Center Events Hub

Learn more about our recurring events below and check out our calendar for upcoming opportunities to participate in Center activities.

Upcoming Events

Regulatory Science Forum with Marc Lipsitch
Using Simulation and Modeling to Improve Vaccine Evaluation
December 3rd: 12 – 1 PM EST
Register here!

Guest Speaker Events

Regulatory Science Forum

The forum is a meeting of faculty and regulatory science contributors who come together to discuss emerging topics in regulatory science with a lunchtime presentation. In addition to the invited speakers listed below, regular participants include faculty from Harvard, MIT, and Harvard-affiliated hospitals as well as industry and government professionals. Expand to see past events:

PAST EVENTS

November 12, 2024
“Use of Clinical Simulation for the Evolution of Digital Health Solutions”
Matthew Prime, International Business Leader for CDS & Algorithms, Roche Information Solutions

October 1, 2024
“How Can the FDA Build Public Trust in its Decisions?”
Aaron S. Kesselheim, Professor of Medicine, Harvard Medical School; Director, Program on Regulation, Therapeutics, and Law (PORTAL)

September 17, 2024
“Opportunities for Large Language Models in Regulatory Science”
Tim Miller, Principal Investigator for Machine Learning, Medical Language Lab in the Computational Health Informatics Program (CHIP)

June 4, 2024
“Regulatory Science and Emerging Technologies”
Scott Steele, Senior Advisor, Center for Biologics Evaluation and Research, FDA

May 7, 2024
“From RegSci Classroom to Corporate Acquisition: The Story of HumanFirst”
Andy Coravos, Managing Director at HumanFirst

March 5, 2024
Clinical Trial Optimization in the Age of Hyper-Customization
Kenneth Getz, Executive Director and Professor, Tufts Center for the Study of Drug Development

February 6, 2024
“Fellows Showcase”
Magdi Elsallab, CRS Fellow
Mahnum Shahzad, CRS Fellow
Trupti Shetty, CRS Fellow
Susmitha Wunnava, CRS Fellow
Ryan Knox, CRS Fellow

December 5, 2023
“The Digital Revolution in Regulated Medical Products: Clinical Trials, Digital Therapeutics, and Regulated AI Devices”
Ariel D. Stern, PhD, Associate Professor, Harvard Business School

November 7, 2023
“The Impact on Risk Evaluation and Mitigation Strategies (REMS) on Clinical Practice and Generic Drug Availability”
Ameet Sarpatwari, PhD, Assistant Director, Program On Regulation, Therapeutics, and Law (PORTAL)

October 3, 2023
“An Insider’s Perspective on Drug Regulation”
Frank S. David, MD, PhD, Managing Director, Pharmagellan
Susan Stewart, JD, LL. M, Chief Regulatory Officer, Rezolute

September 12,2023
“An Inflection Point for High-Quality Diagnostic Tests in Oncology”
Briand Alexander, MD, Chief Executive Officer, Foundation Medicine

May 2, 2023
“Analyzing Biotech Clinical Trails”
Frank S. David, MD, PhD, Managing Director, Pharmagellan

April 4, 2023
“Dubious FDA Approvals”
Vinay Prasad, MD, MPH, Professor, Department of Epidemiology and Biostatistics, University of California San Francisco

March 7, 2023
“Understanding Medication Safety in Pregnancy: Seeing the Forest for the Trees”
Krista Huybrechts, MS, PhD, FISPE, Associate Professor of Medicine and Epidemiology, Harvard Medical School and Harvard T.H. Chan School of Public Health

February 7, 2023
“Fellows Showcase”
Fellows at the Harvard-MIT Center for Regulatory Science: Susmitha Wunnava, Alex Everhart, Magdi Elsallab, Trupti Shetty, and Ryan Knox

January 10, 2023
“Clinical Evidence and Medical Devices: Generating Real-World, Actionable Evidence”
Jill Marion, MS, MBA, Deputy Director, Office of Clinical Evidence and Analysis, CDRH, FDA
Mary Beth Ritchey, PhD, Chief Epidemiologist, Office of Clinical Evidence and Analysis, CDRH, FDA

 

Innovators in Therapeutics Speaker Series

This guest lecture series is geared towards students and trainees in academia interested in learning about the challenges and successes of bringing novel drugs and devices to market. The event includes a networking session that brings together faculty, students, and trainees who are interested in translational research, pharmacology, biotechnology, and regulatory science.

