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What is this project about?

The over-arching goal of this research program is to determine the effectiveness of pharmacogenetic (PGx) testing in reducing incidences of ADRs and increasing treatment efficacy in African populations. This will be achieved through a prospective clinical trial in which PGx testing will be the intervention. The multi-centre study will involve six hospitals, two each in Zimbabwe, Kenya and Nigeria. PGx-guided treatment will be done using our registered PGx-test panel, GenoPharmR, which is inclusive of the genetic diversity of African populations. The primary outcome of the study will be reduction in incidences of ADRs and improved treatment efficacy. Secondary outcomes will include cost-effectiveness of the intervention. Successful implementation of this research program will usher a new era of genomic medicine in Africa at a scale that does not exist at the moment. It will address a public and global health problem of safety in the use of medicines in African populations.


Results

The program will result in regional capacity for genomics guided medical interventions that will improve safety and efficacy of pharmacotherapy. The conduct of the study will be used to build three centres of excellence (CoE) in Zimbabwe, Kenya and Nigeria that will champion drugs and diagnostics research and innovation in Sub-Saharan Africa.


Alignment/Strategic Fit

The Leadership Fellowship aims to enable the conduct of impactful science whilst simultaneously building leadership in drugs and diagnostics  discovery in Africa. The development of a research and innovation ecosystem in drugs and diagnostics discovery that will be achieved through the iPROTECTA project is therefore in alignment with this objective. I will dedicate 50% of my time to build this ecosystem whilst conducting the genomic medicine research project.


Risk

In the conduct of this project, risk of failure or reduced performance, could arise from the novelty of approach I plan to use that does not have a well-established precedence.  For example, whilst spoken about, the practical appetite of the biopharmaceutical & biotechnology industry for joint venture research and innovation with institution in Africa is not well developed. There is also no track record of R&D based drugs and diagnostics  discovery initiatives in Africa to build this model on. Secondly, the iPROTECTA study might demonstrate value of genomics to guide pharmacotherapy but economies and healthcare systems of Africa might have other competing priorities of investment and not adopt genomic medicine as envisioned in the program. My leadership training through this fellowship will help me reduce these risks to levels that will enable reasonable success to build future efforts on. For example, through AiBST research activities, I have demonstrated the feasibility of public universities-central hospitals-biopharmaceutical/biotechnology companies partnerships that efficiently address public health problems, experience which I hope to build on.


Sustainability

In the conduct of this study, three centres of excellence (CoE) in Genomics driven Drugs and Diagnostics research and innovation will be established in Zimbabwe, Kenya and Nigeria. This will be in the form of establishing a critical mass of skilled scientist through the MSc training program, attracting senior scientists to the CoE,  forging research and innovation partnerships with the biopharmaceutical & biotechnology industry in pursuit of clearly defined target product portfolios (TPP) for drugs and diagnostics to address unmet public health needs in Africa. The arising  research and innovation ecosystem is expected to ensure sustainable development of genomic and pharmaceutical medicine capability in Africa. The capacity for drugs and diagnostics research and innovation that will have been established over this 5-year period is expected to attract financial investments through grants, technology transfer agreements and joint ventures in product development.

Funder

BMGF - INV-036801

PI & Team Members

Collen Masimirembwa (PI)

Collaborators

Graduated MSc students

  1. Bianza Mbavha

  2. Vincent Aketch Nyangwara

  3. Marie Hidjo

  4. Rissy Wesonga

  5. Glory Ifeoluwa

  6. Pageneck Chikondowa

  7. Nyasha Mapira

  8. Lawrence Afolabi

  9. Neema Nkaduda

PhD Students

  1. Vincent Aketch Nyangwara (PhD student, Wits)

  2. Tinashe Mazhindu (PhD student, UZ)

  3. Marie Hjdjo (PhD student, Wits)

  4. Joseph olarewajuolusola (PhD student, OAU)

Period
01 November 2021  - 31 October 2026 

Implementation of Clinical Pharmacogenetics

Implementation of Pharmacogenomics Testing for Effective Care and Treatment in Africa (iPROTECTA)
Project Media

Publications

  1. Kanji CR, Mbavha BT, Masimirembwa C, Thelingwani RS. Analytical validation of GenoPharm a clinical genotyping open array panel of 46 pharmacogenes inclusive of variants unique to people of African ancestry. PLoS One. 2023 Oct 3;18(10):e0292131. doi: 10.1371/journal.pone.0292131. PMID: 37788265.

