Advancing the Discipline of Regulatory Science for Medical Product Development: An Update on Progress and a Forward-Looking Agenda: An IOM Workshop (Innovation in Modeling and Integrating Information Session)

Held October 20–21, 2015 at the Keck Center, 500 5th Street, NW Room 100, Washington, DC 20001

Full Meeting Website

Full Meeting Agenda

Background and Workshop Objectives:

The Food and Drug Administration (FDA) defines regulatory science as the science of developing new tools, standards, and approaches to assess the safety, effectiveness, quality, toxicity, public health impact, or performance of FDA regulated products. Since its inception, the IOM’s Forum on Drug Discovery, Development, and Translation has focused on the need for strengthening the scientific basis of drug regulation. In February 2010, the Forum held a workshop, Building a National Framework for the Establishment of Regulatory Science for Drug Development, that examined the state of the science of drug regulation and considered approaches to enhance regulatory science. In September 2011, the Forum held another workshop, Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development, that considered opportunities and needs for advancing innovative regulatory science through workforce and career development. Over the past several years, models to support the discipline have advanced. FDA’s Centers of Excellence in Regulatory Science and Innovation enhance training and educational opportunities for regulatory scientists. Private funders have also established programs: for example, in 2011 the Burroughs Wellcome Fund launched Innovations in Regulatory Science Awards (IRSA), which aim to strengthen regulatory systems capacity by funding regulatory science-based research and collaborations.

This workshop will provide a venue to review progress in building the foundations of regulatory science and to explore a forward-looking agenda for bolstering the field. Participants will examine the current state and scope of the discipline, highlight opportunities to address barriers to success, and explore ways to foster collaboration. The workshop objectives are to:

  • Explore current regulatory science priorities and strategies in federal, academic, and
  • private sector settings.
  • Consider the current state of regulatory science as a discipline.
    • Discuss professional training successes.
    • Highlight opportunities to further support training, workforce, and career development.
  • Explore the core components of a robust discipline of innovative regulatory science.
    • Consider gaps and key opportunities to address needs to support the discipline of innovative regulatory science.
  • Examine needs and barriers to collaboration among, across, and within the public and private sectors.

Innovation in Modeling and Integrating Information

3:45 p.m. Innovation in Modeling and Integrating Information
Panel Moderator: Darrell Abernethy, Associate Director for Drug Safety, Office of Clinical Pharmacology, U.S. Food and Drug Administration

3:50 p.m.Statistical Modeling for Efficient and Adaptive Trial Designs Using Composite Endpoints
BRIAN ALEXANDER, Assistant Professor of Radiation Oncology, Harvard Medical School

4:00 p.m. Models of Clinical Trial PK/PD Translated To Population Drug Use and Exposure
SANDY ALLERHEILIGEN, Vice President Modeling and Simulation, Merck

4:10 p.m. A Quantitative and Integrative Simulation Model for Optimizing Clinical Trial Design to Measure Cognitive Changes of Alzheimer’s Disease
BRIAN CORRIGAN, Senior Director, Pfizer

4:20 p.m. Assessing the Placebo Effect and Drug Efficacy for Rare Diseases in the Brain Using fMRI
ARIANA ANDERSON, Assistant Research Statistician, University of California Los Angeles

4:30 p.m. Panel Discussion and Audience Q&A (30 mins)
Panelists:Innovation in Modeling and Integrating Information speakers (above), and Klaus Romero, Director of Clinical Pharmacology, The Critical Path Institute (C-Path)