Biostatistics and FDA Regulation: The Convergence of Science and Law

May 20, 2014, 8:00 AM - 5:00 PM

Symposium Presented by the Drug Information Association (DIA), the Food and Drug Law Institute (FDLI), and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, in collaboration with the Harvard School of Public Health Department of Biostatistics and Harvard Catalyst | The Harvard Clinical and Translational Science Center.

Biostatistics is the application of statistics — the study of the collection, organization, analysis, interpretation and presentation of data — to a wide range of topics in life sciences. Biostatistics informs the Food and Drug Administration’s regulatory decision-making processes for premarket review of investigational drugs and devices and post-market surveillance of medical products, including decisions to require safety labeling changes and withdraw approval. Recent developments, such as Congress’s creation of a new federal infrastructure for the dissemination of comparative effectiveness information, point to the need for a fresh look at the way in which biostatistical principles inform federal health care policy, particularly at the FDA. This one-day symposium gave attendees the foundational knowledge they need to understand how biostatistics applies in FDA regulation, and also addressed closely related issues residing at the intersection of statistical analysis and life sciences litigation.

Agenda:

8:00 - 8:45am: Registration and Continental Breakfast

8:45 - 9:00am: Welcome and Announcements

Michael Levin-Epstein, Senior Vice President, Product Development and Editor-in-Chief, FDLI

Holly Fernandez Lynch, M.Bioethics, Executive Director, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School

9:00 - 10:30am: Introduction to Statistics and Regulatory Law

  • Why biostatistics matters in regulatory law

  • Establishing clinical effectiveness

  • The limits of biostatistical analysis: risk-benefit assessments

Qi Jiang, Executive Director, Amgen

Robert T. O’Neill, PhD, Statistical Advisor, Office of Translational Sciences, CDER, FDA

Jerald S. Schindler, DrPH, VP & Global Head, Late Development Statistics, Biostatistics & Research Decision Sciences, Merck Research Laboratories

Moderated by Coleen Klasmeier, Partner and Global Coordinator, Food, Drug and Medical Device Regulatory Practice Area Team, Sidley Austin LLP

10:30 - 11:00am: Networking Break

11:00am - 12:15pm: Safety Issues

  • Safety Meta-Analysis

  • CTTI Safety-related Efforts

Lee-Jen Wei, Professor, Department of Biostatistics, Harvard School of Public Health

Geoffrey M. Levitt, Senior VP & Associate General Counsel, Regulatory & Policy, Pfizer, Inc.

Janet Wittes, PhD, President, Statistics Collaborative

Moderated by Qi Jiang, Executive Director, Amgen

12:15 - 1:00pm: Lunch

1:00 - 2:30pm: Statistics Disputes in Life Sciences Litigation

  • Recent Daubert developments

  • Matrixx, Inc. v. Siracusano

  • US v. Harkonen

  • Avandia

Anand Agneshwar, Partner, Arnold & Porter LLP

Christina L. Diaz, Assistant General Counsel, Dispute Resolution & Prevention, Legal, GlaxoSmithKline

Nathan A. Schachtman, Counsel, Ulmer & Berne LLP

Lee-Jen Wei, Professor, Department of Biostatistics, Harvard School of Public Health

2:30 - 3:15pm: Question Time with FDA Officials: Emerging Issues

  • Precision Medicine

  • Next-Gen Statistical Analysis

  • Affordable Care Act

Robert T. O O’Neill, PhD, Statistical Advisor, Office of Translational Sciences, CDER, FDA

Moderated by Christopher T. Robertson, Visiting Professor of Law, Harvard Law School

3:15 - 3:30pm: Networking Break

3:30 - 4:30pm: Can We Handle the Truth: Roundtable Discussion

  • Reconciling Regulatory Expectations and First Amendment Principles

  • Broader Societal Shifts in Information Availability

  • Relevance of FDA Premarket Review and Approved Labeling in New Media Era

Anand Agneshwar, Partner, Arnold & Porter LLP

Jeffrey K. Francer, Vice President & Senior Counsel, PhRMA

Freddy A. Jimenez, Assistant General Counsel, Johnson & Johnson

Moderated by Janet Wittes, PhD, President, Statistics Collaborative

4:30 - 4:45pm: Closing Remarks and Adjournment

Coleen Klasmeier, Partner and Global Coordinator, Food, Drug and Medical Device Regulatory Practice Area Team, Sidley Austin LLP

For questions, contact petrie-flom@law.harvard.edu or 617-496-4662.

Tags

biotechnology   fda   health law policy   pharmaceuticals   regulation