its regulatory science into the 21st century. Doing so will greatly enhance FDA’s ability to support MCM development and licensing. (NBSB, 2010, pp. 43–44)

In August 2010, the U.S. Department of Health and Human Services (HHS) released its review of the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) and made numerous recommendations to transform the MCM enterprise to increase its speed, agility, capacity, and success rate, including the promotion of regulatory innovation and investment in regulatory science at FDA (ASPR, 2010).2 In this regard, FDA has established an MCM initiative that includes (1) enhancing the regulatory review process for the highest-priority MCMs and related technologies; (2) advancing regulatory science to support MCM development and evaluation; and (3) modernizing the legal and regulatory framework to support public health preparedness and response.

At the request of FDA, the Institute of Medicine’s (IOM’s) Forum on Drug Discovery, Development, and Translation and the IOM’s Forum on Medical and Public Health Preparedness for Catastrophic Events jointly convened a workshop on March 29–30, 2011. The workshop, titled Advancing Regulatory Science for Medical Countermeasure Development, was designed to (1) examine ways to advance regulatory science for MCM development and regulatory evaluation; (2) identify scientific opportunities to improve, simplify, or speed MCM development; and (3) identify tools and methods to improve the predictability and success rate of candidate MCMs (see Box 1-1).

Workshop speakers and attendees consisted of experts from federal government agencies, the private sector, and academia, who were invited to discuss the applicability of cutting-edge science to MCM discovery and development with the goal of informing the FDA MCM initiative and the regulatory science-based product review process. Speakers were asked to introduce their comments by providing a brief overview of scientific advances or emerging technologies holding promise to facilitate development of MCMs, and then to focus on what regulatory science advances are needed to address gaps in currently available tools to predict and evaluate product safety, efficacy, and quality. They were also asked to identify how innovative regulatory science methodologies can address emerging tech-

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2 As part of the PHEMCE review, and at the request of the Secretary of HHS and the HHS Assistant Secretary for Preparedness and Response, the IOM’s Forums on Drug Discovery, Development, and Translation and Medical and Public Health Preparedness for Catastrophic Events collaborated to host a workshop in February 2010, which addressed challenges facing the PHEMCE. Workshop participants discussed federal policies and procedures affecting the research, development, and approval of medical countermeasures and explored opportunities to improve the process and protect Americans’ safety and health (IOM, 2010).



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