In response to a request from the Food and Drug Administration (FDA), the Institute of Medicine will conduct a workshop that will explore issues related to Advancing Regulatory Science for Medical Countermeasure Development. More specifically, the workshop will: 1) examine ways to advance regulatory science for developing and evaluating medical countermeasures (MCMs, which includes drugs, devices and biologic medical products) for chemical, biological, radiological/nuclear (CBRN), and emerging infectious disease threats; and 2) identify scientific opportunities to improve, simplify, or speed MCM development and improve the predictability and success rate of candidate MCMs. Subject matter experts will be invited to participate in the workshop to discuss and help explore innovative tools, technologies, and applied scientific knowledge-base from within academia and industry that could facilitate MCM development and manufacturing, as well as evaluation of safety, quality, and efficacy of MCMs and of novel candidate MCM technologies.

The workshop discussions will provide participants an opportunity to better explore the applicability of cutting edge science to MCM discovery and development and to inform FDA’s MCM Initiative (MCMi) and its role in enhancing the regulatory science-based product review process. Specifically, the workshop will feature invited presentations and discussions that will:

• Provide a broad overview of current efforts underway at FDA and within HHS and DoD to support the research, development, evaluation and production of MCMs
• Review novel scientific methodologies used by academia and industry to discover and develop next generation vaccines, biologics, drugs, and devices
• Identify major gaps in currently available tools to predict and evaluate product safety, efficacy and quality
• Identify opportunities for collaboration and coordination with FDA and among relevant federal as well as industry programs to support the MCMi regulatory science program
• Identify regulatory science tools and methodologies to address emerging technologies, targets and novel products as well as innovative approaches for predicting safety and efficacy, for example biomarkers and in silico modeling

An individually authored summary of the workshop will be prepared based on the information gathered and the discussions held during the workshop.