The African applied pharmacometrics training fellowship: 1 year later
Samer Mouksassi1, Rik de Greef1, Paolo Denti2,3, Phumla Sinxadi2,3, Eric Decloedt4, Goonaseelan (Colin) Pillai2
1 Integrated Drug Development, Certara, Princeton, NJ, United States, 2 Pharmacometrics Africa NPC, Cape Town, South Africa, 3 Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa, 4 Division of Clinical Pharmacology, Department of Medicine, Stellenbosch University, Cape Town, South Africa
Objectives:
The Applied Pharmacometrics Training Fellowship in Africa provides advanced skills training required for regulatory quality analyses and reporting among African pharmacometricians. Following the successful completion of the first cohort, we are currently training a second cohort.
The purpose of this paper is to describe progress, lessons learned and to reiterate the strategy, tactics, and curriculum. Our goal is to invite more partners into this collaboration.
Methods:
The 2022 program comprised of a 12-week virtual program with self-learning exercises, live tutorials, and model-base.d data analyses with a further 12‑weeks immersion program conducting a model-based analysis under the mentorship of experienced
pharmacometricians1.
Based on lessons learned, the 2023 program has fully integrated the didactic and the data analysis components into a 6-month program. The entire program is overseen and conducted by academic, pharma, and product development partners. The structured virtual learning curriculum and real-life research datasets expose fellows to model-based analyses and applications in drug development. Fellows are selected from an open-call for doctoral-level scientists, who then work on assignments that reinforce themes of scientific leadership and teamwork, while their mentors gain insights into healthcare needs in traditionally underserved African settings.
Results:
A total of 16 fellows from Congo, Egypt, Ethiopia, Kenya, Nigeria, Tanzania, South Africa, and Sudan completed the 2022 program and qualified for a University of Cape Town certificate of completion. Examples of the modeling analysis projects2,3,4 that were done by fellows from the APT 2022 cohort will be presented at the 31st PAGE meeting, A Coruña, Spain 2023. For the 2023 program, we have selected 8 fellows from an applicant pool of 70 and extended our pool of industry partners. The updated curriculum, program structure, and project descriptions will be presented for comment and critique.
A virtual Certara Africa consulting team with 4 staff located in Cairo (Egypt) and in Cape Town (South Africa) was launched in February 2023.
Conclusions:
A fellowship program in pharmacometrics in Africa leading to scarce skills development and local job creation has been executed and is expected to advance innovative biosimulation applications for global benefit.
Acknowledgments
The authors would like to acknowledge project supervisors from Idorsia Pharmaceuticals (Andreas Krause, Jantine Brussee, Chih-Hsuan Hsin), University of Basel Children’s Hospital and Swiss TPH (Marc Pfister, Jenny Keiser, Britta Steffens, Dominic Bräm), Sandoz (Arne Ring), Eli-Lilly (Iveline Gueorguieva, Emmanuel Chigutsa, Jennifer Lang, Aurélie Lombard), GSK (Maxwell Chirehwa), as well as the large number of subject matter experts who teach in this program (Vincent Buchheit, Felix Boakye-Agyeman, Amy Cheung, Vincent Duval, Richard Franzese, Petra Jauslin, Anna Largajolli, Rita Michel, Adekemi Taylor, Gerly van der Vleuten and Nolan Wood).
References:
[1] de Greef R, Rayner C, Jaffe M, Pillai G. The African applied pharmacometrics training fellowship: skills development linked to job creation. Poster Presented at the WCOP 2021, Cape Town, South Africa.
[2] Ahmed K, Chaba L, Ghoneim A, Brussee J, Hsin CH, Cheung A, Mouksassi S, Pillai G, Krause A. Modeling of the pharmacokinetics of the selective orexin-1 receptor antagonist act-539313 with auto-inhibition. Poster Submitted to the 31st PAGE meeting, A Coruña, Spain 2023
[3] Pillay-Fuentes Lorente V, Nwogu J, Steffens B, Bräm D, Hofmann D, Pfister M, Keiser J. Pemba Island, Tanzania, versus Côte d’Ivoire – Population effect on apparent clearance of active albendazole metabolites. Poster Submitted to the 31st PAGE meeting, A Coruña, Spain 2023.
[4] Ali M, Eniayewi O, Otiende V, Pillai G, Mouksassi S, Ring A. Evaluation of the robustness of methods for model-based bioequivalence analysis for biosimilars: Clenoliximab as a case study. Poster Submitted to the 31st PAGE meeting, A Coruña, Spain 2023.
