A distinguished international panel of speakers representing Private Enterprise, Public Sector, NGOs, Finance, Health Authorities shared their experiences and journeys with multi-stakeholder collaborations that brought new medicines through the complex process of product development, regulatory approval and patient access. Working in pharma and currently seconded to EDCTP as technical R&D advisor, I enjoyed this very lively, educational and stimulating session chaired by Jennifer Dent (BVGH) and Ole Olson (EDCTP).
Jutta Reinhard-Rupp highlighted the practical challenges and complexities of paediatric product development in Africa, while Ingrid Murillo presented the marathon and then final sprint needed to register a novel attenuated TB vaccine through the EU regulatory mechanisms (PRIME, “Article 58”) to accelerate product approval for high medical needs.
The PDP experience in Malaria and HIV, respectively, was provided by MMV (Wiwecka Kastubska) and IAVI (Swati Gupta) describing the science-based evolution and expansion of their product portfolios. They stressed the critical importance of local expert input into developing target product profiles.
Discussing the optimal path to efficient patient access, Agnes Saint-Raymond (EMA) and Ahmed Bellah (WHO) shared their experiences and recommendations for best practices. These were based on experience with evaluating four new products destined for global health needs through EMA, and with the rapid multi-stakeholder response to the Ebola crisis in 2014.
Rounding off a fascinating session, Kim Kreilgaard (European Investment Bank) provided insights into the grant-based and equity/debt based funding mechanisms for innovative research provided by EIB.
So what is the secret recipe for successful partnering ?
- Communicate early and often with key stakeholders, especially regulators and end users
- Establish clear and shared “win-win” goals
- Submit a single regulatory / ethics dossier
- Implement professional project management.
Tony Man, EDCTP R&D Technical Advisor