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Globally, approximately 295,000 women die every year from pregnancy-related conditions and complications, with most of these deaths occurring in low-and middle-income countries (LMICs).
Although investment in global maternal health has increased in the past 30 years, research and development (R&D) of new products has been a neglected area. This underinvestment, combined with legal, regulatory, logistical, and procurement barriers has led to few accessible devices, diagnostics, and medicines for use during pregnancy.
There are limited medicines available for pregnancy-related conditions and a significant lack of R&D into new medicines for pregnant women, due to market and gender equity barriers meaning pregnant women are being left behind. These target product profiles are a clear step in developing a coordinated action plan in how to address the maternal drug drought.
A research paper released in Oct 2022 describes the development of the first ever target product profiles for preterm birth medicines. It’s the first peer reviewed publication on the development of TPPs for any pregnancy condition.
The Accelerating Innovation for Mothers (AIM) project - a collaborative partnership between Burnet Institute, Concept Foundation and Policy Cures Research - was initiated to catalyse the development of new medicines for obstetric conditions.
In the first phase of the AIM project (AIM 1.0) we investigated the current landscape and challenges for pregnancy-specific medicine development, conducted a comprehensive maternal medicines pipeline analysis, and developed four new target product profiles for new medicines to prevent and treat preeclampsia and preterm birth/labour.
In AIM 2.0 we will expand our previous work to include diagnostic tests and devices, and medicines for additional maternal conditions. Burnet Institute will lead two primary objectives that will help us to achieve our goal within the timeframe of the project.
Objective 1: Improve coordination and foster an enabling environment is built on the understanding that collaboration among different stakeholders is optimal to ensure long-awaited innovations for pregnant women are realised. We will consolidate a transparent and efficient research collaboration network. This will foster an enabling environment through which new findings and innovations can be disseminated to peers in the maternal health field and to the public. Through this network, we will continue to raise awareness of the need for, inspire, and guide new innovations for maternal and pregnancy related problems and other topics related to our work. An additional component of this collaborative network will be to establish and strengthen the capacity of an LMIC-based research network to conduct regulatory trials.
Objective 2: Research prioritization to action will streamline and accelerate the identification of highest priority candidates and ensure that necessary clinical research activities can commence promptly. An updated, integrated database of pipeline candidates will be maintained and expanded to include new conditions and products. Systematic and scoping reviews will be conducted on high priority candidates and conditions. New TPPs will be developed for maternal microbiome, and tests for preeclampsia and preterm birth.
By the end of this project, multiple high-priority candidate medicines will be ready for “next-phase” clinical trials consistent with regulatory standards, to be conducted within a newly established LMIC trial network.
Find out more at the AIM website.
2022 - 2025
For any general enquiries relating to this project, please contact:
Principal Research Fellow; Deputy Discipline Head, International Development; Co-Head, Global Women's and Newborn's Health Group
To create and translate knowledge into better health, so no-one is left behind.
85 Commercial Road, Melbourne
VIC, 3004, Australia
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