work and infrastructure necessary to forge the collaboration and communication needed to advance regulatory science.2

In February 2010, the Forum on Drug Discovery, Development, and Translation within the Board on Health Sciences Policy of the Institute of Medicine (IOM) held a workshop, “Building a National Framework for the Establishment of Regulatory Science,” that examined the state of the science of drug regulation and considered approaches for enhancing the scientific basis of regulatory decision making (IOM, 2011).

As a follow-on to that workshop, and building on pronouncements from and developments to advance regulatory science at FDA in the interim months, the Forum convened a workshop on September 20-21, 2011, entitled “Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development.” This workshop provided a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and infrastructure as articulated in the 2010 workshop on regulatory science. The broad objectives of the workshop were (1) to consider opportunities and needs for advancing innovation in the discipline of regulatory science for therapeutics development through an interdisciplinary regulatory science workforce and (2) to examine specific strategies for developing a discipline of innovative regulatory science through development of a robust workforce within academia and industry and at FDA.

Specific objectives included the following:

•  Define and discuss the current regulatory science workforce, with particular attention to the disciplines involved, professional training opportunities, and gaps in the essential components of this workforce.

•  Consider workforce development needs in areas identified as key components of a robust discipline of innovative regulatory science in therapeutics development.

•  Examine the application and advantages of collaborative (multisector and multidisciplinary) approaches for strengthening the national regulatory science workforce.

•  Explore the resources and stakeholder engagement needed, not only within FDA and other federal agencies but throughout the extramural sector, to build the discipline and establish career paths in regulatory science for therapeutics development.


2 The Fiscal Year (FY) 2011 President’s Budget for FDA programs requested $25 million to support Advancing Regulatory Science for Public Health, and ultimately $17.4 million was appropriated by Congress for FY 2011 to support regulatory science at FDA.

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