To conclude my new 2023 blog series on the Innovative Licensing and Access Pathway (ILAP), in this blog I’m going to touch on the Target Development Profile (TDP) Toolkit aspect of ILAP.
Once you have your Innovation Passport (IP) and are working through your Target Development Profile roadmap you will start making use of the Toolkit.
The TDP Toolkit
The Toolkit involves many positive activities to assist development such as:
- Compliance Readiness Inspections
- Certifications
- Continuous Benefit Risk Assessment integrating Real World Evidence
- Clinical Practice Research Datalink (CPRD)
- Assisted Patient Recruitment and Enhanced patient engagement
- Innovative and Flexible Licensing Routes – also see blogs on Project Orbis, and Access Consortium.
- Novel methodology and innovative clinical trial design
- Optimising the Market Access Approach – ILAP Health Authority Access (HTA) Tool
- Rapid Clinical Trial Dossier Pre-Assessment
Top Tip: You may request any tool that you wish to use and is relevant to your application through the TDP. The partners will consider the request in the TDP Roadmap.
Look out for my other ILAP-related blogs in this series…
Fusion Pharma have experience in this area. If you would like to discuss how Fusion Pharma can support you with ILAP, please email us at hello@fusion-pharma-limited.com or phone us on +44 (0) 203 1379 799.
While the information in this article is considered to be true and correct at the date of publication, changes in guidance and/or experience may impact on the accuracy of the information. Please refer to the relevant guidance for the latest information