
What is this project about?
Background
Increasing appreciation for the contribution of African genetic diversity to differential drug responses is gaining traction beyond the realm of academia. In parallel, stakeholders in decision-making entities are on the cusp of forging pan-African drug approval processes. Therefore, a timeous opportunity has arisen, where a collection of individuals with broad-based scientific expertise could evaluate the current landscape of factors, and develop a data driven evidence pipeline which would serve to support policymakers across the continent, especially given Africa’s genetic heterogeneity.
In this vein, data needs to be collected which considers genetic diversity, adverse drug reactions that include under-researched gender-based effects, and regional disease-burdens. Patterns emerging from such carefully collated data overlayed with insight gathered from drug procurement would serve to support an evidence-based drug approval framework towards supporting AMA through AU-NEPAD-JSM.
Approach
Our methodological approach includes a multifaced accumulation of existing African relevant datasets including:
A survey of the prevalence of variants of genes important in drug response (pharmacogenes),
Identification of disease and prescription patterns of medicines with known clinically significant drug-gene interactions;
Analysis of the prevalence of adverse drug reactions associated with actionable drug-gene interactions.
Based on the above data (a-c), conduct extensive stakeholder consultations to inform the translation of scientific evidence to a policy framework.
As these datasets are not equally available across the continent, we plan to create regional maps of overlayed data focusing on clinically actionable drug-gene interactions based on guidelines from various expert groups such as the CIPIC and WDG. Prioritised drugs extrapolated from these datasets, will be investigated in terms of usage patterns, and subsequently linked to specific clinical responses using the Vigibase dataset, to highlight scientifically investigated actionable recommendations. Through a consultative process, we intend to create a user-friendly framework, which could serve as foundational pipeline on which recommendations could be made for integrating this knowledge in the African setting, and be made available for policy makers to draw upon.
We have assembled a core team of experts with the necessary expertise: pharmacogenetics/ -kinetics, pharmacy; precision medicine clinical expertise, expertise developing tools to support pharmacovigilance of ADRs andgenomics, collectively guided by an expert in policy development to ensure the collated data language/ report is developed in an accessible manner to those we hope to support.
Outcome
We seek to collect and synthesise pharmacogenomics evidence in the African setting and through extensive stakeholder consultations develop a target policy profile framework (TPoP-F) that will guide the integration of African genomic heterogeneity in the discovery, development and deployment of healthcaresolutions on the continent.
Funder
BMGF
INV-O58365 (Investment)
PI & Team Members
Collen Masimirembwa (PI)
Janine Scholefield (Co-PI)
Bonginkosi Mbatha (Team Member)
Gaye Agesa (Team Member)
Tinashe Adrian Mazhindu (Team Member)
David Twesigomwe (Team Member)
Nagy Mohamed (Team Member)
Collaborators
None
Period
01 August 2023 - 29 November 2024
Policy Framework for Implementing Pharmacogenomics
Target Policy Profile Framework to Leverage Africa Genomic Heterogeneity

Project Media
Publications
None
The Aim
In the long-term, we anticipate that the TPP-F will dominate and satisfy the notion that Africa's genomic diversity is a necessary asset, and that it becomes a global public good, whose uses will unlock additional value [increased efficacy, effectiveness, reduced adverse outcomes] in medicines, vaccines, devices and test kits used by Africans.
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Objectives
To gather evidence for the importance of pharmacogenomics in drug discovery, development and deployment with respect to safety and efficacy.
To conduct stakeholder engagement towards developing an African-context target policy profile framework (TPoP-F) for the integration of African genomic heterogeneity in drug response across the discovery, development and deployment of health solutions on the continent.
To analyze existing policies, guidelines, legal instruments, technologies and infrastructure to assess the capacity for pharmacogenomics in drug discovery, development and deployment in Africa.
To disseminate the TPP-F to key policy/decision makers and organizations as an authoritative reference document for adoption