  2. M Hidjo MM, Chikwambi Z, Ngwende G, Matenga JA, Masimirembwa C. Warfarin pharmacogenetics in a black Zimbabwean cohort: an observational prospective study. Pharmacogenomics. 2023 Jul 12. doi: 10.2217/pgs-2023-0089. Epub ahead of print. PMID: 37435666.

  3. Mbavha BT, Thelingwani RS, Chikwambi Z, Nyakabau AM, Masimirembwa C; Consortium for Genomics and Therapeutics in Africa. Pharmacogenetics and Pharmacokinetics of Tamoxifen in a Zimbabwean breast cancer cohort. Br J Clin Pharmacol. 2023 Jun 19. doi: 10.1111/bcp.15827. Epub ahead of print. PMID: 37337448.

  4. Mapira NL, Thelingwani RS, Chikwambi Z, Kuona P, Masimirembwa C. Pharmacogenetics of pain management in Zimbabwean patients with sickle cell disease. Pharmacogenomics. 2023 May;24(7):359-369. doi: 10.2217/pgs-2023-0045. Epub 2023 May 30. PMID: 37248824.

  5. Chikondowa P, Munkombwe D, Chikwambi Z, Kuona P, Masimirembwa C. Pharmacogenetics of 6-mercaptopurine in a black Zimbabwean cohort treated for acute lymphoblastic leukaemia. Pharmacogenomics. 2023 May 30. doi: 10.2217/pgs-2023-0026. Epub ahead of print. PMID: 37248698.

  6. Afolabi BL, Mazhindu T, Zedias C, Borok M, Ndlovu N, Masimirembwa C, On Behalf Of Consortium For Genomics And Therapeutics In Africa Cgta. Pharmacogenetics and Adverse Events in the Use of Fluoropyrimidine in a Cohort of Cancer Patients on Standard of Care Treatment in Zimbabwe. J Pers Med. 2023 Mar 28;13(4):588. doi: 10.3390/jpm13040588. PMID: 37108974; PMCID: PMC10141018.

The Aim

The over-arching goal of this research program is to determine the effectiveness of pharmacogenetic (PGx) testing in reducing incidences of ADRs and increasing treatment efficacy in African populations.

Navigate Between Projects

Objectives
  1. Constitution of three Centres of Excellence (CoE) in Genomic Medicine Research & Innovation in Nigeria, Kenya, & Zimbabwe. This will involve memorandums of agreement (MOAs) among key stake holders;  universities, study hospitals and AiBST; Development and ethical approval of the study protocol; recruitment of study personnel; protocol training; community engagement; preparation of hospital study sites; and constitution of a Scientific and Technical Advisory (STAC) Board.

  2. Clinical Validation of GenoPharmR as a genomic medicine intervention for improved treatment outcomes. This will involve a multi-center PGx research to evaluate the clinical and economic impact of PGx guided treatment; clinical implementation workflow; decision support system for the sub-Saharan African healthcare setting; and generation of cost effective/benefit data on PGx testing;

  3. Pharmacogenomic data in diverse African patient groups on treatment. This will involve discovery of novel drug-gene interactions in patient populations involved in the multi-center clinical program; improvement of the current GenoPharmR test to include new clinically relevant drug-gene pairs.

  4. MSc (n=20) graduates in Drugs and Diagnostics Discovery & Development research & innovation. This output will be towards strengthening the CoE with a critical mass of skilled scientists.  The students will uniquely be trained in the science and  technology of drugs and diagnostics discovery, using the target product portfolio (TPP) driven solutions approach. A cohort of MSc students  in Genomics and Precision Medicine (n=10) is already under training and another 10 MSc students on Pharmaceutical Medicine will be trained using other supporting grants.

  5. Raise additional funding in cash and in kind, directly and indirectly, equivalent to at least 2 million USD to ensure sustainability of outputs 1 through to 4. This will involve mentoring scientists at the three centers to apply for research & innovation grants that speak to further development of the above 4  planned outputs; setting up multidisciplinary discovery teams that make business pitches for funders around the novel TPP they will be focusing on; seek for joint venture projects that bring funding; and engage biotech companies for equipment placements that will enable CoE to conduct cutting edge work that attracts business partnerships. All this to be made possible by the skills sets I will acquire through this leadership Fellowship and building on my past experience.

Additional Links

Additional Docs

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