Wednesday, 6 May 2015

TRLs in the health sector


In Societal Challenges and Industrial Leadership, proposers are asked to position their project idea on the spectrum from idea to application or from lab to market, referring to TRLs (Technology Readiness Levels) where relevant. Some H2020 Workprogrammes make extensive use of TRLs in describing topics for proposals. But this is not the case with “Health, demographic change and wellbeing” where the EC says TRLs are not commonly used.
 
TRLs for pharmaceutical drugs
1
Maintain scientific technical watch
2
Research ideas & protocols are developed
3
Hypothesis testing & initial PoC demonstrated in limited number of in vitro & in vivo models
4
PoC & safety of candidate drug formulation is demonstrated in a defined laboratory or animal model
5
Pre-clinical studies, including GLP animal safety & toxicity, sufficient to support IND application
6
Phase 1 clinical trials support proceeding to phase 2 clinical trials. IND application submitted & approved by FDA
7
Phase 2 clinical trial complete. Phase 3 plan approved
8
Phase 3 completed. New drug application approved
9
Post marketing studies & surveillance
However, the US Army Medical Department does use TRLs for pharmaceutical drugs (see box). There are equivalent lists for bio-pharmaceuticals and vaccines, medical devices, and medical informatics. NATO uses similar descriptions. Interestingly, TRL levels 5 to 9 seem to correspond to the widely used definitions of phases 0 to 4 of clinical trials. So why not use TRLs in “Health”?







Regards
Singleimage - H2020 Training Workshops and Advice