Pharmaceutical & Drug Policy
How US tariffs stand to impact prescription drugs
On October 20, the Engelberg Center for Health Care Reform and Friends of Cancer Research hosted the 2010 Conference on Clinical Cancer Research, where key stakeholders came together to address specific challenges in clinical cancer research and discuss potential solutions proposed by expert panels.
Panelists and participants represented the range of stakeholders in the cancer community, including senior officials from the U.S. Food and Drug Administration (FDA) and the National Cancer Institute (NCI), as well as thought leaders from academia, patient advocacy organizations, and the life sciences industry. FDA Commissioner Dr. Margaret Hamburg and NCI Director Dr. Harold Varmus offered keynote remarks, and four panel discussions focused on:
- Expanding the use of adaptive clinical trial design in oncology;
- Innovative and efficient pre-clinical testing;
- Incorporating pain metrics into oncology clinical trials; and
- Using patient-generated data and samples to develop evidence for targeting approved treaments.
Agenda
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October 20
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Welcome
Mark B. McClellan Former Brookings Expert, Director, Margolis Center for Health Policy - Duke University -
Keynote Address
HVHarold Varmus Director, National Cancer Institute -
Panel 1: Expanding the Use of Adaptive Clinical Trial Design in Oncology
MHSModerator: Howard Scher Chief, Genitourinary Oncology Service, Memorial Sloan-Kettering Cancer CenterRSRaji Sridhara Acting Director, Division of Biometrics V - U.S. Food and Drug AdministrationRSRichard Simon Chief, Biometric Research Branch, National Cancer InstituteEREric Rubin Deputy Assistant Secretary, European and Eurasian Affairs - U.S. State DepartmentSFNShelley Fuld Nasso Director, Public and Medical Affairs, Susan G. Komen for the Cure -
Panel 2: Innovative and Efficient Pre-Clinical Testing
MKTModerator: Ken Turteltaub Executive Director, Battelle Center for Fundamental and Applied Systems Technology, Battelle Memorial InstituteJLJohn Leighton Associate Director for Pharmacology/Toxicology, U.S. Food and Drug AdministrationMDMyrtle Davis Chief, Toxicology and Pharmacology Branch, National Cancer InstituteLABLeigh Ann Burns-Nass DSRD Therapeutic Area Leader-Oncology, Pfizer, Inc.ACAdam Clark Director, Scientific and Federal Affairs, Faster Cures -
Lunch and Keynote Remarks
IESIntroduction: Ellen Sigal Friends of Cancer ResearchMHMargaret Hamburg Commissioner - U.S. Food and Drug Administration -
Panel 3: Incorporating Pain Metrics into Oncology Clinical Trials
MCCModerator: Charles Cleeland Department Chair, Department of Symptom Research, MD Anderson Cancer CenterLBLaurie Burke Associate Director for Study Endpoints and Labeling Development, Office of New Drugs, U.S. Food and Drug AdministrationAOAnn O’Mara Head of Palliative Care Research, Community Oncology and Prevention Trials Research Group, National Cancer InstituteMZMartin Zagari Global Health Economics Head, AmgenCBCarole Baas Patient Advocate -
Panel 4: Patient Generated Samples and Data
CSFCo-Moderator: Stephen Friend President, Sage BionetworksRSRichard Schilsky Chief Medical Officer - American Society of Clinical OncologySWSue-Jane WangKBKen Buetow Director, Bioinformatics and Information Technology, National Cancer InstituteJFJamie Freedman Executive Vice President, R&D, GlaxoSmithKlineLFALaurie Fenton Ambrose President, Lung Cancer Alliance -
Summary and Closing Remarks
Mark B. McClellan Former Brookings Expert, Director, Margolis Center for Health Policy - Duke University
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