Celebrating a New Era for Pharmacometrics in Africa: Building on Global Momentum

5 September 2025

Scientific Programme

The PMXAC-2025 scientific program was designed to showcase practical, high-impact pharmacometrics methods that can advance health and regulation across Africa. Presentations will focussed on topics such as bioavailability and bioequivalence (BA/BE), model-based meta-analysis (MBMA), and physiologically based pharmacokinetic (PBPK) modeling, tools that support evidence generation for African populations. The program explored how emerging technologies, including artificial intelligence and large language models, can enhance regulatory efficiency. In addition, it addressed capacity building, career development, and job creation. Through these sessions, the conference aims to foster scientific exchange, mentorship, and collaboration across academia, industry, regulatory agencies, and healthcare systems.

Session 1: History, Present, and Future of Pharmacometrics in Africa

(Chairs: Colin Pillai and Babatunde Adeagbo)

This first session set the scene by outlining the history, enunciating where we came from, what Africa needs and setting out how Africa might attract work so as to also retain its talent. The local and international speakers in this session outlined their vision for what might come next for Pharmacometrics in Africa

History of Pharmacometrics in Africa
Catriona Waitt traces the remarkable journey of pharmacometrics on the African continent — from early NONMEM use in Durban, South Africa to the establishment of vibrant regional chapters across Uganda, Kenya, Nigeria and Tunisia. Her talk highlights unique African challenges such as genetic diversity, neglected diseases, and health system factors, while celebrating the visionaries and networks that built today’s thriving community. Looking forward, it calls for African-led priorities, funding, and innovation to shape the future of pharmacometrics globally

Pharmacometric Future for Africa: starting with the end in mind
Steve Kern‘s thought-provoking keynote lecture explores how pharmacometrics can directly meet the needs of African patients, clinicians, and regulators. He emphasizes the importance of trust in science, clear communication of results, and thoughtful implementation of findings in real-world health systems. Setting a tone for meeting to be future oriented, Steve imagines a future where model-informed approaches and AI-driven intelligence transform care — from shortening TB treatment to preventing drug resistance — positioning pharmacometrics as a foundation for informed decision making

Careers in Pharmacometrics
This inspiring session features 3 personal journeys from early career African scientists showcasing the diversity of career paths in pharmacometrics. Aida Kawuma (Uganda) shares her path from pharmacy school to international consulting, highlighting sacrifice, flexibility, and mentorship along the way. Complementing her story, video testimonies from Linda Chaba (Kenya)and Eliford Kitabi (Tanzania) add perspectives on navigating academia and regulatory opportunities while remaining connected to African science. Together, these voices demonstrate that a rewarding global career in pharmacometrics can be built without borders.

Session 2: BA-BE for Africa: Innovation and Regulatory Impact

(Chairs: Phumla Sinxadi and Natalie )

In this session, experts discussed how bioavailability and bioequivalence (BA-BE) studies ensure the safety and effectiveness of generic medicines, a major priority in Africa, where generics account for over 95% of all medicines. Typically based on easy-to-implement analysis methods like non-compartmental analysis (NCA), pharmacometricians often down-play the importance of these techniques. Presentations highlighted how advances in AI, including large language models, can boost the speed, accuracy, and efficiency of BA-BE evaluations.

Innovation in open-source tools for bioequivalence evaluations, PKNCA and more
Bill Denney explores how open-source tools are transforming pharmacometric workflows. From data cleaning with tidyverse to analysis using PKNCA and replicateBE, and advanced modeling with nlmixr2, he demonstrates the efficiency and flexibility these tools and platforms offer. The talk also highlights how open-source, community-driven software development enables innovation, cost savings, and integration across systems.

Leveraging AI and Large Language Models for BA-BE Dossier Assessment
Mahlodi Maropa shares a regulator’s perspective on how AI can transform the regulatory review of bioavailability and bioequivalence studies. The talk explores how automation can reduce backlogs and free reviewers of submission dossiers to focus on technical content. She also showcases SAHPRA’s nascent portfolio of AI tools that are being rolled out for dossier triage and outlines the agency’s vision for digitalization, regulatory efficiency, and enhanced public health delivery.

Model-Based Bioequivalence: The Key to Unlocking Regulatory Pathways for Complex Generics
Mahmoud Ali Afifi’s animated presentation outlines how model-based bioequivalence (MBBE) offers solutions where traditional non-compartmental analysis (NCA) falls short e.g. for drugs with high variability, long half-lives, or nonlinear kinetics. His talk describes simulation-based exploration of trial designs using case studies with biosimilars – comparing rich versus sparse sampling – with the potential to reduce subject numbers, lower trial costs, and deliver robust regulatory evidence — potentially transforming the assessment of complex generics.

