A document by Tirhani Maluleke. Click on the document to view its contents.

There has always been high interest in the use of traditional medicines for COVID-19 from early in the course of the pandemic. Significant advances in the science of ethnopharmacology has helped to introduce chemical entities identified from natural sources into modern medicine. However, the wider integration of natural products into the modern drug discovery process will require enhanced collaboration among different stakeholders including the pharmaceutical industry, academic research units, regulatory bodies, ethics review committees, local, regional, continental and international organizations. Revisiting this topic holds promise of benefit for both the current and future pandemics.

Pharmacometrics, the mathematical approaches to describe the transfer of drug through different biological compartments, are essential tools in clinical pharmacology research. The ethical necessity to study drugs accurately in the populations where they are to be used is increasingly recognized. To maximise the value of clinical data, study design and analysis must be appropriate. Historically, many datasets have been sent from African countries to better-resourced settings for analysis, but in recent years it has been demonstrated that capacity can be built and sustained within low and middle-income countries (LMIC)3. We report the establishment of the Uganda Chapter of Pharmacometrics Africa, to share learning with other countries seeking to build similar capabilities.

Pharmacometrics Africa is a not-for-profit company registered in South Africa as an established platform for interested groups to establish and run open-access quantitative clinical pharmacology educational programs in partnership with local research organizations and academic groups. Pharmacometric research and clinical application is pivotal in characterising and optimising treatments, especially for complex or understudied populations. The application of pharmacometrics in drug development during recent years has led to an increase in the adoption of this technique in many drug companies and increased the demand for skilled pharmacometricians globally. Stringent regulatory authorities such as the US-FDA and EMA have increasingly populated their review groups with these scientists, further increasing the demand for the expertise and, more importantly, evidencing the impact and importance of pharmacometrics within the drug development cycle. Creative solutions are required to provide adequate training resources for the future. Pharmacometrics is nascent in Africa. Here, we report on establishing the Ugandan Chapter of Pharmacometrics Africa. This aims to transfer primary training responsibility to local institutions and faculty for sustainability and to build upon regional strengths in pharmacometrics. Creating a local centre of excellence will help attract both regional and international collaborations on quantitative clinical pharmacology. We summarize our experience, key lessons learnt and future perspectives.

There is a critical skills gap on the African continent in regulatory sciences, and an acknowledged need to develop a long-term strategy for training and professional development of African regulatory personnel. Capacity building programs for African regulators should link education, training and research with career development in an approach that combines an academic base and experiential learning aligned within a competency framework. A regulatory ecosystem that engages with a broad range of stakeholders will mean that expertise in the ever-expanding field of regulatory science filters into teaching and research in a symbiotic way. In this way capacity development interventions will be a collaborative approach between the learning context (academic and training institutions) and the performance context (regulatory agencies and industry), which will ultimately best serve the patients. Monitoring and evaluation of capacity development interventions will be essential to show value of investments and ultimately guide continued funding and sustainability. This paper reviews the skills and human capacity gap and outlines a staged tactical approach for Africa that builds on previous efforts to strengthen African regulatory ecosystems.