Global Conference on Regulatory Science 2020

October 20-21, 2020  |  10am – 3:30pm ET | Virtual Conference

Agenda

Thanks everyone who joined us for our first Global Conference on Regulatory Science! For those who could not join, you can view the conference recap from HMS.

Hosted by Harvard-MIT Center for Regulatory Science, the 2020 Global Conference on Regulatory Science convened academic scientists and physicians, international regulators, industry experts and patient groups to explore emerging topics at the intersection between regulatory science and therapeutic development.

The first in an annual series of conferences, a key aim was to advance and sustain a dialogue between academic investigators active in the field and government and industry groups for whom the evaluation, regulation and marketing of medical products is a central concern. The two-day conference included plenary presentations, panel discussions, breakout sessions, and a poster session.

2020 Theme: Machine Learning and Data Science. The conference covered diverse ways in which new computational approaches are integrating preclinical and clinical trial data, real-world evidence, information from electronic devices etc. to change drug development and medical care.

CONFERENCE WORKING GROUPS

Education in Regulatory Science

This working group considered state-of-the-art methods to prepare and continually maintain a workforce equipped to maximize the application of regulatory science to the U.S. Food and Drug Administration’s regulatory activities.

Working Group Report

Digital Pathology, AI and Image-Based Biomarkers in Research and Clinical Practice

This workshop covered emerging digital pathology technologies, image-based biomarkers and diagnostics, construction of multiplexed tissue and tumor atlases, use of digital pathology in clinical and research settings, and the regulation of new devices and tests.

About Workshop

Speakers

Adam Palmer, UNC

Amy Abernethy, FDA

Andy Coravos, Elektra Labs

Annie Saha, FDA

Ariel Stern, HBS

Barry Liden, Edwards Lifesciences

Fadia Shaya, UMB

Florence Bourgeois, Harvard-MIT CRS

G Caleb Alexander, JHU

George Daley, HMS

Heidi Dohse, Tour de Heart

Helga Gardarsdottir, Utrecht University

Janet Woodcock, FDA

John Lim, Duke-NUS

Joseph Ross, Yale

Kari Stefansson, deCODE Genetics

Laura Maliszewski, Harvard-MIT CRS

Leslie Wilson, UCSF

Luca Foschini, Evidation Health

Margaret Hamburg, NAM

Mark Namchuk, HMS

Meredith Buxton, GCAR

Michael Rosenblatt, Flagship

Ned Sharpless, NCI

Nilay Shah, Mayo Clinic

Paul Beninger , Tufts

Peter Mol, EMA

Peter Sorger, Harvard-MIT CRS

Raffaella Sadun, HBS

Ray Dorsey, U of Rochester

Sandro Santagata, BWH

Sean Khozin, Janssen

Steve Goodman, Stanford

Steve Galson, Amgen

Timo Minssen, U of Copenhagen

Setting the Stage

Keynotes

Self-regulation, Research Oversight and Governance by Scientists

Patient Input in Digital Medicine and Clinical Trials

COVID-19

Data science

Working Groups

Closing Thoughts