Ongoing Events

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

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. 


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:



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


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

Scientific Symposia and Seminars

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


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:



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

December 6, 2022
“Regulatory Flexibility in the 21st Century: A Tale of Three Products”
Caleb Alexander, MD, MS, Professor of Epidemiology and Medicine, Johns Hopkins Bloomberg School of Public Health 

November 11, 2022
“Precision Reimbursement: Using Payment Innovation to Improve Patient Outcomes, Value, and Knowledge”
Mark Trusheim, MS, Strategic Director of NEWDIGS, Center for Biomedical System Design at Institute for Clinical Research and Health Policy Studies, Tufts Medical Center 

September 13, 2022
“A National Pediatric Medical Device Ecosystem: Bridging the Technology Divide”
Dr. Vasum Peiris, Chief Medical Officer and Director – Pediatrics and Special Populations, Center for Devices and Radiological Health, FDA


June 7, 2022
“Preparing for the Future of Evidence Generation”
Joe Franklin, JD, PhD, Product Counsel at Verily Life Sciences

May 3, 2022
“Technology and Health: Contextualizing Progress in the Digital and Data Revolution”
Dr. David Shaywitz, VP Distinguished R&D Fellow, Data and Digital at Takeda

April 5, 2022
“The Crucial Interplay Between Health Information Technology Regulation and FDA Regulatory Science”
Dr. Ken Mandl, Director, Computational Health Informatics Program (CHIP)

February 1, 2022
“Fellows Showcase”
Fellows at the Harvard-MIT Center for Regulatory Science: Alex Everhart, Susmitha Wunnava, and Ryan Knox

January 11, 2022
“Use of Real World Data/Evidence for Medical Product Evaluation: Promise and Perils”
Dr. Joseph Ross, Professor of Medicine and Public Health at Yale University

December 15, 2021
“Improving Precision in Estimating Treatment Effects in Randomized Trials: Covariate Adjustment for Binary, Ordinal, and Time-to-Event Outcomes”
Dr. Michael Rosenblum, Professor of Biostatistics at Johns Hopkins Bloomberg School of Public Health

November 30, 2021
“New Funding and Business Models for Accelerating Biomedical Innovation”
Andrew Lo, Charles E. and Susan T. Harris Professor at the MIT Sloan School of Management

September 24, 2021
“COVID-19: Developing a Vaccine During a Pandemic”
Dan Barouch, William Bosworth Castle Professor of Medicine and Professor of Immunology at Harvard Medical School


May 11, 2021
“Benefit-Risk Analysis to Capture Regulatory Decision-Making”
GK Raju, CEO of Light Pharma 

Apr 16, 2021
“Real-world COVID-19 Vaccine Effectiveness and the Mass Vaccination Experience in Israel”
Ben Reis, Director of the Predictive Medicine Group at the Children’s Hospital Informatics Program & Assistant Professor of Pediatrics at Harvard Medical School

March 16, 2021
“Ushering in safe, effective, and ethical medicine in the digital era”
Dr. Ariel Stern, Associate Professor at Harvard Business School & Andrea Coravos, CEO of Elektra Labs

February 12, 2021
“Brand-Generic Patent Litigation and Drug Regulation:  An Ounce of Planning Is Worth a Pound of Patent Protection”
Bruce Chabner, Clinical Director Emeritus of the MGH Cancer Center & Dov Grossman, Partner at the law firm Williams & Connolly LLP

January 19, 2021
“Fellows Showcase”
Fellows at the Harvard-MIT Center for Regulatory Science: Alejandra Avalos-Pacheco, Massimiliano Russo, Andrea Arfe, Xinzhou Guo, Michael Sinha

Dec 11, 2020
“The US Biosimilar Market: Progress, Challenges, and Possible Reforms”
Ameet Sarpatwari, Assistant Professor at Harvard Medical School and Assistant Director of PORTAL

Nov 17, 2020
“Diversity, inclusion, and equity in clinical research”
Barbara Bierer, Faculty Director of the Multi-Regional Clinical Trials Center BWH & Professor of Medicine at Harvard Medical School

Sep 15, 2020
“Insulin Biosimilars, Tumor Agnostic Therapies, and Digital Medicine Workshops in Review”
Aaron Kesselheim, Professor of Medicine at Harvard Medical School & Ariel Stern, Associate Professor at Harvard Business School & William Gordon, Instructor in Medicine at Brigham & Women’s Hospital


Sept 24, 2019
“Patient-customized oligonucleotide therapy for ultra-rare genetic diseases”
Jim Kuk Kim, BCH research fellow

Oct 22, 2019
“RWE for regulatory decision-making: Calibration against RCTs”
Jessica Franklin, Assistant Professor of Medicine at Harvard Medical School

Nov 22, 2019
“Regulatory considerations when n=1”
Matt Might, Director of the Hugh Kaul Precision Medicine Institute at the University of Alabama at Birmingham

Jan 24, 2020
“Fellows Showcase”
Regulatory Science Fellows of the Harvard-MIT Center for Regulatory Science

Feb 25, 2020
“Precision medicine with imprecise EHR data” 
Tianxi Cai, John Rock Professor of Population and Translational Data Sciences at the Harvard T.H. Chan School of Public Health

May 19, 2020
“PanFab and addressing PPE shortages: Sterilizing N95 respirators for re-use”
Deborah Plana, MD-PhD Student at Harvard-MIT HST & Avilash Cramer, PhD Student at MIT


Oct. 26, 2018
“Labeling changes and costs for clinical trials performed under the U.S. Food and Drug Administration pediatric exclusivity extension, 2007-2012”
Michael Sinha, MD, JD, MPH, Harvard-MIT CRS fellow

Nov. 27, 2018
“Prices and other incentives in biomedical R&D”
Frank David, founder and managing director, Pharmagellan

Jan. 25, 2019
“Regulatory policies advancing rigorous evaluation of medicines for children”
Florence Bourgeois, MD, MPH, co-director, Harvard-MIT CRS

Feb. 26, 2019
From bigger data to smarter evidence”
Gigi Hirsch, MD, Massachusetts Institute of Technology

March 22, 2019
Safe, effective, and ethical digital medicine”
Andy Coravos, MBA, Elektra Labs

April 23, 2019
Trial designs in Glioblastoma”
Lorenzo Trippa, MD, PhD, Dana-Farber Cancer Institute

May 21, 2019
“Functional precision medicine”
Anthony Letai, MD, PhD, Dana-Farber Cancer Institute