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.
Agenda
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