Upcoming Events

The Center hosts workshops, symposia, and other community-building and educational opportunities for the regulatory science community. To stay updated on the latest news and events from the Center, as well as local regulatory science opportunities, sign up for our bimonthly mailing list here.

Previous Events

RegSci Forum: “Brand-Generic Patent Litigation and Drug Regulation:  An Ounce of Planning Is Worth a Pound of Patent Protection”
February 12, 2021 | 12pm – 1pm ET
Virtual Webconference


Speakers:

Dr. Bruce Chabner, Clinical Director Emeritus of the MGH Cancer Center &
Dov Grossman, Partner at the law firm Williams & Connolly LLP

About the talk:
This talk will focus on what anyone working on innovative small molecule drugs should understand: the interplay between the FDA approval process and patent litigation. It will provide an overview of how patent litigation factors into the drug approval process, discuss the differing strategic considerations for brand and generic companies in such litigation, and review various examples of “Hatch-Waxman” brand-generic patent litigation.

RSVP & Zoom information in link below:

2020 Regulatory Science Doctoral Student Symposium
Feb 4, 2020 l 8:30am-4:00pm
Cotting House, Harvard Business School

This symposium provides an opportunity for doctoral students to present their research in a friendly, supportive environment and to receive feedback from faculty and other students who are also interested in questions of regulatory science. Last year, students and faculty joined us from diverse fields including health economics, bioethics, policy, pharmaceutical and medical device R&D, biomedical research, and more.

Regulatory Science Faculty-Student Mixer
Nov 6, 2019 l 5:00pm – 7:00pm
Vanderbilt 101, Harvard Medical School

Come meet your fellow faculty, trainees, and students from Harvard, MIT, and other Boston institutions who are interested in regulatory science, and learn about the Harvard-MIT Center for Regulatory Science (CRS). This event will feature CRS faculty including Ariel Stern from HBS, Aaron Kesselheim from PORTAL and HMS, Giovanni Parmigiani from Dana-Farber Cancer Institute, Florence Bourgeois from Boston Children’s Hospital, and more. Our faculty will briefly provide an overview of their research, and we will also discuss the CRS fellowship and announce our upcoming events such as the Doctoral Student Symposium. Refreshments will be served. This event is free and open to any academic researchers with interest in this topic. Please help us to plan by RSVPing here!

Innovators in Therapeutics Speaker Series: Jeb Besser
October 17, 2019 l 4:00pm – 5:30pm
Cannon Room l Harvard Medical School

Please join us for the Innovators in Therapeutics Speaker Series, which provides students and trainees in academia an opportunity to learn about the challenges and successes of bringing novel drugs and devices to market. Our featured speaker is James Besser, a Principal at Manchester Management.

Harvard-MIT CRS Open House
September 19, 2019 l 4:00pm – 5:00pm
Harvard Medical School

Please join us at our open house to learn about research and opportunities at the Harvard-MIT Center for Regulatory Science (CRS). In addition to introducing the mission of the center, our faculty and fellows will share their research in regulatory science and discuss the events, fellowship program, and other opportunities to engage with the Center. There will be time for attendees to ask any questions they may have about the Center and mingle with faculty, staff, and trainees. All are welcome!

Innovators in Therapeutics Speaker Series: Stelios Papadopoulos, Biogen
May 8, 2019 l 3:30pm – 5:30pm
Cannon Room l Harvard Medical School

Please join us for the Innovators in Therapeutics Speaker Series, which provides students and trainees in academia an opportunity to learn about the challenges and successes of bringing novel drugs and devices to market. Our featured speaker is Dr. Stelios Papadopoulos, Chairman of the Board for Biogen. Dr. Papadopoulos will describe the challenging path that CABOMETYX took to gain regulatory approval for treating renal cell carcinoma and hepatocellular carcinoma. Dr. Papadopoulos will also share his journey of how he went from completing his Ph.D. at New York University to become one of the most successful innovators in drug development.

