The development and application of regulatory science – which FDA has defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products – calls for a well-trained, scientifically engaged, and motivated workforce. FDA faces challenges in retaining these regulatory scientists and providing them with opportunities for professional development. In the private sector, advancement of innovative regulatory science in drug development has not always been clearly defined, well coordinated, or connected to the needs of the agency. Moreover, resource constraints and an increasingly complex workload make it difficult for FDA scientists to interact with other scientists and enhance their scientific knowledge base. Several barriers to the advancement of regulatory science have been identified – including workforce and resource constraints in all sectors, systemic barriers to collaboration and scientific exchange, and deficiencies in the regulatory science infrastructure.
In 2010, the IOM’s Forum on Drug Discovery, Development, and Translation held a workshop that examined the state of regulatory science and considered approaches to enhance it. As a follow-up to that workshop, the Forum held a workshop on September 20-21, 2011, to provide a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and infrastructure as discussed in the 2010 workshop. At the workshop, speakers considered opportunities and needs for advancing innovation in the discipline of regulatory science for therapeutics development through an interdisciplinary regulatory science workforce and examined specific strategies for developing a discipline of innovative regulatory science through the development of a robust workforce within academia and industry and at FDA. This document summarizes the workshop.
Institute of Medicine of The National Academies. December 21, 2011