News

Call for Applications – Research Fellowship in Pharmacometrics @ University College London

10 October 2023

Our colleagues at the UCL GOS Institute of Child Health are looking for applicants for their Pharmacometrics research efforts: The successful applicant will build patient-level models arising from preclin! ical and clinical studies. These models will be used to inform drug development on therapeutics to provide neuroprotective effect in neonatal asphyxia along with working on a major global health challenge: optimising nutrient supplement dosing in pregnancy. This projects are collaborations between clinicians and researchers at major UK academic centres (UCL, Kings College, University of Oxford). The role includes an opportunity to gain experience of open source pharmacometric modelling and undertake teaching and supervision of masters level students. This post is available for 11 months in the first instance. For more information, or to apply, visit the link found here.

Applied Pharmacometrics Training (APT) Fellowship – Applications Opening Soon!

2 October 2023

The Applied Pharmacometrics Training Fellowship – Africa Region is a collaboration between Certara, Pharmacometrics Africa, CP+ Associates, together with several pharma industry and academic partners. This is an intensive doctoral-level fellowship program that upskills participants to conduct regulatory quality clinical pharmacology and pharmacometrics analyses that could inform decision making. The program is an effort to increase the application of model-based drug development in Africa. Participation in this program provides opportunities to integrate work and education while facilitating the development of an international contact network. Consisting of an intensive 24-week virtual program, complemented by 2 week-long face-to-face sessions, fellows mainly work from their home location and interact using remote technology tools. The program provides online tutorials combined with hands-on project work in cooperation with partners from industry and academia. All projects end in a publishable unit, defined as a poster at a conference and/or a peer-reviewed manuscript. The fellowship aims to build scientific and leadership capability in Africa by enhancing the skills of local scientists and by facilitating knowledge transfer to their wider scientific communities. The relationships forged between the hosts of this program and the fellows’ home institutions will further the endeavour to create next-generation medicines to ease suffering and improve quality of life for patient populations around the world. Successful participants in this program are eligible for mentorship, coaching and sponsorship towards employment in research centres in Africa or with the consulting team of Certara located on-site in Africa. Overall Program Benefits The program provides fellows an opportunity to

Call for applications – PhD in Clinical Pharmacology with a focus on Physiologically Based Pharmacokinetic (PBPK) modelling.

2 October 2023

The Research Department of the Infectious Diseases Institute (IDI) requests applications from suitably qualified candidates for a PhD position in the field of Clinical Pharmacology with a focus on Physiologically Based Pharmacokinetic (PBPK) modelling in understudied populations. This scholarship will be embedded within the study entitled “MILK-PBPK: Maternal and Infant Lactation Pharmacokinetics-PBPK”, with Prof. Catriona Waitt as the Principal Investigator (PI). This opportunity is fully funded by a grant from the Bill and Melinda Gates Foundation. Physiologically based pharmacokinetic (PBPK) modelling is a mechanistic approach to studying and predicting the pharmacokinetics of drugs based on physiologic and anatomic characteristics, as well as the physical and chemical properties of a given drug. This doctoral position will employ PBPK modelling techniques to optimize treatment for malaria and other conditions relevant to Africa, especially in understudied populations including pregnant or lactating women and their infants. In the period 2024-2027, we seek to support two scholars at Makerere University with hands-on research training, high-level mentoring, and protected time to develop into a capable researcher able to use PBPK models to inform medication use in African populations. During these three years, the scholar will be a core member of the MILK-PBPK study team, thereby gaining access to the clinical context in which clinical pharmacokinetic studies are undertaken and provided with the necessary support to develop and implement their PhD work within this already fully funded study. The scholar will be directly supervised by the study PI, Dr Adeniyi Olagunju from the University of Liverpool

Bridging the Skills Gap: Empowering African Regulators through Innovative Training [Report]

