Target Product Profiles in Drug R&D – Aspirational profiles
Aspirational Target Product Profiles (ATPPs)
ATPPs provide the context for and set targets along a range of key criteria that are required to be met for a new treatment. They are constructed with the needs of patients, physicians, payers and the developing organization in mind and thus require an in-depth understanding of those needs. They are intended to be fixed, and will not change as the properties of any new treatment become known. In this way they set out the aims of a drug development programme and act as a guide to focus efforts and set targets.
The key requirements for the treatment may not be expressed through efficacy and safety alone. For example, the treatment may be needed to reduce the number of days of hospitalized per year, it could provide a more stable formulation that permits flexible transport and storage, it could lead to less frequent dosing which provides improved compliance, or it may deliver a reduced potential for abuse. These key criteria will be built through a detailed understanding of patient, payer, physician and market needs and could include:
- Product vision
- Therapeutic area
- Indication
- Unmet need
- Key benefits that the treatment will provide
- Patient population
- Patient pathway
- Positioning
- Competition
- Efficacy profile
- Safety and tolerability profile
- Dosage, duration and regimen
- Formulation
- Target price and prescriber
Ideally ATTPs need to be fixed and stable over a number of years as they serve as a long-term guide for research and business development groups. Thus, the time horizon of an ATPP is typically 5 to 10 years, but in practice they should be reviewed and updated at regular intervals to reflect changes in the commercial and medical environment. If there are critical time factors (ie a competitor nearing launch) then this timeline would be detailed and provide a basis for decision making given the progress of the competitor. They can also signal trends in disease areas and where new treatments may be needed in the future.
ATPPs lay out the critical elements that need to be demonstrated. It is also good practice to describe the minimally acceptable level of the key criteria that must be reached, and if any of those criteria are critical, non-negotiable or not subject to trade-off with other criteria. This guide can help set the hurdles during development and speed decision making when results of studies are known.
ATTPs can also serve to build company strategy in terms of which disease areas they wish to focus on now and in the future. They can highlight any gaps in the current portfolio and guide not only internal research organisations but align business development search and evaluation activities.
Aspirational TPPs fit into company strategy as they lay out what kind of treatments the organisation looks to develop in which disease areas. There is therefore a link to the current portfolio where gaps are highlighted and any shortcomings of drugs in development are made clear.
Aspirational TPPs can align the business development organisations in their search and evaluation efforts to source external treatments. ATPPs require regular review and updates as market conditions change, regulatory requirements shift, or competitors appear.
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