Kantoff-Sang Lecture Videos

5/2/2013: Regulatory Science Symposium: Perspectives

Speakers:

  • Joshua Boger, PhD
  • Janet Woodcock, MD
  • Michael Rosenblatt, MD
  • Daniel Carpenter, PhD
  • Elliott Antman, MD
  • William Chin, MD

Panelists:

Elliott Antman, Daniel Carpenter, William Chin, Elazer Edelman, Michael Rosenblatt, Janet Woodcock

Translational Activity:

This year's topic, Regulatory Science: Perspectives, honored Philip Kantoff, MD, through the generous gifts made in memory of Heng-Kang Sang, PhD. The lecture, moderated by Joshua Boger, was intended to discuss regulatory science from a range of perspectives: academia, industry, and regulatory bodies.

Janet Woodcock, MD, director of the Center for Drug Evaluation and Research at the FDA, discussed the regulatory perspective, defining regulatory science as "creating or using scientific tools from a broad spectrum and then assessing their efficacy." One of her lecture points addressed the challenges of clinical trials today, including the high cost, and the number of failure rates, making them inaccessible to certain patients.

Michael Rosenblatt, MD, executive vice president and chief medical officer of Merck & Co. Inc., spoke from the perspective of industry, describing regulatory science as "a collection of sciences that has three main driving components: patient need, innovation, and access (access being the sub-population of patients who should get a medicine/who shouldn't). Regulatory science is the convergence of these three components."

And Elliott Antman, MD, associate dean for clinical and translational research at Harvard Medical School, discussed the academic perspective, focusing on adaptive design, missing data, and comparative effectiveness, emphasizing that academia needs to become more organized in the way it applies biologic insights to improve trial design.

The speakers, including Daniel Carpenter, PhD, who addressed the social science perspective on regulatory affairs, were joined by panelists William Chin, MD, and Elazer Edelman, MD, PhD, to conclude the symposium. The discussion came to the overwhelming conclusion that collaboration among regulatory bodies, academia, and industry on issues of regulatory science is critical in order for researchers to advance discoveries in a safe and efficient manner.

Full Video: The Second Annual Kantoff-Sang Lecture, Regulatory Science Symposium: Perspectives

Welcome and Intro
Joshua Boger, PhD
Founder, Vertex Pharmaceuticals

Janet Woodcock, MD
Director of the Center for Drug Evaluation and Research, Food and Drug Administration (FDA)

Michael Rosenblatt, MD
Executive Vice President and Chief Medical Officer, Merck & CO. Inc.

Daniel Carpenter, PhD
Allie S. Freed Professor of Government and Director of the Center for American Political Studies, Faculty of Arts and Sciences at Harvard University

Elliott Antman, MD
Associate Dean for Clinical and Translational Research, Harvard Medical School

Kantoff-Sang Lecture: Panel Discussion

Panelists: Elliott Antman, Daniel Carpenter, William Chin, Elazer Edelman, Michael Rosenblatt, Janet Woodcock

Closing
William Chin, MD
Executive Vice President of Science and Regulatory Affairs, Pharmaceutical Research and Manufacturers of America (PhRMA);
Delia Sang, MD
Donor, Clinical Instructor in Ophthalmology, Massachusetts Eye and Ear