30 August 2023

Many regulatory agencies across the African continent have been grappling with a critical shortage of skilled professionals due to resource constraints and a paucity of training opportunities. It is this gap that the South African Health Products Regulatory Authority (SAHPRA) and other African agencies highlighted in a paper published in the British Journal of Clinical Pharmacology, and intended to fill when they invited Pharmacometrics Africa to develop Africa-centric training opportunities in the regulatory sciences. Read on to discover what these efforts entailed, or download the report now. Pharmacometrics Africa and its partner network collaborated with a network of dedicated subject matter experts to proudly conclude the second iteration of their course, “A Primer for Clinical Assessors within African Regulatory Agencies.” This innovative initiative spans over 12 weeks and delivers a comprehensive curriculum aimed at building and refining the essential competencies required by clinical assessors working within regulatory bodies across Africa. The course takes participants on an intensive journey into assessing the clinical sections of regulatory dossiers with regards to efficacy and safety of new medicines that will be used in Africa. Through a combination of live tutorials and online coursework, participants dive deep into the intricacies of the field. What sets this initiative apart is its holistic approach, focusing on three distinct yet interconnected phases: Construction, Deconstruction, and Reconstruction of the Regulatory Dossier. These stages encompass the entire spectrum of regulatory work, from building robust dossiers to assessing their contents and supporting marketing authorizations. Recognizing the importance of varied perspectives,

Bringing together learning and job creation opportunities: Applied Pharmacometrics Training @ PAGE 2023

20 July 2023

Over two years, the Applied Pharmacometrics Training (APT) program has nurtured several cohorts of talented pharmacometricians through its comprehensive 3-6 month virtual program, equipping them with the skills and knowledge to conduct regulatory-quality pharmacometrics analyses and reports. Recently, several participants from the program were selected to attend the Population Approach Group Europe (PAGE) 2023 conference in A Coruña, Spain. This event brought together leading experts, researchers, and industry professionals from the pharmacometrics field, providing an invaluable opportunity for the APT fellows to engage in cutting-edge discussions, gain exposure to the latest research, and network with key stakeholders in the industry. “It was inspiring to see the 2023 scientists shifting perspective and growing into solving real life problems with applied pharmacometrics” Samer Mouksassi During the conference, the APT participants showcased what they learned about applied pharmacometrics by presenting scientific posters, each highlighting global and locally-relevant contributions to the field of pharmacometrics. With a broad complement of support from not only the program leaders (Pharmacometrics Africa and Certara) but also industry experts supporting their work, the posters captured the attention of the PAGE community. The immersion program provided these participants with a unique platform to demonstrate their proficiency and expertise, helping them learn and demonstrate critical skills in presenting scientific research to the broader pharmacometric community. As they navigated through the conference’s numerous sessions and workshops, the APT fellows had the chance to engage in stimulating discussions, receive constructive feedback from subject matter experts, and collaborate with fellow researchers. This experience further

Paper: A commentary on establishing a local centre of excellence for research and training in pharmacometrics: Lessons from the pharmacometrics Africa–Uganda chapter

7 July 2023

Pharmacometrics involves the development and application of mathematical models, informed by knowledge on pharmacology, physiology and the disease process, to characterize the interactions between drugs and patients. It is applied to studying pharmacokinetics, pharmacodynamics and disease progression. The ethical necessity to study drugs in the populations where they are to be used is increasingly recognized. To maximize the value of clinical data, study design and analysis must be appropriate. Historically, many datasets have been sent from African countries to better-resourced settings for analysis, but in recent years, it has been demonstrated that capacity can be built and sustained within low- and middle-income countries (LMIC)1 We report the establishment of the Ugandan Chapter of Pharmacometrics Africa, to share learning with other countries seeking to build similar capabilities.