Session 3: Strengthening Evidence Synthesis in Africa through MBMA and PBPK

(Chairs: Catriona Waitt and Ochuko Orherhe)

In this session, experts explored how model-based meta-analysis (MBMA) and physiologically based pharmacokinetic (PBPK) modelling can strengthen evidence-based decision-making in Africa. MBMA offers a practical entry point for African scientists by pooling existing trial and real-world data, a holistic approach to evidence generation, without the need for new studies, and is increasingly supported by regulators such as the FDA. PBPK modelling, on the other hand, helps fill evidence gaps in understudied populations such as pregnant women and children, enabling safe, cost-effective dosing decisions and reducing the need for large clinical trials. Presentations highlighted how these approaches can advance science, policy, and access across the continent.

Impact of CYP2D6 phenotype on exposure of antidepressants during pregnancy: extrapolation approach using PBPK modeling
Karen Rowland-Yeo demonstrates how physiologically based pharmacokinetic (PBPK) modelling combined with real-world data can shed light on medication use during pregnancy. Her talk describes how CYP2D6 phenotype influences drug exposure across trimesters, with case studies on metoprolol, SSRIs, and venlafaxine. She explains how PBPK simulations can guide dose adjustments for mothers and assess safety in breastfed infants — offering a framework for more precise, evidence-based prescribing in these vulnerable populations

Strengthening Evidence-Based Decision-Making through Model-Based Meta-Analysis (MBMA)
Innocent Asiimwe explains how model-based meta-analysis (MBMA) can pool clinical and real-world data to guide drug development decisions. He uses antibody-drug conjugates as a case example to shows how MBMA links exposure and response data, and how the Clinical Utility Index (CUI) balances efficacy and safety. He nicely illustrates how this approach supports dose selection, continuous benefit–risk assessment, and more efficient, evidence-based regulatory decisions

PMXAC25 - Session 4: Panel Discussion, Closing Remarks and Awards

Panel Discussion – From needs to action

Dan Hartman guided the panellists to reflect on the core conference themes: the role of cross-sector collaboration (academia, industry, regulation), sustaining momentum beyond the meeting, and translating ideas into action. Many emphasized capacity building in Africa — not just training, but retention, funding, and creating local leadership networks. They noted the importance of storytelling, communication, and trust to make pharmacometric science accessible to diverse stakeholders (clinicians, regulators, funders).

Meeting closure and Awards

In the closing segment, Bernhards Ogutu announced the winners of the poster competition.

The organising committee then expressed gratitude to the sponsors, speakers, delegates, and issued a call for ongoing engagement.

Speakers

Steve Kern

Global Health Labs

Executive Director

Steven E. Kern, PhD is the Executive Director of Global Health Labs, an innovation laboratory working in partnership with the Bill and Melinda Gates Foundation. From 20013-2022, he was the Deputy Director of Quantitative Sciences at the Gates Foundation. Prior to that, he was Global Head of Pharmacology Modeling at Novartis Pharma in Basel Switzerland where he led a team focused on model-based drug development. He joined Novartis in 2010 from the University of Utah where he was Associate Professor of Pharmaceutics, Anesthesiology, and Bioengineering.

Mahmoud Ali Afifi

Certara

Associate Scientist/Pharmacometrics Consultant

Mahmoud Ali Afifi is an Associate Scientist in Pharmacometrics at Certara, where he supports model-informed drug development and regulatory submissions. He is a Clinical Pharmacist by training and holds two Master’s degrees—in Health Informatics and in Applied Statistics and Econometrics. He also completed the Pharmacometrics Africa Fellowship. Mahmoud has 4 years of experience in drug development as a pharmacometrician and over nine (9) years of experience in clinical data analytics and real-world evidence as a clinical researcher and biostatistician, supporting clinical trials and observational studies. His fellowship graduation project, conducted in collaboration with Sandoz, focused on model-based bioequivalence in biosimilars.

Mahlodi Moropa

SAHPRA

Manager: Clinical Preregistration Evaluations

Dynamic manager with more than 10 years (about 18 years) proven expertise in medicines regulatory field at South African Health Product Regulatory Authority excelling in clinical evaluations, operations management, compliance management and team leadership. Streamlined workflows, enhancing efficiency while fostering strong relationships across departments. Results-driven management professional with proven ability to lead teams to success. Strong focus on team collaboration, operational efficiency, and achieving measurable outcomes. Adept at strategic planning, process improvement, and fostering culture of accountability and excellence. Known for adaptability and consistently meeting changing organizational needs.

