The Applied Pharmacometrics Training Program – Year 3 Sustainability
Innocent Gerald Asiimwe1,2, Samer Mouksassi3, Rik de Greef4, Eric Decloedt5, Paolo Denti2,6, Phumla Sinxadi2,6, Catriona Waitt1,2,7, Goonaseelan (Colin) Pillai2,6,8
1The Wolfson Centre for Personalized Medicine, Department of Pharmacology and Therapeutics, Institute of Systems, Molecular and Integrative Biology, University of Liverpool, Liverpool, United Kingdom. 2APT-Africa Fellowship Program, c/o Pharmacometrics Africa NPC, K45 Old Main Building, Groote Schuur Hospital, Cape Town, South Africa. 3Certara, Cairo, Egypt. 4Certara, Princeton, USA. 5Division of Clinical Pharmacology, Department of Medicine, Stellenbosch University, Cape Town, South Africa. 6Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa, 7Infectious Diseases Institute, Makerere University College of Health Sciences, Kampala, Uganda. 8CP+ Associates GmbH, Basel, Switzerland.
Objectives: The number of trained pharmacometricians on the African continent remains low, often driven by limited training opportunities and the emigration of experts to high income countries. To help increase African pharmacometrics capacity, the Applied Pharmacometrics Training (APT) fellowship program was initiated to train doctoral-level African scientists,1,2 but also foster job creation in order to retain African talent on the continent. With the 3rd cohort of fellows completing the program we report on our sustainability plans and invite collaborations aimed at increasing efforts towards more local clinical data analysis within Africa.
Methods: Initiated by Pharmacometrics Africa in 2022, with support from the Bill & Melinda Gates Foundation, Certara and other partners, the APT program is open to (MSc) PhD and recent post-doctoral scientists and clinicians from African countries. We reported at WCoP 20221 and PAGE 20232 on the evolution of this six-month program of online training involving self-paced exercises, interactive tutorials, model-based data analyses, and a data analysis project using state-of-the-art methodologies. The project is guided by seasoned pharmacometricians from Pharma and academia, aimed at creating a publishable unit. Logistics, certification, and funding are managed collaboratively, with Pharmacometrics Africa overseeing logistics and liaising with sponsors, while Certara was the initial primary source of funding for travel, accommodation during face-to-face events, and stipends. Job creation initiatives aimed at retaining African talent involved inviting successful fellows to join a consulting team in Africa or integrating them into local research centers that had links to Pharmacometrics Africa.
Results: In the first three years, over 170 applications were received from applicants based in/affiliated with African countries, of which 29 fellows (41% female, median age 35 [range 27 to 46] years) from nine African countries (Egypt, Ethiopia, Kenya, Malawi, Nigeria, Sudan, South Africa, Tunisia, and Uganda) were selected into the full program. Out of a total of 13 pharmacometrics projects, seven have been completed of which six3-8 have been presented at international conferences (PAGE and PKUK); so far, two of these have been submitted for full publication in a journal. Regarding job creation, a total of seven fellows have so far been absorbed into Certara’s Africa consulting team and related African research centres including Stellenbosch University in South Africa, the Infectious Diseases Institute at Makerere University in Uganda, and Pharmacometrics Africa.
Conclusions: A pharmacometrics fellowship program targeting skills development, job creation and establishment of a critical mass of African pharmacometricians is in its third year. We have showcased successful research outcomes and creation of jobs. Future success of this program depends on collaborations for sustainability to enhance realization of the program goal of fostering the growth of model-informed drug development on the African continent.
Acknowledgements:
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 (Ivelina Gueorguieva, Emmanuel Chigutsa, Jennifer Lang, Aurélie Lombard, Eunice Yuen, Venkatesh Pilla Reddy), Glaxo Smith-Kline (Maxwell Chirehwa), Genentech (Kenta Yoshida, Sravanthi Cheeti, Francois Mercier), Merck (Islam R. Younis, Matthew Rizk), Medicines for Malaria Venture (Nathalie Gobeau, Robin Denhardt Eriksson) as well as the large number of subject matter experts who have taught in this program (Amy Cheung, Vincent Duval, Felix Boakye-Agyeman, Richard Franzese, Petra Jauslin, Anna Largajolli, Adekemi Taylor, Gerly van der Vleuten, Nolan Wood, Floris Fauchet, Justin Hay and Vincent Buchheit)
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 2022, Cape Town, South Africa.
[2] Mouksassi S, de Greef R, Denti P, Sinxadi P, Decloedt E, Pillai G. The African applied pharmacometrics training (APT) fellowship: 1 year later. Poster presented at PAGE 2023, A Coruna, Spain.
[3] 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 presented at PAGE 2023, A Coruna, Spain.
[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 presented at PAGE 2023, A Coruna, Spain.
[5] 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 presented at PAGE 2023, A Coruna, Spain.
[6] Kawuma AN, Benecke RM, Chirehwa MT. Developing a shiny app to expedite the simulation of PKPD profiles of mAbS and exploration study designs. Poster presented at PAGE 2023, A Coruna, Spain.
[7] Asiimwe IG, Ndzamba BS, Mouksassi S, Pillai G, Lombard A, Lang J. Machine learning for covariate screening: application to a desipramine semi-mechanistic population pharmacokinetic model.
[8] Elhefnawy ME, Patson N, Mouksassi S, Pillai G, Shcherbinin S, Chigutsa E, Gueorguieva I. Quantifying the rate of natural amyloid plaque accumulation over time and its predictors in participants with Alzheimer’s disease. Presentation presented at PKUK 2023, Lancaster, UK.
