Attachment I1 - Technology Readiness Level for drug and biologics (REFERENCE ONLY)

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SMARGORP ADRAB

Integrated Technology Readiness Levels (TRLs)
for Medical Countermeasure Products (Drugs and Biologics)

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Integrated Technology Readiness Levels (TRLs) for Medical Countermeasure Products (Drugs and Biologics)[1],[2]

Based on October 2004 DOD Medical TRLs and May 2008 HHS PHEMCE TRLs NOTE: When using these criteria, a medical countermeasure product should be rated at a particular level only after the sponsor has completed all activities listed at that level (e.g., a product is rated at TRL 4 once it completes all of the activities listed in TRL 4).

Review of Scientific Knowledge Base
TRL 1

Active monitoring of scientific knowledge base. Scientific findings are reviewed and assessed as a foundation for characterizing new technologies.

Development of Hypotheses and Experimental Designs
TRL 2

Scientific "paper studies" to generate research ideas, hypotheses, and experimental designs for addressing the related scientific issues. Focus on practical applications based on basic principles observed. Use of computer simulation or other virtual platforms to test hypotheses.

Target/Candidate Identification and Characterization of Preliminary Candidate(s) Begin research, data collection, and analysis to test hypothesis. Explore alternative concepts, identify and evaluate critical technologies and components, and begin characterization of candidate(s). Preliminary efficacy demonstrated in vivo. TRL 3

3A Identify target and/or candidate.
3B Demonstrate in vitro activity of candidate(s) to counteract the effects of the threat agent. 3C Generate preliminary in vivo proof-of-concept efficacy data (non-GLP (Good Laboratory Practice)).

Candidate Optimization and Non-GLP In Vivo Demonstration of Activity and Efficacy Integration of critical technologies for candidate development. Initiation of animal model development. Non-GLP in vivo toxicity and efficacy demonstration in accordance with the product's intended use. Initiation of experiments to identify markers, correlates of protection, assays, and endpoints for further non-clinical and clinical studies. Animal Models: Initiate development of appropriate and relevant animal model(s) for the desired indications. Assays: Initiate development of appropriate and relevant assays and associated reagents for the desired indications. Manufacturing: Manufacture laboratory-scale (i.e., non-GMP (Good Manufacturing Practice)) quantities of bulk product and proposed