Level General description Technology readiness level ...• The final product design validated and...
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Level General description Technology readiness level - BioPharma 1 to 3 Non applicable Non applicable 4 Validation of the technology in the laboratory • Preclinical R&D. Optimization of candidates and in vivo demonstration of activity and efficacy. Identification and integration of critical technologies (animal models, biomarkers, assays, etc.) in continued characterization of and development of potential candidates. • Initiation of GMP process development and manufacturing of non- GMP material and drug formulations. • Evaluation of safety, pharmacodynamics and pharmacokinetic properties. • Formulation of a Target Product Profile initiated. 5 Validation of technology in a relevant environment • Further characterization of candidate, i.e. absorption, distribution, metabolism and elimination. • Manufacturing process established amenable to large scale GMP manufacturing and consistent with the intended use of the drug. Development of in process controls and relevant analytical assays. • Continued development of animal models for efficacy and dose- ranging studies. Selection of candidate drug. GLP safety studies for IND submission and Phase 1. 6 Demonstration of technology in relevant environment • Clinical development. GMP production, IND submission and Phase I clinical evaluation performed proceeding to Phase II. • Additional safety evaluations conducted necessary to support further development. 7 Technology prototype demonstrated in an operational environment • Phase II clinical study is completed. Manufacturing process scale- up and process validation initiated and stability testing ongoing. • Continued safety studies to support further clinical testing. • TPP refined when necessary. Phase III clinical plans defined and approved by regulatory authorities. approved by regulatory authorities. 8 Technology system completed and qualified through test and demonstration • Manufacturing processes validated. • Pivotal clinical Phase III testing and safety studies completed. • NDA or BLA prepared and submitted. Approved by appropriate regulatory authorities. 9 Technology system in its final form ready for full (commercial) deployment in relevant operating environment • Product launched. • Post-marketing studies (Phase IV) and surveillance. Readiness level guide Technology readiness level - TRL Intellectual Property readiness level - IPRL Customer readiness level - CRL Funding readiness level - FRL
Transcript of Level General description Technology readiness level ...• The final product design validated and...
Level General description Technology readiness level - BioPharma
1 to 3 Non applicable Non applicable
4 Validation of the technology in the laboratory
• Preclinical R&D. Optimization of candidates and in vivodemonstration of activity and efficacy. Identification and integrationof critical technologies (animal models, biomarkers, assays, etc.)in continued characterization of and development of potentialcandidates.
• Initiation of GMP process development and manufacturing of non-GMP material and drug formulations.
• Evaluation of safety, pharmacodynamics and pharmacokineticproperties.
• Formulation of a Target Product Profile initiated.
5 Validation of technology in a relevant environment
• Further characterization of candidate, i.e. absorption, distribution,metabolism and elimination.
• Manufacturing process established amenable to large scale GMPmanufacturing and consistent with the intended use of the drug.Development of in process controls and relevant analytical assays.
• Continued development of animal models for efficacy and dose-ranging studies. Selection of candidate drug. GLP safety studies forIND submission and Phase 1.
6 Demonstration of technology in relevantenvironment
• Clinical development. GMP production, IND submission and PhaseI clinical evaluation performed proceeding to Phase II.
• Additional safety evaluations conducted necessary to supportfurther development.
7 Technology prototype demonstrated in anoperational environment
• Phase II clinical study is completed. Manufacturing process scale-up and process validation initiated and stability testing ongoing.
• Continued safety studies to support further clinical testing.
• TPP refined when necessary. Phase III clinical plans definedand approved by regulatory authorities. approved by regulatoryauthorities.
8 Technology system completed and qualified through test and demonstration
• Manufacturing processes validated.
• Pivotal clinical Phase III testing and safety studies completed.
• NDA or BLA prepared and submitted. Approved by appropriateregulatory authorities.
9 Technology system in its final form ready for full (commercial) deployment in relevant operating environment
• Product launched.
• Post-marketing studies (Phase IV) and surveillance.
Readiness level guideTechnology readiness level - TRL
Intellectual Property readiness level - IPRL Customer readiness level - CRL
Funding readiness level - FRL
Level General description Technology readiness level - Med tech & Diagnostics
1 to 3 Non applicable Non applicable
4 Validation of the technology in the laboratory
• Preclinical R&D. Laboratory testing of critical components andprocesses.
• Proof of concept of device demonstrated in relevant laboratory andanimal models.
5 Validation of technology in a relevant environment
• Further development of device candidates and system solutions.Validation of system components and processes in relevantlaboratory environment.
• Classification of device by appropriate regulatory body and whenappropriate an Investigational Device Exemption (IDE) prepared andsubmitted for review.
6 Demonstration of technology in relevantenvironment
• System/device prototype demonstrated in an operationalenvironment. Clinical testing to demonstrate safety may be required.
