Biomarkers in Cancer Drug Approvals: New Opportunities and Challenges: A Health Policy and Bioethics Consortium
Description
The FDA recently approved Keytruda and Vitrakvi, two cancer drugs targeting biomarkers without reference to the site of the disease. Defining cancer in terms of biomarkers alone may require us to rethink the design of clinical trials and raises challenges for the traditional FDA approval process.
What is the future of these so-called "tumor-agnostic" therapies, and how will they be translated into effective treatment options in cancer and other diseases?
This event was free and open to the public.
Panelists
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Steven Lemery, Associate Deputy Director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
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Deborah Schrag, Professor of Medicine, Harvard Medical School and Chief, Division of Population Sciences, Department of Medical Oncology, Dana-Farber Cancer Institute
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Lisa McShane, Associate Director, Division of Cancer Treatment and Diagnosis, National Cancer Institute
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Spencer Hey, Faculty and Co-Director of Research Ethics, Center for Bioethics, Harvard Medical School and Research Scientist, Brigham and Women's Hospital
The Health Policy and Bioethics Consortia is a monthly series that convenes two international experts from different fields or vantage points to discuss how biomedical innovation and health care delivery are affected by various ethical norms, laws, and regulations.
They are organized by the Harvard Medical School Center for Bioethics and the Program on Regulation, Therapeutics, and Law (PORTAL) at Brigham and Women's Hospital, in collaboration with the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Support provided by the Oswald DeN. Cammann Fund at Harvard University.
Tags
bioethics clinical research fda genetics health law policy human subjects research pharmaceuticals regulation