Accelerating Innovation for Mothers (AIM) 2.0

Globally, approximately 287,000 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.

Objective

Our objective is to define and implement the pathways for accelerating development and introduction of innovative products for pregnancy-specific conditions through global partnerships.

Timeline

2022–2025.

Approach

The Accelerating Innovation for Mothers (AIM) project is a collaborative partnership between Burnet Institute, Concept Foundation and Policy Cures Research. It 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.

Two research papers released in 2022 describe the development of the first ever target product profiles for maternal medicines, for preterm birth/labour and pre-eclampsia. An additional three research papers released in 2022 describe the landscape of medicines development over the last 20 years, for pre-eclampsia, postpartum haemorrhage and fetal growth restriction.

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 con1nue to raise awareness of the need for, inspire, and guide new innova1ons 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 ac1vi1es 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.