Previous guests included:

  • Mathai Mammen, M.D, Ph.D, CEO, FogPharma
  • Jeffrey Jonas, M.D., Director, Sage Therapeutics and Chairman of the Board, Noema Pharma
  • Michael Rosenblatt, M.D., Senior Advisor at Flagship Pioneering
  • David Altshuler, Executive Vice President, Global Research and Chief Scientific Officer at Vertex Pharmaceuticals
  • Adam Rodgers, Interim President, NerveGen Pharma
  • Ted Love, President and CEO of Global Blood Therapeutics
  • Vas Narasimhan, CEO of Novartis
  • James Besser, a Principal at Manchester Management
  • Jeff Leiden, Chairman, President, and CEO of Vertex
  • Stelios Papadopoulos, Chairman of the Board for Biogen
  • John Maraganore and Sarah Nochur, CEO and Head of Regulatory Affairs at Alnylam

Student Events

Regulatory Science Doctoral Student Symposium

This annual event takes place at Harvard Business School and brings graduate student researchers from Harvard and MIT around current research topics in regulatory science. The goal of this event is to provide students with a chance to present their research in a friendly, supportive environment and to receive feedback from faculty and colleagues who are also interested in regulatory science-related questions. During this symposium, students present on a variety of topics including health economics, health policy, pharmaceutical R&D, data science, regulation, and bioethics. We are fortunate to be joined by faculty mentors from across Harvard who moderate and provide their expertise during the day. Our faculty guests have included Ariel Stern from HBS, Aaron Kesselheim from PORTAL, Florence Bourgeois from Boston Children’s Hospital, Josh Krieger from HBS, and Frank David from Pharmagellan.

It was such an intimate feedback setting. I really appreciated getting the time and direct feedback of leaders in the field.” -Student Presenter

 

Regsci Student-Faculty Mixer

Our fall mixer (typically in October) brings together faculty, trainees, and students from Harvard, MIT, and other academic institutions in Boston who are interested in regulatory science and interested in learning about opportunities at the Harvard-MIT Center for Regulatory Science (CRS). The event allows trainees and faculty to network with other researchers working across a breadth of research topics. The event typically features CRS faculty from Harvard Medical School, Harvard Business School, and affiliated hospitals who provide an overview of their research and chat in small groups with students and trainees. Past confirmed faculty include Ariel Stern, Aaron Kesselheim, Peter Sorger, Florence Bourgeois, and Josh Kreiger. This event is free and open to any academic faculty, trainees, and students with an interest in regulatory science, but for the time being the event is not open to individuals in industry. 

 

Regulatory Science Community Events

Annual Symposium of the Harvard-MIT Center for Regulatory Science

The Harvard-MIT Center for Regulatory Science hosts an annual meeting of the regulatory science community, an event which is now the Global Conference on Regulatory Science. This scientific meeting open to the entire community aims to promote open, multi-stakeholder dialogue about important regulatory science challenges and advances. In addition to members of the Center, this conference includes broad participation from academia, regulatory agencies, industry, and patient advocates to share cutting edge research and discuss solutions to the most pressing issues in regulatory science. 

2022 Global Conference on Regulatory Science
2021 Global Conference on Regulatory Science

2020 Global Conference on Regulatory Science
Agenda 2019 Harvard-MIT Center for Regulatory Science Annual Symposium
Agenda 2018 Harvard-MIT Center for Regulatory Science Annual Symposium
Agenda 2017 Harvard-MIT Center for Regulatory Science Annual Symposium

RegSci Early Career Seminar Series

The RegSci Early Career Seminar Series is co-hosted by the Harvard-MIT Center for Regulatory Science and the Therapeutics Graduate Program. We invite early career speakers to share their career trajectory and work as regulatory science professionals. This event is geared towards giving trainees a better understanding of career options in regulatory science, as well as providing them the opportunity to ask their questions and learn about tips and tricks from other recent graduates who have successfully transitioned. While content is geared toward trainees (graduate and professional students), all are welcome!

  • Sowmya Chary, Associate Medical Director at Biogen
    Regulatory science in industry, more
  • Annabelle Fowler, FDA Public Health and Regulatory Research Fellow
    Fellowships and Regulatory Science at the FDA, more