PBPK2024 workshop: optimising drug therapies

Posted on: 9 February 2024 by Professor Catriona Waitt in February 2024

Professor Catriona Waitt is a Professor of Clinical Pharmacology and Global Health. Here she tells about the physiologically based pharmacokinetic modelling (PBPK) workshop she held recently in Uganda.

From 29 to 31 January we held a workshop in Kampala, Uganda on physiologically based pharmacokinetic modelling - #PBPK2024.

The workshop was the result of a partnership between the Maternal and Infant Lactation pharmacoKinetics (MILK) programme that I lead, and a programme surrounding Development of Solutions to Improve Global Health, led by Professor Saskia de Wildt from Radboud University Medical School, Netherlands. We are both current beneficiaries of funding from the Bill and Melinda Gates Foundation with specific objectives to increase the application of PBPK to global health challenges.

#PBPK2024 was hosted by the Infectious Diseases Institute, Makerere University College of Health Sciences in partnership with Radboud University Medical School and other global partners to provide hands-on demonstration of the application of physiologically-based pharmacokinetic modelling.

Raising awareness

The goal was to bridge the gap between PBPK modelling specialists and stakeholders in global drug development and clinical care, in order to increase awareness of the technique with specific reference to the global health challenges affecting our populations. Pregnant and breastfeeding women and children often face challenges in pharmacotherapy due to limited dosing information. PBPK models, validated with clinical data, offer a promising solution. While PBPK is increasingly used in drug development, its application in addressing dosing questions for children, pregnant and lactating women is a relatively new area of application and this was the focus of the workshop.

International collaboration

#PBPK2024 brought together 65 delegates and 11 tutors from seven countries. Tutors from Radboud University Medical School and Simcyp (Certara) were joined by Shakir Atoyebi, PhD student in Pharmacology and Therapeutics at the University of Liverpool. Delegates included senior clinical pharmacologists, clinical pharmacists, regulators from the Uganda National Drug Authority and investigators from across Africa. The regulatory perspective on PBPK was covered by representatives from the UK Medicines and Healthcare Products Regulatory Agency. Specific to the question of antimalarial use in pregnancy and breastfeeding, collaborators from the Medicines for Malaria Venture brought their expertise.

Delegates delved into the fundamentals of PBPK modelling, exploring its impact on drug development and considering crucial factors when applying these models to evaluate drug dosing in specific understudied populations. Through interactive simulations, delegates gained practical experience using PBPK models to assess the impact of physiological changes on drug disposition. Discussions revolved around establishing the necessary framework for incorporating simulation-based evidence to inform optimal drug use. The workshop addressed regulatory aspects of PBPK modelling, providing insights into its integration into the drug development and approval process. A guided tour through clinical, research and laboratory facilities at the Infectious Diseases Institute enabled delegates to place their learning in context, and to interact with a number of study teams enabling growth of the collaborative network.

Catalyst for change

The workshop marked the first dedicated PBPK event in East Africa, laying a strong foundation for future collaborations and growth in the region. Delegates recognised the critical need to use PBPK models for addressing complex questions related to dose selection in traditionally underserved populations. All left with hands-on experience of using the software, with an appreciation of how to apply this knowledge in real-life scenarios.

In conclusion, the PBPK2024 workshop in Kampala was a catalyst for change, offering a promising avenue to optimise drug therapy for the most complex and understudied populations.

_{Representatives from the University of Liverpool, Department of Pharmacology and Therapeutics: Shakir Atoyebi, PhD Student; Innocent Asiimwe, Postdoctoral Research Associate; Catriona Waitt, Professor of Clinical Pharmacology and Global Health; Bonniface Obura, PhD Student.}