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A common set of definitions for determining the progress of research and development programs in the field of medical countermeasures
Technology Readiness Levels provide a common set of definitions for determining the progress of research and development programs in the field of medical countermeasures. The TRL criteria allow a research and development program to be classified by its degree of maturity, from basic research about the mechanisms of a disease to the evaluation of a candidate countermeasure using animal models and clinical studies. The BARDA TRLs evaluate the development of medical countermeasures and product development tools against both natural and man-made public health threats.
These TRLs are used when rating a medical countermeasures, such as a drug or a vaccine.
These TRLs are used when rating Product Development Tools (PDTs), such as assays, models, and reagents.
These TRLs are adapted from the harmonized Quantitative Technology Readiness Level (Q-TRL) and are used when rating diagnostics and medical devices.
The processes of developing medical countermeasure products or product development tools are distinct but closely related endeavors. To successfully develop a medical countermeasure, appropriate effort and funding must be directed to the maturation of the analytical tools and animal models used during the development process. Similarly, the necessary in vitro and in vivo assays and models cannot be fully refined and verified without a candidate product to provide a substrate for evaluation. Both development efforts must proceed in parallel to achieve an approved or licensed product. Furthermore, the regulatory approval and licensure process benefits from reliable and reproducible analytical tools and animal models.
BARDA’s Broad Agency Announcement (BAA) sets forth the advanced research and development Areas of Interest (AOIs) and solicits proposals focusing on these areas in order to protect Americans from emerging threats. Learn more about opportunities to partner with us: https://www.medicalcountermeasures.gov/barda/barda-baa
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