PACoPPDeT

The challenge

The momentum behind Africa’s local pharmaceutical manufacturing agenda is positioning the continent as a frontier for product development, driven by its growing population and disease burden. Realising this potential, not just in drug development, but also in drug discovery, requires investment in R&D, cost-competitive technologies, and workforce development through sustained collaboration. Despite accounting for a substantial proportion of the world’s disease burden, sub-Saharan Africa hosts only a small proportion of clinical trials. Furthermore, expertise is concentrated at the phase II and phase III stages of product development, and African-based researchers rarely take the lead in key areas such as protocol development or data analysis.

Sub-Saharan Africa is therefore not well placed to discover and develop new interventions or usher them through the clinical evaluation and regulatory pathway to implementation. It is encouraging that attention is being given to manufacturing capacity in the region; however, a broader perspective is needed so that the interventions manufactured also originate in Africa and are designed to address African health priorities.

Pharmaceutical discovery and development is a long and complex process with a number of well-established steps from early pre-clinical discovery stages through clinical evaluation in progressively larger trials, regulatory approvals and high-quality manufacturing. Many African countries currently have few researchers with a comprehensive end-to-end overview of this pathway. 

Central to pharmaceutical development is ‘pharmacometrics’ – use of statistical and modelling techniques to optimise drug dose regimen design. The Pharmacometrics Africa NPC organisation has been established to build capacity in this area. 

The project

The PACoPPDeT project is developing a master’s training programme to further strengthen pharmacometrics capacity in sub-Saharan Africa, building on the model established by the Pharmacometrics Africa initiative.

Targeted at mid-career researchers, the programme will offer a two-year master’s course covering areas such as drug discovery, pharmacokinetics and pharmacodynamics, pharmacogenomics, biostatistics, preclinical and clinical drug development, regulatory science, and scientific leadership. Two cohorts of 15 students will be selected from across the breadth of sub-Saharan Africa. A further 100 individuals will be able to gain certificate-level qualifications by undertaking specific modules.

The course will be a mix of face-to-face and virtual learning, as well as a hands-on placement in a partner organisation, and will draw on existing modules that project partners have successfully used in experiential training programs. It will be delivered by subject matter experts from a range of sectors, including academia, industry and medicines regulation. 

All materials will be made freely available, so other institutions can develop similar courses. In addition, the project will translate its materials into French to support uptake in francophone countries in sub-Saharan Africa. After completing the course, graduates will be expected to contribute to teaching, diffusing the knowledge learned and expanding the programme’s reach. 

Students will also benefit from a structured mentoring scheme and will have extensive networking opportunities. The aim is to develop students’ peer networks so they have access to a pool of expertise spanning all stages of pharmaceutical development that they can call upon when needed. 

Impact

The PACoPPDeT project will add significantly to pharmacometrics capacity in sub-Saharan Africa. It will:

• Provide mid-career professionals (30 MSc and 100 certificate-level degrees) with the knowledge and skills to play a lead role in the development and clinical evaluation of new pharmaceutical products.
• Create a regional network of well-connected and mutually supportive experts in pharmaceutical product development.
• Build leadership and entrepreneurial skills to encourage Africa-led drug discovery and development.

Ultimately, the project will help to create a stronger R&D ecosystem in Africa that is better able to support the discovery, clinical evaluation and licensing of new pharmaceutical products tailored to the needs of African populations, delivering both health and economic benefits to the region.