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Discovery and Validation of Biomarkers 2017

A workshop on the development and use of biomarkers, regulation, and therapeutic innovation

Hosted by Harvard Medical School, Harvard Business School, and the Kennedy School of Government

April 3, 2017

Batten Hall Room 302, Harvard Business School


08:30-08:35 Introductory Remarks

      Aaron Kesselheim, M.D., J.D., Director of the Program On Regulation, Therapeutics, And Law
      Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital and Harvard Medical School


08:35-09:20 Three Perspectives on Biomarkers’ Use in Approving New Drugs

  • Development
    • Vishal Vaidya, Ph.D., Director, Biomarker Analytics Global Lead at Pfizer
  • Government
    • Christopher Leptak, M.D., Ph.D., Director, Office of New Drug’s Regulatory Science Program, Food and Drug Administration
  • Clinical care
    • Jerry Avorn, M.D., Professor of Medicine, Harvard Medical School

Group Discussion

Coffee Break

10:00-10:45 Biomarker Discovery and Validation in 2017

  • Biomarkers and Discovery in Oncology
    • Bruce Chabner, M.D., former head, National Cancer Institute)
  • Ethical Challenges in Biomarker-driven Research
    • Spencer Hey, Ph.D., Program on Regulation, Therapeutics, And Law and Harvard Medical School Center for Bioethics
  • Discovering Biomarker Diagnostics
    • David Litwack, Ph.D., Policy Advisor of the Office of In Vitro Diagnostics and Radiological Health at the FDA Center for Devices and Radiological Health

10:45-11:45 Group Discussion

Break for Lunch

12:15-12:45 How Can Government/Clinicians/Academia/Industry Work Together to Overcome the Challenges with Biomarker Discovery and Use in Patient Care?

  • Incentives for Biomarker Discovery and Development
    • Ariel Stern, Ph.D., Assistant Professor of Business Administration in the Technology and Operations Management Unit at Harvard Business School
    • Amitabh Chandra, Ph.D., Malcolm Wiener Professor of Public Policy, Director of Health Policy Research at the Harvard Kennedy School of Government
  • Biomarkers and Cardiovascular Disease
    • Elliott Antman, M.D., Professor of Medicine, Harvard Medical School, President, American Heart Association
  • Biomarkers and Infectious Diseases
    • John Powers, M.D., Professor of Clinical Medicine, George Washington University School of Medicine

12:45-2:00 Group Discussion

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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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We seek a talented, collaborative interdisciplinary scientist to catalyze the development and application of computational approaches for the analysis of high-dimensional cell and molecular profiling data and integrative modeling of multiscale dynamical biological systems. The successful candidate will work on computational analysis of large multi-omics datasets (including genomics, transcriptomics, proteomics, and phenomics) and mathematical modeling of complex biological systems. Expertise in predictive pattern recognition applied to molecular profiling data and mathematical modeling of biological and disease processes, and demonstrable ability to interpret the output of such analyses in the clinical context, are prerequisite. The successful candidate will be also expected to participate in collaborative projects with Seattle-based leading academic research groups on computational analysis of high-dimensional tissue, cell and molecular profiling data to advance Celgene’s patient-focused Molecular Medicine and Immuno-Oncology efforts.

Please apply here

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