Therapeutics

• TRL 1: Review scientific knowledge base.
• TRL 2: Development of product hypothesis.
• TRL 3: Identification and characterisation of product candidate.
• TRL 4: Optimisation and initial demonstration of safety and efficacy.
• TRL 5: Advanced characterisation of product and initiation of manufacturing.
• TRL 6: Regulated production and early clinical studies.
• TRL 7: Scale-up, initiation of GMP process validation and phase III clinical trials.
• TRL 8: GMP validation and consistency lot manufacturing, phase III clinical trials.
• TRL 9: Post-approval activities, reimbursement, clinical implementation.

• Discovery research and idea generation
• Preclinical testing and feasibility
• Early clinical studies and product development
• Late clinical studies and evidence building
• Market launch and exit

Diagnostics

• TRL 1: Idea generation - basic principles observed.
• TRL 2: Idea development - technology concept formulated.
• TRL 3: Experimental proof of concept, feasibility, prototyping.
• TRL 4: Technology validated in lab research/local environment.
• TRL 5: Technology validated in relevant environment.
• TRL 6: Clinical validation of technology in relevant environment.
• TRL 7: Clinical validation of prototype in operational environment, regulatory applications.
• TRL 8: Technology assessed and qualified, market launch preparations.
• TRL 9: Market launch.