First joint regulatory platform between product development partnerships aims to streamline pathways to patient access
DNDi and Medicines for Malaria Venture (MMV) have launched the first joint regulatory sciences platform between two non-profit medical research organizations (also called product development partnerships), bringing together the deep malaria-specific expertise of MMV with DNDi’s extensive experience in developing and registering medicines for neglected diseases. By joining forces, the two organizations aim to shape faster, smarter pathways from clinical development to patient access across both organizations.
Both DNDi and MMV are advancing ambitious, transformative pipelines, including novel drug classes and innovative treatment approaches that do not fit neatly into conventional frameworks. Bringing these medicines to patients requires new ways of thinking about regulatory strategy: earlier engagement with authorities, adaptive approaches to clinical evidence, and a willingness to define new standards where none yet exist.
Historically, product development partnerships have navigated the fragmented and complex regulatory landscape independently, duplicating effort and limiting collective influence. This collaboration aims to change that, setting a new standard for how global health organizations can work together to maximize their impact and speak with one voice to regulatory authorities and stakeholders. This is increasingly important as the global regulatory environment evolves and new actors emerge. A unified voice will enable both organizations to engage more efficiently across this changing landscape.
“Pooling our resources, avoiding duplication, and speaking with a stronger, unified voice are compelling solutions to current global health challenges”
The platform is led by Fabienne Benoist, who serves as Regulatory Head across both organizations.
“Pooling our resources, avoiding duplication, and speaking with a stronger, unified voice are compelling solutions to current global health challenges”, said Fabienne Benoist. “And it all comes back to one thing: bringing medical innovation to patients who need it most.”
The platform operates across two levels: at the product level, where the two organizations align on regulatory strategy and clinical data requirements; and at the ecosystem level, where they coordinate advocacy and share regulatory intelligence with the broader global health community.
DNDi and MMV have a long history of collaboration, from sharing knowledge and resources to joint research initiatives and the transfer of compounds. For example, in 2015, DNDi transferred two malaria treatments it had developed (ASAQ and ASMQ) to MMV to advance their access. In 2019, DNDi and MMV jointly launched the Pandemic Response Box to provide researchers with free access to 400 promising compounds to accelerate the discovery of new treatments.
This joint regulatory platform deepens further deepens their collaboration and will demonstrate how working together—rather than in parallel—can increase the impact of research and development.
Find out more about this platform in the interview with Fabienne Benoist, Head of the Joint Regulatory Platform.
Photo credit: MMV
