A critical function of the IMPT Secretariat is to serve as a knowledge manager for the MPT field. In this way, we collect and disseminate MPT-relevant resources, as well as synthesize data and stakeholder expertise into useful tools and frameworks in order to inform future work within the MPT field. While the IMPT Secretariat continues to develop new resources to meet the needs of an evolving field, we want to highlight a tool – originally developed in 2015 – that is still relevant to stakeholders in the MPT field today: generalized Target Product Profiles (TPPs) for intravaginal ring (IVR) MPTs and long-acting injectable MPTs.
As we describe more fully in a summary brief on the subject, TPPs are an important part of the biomedical product development process as they serve as a platform for structured target-setting and evaluation when working with a regulatory agency. A TPP includes optimal and minimal targets and relevant data for the following product attributes: indications, dosage, mechanism of action, target populations, efficacy, storage/shelf life, preclinical and clinical safety, pharmacokinetics, and contraindications. These are all critical factors for successful product development, and become increasingly complex as multiple indications are considered.
While most TPPs are developed for a specific product, generalized TPPs for particular dosage forms are useful to the MPT field in two primary ways. First, a generalized TPP may be used earlier on in the MPT product development process, before work with regulatory agencies, as a collaborative tool between MPT product developers and funders. More specifically, such tools may inform GO/NO GO and other decision-making during the planning and progression of a given product development project. Second, a generalized TPP may serve as a useful starting place for MPT developers as they develop product-specific TPPs needed for regulatory assessment and approval.
Thus, the IMPT Secretariat, in collaboration with MPT product developers, funders, and other key scientific advisors, developed two generalized TPPs for MPT dosage forms currently in the product pipeline, aiming to address the necessary label claims for a high-impact MPT. These TPPs were informed by objective expert knowledge and clinical data, and can provide a robust and unbiased platform for future MPT product development efforts. Another important outcome of this exercise was the recognition that the impact of a future MPT will not be solely based on clinical attributes as listed in a traditional TPP, but will also be shaped by market-based attributes such as product adherence and product feature acceptability. The IMPT has also developed resources to inform target-setting around these attributes.
As we look to the future, the profiles that need to be set for specific MPT products should integrate the clinical and regulatory aspects outlined in a traditional TPP with the country and population-specific market details of the target populations for each product to ensure maximum public health impact. In an era of limited resources to support the exciting innovations in the works – the continued development and refinement of these product-neutral tools will become increasingly important.