Uganda Chapter – Maternal and Infant Lactation pharmacoKinetics (MILK) study newsletter (April – June 2023) #2

1 July 2023

This newsletter from the Uganda chapter of Pharmacometrics Africa offers unique insights into the current status of the Maternal and Infant Lactation pharmacoKinetics (MILK) project. This edition covers key project activities and features a profile of postdoctoral Pharmacokinetic researcher Aida Kawuma. Read more about the program below, or view the newsletter here. About MILKAbout half of all women worldwide require medication whilst breastfeeding. Historically, breastfeeding women have been excluded from drug research, largely with the intention of protecting the mothers and their infants from harm. However, lack of data to inform safe medication use in this population itself brings risk. In low-income settings drugs are frequently used ‘off-label’ through necessity and in high-income settings the ‘safest’ recommendation may be to avoid breastfeeding. MILK strengthens existing collaborations and my existing work on HIV antiretrovirals by studying treatments for several priority infections (tuberculosis, malaria and maternal infection around the time of delivery) in breastfeeding mother-infant pairs. Carefully designed clinical studies with mathematical (pharmacometric) approaches to data analysis will elucidate drug transfer from mother to breastfed infant. Work with patient groups and policymaking stakeholders maximises impact through data sharing and prioritisation of ongoing work.

Uganda Chapter – Maternal and Infant Lactation pharmacoKinetics (MILK) study newsletter (April – June 2023)

30 June 2023

Second iteration of Clinical Assessors course for African regulators celebrates its graduates

5 June 2023

In the digital age, learning has become more accessible than ever, and online courses have gained immense popularity. Recently, we had the privilege of hosting a memorable graduation ceremony for the second iteration of our course, “Clinical Assessors within African Regulatory Agencies.” It was a celebration of their remarkable achievements, a testament to their dedication, and a reminder that education knows no boundaries. The objective of developing this 12-week course was to address the critical skills gap in regulatory sciences on the African continent. The course, accredited by The University of Witwatersrand, was attended by participants from five (5) regulatory agencies – Ghana Food and Drugs Authority, Kenya’s Pharmacy and Poisons Board, Nigeria’s National Agency for Food and Drug Administration and Control, SAHPRA, Tanzania’s Medicines and Medical Devices Authority, the Medicines Control Authority of Zimbabwe. “The tutorial sessions in the course created a rich, mutually valuable learning environment for the regional and international faculty who endeavoured to discuss examples of work at the five participating African regulatory agencies. This assisted in contextualising international best practice of regulatory sciences with the local environment,” said Professor Colin Pillai, CEO of Pharmacometrics Africa. We remain inspired by their achievements and look forward to witnessing the impact they will make in their respective fields.

Training Opportunity: Clinical Investigator (+ Site Staff) Certification Course [24-28 April 2023]

31 March 2023

PharmaTrain and the European Clinical Research Infrastructures Network (ECRIN) have developed an international standardised Clinical Investigator Certification (CLIC) Course syllabus as training platform for investigators, site staff as well as regulatory and other scientists. This course, led by our colleagues at the Fundisa Academy African Academy of Medicines Development and the Tiervlei Trial Centre (TTC), provides training and important insights for clinical trial investigators and site staff wishing to attain certification. For more information, please download the informational brochure and apply today! Description: The planning, preparing, and organising of clinical trials has become a highly complex task that includes important issues such as: the need to protect patients, generate reliable data, perform trials efficiently within short timelines, fulfil quality requirements according to current legislation and inspection requirements, and conduct clinical trials within budget to ensure sustainable business. Since COVID-19 emerged in 2020, it has caused unprecedented disruption of clinical trials. To protect patient safety and trial integrity, the pharmaceutical industry made strides to accelerate trial innovations such as digital tools and virtualization, with support from regulatory authorities. The increased complexity of medicines development and regulatory requirements require well-trained staff in industry, CROs and Regulatory Agencies. The 2018 SAHPRA draft guidance on “Capacity Building and Transformation in Clinical Trials Research in South Africa” requires public or private clinical trial sites to offer training at all staff levels. PharmaTrain and the European Clinical Research Infrastructures Network (ECRIN) have developed an international standardised Clinical Investigator Certification (CLIC) Course syllabus as training platform for

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