Target product profiles

Target product profiles (TPPs) are a well-recognised strategy to promote development of innovative medical products such as devices, diagnostic tests and therapeutics. The WHO defines a TPP as a document that describes the minimum and preferred (or optimal) characteristics of a target product, aimed at a particular disease or diseases. They specify the key characteristics that the intervention must address, such as (but not limited to) clinical indication, target population, desired efficacy, safety, formulation/presentation, stability and storage. TPPs identify upfront the characteristics a product should take, in order to fulfil a specific, unmet clinical need. The AIM project aims to develop new TPPs for maternal health conditions, in order to spur the development of new medicines for use in the antenatal, intrapartum or postpartum period.

In collaboration with Burnet Institute, we have developed two new TPPs for novel medicines to prevent and treat pre-eclampsia. To achieve this, we have been guided by an expert advisory group and used a structured process of interviews with expert stakeholders, an international online survey and public consultation to understand and incorporate the views of relevant stakeholders into TPP development.

Concurrently, feedback was sought through an international online stakeholder survey, which followed the structure of the two TPPs. The two TPPs are now undergoing the final revision process. The outputs of expert interviews and the international online survey are being analysed, with a particular focus on areas where consensus was not reached, defined as variables with >25% of respondents indicating they disagreed or strongly disagreed.

We are currently developing two new TPPs for novel medicines to prevent preterm birth and manage spontaneous preterm labor.

To find out more, click here