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  5. Preparedness Research
  6. Intramural MCM Regulatory Science Research
  1. Preparedness Research

Intramural MCM Regulatory Science Research

ORES funds medical countermeasure regulatory science to develop tools, standards, and approaches to assess MCM safety, efficacy, quality, and performance.

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FDA scientist working with lab equipment at FDA headquarters in White Oak, Maryland

Priority research areas | Intramural challenge grants 

The Office of Regulatory and Emerging Science (ORES) provides funding to support high-priority regulatory science research for internal FDA scientists as well as for external scientists that align with U.S. Government medical countermeasure (MCM) priorities to develop the tools, standards, and approaches necessary to assess MCM safety, efficacy, quality, and performance.

Our goal is to help translate cutting-edge science and technology into safe and effective MCMs needed to respond to chemical, biological, radiological, and nuclear threats (CBRN) and emerging infectious diseases. 

Intramural MCM Funding

Intramural MCM regulatory science is funded through a competitive award process by FDA scientists under the Medical Countermeasures Intramural Regulatory Science Challenge Grant Program.

Priority research areas

  • Developing animal models and tools to evaluate safety and efficacy

  • Identifying and qualifying biomarkers for safety and efficacy

  • Using protein engineering to stabilize vaccine proteins

  • Developing methods to assess medical countermeasure product quality and related product release assays

  • Validating next-generation in vitro diagnostics platforms

  • Assessing the performance of emergency medical equipment

  • Enhancing emergency preparedness and response capabilities, including tracking and evaluating the safety and clinical benefit of medical countermeasures used during public health emergencies

Current Projects 

Project Awardee Center
Construction of Reference Genome Database of Botulinum Neurotoxin Producing Clostridia  Shashi Sharma     CFSAN
Validating and Implementing Versatile Radiochemical Separation Procedures Applicable for Multiple Detection Techniques     Zhichao Lin   ORA
Leveraging artificial intelligence tools to predict antigenic evolution of viruses with pandemic potential     Gabriel Parra     CBER
Evaluating COVID-19 vaccine antibody responses to emerging SARS-CoV2 variants in persons with complex immune histories from prior vaccinations and infections     Carol Weiss     CBER
Modification of influenza virus polymerase genes to complement a host cofactor and improve vaccine virus antigen yield.     Ewan Plant     CBER
Evaluation of mucosal vaccines and adjuvants in animal models and in primary human cells.      Hana Golding     CBER
Profiling of Immunoglobulin Repertoires Associated with SARS-CoV-2 Vaccine Breakthrough Infections and Efficacy of Vaccine Medical Countermeasures     Li-Rong Yu     NCTR

Resources for You

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