As part of my 2023 series on the Innovative Licensing and Access Pathway (ILAP), in this blog we are going to explore the Target Development Profile (TDP) aspect of ILAP.
Once you have your Innovation Passport (IP) (see my earlier blog) you then have access to the Pathway and the road map called the Target Development Profile (TDP).
Your TDP will be based on your product’s characteristics and will be defined with the help of a product-specific team of experts. The TDP will:
- define key regulatory and development attributes
- highlight potential issues, and
- produce a road map for providing early patient access
The TDP should be a living document, revised over the length of the development programme as fresh knowledge is gained. It will include details on how to collaborate with other UK stakeholders for coordinated and efficient evidence generation and evaluation and examine commercial and managed access factors.
Top Tip: The timing of the TDP meeting should be scheduled ASAP following the positive outcome from the Innovation Passport decision or at the date suggested in the approval letter.
You, as the IP holder, should submit the TDP application form which must include details of the following:
- Kick-off meeting and stakeholders, plus items to be discussed at the kick-off meeting
- About the product development
- Future development and evidence generation (including details of intended clinical trials in the UK)
- Scientific advice
- Patient engagement including the use of Patient Reported Outcome (PRO) measures
- Special populations
- Product life cycle
- Any additional information
You will then be invited to meet the MHRA and ILAP partner colleagues to present a summary of the content of each of these aspects. Following the meeting, the partners will create the TDP roadmap which should be sent to you in around 4 to 6 weeks.
Top Tip: At this initial TDP meeting ensure you highlight specific challenges and opportunities for discussion and which tools of the Toolkit you are interested in applying.
The TDP Toolkit blog goes into further details.
- Initial Target Development Profile (TDP): £4,451
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 email@example.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.