Agenda

Download the electronic version of the Agenda


Registration and breakfast

Welcome and Introduction to the Center for Regulatory Science (CRS)
Florence Bourgeois and Aaron Kesselheim, Harvard-MIT CRS Co-Directors

Keynote: Richard Platt, Harvard Pilgrim Health Care Institute

Session 1: Digital Health
Chaired by Florence Bourgeois, Harvard-MIT CRS

  • Andy Coravos, Elektra Labs
  • Liza Hoffman, Beth Israel Deaconess Medical Center
  • John Brownstein, Boston Children’s Hospital

Morning Coffee Break

Session 2: Legal and Ethical Challenges in International Clinical Trials
Chair Barbara Bierer, Brigham and Women’s Hospital

  • Stephen Rosenfeld, Quorum Review IRB
  • David Peloquin, Ropes & Gray LLP
  • Barbara Bierer, Brigham and Women’s Hospital

Panel 1: Towards an “Agile” Regulatory Framework
Chaired by Gigi Hirsch, Massachusetts Institute of Technology

  • Paul Howard, Food and Drug Administration
  • Anne-Virginie Eggimann, Bluebird Bio
  • Ed Pezalla, Enlightenment Bioconsult

Lunch

Session 3: Repurposing for Unmet Needs
Chaired by Artem Sokolov, Harvard Medical School

  • Mark Albers, Massachusetts General Hospital
  • Joohee Sul, Food and Drug Administration
  • Sandro Santagata, Brigham and Women’s Hospital

Panel 2: Complex generics
Chaired and Moderated by Michael Sinha, Harvard-MIT CRS

  • Rena Conti, Boston University
  • Wenlei Jiang, Food and Drug Administration

Afternoon Coffee Break

Session 4: Real World Evidence and Regulatory Decision Making
Chaired by Sebastian Schneeweiss, Brigham and Women’s Hospital

  • Jacqueline Corrigan-Curay, Food and Drug Administration
  • Jeremy Rassen, Aetion
  • Jessica Franklin, Brigham and Women’s Hospital

Closing remarks
Florence Bourgeois and Aaron Kesselheim, Harvard-MIT CRS Co-Directors

Drinks Reception with Student and Trainee Poster Session