Harvard-MIT Regulatory Science Symposium

Harvard-MIT Center for Regulatory Science Annual Symposium

March 7, 2017

American Academy of Arts and Sciences | 136 Irving St. Cambridge MA


The Harvard-MIT Center for Regulatory Science is hosting industry-academic-FDA meetings in the Spring of 2017 to identify areas of regulatory science where a private-public partnership can make significant progress toward addressing a need in therapeutic development or evaluation.

This all-day day symposium will gather together the Boston-area community in regulatory science. The program will feature faculty speakers from multiple institutions across the full spectrum of regulatory science activities and will include active, moderated discussion to identify where the Center should focus in the coming year.

The FDA defines regulatory science as “the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products.” Within this guidance regulatory science will require many elements of translational medicine including innovation in measurement, trials focused on evidence generation and analysis of policies and their impact. This all-hands meeting will promote dialogue among Center members and build connections to other individuals in the broader research community. A summary paper will capture the major findings of the meeting and our agreed priority areas for 2017.


9:00 Registration and light breakfast

9:15 Welcome and introduction

9:30 Session 1 – The science of evaluation  Chair Peter Sorger

Regulatory Incentives for Pharmaceutical Innovation: the FDA’s Breakthrough Therapy Designation

Ariel Stern, HBS

Precision Medicine in the Non-Oncology World

Scott Kennedy, Novartis

How Does the 21st Century Cures Act Change the FDA Drug and Device Approval Paradigm?

Aaron Kesselhiem, BWH

Rationale for and development of disease-specific platform trials

Brian Alexander, DFCI

Pharmacoepidemiology on the Front Line: Addressing Current Issues in Drug Effectiveness, Safety, and Affordability

Jerry Avorn, BWH


12:45 Special Lunch Session: Perspectives on partnering to advance regulatory science Chair Bruce Chabner

12:45-1:15 Break and pick up buffet lunch – Ballroom 2

1:15-1:30 Regulatory Science at FDA

York Tomita, FDA

1:30 -1:45 The role of academic centers in regulatory science

Elazer Edelman, MIT

1:45-2:00 Break


2:00 Session 2 – Applied computation to streamline drug development Chair Aaron Kesselheim

Model Aided Drug Invention: Systems approaches de-risking and accelerating R&D in pharma and biotech

John Burke, Applied BioMath

The impact of patient-to-patient variability on combination cancer therapies

Adam Palmer, HMS


3:25 Session 3 – Measuring safety and mitigating toxicities Chair Brian Alexander

Innovation in Drug Safety through Collaboration: Industry Perspective

Jay Mettetal, AstraZeneca

Micro-Nanofluidic real time quality monitoring for biologics

Jay Han, MIT

Unraveling the efficacy and toxicity of Immune Checkpoint Inhibitors in combination therapy

Gerald Feldman, FDA

Integrating Multi-Omic Techniques to Predict and Classify Toxicity in vitro

Susanne Ramm, HMS, BWH

Identifying and predicting poisons in food products

Tony Sinskey, MIT 

6:00 Drinks reception


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