Innovators in Therapeutics Speaker Series: Jeff Leiden, Vertex
April 23, 2019 l 4:30pm – 6pm
Cannon Room l Harvard Medical School

Please join us for the Innovators in Therapeutics Speaker Series, which provides students and trainees in academia an opportunity to learn about the challenges and successes of bringing novel drugs and devices to market. Our featured speaker is Dr. Jeff Leiden, the Chairman, President, and CEO of Vertex Pharmaceuticals.

Harvard-MIT CRS Regulatory Science Annual Symposium 2019
Apr 2, 2019 l 8:30am-6pm
American Academy of Arts and Sciences, Cambridge MA

Join us for the annual meeting of the Boston area regulatory science community, hosted by the Harvard-MIT Center for Regulatory Science. This is a scientific meeting open to the entire community that aims to promote open, multi-stakeholder dialogue about important regulatory science challenges and advances. In addition to members of the Center, this symposium welcomes broader participation from academia, regulatory agencies, industry, and patient advocates. In addition to scientific talks and panel discussions, there will be a poster session open for graduate students and fellows to present their research. The agenda can be seen here.

This year’s featured topics include:

  • Real-World Evidence
  • Digital Health
  • Advances in International
  • Clinical Trials
  • Complex Generics
  • Drug Repurposing for Unmet Needs
  • Regulatory Frameworks
The Regulatory Science Doctoral Student Symposium
Feb 4, 2019 l 8:30am-2:15pm
Cotting House, Harvard Business School

The Harvard-MIT Center for Regulatory Science is holding a student symposium on February 4, 2019. 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. We encourage students to join us from diverse fields including economics, bioethics, healthcare policy, public policy, drug/device regulatory policy, pharmaceutical R&D, patent law, biomedical research, and more. Although this is a student-focused event, we are open to considering post-docs, fellows, and other trainees who fill out the application form, pending availability of additional presentation slots. If you are not interested in presenting but would like to attend the event, please mark your calendar and join us on February 4!

Innovators in Therapeutics Speaker Series: John Maraganore and Sara Nochur, Alnylam
November 15, 2018 l 4:30pm – 6pm
Cannon Room l Harvard Medical School

Please join us for the Innovators in Therapeutics student speaker series organized by the Harvard-MIT Center for Regulatory Science and the Harvard Program in Therapeutic Science. The first installment of this series will feature John Maraganore, the CEO of Alnylam, and Sara Nochur, Alnylam’s Senior Vice President for Regulatory Affairs. Dr. Maraganore and Dr. Nochur will describe Alnylam’s path through development and FDA approval of the first RNAi therapeutic, ONPATTROTM (patisiran), for the treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis. Dr. Maraganore and Dr. Nochur will focus on the regulatory science aspects of gaining approval for this innovative therapeutic.

Regulatory Science Faculty-Student Mixer
October 16, 2018
Modell Center Atrium l Harvard Medical School

Join other faculty, trainees and students from Harvard and MIT who are interested in regulatory science, and learn about the new Harvard-MIT Center for Regulatory Science (CRS). This event will feature CRS faculty including Ariel Stern from HBS, Aaron Kesselheim from PORTAL and HMS, Brian Alexander from Dana-Farber, and more. We will introduce the Center, provide an overview of faculty research, discuss the CRS fellowship and announce more of our upcoming events. Refreshments will be served.

Anticancer Drug Development Workshop
September 29, 2018 Le Meridien l Cambridge, MA

The Anticancer Drug Development Workshop is an advanced clinical development workshop discussing the specific strategies leading to successful development pathways for new anticancer agents. The program will feature faculty speakers from FDA, the Harvard-MIT Center for Regulatory Science and Duke University, representing the full spectrum of anticancer drug development processes and regulatory science activities. The workshop is targeted towards early-career drug development investigators and fellows, but anyone with limited knowledge of regulatory science will benefit.