Emergency Preparedness and Response
Pillar II: Advance Regulatory Science for MCM Development and Evaluation
Pillar II supports MCM regulatory science initiatives that develop the tools, standards, and approaches to assess MCM safety, efficacy, quality, and performance and that help translate cutting-edge science and technology into innovative, safe, and effective MCMs.
- Developing animal models
- Identifying and qualifying biomarkers for safety and efficacy
- Using protein engineering to stabilize vaccine proteins
- Developing methods to assess MCM product quality and related product release assays
- Validating next‐generation in vitro diagnostics platforms
- Assessing the performance of emergency medical equipment
- Tracking and evaluating the safety and clinical benefit of MCMs during public health emergencies.
- Developing, characterizing, and qualifying animal models for MCM development
- Modernizing tools to evaluate MCM product safety, efficacy, and quality
- Developing and qualifying biomarkers of diseases or conditions
- Enhancing emergency preparedness capabilities, including science response and risk communication
- Cross-Species Immune System Reference – Stanford University
- Organs-On-Chips for Radiation Countermeasures – Wyss Institute for Biologically Inspired Engineering
- Adverse Events Monitoring and Analysis Pilot Program - MITRE Corporation
- Defense Advanced Research Projects Agency (DARPA) – FDA entered in an MOU with DARPA to support innovation in medical product development, including for medical countermeasures, and new technologies that can advance regulatory science
- National Interagency Confederation for Biological Research – FDA is a member of the NICBR, a collaboration of Federal agencies involved in medical research and advanced biotechnology whose goal are to enhance public health, medical research, and biotechnology development by coordinating scientific interactions and leveraging resources.
- Defense Threat Reduction Agency (DTRA) and the National Center for Biotechnology Information (NCBI) – FDA is collaborating with DTRA and NCBI to establish a publicly available reference database that will be critical to developers seeking to validate their candidate multiplex in vitro diagnostic tests National Institutes of Health (NIH) – FDA established a scientific forum with NIH to address issues related to animal models, efficacy protocols, and regulatory issues