About the TRLs
Tools for Monitoring Development Progress
The Technology Readiness Levels (TRL) provide a common set of definitions for determining the progress of research and development programs in the field of medical countermeasures. These Technology Readiness Level 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 TRL format, previously developed by NASA and the Department of Defense, was adapted for use in these documents to specifically evaluate the development of medical countermeasures against both natural and man-made public health threats. The following TRL schematics are attached:
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.
The processes of developing medical countermeasure products or product development tools are two distinct but closely related endeavors. In order to successfully develop a medical countermeasure, appropriate effort and funding must be directed towards the maturation of the analytical tools and animal models that will be used during the medical countermeasure 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 of these development efforts must proceed in parallel in order to achieve an approved or licensed product. Furthermore, the regulatory approval and licensure process itself greatly benefits from reliable and reproducible analytical tools and animal models.
These documents have been developed through the working groups of the Public Health Emergency Medical Countermeasures Enterprise, and have been reviewed by subject matter experts at the Department of Defense, the Department of Homeland Security, the Department of Veterans Affairs, and the Department of Health and Human Services. Specifically, they reflect the integration of TRL definitions previously developed by the Department of Defense and the Department of Health and Human Services. The scientists, physicians, and policy experts who have been involved in the creation of these criteria believe that they are an essential tool for researchers and product developers in the public and private sectors to consistently evaluate and communicate the status of medical countermeasure development programs.