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.

RegSci Forum “Benefit-Risk Analysis of Regulatory Decision-Making”
May 11, 2021 | 12pm – 1pm ET
Virtual Webconference

Speaker:
GK Raju, CEO of Light Pharma & Executive Director of Pharma Manufacturing Initiatives, MIT CBI

About the talk:
More details to come

 

 

RegSci Early Career Seminar
April 29, 2021 | 5:30pm – 6:30pm ET
Virtual Seminar

Speaker:
Annabelle Fowler, Public Health and Regulatory Research Fellow, FDA

About the talk:
Our second RegSci Early Career Seminar, co-hosted by the Harvard-MIT Center for Regulatory Science and the Therapeutics Graduate Program, will feature Annabelle Fowler, Public Health and Regulatory Research Fellow at the FDA. At this event, Annabelle will describe the role of regulatory science at FDA and discuss her current work and career path thus far. This event will be geared toward trainees (graduate and professional students), but all are welcome!

RegSci Forum: “Real-world COVID-19 Vaccine Effectiveness and the Mass Vaccination Experience in Israel”
Apr 16, 2021 | 11am – 12pm ET
Virtual Webconference

Speaker:
Ben Reis, Director of the Predictive Medicine Group at the Children’s Hospital Informatics Program & Assistant Professor of Pediatrics at Harvard Medical School

About the talk:
Dr. Ben Reis will lead a discussion on the recent New England Journal of Medicine paper he co-authored, providing the first real-world study of effectiveness of the Pfizer-BioNTech COVID-19 vaccine. This was the largest study yet to quantify the impact of the vaccine outside the confines of a clinical trial. The study used innovative epidemiological methods to analyze vaccine effectiveness for preventing symptomatic disease, severe illness and death. Dr. Reis will discuss his study and the lessons learned from the nation-wide mass vaccination experience in Israel. The study has been featured in The New York TimesBloomberg, Wall Street Journal, and Time Magazine

Previous Events

RegSci Forum: “Ushering in safe, effective, and ethical medicine in the digital era”
March 16, 2021 | 12pm – 1pm ET
Virtual Webconference

Speakers:
Dr. Ariel Stern, Associate Professor at Harvard Business School
Andrea Coravos, CEO of Elektra Labs

About the talk:
From clinical trials to care delivery, “digital” has become an integral part of how we think about medicine, health, and biology.  The Covid-19 pandemic has accelerated this conversation, and forced a roadmap, once measured in years or decades, to unfold over days, weeks, and months.  Yet the scaffolding for this roadmap had already emerged prior to the Covid-19 pandemic.  In this presentation, we will describe a special collection of papers on “Digital Medicine,” which emerged from the Harvard Digital Medicine Symposium, which was sponsored by the Harvard-MIT Center for Regulatory Science and held in Boston in May of 2019. Looking both back and ahead, we describe these topics’ ongoing relevance as we contemplate the post-pandemic future of health care. An overview of this work can be seen here.

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.

2021 Regulatory Science Doctoral Student Symposium
Feb 9, 2021 l 9:00am-12:00pm ET
Virtual Event

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 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.

 

RegSci Forum: “Fellows Showcase”
January 19, 2021 | 12pm – 1pm ET
Virtual Webconference

Please join us for a special edition of the Regsci forum, this special Fellows Showcase will include lightning talk research presentations from Regulatory Science Fellows from the Harvard-MIT CRS and give you a taste of the amazing research from our fellows!

Presentations Include:

  • “Data Sources and  Misclassification Methods for Paclitaxel Signal Discernment,”   Alejandra Avalos
  • “Inference in response-adaptive clinical trials when the enrolled population varies over time,” Massimiliano Russo
  • “Master protocols for pediatric clinical trials,” Andrea Arfe
  • “Using Short-Term Endpoint in Pediatric Studies — The Risk of Direct Extension from Adults,” Xinzhou Guo
  • “Factors Affecting Buprenorphine Utilization and Spending in Medicaid,” Michael Sinha

 

 

RegSci Forum: “The US Biosimilar Market: Progress, Challenges, and Possible Reforms”
Dec 11, 2020 l 12pm - 1pm ET
Virtual Event

Speaker:
Ameet Sarpatwari, Assistant Professor at Harvard Medical School and Assistant Director of PORTAL

About the talk:
In 2010, Congress passed the Biologics Price Competition and Innovation Act (BPCIA) to address high biologic prices by creating an abbreviated approval pathway for other manufacturers to start selling their own versions of originator biologics called biosimilars. However, over a decade later, the BPCIA has not yet led to vigorous price competition from biosimilars. This talk examines the role that FDA regulatory policy, patent litigation, and market dynamics have played in this stunted growth while highlighting emerging signs of progress and possible reforms to make the US biosimilars market more vibrant.   

RegSci Forum: “Diversity, inclusion, and equity in clinical research”
Nov 17, 2020 | 12pm – 1pm ET
Virtual Webconference

Speaker:
Barbara Bierer, Faculty Director of the Multi-Regional Clinical Trials Center BWH & Professor of Medicine at Harvard Medical School

About the talk:
Why, and to what extent, should study populations in clinical research represent the diversity of U.S. and global populations? Why be concerned about representation if the numbers of trial participants of any subgroup is generally insufficient to support valid statistical analysis? Whose responsibility is it to address diverse participation? Is inclusion a matter of understanding biological heterogeneity or social justice?

Long before the COVID-19 pandemic exposed the stark realities of the disproportionate burden of disease on Black and Brown individuals, people of color have been underserved and understudied in clinical research. Dr. Bierer will discuss the findings and recommendations of the MRCT Center on this topic, and specifically the results of a 3-year effort to understand barriers to inclusion and to identify practical and actionable solutions.

Regulatory Science Faculty-Student Mixer
Oct 2, 2020 | 12pm - 1pm ET
Virtual Webconference

Join us for an opportunity to remotely meet faculty, trainees, and students from Harvard, MIT, and other academic institutions who are interested in regulatory science, and learn about the Harvard-MIT Center for Regulatory Science (CRS). This virtual event will feature CRS faculty from Harvard Medical School, Harvard Business School, and our affiliated hospitals who will briefly provide an overview of their research and chat in small breakout groups with students and trainees. 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. Advance registration is required. 

This event is only open to faculty, students, and trainees.

RegSci Forum: “Insulin Biosimilars, Tumor Agnostic Therapies, and Digital Medicine Workshops in Review”
Sep 15, 2020 | 12pm – 1pm ET
Virtual Webconference

Speakers:
Dr. Aaron Kesselheim, Professor of Medicine at Harvard Medical School
Dr. Ariel Stern, Associate Professor at Harvard Business School
Dr. William Gordon, Instructor in Medicine at Brigham & Women’s Hospital

About the talk:
This seminar will feature an account of scientific workshops from the Center over the past year, including a summary of stakeholder discussions and scientific outputs. These include presentations on:

  • Insulin Biosimilars Workshop: An expert roundtable around the issue of biosimilar insulin, learn more here.
  • Tumor Agnostic Cancer Therapies Workshop: Workshop on ethical and regulatory challenges arising from the testing and approval of new tumor-agnostic cancer therapies
  • Harvard Digital Medicine Symposium: A Symposium held to bring all stakeholders to discuss the state of the art in digital medicine, jointly sponsored by Harvard Business School and the Harvard-MIT Center for Regulatory Science. Recap in npj Digital Medicine here.
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.