Target Product Profiles in Drug R&D – Emerging profiles
Emerging TPPs
As a drug moves through development its properties, activity and effect on disease are revealed. ETPPs are used to summarize these aspects for the drug given the current understanding of the drug’s performance and how they align with the critical elements of the Aspirational TPPs.
ETPPs typically describe the value critical aspects of the drug from the developer’s perspective – which may be the potential usage and uptake in patients for a commercial drug developer, or how the drug can enable access to hard to reach neglected diseases from a not-for-profit drug developer, or even how the approach may drive the science in a new area and foster innovation from a more academically focussed developer. ETPPs should cross reference the critical requirements of the ATPPs, unless the drug in question is in a new and unexpected area where no ATPP exists. Some examples of the elements of ETPPs are:
- Efficacy and toleration profile
- Number of hospital days saved
- Sttability data for the formulation which will enable access to difficult to reach geographies
- Performance in a specific patient population
- Dose reduction due to use in combination therapy
- Regimen and dosage advantages
- Manufacturing advantages
- Bacterial resistance versus other antibiotics
Some of these elements might be known – for example the results of a phase one trial may reveal the safety in healthy volunteers. But other elements may be yet to be established – for example efficacy in a general patient population may need to be determined in a phase 3 trial.
ETTPs can quickly describe a drug in development and its intended profile. Hence they are a way of advertising the product and its “unique selling points” to a potential partner when it comes to funding the next stage of development.
For a commercial drug developer ETPPs can also drive a valuation. Eg by showing how the new drug will be used and uptake in a particular patient population this can lead to a forecast of patient numbers and ultimately to a valuation taking into account market share, access, pricing, and cost of sales. Depending on the stage of development of the drug some attributes may not be fully established fully as described above. But by considering what is known (ie through early clinical data) and by taking into account a range of possible outcomes of these unestablished attributes a range of value can also be developed. As the drug progresses and more is known, this value also becomes clearer and less uncertain. The very best ETTPs will lay out the acceptable trade-offs between the critical criteria, and those criteria where no trade-off is possible.
Comparing ETPPs to ATPPs can lead to a discussion concerning the probability of the meeting the critical criteria of the ATPPs, and hence a plan of how to resolve those questions by doing the right experiments, and efficient use of resources in the phases of drug development.
For drugs in development Emerging TPPs need to be cross referenced to Aspirational TPPS by governance at least annually, and at major milestones, for example – clinical study read-out. This also ensures that the development project continues to align with company strategy.
A general introduction to the three kinds of TPP, plus more detail on the other two, are available in related articles in this section.
Our associates have many years’ experience in the use of TPPs. Get in touch with us – we’d be pleased to talk to you about TPP development and use.
Written by Graham Finch, Nick Brindley, Mike Florence and Pauline Stewart-Long