Agenda
Building a National Framework for the Establishment of
Regulatory Science for Drug Development
February 26, 2010
National Academy of Sciences Building
Lecture Room
2100 C Street NW
Washington , DC
The IOM's 2007 report, The Future of Drug Safety: Promoting and Protecting the Health of the Public, identified the need for an improved science base for drug evaluation, including both internal resources and extramural funding for collaboration with academia. A 2008 IOM Drug Forum meeting examined this question in a public workshop that explored the science of drug regulation, focusing on the gap between leading edge technologies of drug development and the capacity of the FDA to adapt the process of regulatory evaluation to these technologies. A subsequent report by the FDA Science Board examined in depth the need for an enhanced science base, including infrastructure development, multi-sectoral collaboration, and the expansion of a workforce capable of addressing the rapidly evolving science of drug discovery and development. Together these meetings and reports suggest a widening gap between the scientific developments in areas that are relevant to FDA and its ability to meet each innovation and simultaneously regulate products that make up 25% of the U.S. economy. Despite the importance and urgency to the nation of developing a sound science for regulatory decisions, there also exists a gap in understanding between the public, policymakers, and the agency on what is required to carry out such a task.
To address these concerns, the IOM Drug Forum will convene a public workshop to examine the state of the science of drug regulation and consider approaches for enhancing the scientific basis of regulatory decision making. This
workshop will provide an opportunity to fully explore the concept of regulatory science, examine how it can be used to improve regulatory decision making, and consider alternative mechanisms and institutional frameworks for its development and application in regulatory decision making. It will feature experts on the science of drug regulation, as well as stakeholders in drug development and the regulatory process, including representatives of patient groups, academia, government, and industry.
A range of approaches and innovative mechanisms will be considered, which may include: fostering the scientific discipline of regulatory science; promoting closer collaboration between of regulatory and academic researchers; and developing a solid infrastructure to support regulatory science. Specific models to be considered may include: regulatory science centers of excellence; innovative federal grant-making mechanisms; and medical education and professional development programs.
The meeting will be available via webcast, and participants will be able to remotely submit questions to the panelists. Immediately following the workshop, presentation slides and other supporting materials will be available on the Drug Forum website. A summary of the proceedings will be subsequently published and made available free of charge through the website.
Building a National Framework for the Establishment of
Regulatory Science for Drug Development
February 26, 2010
8:00 – 8:15 Opening Remarks
Drug Forum Co-Chairs
Gail Cassell, Eli Lilly
Jeff Drazen, New England Journal of Medicine
8:15 – 8:45 Regulatory Science: Overview
Moderator: Jeff Drazen, New England Journal of Medicine
Garret FitzGerald, University of Pennsylvania
8:45 – 9:45 Keynote Speaker
Congresswoman Rosa DeLauro (D-CT)
9:45 – 10:30 FDA Initiatives on Regulatory Science
Margaret Hamburg, FDA Commissioner
10:30 – 10:45 Break
10:45 – 12:00 Session 1: Opportunities for Enhancing Regulatory Science
Moderator: Mark McClellan, Brookings Institute
THE IOM AND FDA SCIENCE BOARD RECOMMENDATIONS
Gail Cassell, Eli Lilly
ACADEMIC PERSPECTIVE
Phil Pizzo, Dean, School of Medicine Stanford University, Chair, Council of Deans American Association of Medical Colleges
A BLUEPRINT FROM THE PATIENT’S PERSPECTIVE
Ellen Sigal, Friends of Cancer Research
12:00 – 12:15 Break and Working Lunch
Guests are asked to pick up lunch and return to their seats.
12:15 – 1:45 Session 2: Opportunities for Enhancing Regulatory Science (cont’d)
Moderator: Barbara Alving, NCRR
TRANSLATIONAL APPROACHES TO UNDERSTAND AND PREDICT RARE ADVERSE REACTIONS TO DRUGS
Paul Watkins, Hamner - University of North Carolina Institute for Drug Safety Sciences
A ROLE FOR REGULATORY SCIENCE IN EMERGING TECHNOLOGIES: GENOMICS
Allen Roses, Duke University
OPPORTUNITIES IN STATISTICAL DESIGN, ANALYSIS, AND MODELING
Susan Ellenberg, University of Pennsylvania
IT INFRASTRUCTURE, INFORMATICS AND SCIENTIFIC COMPUTING IN REGULATORY SCIENCE
Sangtae Kim, Morgridge Institute for Research
1:45 – 2:45 Panel 1: A Comparison of Existing and Potential Mechanisms for Promoting Regulatory Science
Moderator: Peter Honig, FDA and Merck (ret.)
PANELISTS:
• Jesse Goodman, FDA
• Dale Nordenberg, CDC
• Judith Kramer, Duke University
• Margaret Anderson, FasterCures
• Harry Greenberg, Associate Dean for Research, Stanford University School of Medicine
2:45 - 3:00 Break
3:00 – 3:45 Panel 2: Energizing Public Policy to Advance the Science
Moderator: Janet Tobias, Ikana Media
PANELISTS:
• Steven Grossman, HSP Group and Alliance for a Stronger FDA
• Michael Manganiello, HCM Strategists
• Mary Woolley, Research! America
3:45 – 4:15 An HHS Perspective
PROTECTING THE PUBLIC THROUGH REGULATORY SCIENCE—A NATIONAL PRIORITY
Bill Corr, Deputy Secretary, HHS
4:15 – 4:30 Summary and Next Steps
Gail Cassell, Eli Lilly
4:30 Adjourn
Back to Meeting