related public health emergencies must be based on understanding of contemporary and emerging science within the context of the risk analysis paradigm.” A number of gaps in the regulatory science discipline and infrastructure have been identified. They include workforce and resource constraints; cultural differences and systemic barriers to collaboration and exchange among the agency, academia, and industry; and deficiencies in the network and infrastructure necessary to forge the collaboration and communication needed to advance regulatory science. There has been recognition that collaborative approaches are necessary to advance regulatory science. In early 2010, FDA and NIH announced a unique collaboration, with establishment of a joint FDA-NIH leadership council to enable cross-agency efforts to improve regulatory science.
This workshop will explore issues related to strengthening a workforce for innovative regulatory science in therapeutics development. The workshop will (1) consider opportunities and needs for advancing innovation in the discipline of regulatory science for therapeutics development through an interdisciplinary regulatory science workforce and (2) examine specific strategies for developing a discipline of innovative regulatory science through development of a robust workforce within academia and industry and at FDA.
• Define and discuss the current regulatory science workforce, with particular attention to discussion of the disciplines involved and professional training opportunities.
— Identify gaps between the essential components of a workforce that will produce innovation in regulatory science and the current reality.
• Consider workforce development needs in areas identified as key components of a robust discipline of innovative regulatory science in therapeutics development.
• Examine application and advantages of collaborative (multisector and multidisciplinary) approaches for strengthening of a robust national regulatory science workforce.
— Identify and discuss specific opportunities for enhancing collaboration and coordination—among relevant federal programs and between FDA and the extramural community—to strengthen a regulatory science workforce supporting innovation in therapeutics development.
— Identify barriers to implementation of collaborative models, and discuss potential solutions to address those identified barriers.
• Explore the resources and stakeholder engagement needed, not only within FDA and other federal agencies, but also throughout