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Introduction
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The Food and Drug Administration (FDA) has defined regulatory science as the “science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products” (FDA, 2010). The development and application of regulatory science calls for a well-trained, scientifically engaged, and motivated workforce. FDA faces challenges in retaining these scientists and providing them with opportunities for professional development. Stretched thin by resource constraints and a workload of constantly increasing complexity, FDA scientists are hard pressed to interact with other scientists and enhance their scientific knowledge base. Moreover, in the private sector, including industry and academia, the advancement of the science of innovation in drug discovery and development has not always been clearly defined, well coordinated, or connected to the needs of the regulatory agency. A number of gaps in the regulatory science discipline and infrastructure have been identified, including workforce and resource constraints not only within FDA but also in the extramural community; cultural differences and systemic barriers to collaboration and exchange among the agency, academia, and industry; and deficiencies in the net-

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1The planning committee’s role was limited to planning the workshop, and the workshop summary has been prepared by the workshop rapporteurs as a factual summary of what occurred at the workshop.



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1 Introduction 1 The Food and Drug Administration (FDA) has defined regulatory sci- ence as the “science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products” (FDA, 2010). The development and application of regulatory science calls for a well-trained, scientifically engaged, and motivated workforce. FDA faces challenges in retaining these scientists and provid- ing them with opportunities for professional development. Stretched thin by resource constraints and a workload of constantly increasing com- plexity, FDA scientists are hard pressed to interact with other scientists and enhance their scientific knowledge base. Moreover, in the private sector, including industry and academia, the advancement of the science of innovation in drug discovery and development has not always been clearly defined, well coordinated, or connected to the needs of the regu - latory agency. A number of gaps in the regulatory science discipline and infrastructure have been identified, including workforce and resource constraints not only within FDA but also in the extramural community; cultural differences and systemic barriers to collaboration and exchange among the agency, academia, and industry; and deficiencies in the net - 1 The planning committee’s role was limited to planning the workshop, and the workshop summary has been prepared by the workshop rapporteurs as a factual summary of what occurred at the workshop. 1

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2 STRENGTHENING A WORKFORCE FOR INNOVATIVE REGULATORY SCIENCE work and infrastructure necessary to forge the collaboration and com- munication 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 enhanc- ing 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 Sci - ence 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 devel - opment 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: • efine and discuss the current regulatory science workforce, with D particular attention to the disciplines involved, professional train - ing opportunities, and gaps in the essential components of this workforce. • onsider workforce development needs in areas identified as key C components of a robust discipline of innovative regulatory science in therapeutics development. • xamine the application and advantages of collaborative (multi­ E sector and multidisciplinary) approaches for strengthening the national regulatory science workforce. • xplore the resources and stakeholder engagement needed, not E 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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3 INTRODUCTION In her introductory remarks, the co-chair of the planning committee, Elaine Gallin, Principal, QE Philanthropic Advisors, remarked that, as the Forum offers a neutral venue where stakeholders in drug development can meet to discuss issues of mutual interest and concern, the Forum and this workshop format can enhance the needed collaboration among government, academia, industry, foundations, and patient groups that is critical in enhancing regulatory science. The other co-chair of the planning committee, Barry Coller, Vice President for Medical Affairs, Physician-in-Chief, and David Rockefeller Professor, The Rockefeller University, observed that while everyone has a sense that regulatory science is important, everyone also has a slightly different sense of why it is important. Coller emphasized that the focus of the workshop was on innovative regulatory science in therapeutics development, which calls for an interdisciplinary workforce to develop those innovative skills and methodologies. By bringing together stake - holders from all the sectors interested in regulatory science, the workshop provided an opportunity to compare diverse perspectives and find areas of agreement. SCOPE OF THE WORKSHOP AND ORGANIZATION OF THE SUMMARY Over the course of the workshop many participants offered their individual definitions of the concept of regulatory science in therapeutics development and elaborated on how regulatory science relates to drug development more generally. Although the scope of the workshop was focused on regulatory science in therapeutics development, a number of workshop discussants offered viewpoints or illustrations that were relevant to regulatory science more generally (e.g., application of regu- latory science to regulation of tobacco products; post-approval safety monitoring of therapeutics). These perspectives were sought to the extent they could illuminate and elaborate on fundamental principles and com - ponents undergirding the development and practice of innovative reg - ulatory science and its application to therapeutics development. This report summarizes the presentations and discussions of the workshop, highlighting key themes and identified needs in the development of an innovative regulatory science workforce for therapeutic development. • Chapter 2 provides perspectives from FDA, the National Institutes of Health (NIH), industry, academia, and the patient on the importance of innovative regulatory science with a primary focus on its role to support and advance drug development and how to strengthen that science.

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4 STRENGTHENING A WORKFORCE FOR INNOVATIVE REGULATORY SCIENCE • Chapter 3 examines definitions of innovative regulatory science for therapeutics development and lists certain “core competencies” considered part of the multidisciplinary pursuit of regulatory sci - ence. This chapter addresses difficulties and discordance in defining regulatory science as identified by many workshop participants. • Chapter 4 looks at how education and training could be structured to achieve the development of a regulatory science workforce that encompasses the needed competencies. • Chapter 5 samples potential regulatory science career paths inside and outside academia. • Chapter 6 considers international dimensions and needs for a regu- latory science workforce to achieve innovation on a global scale. • Chapter 7 reviews new collaborative models to strengthen and support regulatory science research and practice and provides par- ticipant summaries of the workshop discussions and suggestions for moving the field forward.