Global Conference on Regulatory Science 2022

October 11-12, 2022 | Virtual Conference

2022 Conference Speakers

Conference Proceedings

Evolving Use of Real-World Evidence in Therapeutic Development and Regulation

Hosted by the Harvard-MIT Center for Regulatory Science, the 2022 Global Conference on Regulatory Science took place on October 11-12. Day one of the conference featured plenary presentations and panel discussions exploring learn how real-world evidence is informing regulatory decision-making and advancing knowledge throughout the product lifecycle. Diverse stakeholders discussed real-world evidence frameworks and present use cases in the following areas:

Drug development and approval in rare conditions
Demonstration projects
Post-market evidence generation for medical devices
Patient community perspective

Day two of the conference included a working group on Optimizing the Development of Regulated Digital Health Products Using Real-World Evidence and a special session on Medical Device Post-Marketing Safety Surveillance.

Poster Winners

Congratulations to the following poster presenters:

Best Poster
“Characterizing the Use of Recalled Devices in New Device Authorizations Under the US Food and Drug Administration’s 510(k) Pathway” by Kushal Kadakia

Audience Choice
“Tapping the untapped potential of Regulatory: Delivering Digital Regulatory Capabilities” by Sridevi Nagarajan

Setting the Stage

Welcome Remarks

Florence Bourgeois, Harvard-MIT CRS

Evolving Use of Real-World Evidence in Drug/Device Development: Towards Totality of Evidence

Carla Rodriguez-Watson, Reagan-Udall Foundation

Stakeholder Perspectives on Use of Real-World Evidence

Including the Patient Experience in Evidence Generation

Jennifer King, GO2 Foundation for Lung Cancer

Perspectives of Global Regulators on the Use of RWD/E in Rare Conditions

Moderators: Gracy Crane, Roche and Elodie Aubrun, Novartis

FDA and Real-World Evidence

John Concato, FDA

Faster, Better, Cheaper: The Increasing Role and Opportunities for Real-World Evidence in Informing Regulatory Pathways

Christopher Boone, AbbVie

Building the Infrastructure to Advance Evidence Generation

RWE Reproducibility and Validity with Implications for Expanded Effectiveness Claims

Sebastian Schneeweiss, Brigham & Women’s Hospital

Preparing for the Future of Evidence Generation

Joe Franklin, Verily Life Sciences

Building and Validating Real-world Data Cohorts to Support Regulatory Use

Jessica Franklin, Optum

Real-World Evidence Generation for Medical Devices

Moderator: Sanket Dhruva, UCSF

Special Guests

Interview with Dr. Aaron Kesselheim

Moderator: Laura Maliszewski, Harvard-MIT CRS

Harnessing Connections to Build a Regulatory Science Collaborative Community

Tina Morrison, FDA

Closing Thoughts

Moderator: Peter Sorger, Harvard-MIT CRS

Day 2 Workshop

Optimizing the development of regulated digital health products using real-world evidence

Moderators: Ariel Stern, HBS and Smit Patel, DiMe