• Depending on the classification of the device Premarket approvalor Premarket notification (510(K)) apply.
7 Technology prototype demonstrated in anoperational environment
• Clinical safety and effectiveness trials conducted using a fullyintegrated prototype version of the medical device in an operationalenvironment.
• Data evaluated to support further development
• The final product design validated and final prototype and/or deviceintended for commercial use produced and tested.
8 Technology system completed and qualified through test and demonstration
• Premarket application or premarket notification submitted andapproved.
9 Technology system in its final form ready for full (commercial) deployment in relevant operating environment
• Product launched.
• Post-marketing studies and surveillance.
Readiness level guideTechnology readiness level - TRL
Intellectual Property readiness level - IPRL Customer readiness level - CRL
Funding readiness level - FRL
Level General description Technology readiness level - Digital Health
1 to 3 Non applicable Non applicable
4 Validation of the technology in the laboratory
• System components integrated and tested regarding preliminaryefficiency and reliability.
• Software architecture and other system components developmentto address reliability, scalability, operability, security, etc.
5 Validation of technology in a relevant environment
• System component architecture established.
• System tested in relevant testing environment as expected in theoperational environment.
• Verification, validation and accreditation when appropriate initiated.
6 Demonstration of technology in relevantenvironment
• Representative model or prototype system demonstrated inrelevant live or simulated environment. System component releasesare “beta” versions and configuration controlled.
• Support structure in development and verification and validationand when needed accreditation for safety reasons in progress.
7 Technology prototype demonstrated in anoperational environment
• System tested in an operational environment. Support structure inplace and System component releases in distinct versions.
• Verification, validation and when appropriate accreditationcompleted.
8 Technology system completed and qualified through test and demonstration
• Development completed. System demonstrated to work under reallife conditions.
• Testing of design specifications. System component releases areproduction versions.
• Support structure in place to resolve technical issues.
9 Technology system in its final form ready for full (commercial) deployment in relevant operating environment
• Product launched.
Readiness level guideTechnology readiness level - TRL
Intellectual Property readiness level - IPRL Customer readiness level - CRL
Funding readiness level - FRL
Level Intellectual Property readiness level - IPRL
1 to 3 Non applicable
4 • Novelty / patentability confirmed by IP professional
• Other forms of protection confirmed possible if patent is notrelevant (e.g. software).
5 • First patent application filed.
• Initial IP Strategy supporting value creation in place.
6 • FTO assessment made.
• First initial feedback on patent application obtained from patentauthority.
7 • Patent entered national phase.
• Other relevant forms of IPR initiated (Trademark, design etc.)
8 • First patent granted.
• IP strategy in place and actively implemented.
9 • Patent maintained and in force in relevant countries / markets.
Readiness level guideTechnology readiness level - TRL
Intellectual Property readiness level - IPRL Customer readiness level - CRL
Funding readiness level - FRL
Level Customer readiness level - CRL
1 to 3 Non applicable
4 • Problem / need confirmed from multiple sources and producthypothesis refined if required
• Key Opinion Leaders (KOLs) identified.
5 • Product (core features) / solution fit confirmed by customers.
• Customers (focus group, advisory board etc) engaged in providinginput on market requirements.
6 • Testing of product/prototypes by users/customers where the valueand benefits of the product is evaluated and confirmed
• Partnerships are formed with key stakeholders across the valuechain (e.g. suppliers, partners, customers).
7 • Customer / supply agreements in place; all relevant stakeholdersengaged in product/process qualifications.
• Product design is complete.
8 • Customer qualifications complete; initial products manufacturedand sold to a few customers. Payment willingness confirmed.
• Business development and sales mature and adapt to supportlarger scale sales efforts (e.g. clear sales process/organization, CRMsystems etc)
9 • Widespread product deployment with sales to multiple customers.
Readiness level guideTechnology readiness level - TRL
Intellectual Property readiness level - IPRL Customer readiness level - CRL
Funding readiness level - FRL
Level Funding readiness Level - FRL
1 to 3 Non applicable
4 • Budget and activity plan for 12-18 months drafted
• Succinct oral pitch prepared; written business concept in place.
5 • Soft funding (0,1 - 0,5 Meuro) obtained.
• Pitch deck tested and fine-tuned; supporting documentation inplace.
6 • Investment prospectus prepared.
• Pitch deck including financials and business prospect ready.
7 • Complete business plan incuding financials and milestone plan.
• Series A round initiated.
8 • Follow-up investments with series A investors ongoing.
9 • Extended investor network with series B.
Readiness level guideTechnology readiness level - TRL
Intellectual Property readiness level - IPRL Customer readiness level - CRLFunding readiness Level - FRL
