli LillyLSLaurie Strawn Associate Director, Worldwide Regulatory Strategy - PfizerKNKannan Natarajan Senior Vice President and Global Head - Novartis PharmaceuticalsRSRaji Sridhara Acting Director, Division of Biometrics V - U.S. Food and Drug Administration -
Morning Keynote: A Path to 21st Century Cures
8:35 am - 9:00 am
HFUHon. Fred Upton Chairman - United States House of Representatives, Energy & Commerce Committee -
Lunch Keynote: State of FDA's Breakthrough Therapy Designation
12:45 pm
JWJanet Woodcock Director, Center for Drug Evaluation and Research - US Food and Drug Administration -
Welcome
8:30 am - 8:35 am
ESEllen Sigal Chairperson and Founder - Friends of Cancer Research
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