as seen through the lens of translational science. In a panel discussion, panelists provided observations about the core competencies needed for an effective regulatory science workforce and offered perspectives on the role of regulatory science in their respective sectors and agencies.
A Regulatory Science Taxonomy
In Coller’s view, regulatory science is a subset of translational science. He provided the following definitions as a basis for the discussion:
• Translational science is the application of the scientific method to address a health need.
• Regulatory science is the application of the scientific method to improve the development, review, and oversight of new drugs, biologics, and devices that require regulatory approval prior to dissemination.
Translational science traditionally has been broken down into four phases:
• T1: Discovery to candidate health application
• T2: Health application to evidence–based practice guidelines
• T3: Practice guidelines to health practice
• T4: Practice to population health impact
The taxonomy of regulatory science can be aligned with the translational science taxonomy through four analogous phases, as follows:
• RS1: Preclinical evaluation of safety and efficacy
• RS2: Clinical trial design and analysis
• RS3: Postmarketing review of safety and optimal utilization
• RS4: Health policies, including social aspects of regulatory science
From this taxonomy, it is possible to develop a list of the multidisciplinary research expertise needed in regulatory science. (See Box 3-3
1This section is based on the presentations by Barry Coller, Vice President for Medical Affairs, Physician-in-Chief, and David Rockefeller Professor, The Rockefeller University, and Rob Califf, Professor of Medicine and Vice Chancellor for Clinical and Translational Research, Duke University Medical Center.