Discovery and Validation of Biomarkers 2017

A workshop on the development and use of biomarkers, regulation, and therapeutic innovation

Hosted by Harvard Medical School, Harvard Business School, and the Kennedy School of Government

April 3, 2017

Batten Hall Room 302, Harvard Business School

Agenda

08:30-08:35 Introductory Remarks

Aaron Kesselheim, M.D., J.D., Director of the Program On Regulation, Therapeutics, And Law
Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital and Harvard Medical School

08:35-09:20 Three Perspectives on Biomarkers’ Use in Approving New Drugs

• Development
  • Vishal Vaidya, Ph.D., Director, Biomarker Analytics Global Lead at Pfizer
• Government
  • Christopher Leptak, M.D., Ph.D., Director, Office of New Drug’s Regulatory Science Program, Food and Drug Administration
• Clinical care
  • Jerry Avorn, M.D., Professor of Medicine, Harvard Medical School

Group Discussion

Coffee Break

10:00-10:45 Biomarker Discovery and Validation in 2017

• Biomarkers and Discovery in Oncology
  • Bruce Chabner, M.D., former head, National Cancer Institute)
• Ethical Challenges in Biomarker-driven Research
  • Spencer Hey, Ph.D., Program on Regulation, Therapeutics, And Law and Harvard Medical School Center for Bioethics
• Discovering Biomarker Diagnostics
  • David Litwack, Ph.D., Policy Advisor of the Office of In Vitro Diagnostics and Radiological Health at the FDA Center for Devices and Radiological Health

10:45-11:45 Group Discussion

Break for Lunch

12:15-12:45 How Can Government/Clinicians/Academia/Industry Work Together to Overcome the Challenges with Biomarker Discovery and Use in Patient Care?

• Incentives for Biomarker Discovery and Development
  • Ariel Stern, Ph.D., Assistant Professor of Business Administration in the Technology and Operations Management Unit at Harvard Business School
  • Amitabh Chandra, Ph.D., Malcolm Wiener Professor of Public Policy, Director of Health Policy Research at the Harvard Kennedy School of Government
• Biomarkers and Cardiovascular Disease
  • Elliott Antman, M.D., Professor of Medicine, Harvard Medical School, President, American Heart Association
• Biomarkers and Infectious Diseases
  • John Powers, M.D., Professor of Clinical Medicine, George Washington University School of Medicine

12:45-2:00 Group Discussion