The Desired Product Profile (Target Product Profile)
Due to the length of time it takes to get from Target Discovery all the way to product launch it’s important that the Development organization agrees with and looks forward to the clinical candidates being sought by Discovery. The likelihood that Discovery will focus attention on areas of interest to Development can be increased through the use of Desired Product Profiles (often called Target Product Profiles 1 – we will not use the term here as it can confuse use of the word ‘target’ as both noun and adjective, as well as the fact that these words refer to a specific FDA document. 2).
Each Desired Product Profile outlines what would be needed for each potential disease indication, usually
- Global Health and Market Impact, especially the Unmet Medical Need
- Desired route of administration (if more than one, then develop separate DPPs for each)
- Dose frequency
- Desired Indication of Efficacy and Onset of Action
- Safety profile
- Maximal Cost per Dose (Affordability)
- Reimbursability (whether third party payors will reimburse patients) 3 – unique factors that differentiate from competition or established therapies.
The style of the document and the manner in which the profiles are created, approved and utilized are likely to vary across different companies. It is important that both Discovery and Development managers agree to the goals set forth in the profiles.
It is not uncommon for Development managers to treat these as classified documents and restrict the profiles to only Development managers, which negates the reason for creating them – the profiles must be shared with Discovery managers.
In both Discovery and Development the potential value of the ultimate product will be influenced by the profile. While the profiles are relatively stable, they should be reviewed from time to time, as changes in the regulatory and reimbursement environments may have an impact. Such changes could have a dramatic impact on the actual projects that relate to the desired product profile and their relative prioritization within the portfolio.
- Curry S, Brown, R, The Target Product Profile as a Planning Tool in Drug Discovery Research, Pharmatech 2003; 67-71. ↩
- http://www.fda.gov/CDER/guidance/6910dft.htm ↩
- Bert Spilker, “Guide to Drug Development, A Comprehensive Review and Assessment”, Wolters Kluwer, Lippincott Williams & Wilkins, New York, 2009, p. 976 ↩