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Life Science TRLs

Technology Readiness Levels (TRL)* provide a metric that may help to describe the progression of a technology in its development. Several groups have adopted the TRL system for use regarding life science technologies, including the Department of Health and Human Services. TRLs are based on a scale from 1 to 9 with 9 being the most mature technology. The TRLs enables consistent, uniform discussions of technical maturity across different types of technologies. The TRL format was originally developed by NASA and the Department of Defense.

*adapted from the National Institutes of Health (NIH)

Review of Scientific Knowledge Base

Active review and analysis of scientific literature. Identify rationale for a potential new product.

Development of Hypotheses and Experimental Designs

Screen potential compounds; initial experimental designs for technology solution; Initial intellectual property search for patentability.

Identification and Characterization of Preliminary Product; Proof-of-principle

Select compounds to advance to lead, begin non-GLP testing program; Explore prototypes, critical design features and components; demonstrate in vitro efficacy; file IP.

Optimization and Demonstration of Activity and Efficacy

Identify markers, assays, and endpoints for nonclinical and clinical studies, define formulation and product profile, select final pre-clinical lead compound; Initiate Design Control activities, establish Design and Development Plan, develop regulatory strategy.

Advanced Characterization of Product and Initiation of Manufacturing

Explore potential manufacturing options as well as manufacturability and sustainability of product design, including third-party partners and seek regulatory guidance, if appropriate. Begin studies supporting regulatory requirements.

Regulated Production, Regulatory Submission, and Clinical data

Prepare and submit regulatory filings, if appropriate. Begin P1 safety for NCE/NBE or P2 on repurposed compound; Manufacture product compliant with quality protocols or GMP depending on device classification.

Scale-up, Initiation of GMP Process Validation, and Phase 2 Clinical Trial(s)

Scale-up manufacturing, process validation; P2 efficacy program; post-P2 FDA meeting; device scale-up, device and diagnostic outcomes validated, regulatory submissions for marketing clearance; supply chains finalized.

Completion of GMP Validation and Consistency Lot Manufacturing, Clinical Trials Ph3, and FDA Approval or Licensure

Relevant regulatory submissions to request marketing.

Market launch and post-market surveillance

Supply chain contracts active, sales and distribution forces active, post-marketing studies active (as required).

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