to support MCM development and evaluation; and (3) modernizing the legal and regulatory framework to support public health preparedness and response. Regulatory science for MCM development and evaluation is essential for FDA to establish clear regulatory pathways for product approval based on the most advanced scientific foundations available and realize the promise of new technologies for flexible, rapidly scalable development and manufacturing of vaccines and other MCMs.

This workshop will (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.

Meeting Objectives:

  • Provide a broad overview of current efforts underway at FDA and other agencies within HHS and the Department of Defense (DoD) to support the research, development, evaluation, and production of MCMs.
  • Review novel scientific methodologies used by academia and indusry to facilitate development of 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 MCM initiative’s regulatory science program and to develop better defined pathways for product approval.
  • 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.
8:00 a.m. Welcome and Introductions

LESLIE BENET, Workshop Co-Chair

Professor, School of Pharmacy

University of California, San Francisco

JOHN REX, Workshop Co-Chair

Infection Clinical Vice President


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