The New Frontiers in Science Distinguished Lectureship Program at the FDA is the first program in a new regulatory science initiative adopted by the HRA Board of Directors in the summer of 2011.

This program aims to strengthen scientific expertise at the FDA and to foster interactions between the scientific community and the FDA by bringing outstanding scientific leaders to the FDA for short periods to serve as Distinguished Lecturers. Funding from three HRA member organizations have made this program possible: the Burroughs Wellcome Fund, the Doris Duke Charitable Foundation and JDRF. Several representatives from HRA serve on a Joint Planning Committee to identify lecturers for the program, which is focusing on the FDA’s regulatory science priority area of emerging technologies.  For a more detailed description of the New Frontiers Program click here.

Check out the recent evaluation of the New Frontiers program conducted by the FDA.

2016 offerings:

  • March 9, 2016:Bray Patrick-Lake, MFS, Director of Stakeholder Engagement, Clinical Trials Transformation Initiative “Bridging 2 Worlds – Patient Engagement in Medical Product Development
  • May 11, 2016:  Harlan M. Krumholz, MD, SM, Professor of Medicine, Epidemiology, and Public Health, Yale School of Medicine:  “Precision FDA: Patient-Powered, Data-Driven, and Transparent.”  To listen to the presentation click here.
  • December 1, 2016:  Gene Editing Workshop: Technologies and Application on FDA-Regulated Products

       Keynote Speaker:

    • Jennifer Doudna, PhD
      HHMI Investigator, Howard Hughes Medical Institute, Innovative Genomics Initiative, University of California

       Session Speakers:

    • J. Keith Joung, MD, PhD
      Associate Chief of Pathology for Research,
      Massachusetts General Hospital and Harvard Medical School
    • Matthew Porteus, MD, PhD
      Associate Professor, Pediatrics
      Stanford University, School of Medicine
    • Joseph Tector, MD, PhD, FACS
      Professor of Surgery
      University of Alabama at Birmingham
    • Paul A. Nakata, PhD
      Molecular Biologist, Assistant Professor
      Children’s Nutrition Research Center

2014 offerings:

      • June 11, 2014:  Thomas Fogarty, M.D., Founder and Director, Fogarty Institute for Innovation, spoke on medical innovation to a packed conference room and online to FDA staff working remotely.  Commissioner Margaret Hamburg introduced Dr. Fogarty, an internationally-renowned cardiovascular surgeon and innovator who counts among his 135 medical patents the patent for the balloon catheter.  For more about Dr. Fogarty and the Fogarty Institute for Innovation, see .
      • September 3, 2014:  Anthony Atala, M.D., Director of the Wake Forest Institute for Regenerative Medicine and the W. H. Boyce Professor and Chair of the Department of Urology at Wake Forest University (see,-MD,-Director-and-Chair.htm  for additional information) lectured on “Regenerative Medicine:  Current Concepts and Changing Trends.”  Dr. Atala’s work focuses on growing new human cells, tissues and organs.  He currently serves as Editor-in-Chief of three journals:  Stem Cells – Translational Medicine, Current Stem Cell Research and Therapy, and Therapeutic Advances in Urology.  He has served in leadership roles on the NIH Working Group on Cells and Developmental Biology, the NIH Bioengineering Consortium, and the NCI’s Advisory Board, and has received over 200 national and international patents.  Dr. Atala has published over 300 peer-reviewed articles and has edited thirteen books on regenerative medicine and urology.

2013 offerings:

      • March 20, 2013:  Leroy Hood, M.D., Ph.D., of the Institute for Systems Biology presented “Systems Medicine, the Emergence of Transformational Technologies and Proactive P4 Medicine.”   Following his lecture, Dr. Hood visited with staff in the Office of Cellular Tissues and Gene Therapies and the Office of Biostatistics and Epidemiology in the Center for Biologics Evaluation and Research (CBER); in the Office of Translational Sciences, the Office of New Drugs and the Office of Pharmaceutical Science in the Center for Drug Evaluation and Research (CDER); and in the Office of the Chief Scientist.
      • November 13, 2013:  Irving Weissman, M.D., Director, Institute for Stem Cell Biology & Regenerative Medicine at Stanford University, “Stem Cells and Cancer Stem Cells: From Discovery to the Clinic.”  Following the lecture, Dr. Weissman met with staff in several FDA centers and divisions.

2012 offerings:

      • September 17, 2012:  Sanjiv Gambhir, M.D., Ph.D., Virginia and D. K. Ludwig Professor of Cancer Research, Stanford University, presented “Emerging Strategies for the Early Detection of Cancer,” the inaugural lecture in the New Frontiers  program.  The lecture, which was introduced by FDA Commissioner Margaret Hamburg and FDA Chief Scientist Jesse Goodman, was well-attended by FDA staff.   Several representatives from HRA member organizations were also in attendance.  Following the lecture, Dr. Gambhir met with staff members at the Center for Devices and Radiological Health (CDRH) and the Office of the Commissioner.  The full recording of the lecture is available at the following link (Dr. Gambhir’s presentation starts at the 10:30 minute mark)
      • December 5, 2012:  Arthur L. Caplan, Ph.D., Drs. William F. and Virginia Connolly Mitty Professor and Department Chair, Department of Bioethics, New York University, Langone Medical Center presented the second lecture under the New Frontiers program“Ethics, Compassion and Evidence.”  Following the lecture, Dr. Caplan met with staff in several different divisions at FDA.