Linda Chaba

University of California, San Francisco (UCSF)

Assistant Professional Researcher

Linda is a biostatistician by training, specializing in early-stage tuberculosis (TB) drug development, with expertise in statistical modelling, machine learning, and pharmacometrics at the University of California, San Francisco (UCSF). Her current research focuses on optimizing drug discovery pipelines and treatment strategies to improve TB therapeutic outcomes. Beyond TB, she contributes to other infectious disease research across diverse areas, including malaria studies in vulnerable populations. She is passionate about integrating statistical methodologies with translational research to address critical global health challenges.

Karen Rowland Yeo

Certara UK Limited’s Simcyp Division

Senior Vice-President at Certara UK Limited’s Simcyp Division

Karen Rowland Yeo is a Senior Vice-President at Certara UK Limited’s Simcyp Division. She has over two decades of experience of applying PBPK models in both global health and drug development across most therapeutic areas and is currently focused on driving advancement of PBPK modelling in maternal and child health. Karen is the incoming Editor-in-Chief of the ASCPT journal Clinical Pharmacology & Therapeutics; in this role she hopes to advance the outreach of the journal to LMIC settings.

Innocent Gerald Asiimwe

University of Liverpool

Pharmacist

Innocent Gerald Asiimwe, a pharmacist from Uganda, has worked in Uganda and Botswana before advancing his studies in the UK at the University of Liverpool, where he earned an MSc in Clinical Research, an MRes in Biomedical Sciences and Translational Medicine, and a PhD in Pharmacology. He later worked as a postdoctoral researcher in Prof Sir Munir Pirmohamed’s group on an MRC-funded project analyzing diseases, drugs, and therapeutic targets using large-scale data. He is currently a pharmacometrician at the University of Liverpool, contributing to the UNITE4TB Pharmacology work package, focusing on high-dimensional pharmacogenetic data and employing advanced AI methods, including machine learning, to improve treatments for drug-resistant TB.

Eliford Kitabi

Division of Pharmacometrics, Food and Drug Administration (FDA)

Pharmacometrician

Eliford Kitabi is a pharmacometrician in the Division of Pharmacometrics, Food and Drug Administration (FDA), Silver Spring, USA. He is currently the Office of Clinical Pharmacology (OCP) Team Lead (TL) in cardiovascular safety reviews. He has Bachelor of Pharmacy from University of Dar Es Salaam in Tanzania, PhD in Clinical Pharmacology from Karolinska Institutet, Stockholm-Sweden, and completed post-doctoral research from the University of Maryland Baltimore, USA. He has more than 10 years of experience in clinical pharmacology research and teaching. His research goals are to optimize drug therapy and drug development through innovative mathematical modeling and simulations.

Catriona Waitt

University of Liverpool / Infectious Diseases Institute Makerere University

NIHR Professor of Clinical Pharmacology and Global Health

Catriona Waitt is a Professor of Clinical Pharmacology and Global Health at the University of Liverpool. She has been based in Uganda since 2015 where she leads the Maternal and Infant Lactation pharmacoKinetics (MILK) CENTRE at the Infectious Diseases Institute, Makerere University, alongside several other clinical trials around maternal health. She leads the Uganda Chapter of Pharmacometrics Africa.

Bill Denney

Human Predictions, LLC

Executive Director

Bill founded Human Predictions after 8 years working inside large pharmaceutical companies and has over 20 years of experience in mathematical modeling. Prior to starting Human Predictions, Bill was a Director of Clinical Pharmacology at Pfizer combining the science of drug development, the art of clinical trial execution, and the mathematics bringing those together efficiently. At Pfizer, Bill designed clinical development plans, designed and ran clinical studies, quantified clinical and nonclinical study results, and trained colleagues on clinical development and modeling. In this position, he developed MBMA tools and models to enhance transparency and understanding of internal development compounds, marketed therapies, and competitive research. He led the team that developed a tool to efficiently review ongoing clinical study datasets for trend reviews of both safety and efficacy. He pioneered new methods for understanding precision of clinical trials and optimization of new trial design based on prior studies.

Aida Kawuma

PumasAI/ Infectious Diseases Institute

Pharmacometrician

Aida Kawuma is a scientist at PumasAI specializing in pharmacometrics analyses across a diverse range of drugs, from small molecules to biologics. She trained as a pharmacist at Makerere University and holds a Master’s degree in Pharmacology as well as a PhD in Pharmacometrics from the University of Cape Town, South Africa. Aida is a member of the MILK Centre modelling group at the Infectious Diseases Institute, Makerere University, and the Uganda Chapter of Pharmacometrics Africa. She lives in Kampala, Uganda, with her husband and three sons.