Target product profiles for novel medicines to prevent and treat preeclampsia: An expert consensus

Annie Ra Mcdougall; Andrew Tuttle; Maya Goldstein; Anne Ammerdorffer; A Metin Gülmezoglu; Joshua P Vogel

doi:10.1371/journal.pgph.0001260

Target product profiles for novel medicines to prevent and treat preeclampsia: An expert consensus

PLOS Glob Public Health. 2022 Nov 18;2(11):e0001260. doi: 10.1371/journal.pgph.0001260. eCollection 2022.

Authors

Annie Ra Mcdougall¹, Andrew Tuttle², Maya Goldstein², Anne Ammerdorffer³, A Metin Gülmezoglu³, Joshua P Vogel^{1

4}

Affiliations

¹ Maternal, Child and Adolescent Health Program, Burnet Institute, Melbourne, Australia.
² Policy Cures Research, Sydney, Australia.
³ Concept Foundation, Geneva, Switzerland.
⁴ School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.

Abstract

Background: Preeclampsia and eclampsia are a leading cause of global maternal and newborn mortality. Currently, there are few effective medicines that can prevent or treat preeclampsia. Target Product Profiles (TPPs) are important tools for driving new product development by specifying upfront the characteristics that new products should take. Considering the lack of investment and innovation around new medicines for obstetric conditions, we aimed to develop two new TPPs for medicines to prevent and treat preeclampsia.

Methods and findings: We used a multi-methods approach comprised of a literature review, stakeholder interviews, online survey, and public consultation. Following an initial literature review, diverse stakeholders (clinical practice, research, academia, international organizations, funders, consumer representatives) were invited for in-depth interviews and an online international survey, as well as public consultation on draft TPPs. The level of stakeholder agreement with TPPs was assessed, and findings from interviews were synthesised to inform the final TPPs. We performed 23 stakeholder interviews and received 46 survey responses. A high level of agreement was observed in survey results, with 89% of TPP variables reaching consensus (75% agree or strongly agree). Points of discussion were raised around the target population for preeclampsia prevention and treatment, as well as the acceptability of cold-chain storage and routes of administration.

Conclusion: There is consensus within the maternal health research community on the parameters that new medicines for preeclampsia prevention and treatment must achieve to meet real-world health needs. These TPPs provide necessary guidance to spur interest, innovation and investment in the development of new medicines to prevent and treat preeclampsia.

Copyright: © 2022 Mcdougall et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Grants and funding

This work was supported by The Bill and Melinda Gates Foundation (INV-023749 to AMG). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of manuscript.