Research
Breastfeeding mothers who require medication lack access to the evidence necessary to make truly informed choices for themselves and their infant. Lactation pharmacokinetic studies are few, and often have methodological limitations. There is demand from regulators that research must become more inclusive, and that lactation studies should be done in a timely manner, but such studies are still rare.
The complexity of the population makes the design, delivery and interpretation of lactation pharmacokinetic studies challenging. I plan to leverage my work in Uganda over the past decade to build a globally-relevant, internationally credible centre of excellence for lactation pharmacology, the MILK-CENTRE (Maternal and Infant Lactation pharmacoKinetics: Centre of Excellence for lactatioN Therapeutics Research and Engagement). The centre will have capability to respond to changing epidemiology and global threats, provide capacity building and support for partners, foster increasing industry relationships and influence global policy.
My Wellcome Clinical Research Career Development Fellowship (parts 1 and 2) increased understanding of the transfer of medication through breastmilk from mother to infant. Priority drugs studied were antiretrovirals, antimalarials, anti-tuberculosis drugs (both drug-sensitive and drug-resistant tuberculosis) and antibacterials. This work was undertaken between the Infectious Diseases Institute, Makerere University College of Health Sciences in Kampala, Uganda, the University of Cape Town, South Africa and the University of Liverpool. An accompanying Public Engagement Enrichment grant, ATtaining EQUity of Access TO Reseach (At The EQUATOR) ensured the priorities of communities were addressed, study design and methods were discussed and results were communicated in an appropriate and timely manner.
I was Chief Investigator on the EDCTP-funded VirTUAL Consortium which combined pharmacometric techniques (physiologically-based pharmacokinetic modelling and population pharmacokinetic modelling) with a clinical trial and observational pharmacokinetic studies to understand the drug-drug interactions between antiretrovirals and anti-tuberculosis drugs, including among individuals who are often excluded from clinical trials. In addition to the primary data, this enabled integration of clinical and pharmacometric methods and provides a valuable paradigm to use for future evaluation of complex pharmacology in complex populations. To build capacity in pharmacometric approaches, I am a member of the leadership team of Pharmacometrics Africa (www.pmxafrica.org) and the Uganda chapter was launched in September 2021.
Pharmacology in complex populations
It is essential that drugs are studied in the populations who will receive these drugs, that the studies are done ethically and efficiently and that capacity is built in the regions of the world where the diseases requiring drug treatment are prevalent. I focus primarily on drug exposure in pregnancy and breastfeeding (and to the infant) and the work requires clinical trials, observational studies, pharmacokinetic modelling (both PBPK and population PK), bioanalysis in appropriate body fluids and public engagement and involvement.
Drug drug interactions
Many key diseases co-exist and it is important to understand how the use of one drug can impact on the exposure of another drug given at the same time. I am Chief Investigator on the EDCTP-funded VirTUAL consortium which combines pharmacokinetic modelling, plasma and intracellular pharmacokinetic analysis, a clinical trial and observational pharmacokinetic studies in order to understand interactions between second-line antiretroviral therapy and first-line TB treatment.
Public engagement
Whilst public engagement and involvement is a component of all of my funded projects, there is a specific need to listen, co-create and innovate in partnership, particularly for complex and understudied groups. Wellcome Public Engagement enrichment award, ATtaining EQUity of Access TO Research (At The EQUATOR) is furthering this agenda.
Research groups
Research grants
Maternal and Infant Lactation pharmacoKinetics: Centre of Excellence for lactatioN Therapeutics Research and Engagement (MILK-CENTRE)
DEPARTMENT OF HEALTH & SOCIAL CARE (UK)
December 2024 - November 2029
Establishing PBPK Capability in MILK Program
BILL & MELINDA GATES FOUNDATION (USA)
July 2023 - June 2026
Provision of a MassArray Mass-spectrometry based multiplex genotyping platform (Agena Biosciences).
MEDICAL RESEARCH COUNCIL
July 2023 - June 2025
Drug Optimisation in LMICs of Pregnant HIV women and their Infants: temporary switch to CAB/RPV long acting injections
UK RESEARCH AND INNOVATION
January 2024 - March 2029
HIV self-testing Evaluation in Uganda and Nigeria
CHILDREN'S INVESTMENT FUND FOUNDATION - CIFF (UK)
January 2022 - December 2024
Maternal and Infant Lactation pharmacoKinetics (MILK)
WELLCOME TRUST (UK)
March 2021 - March 2026
CAPA-CTII
EUROPEAN AND DEVELOPING COUNTRIES CLINICAL TRIALS PARTNERSHIP (EDCTP) - (NETHERLANDS)
February 2019 - March 2022
VIrTUAL - Vulnerable populatIon TUberculosis AntiretroviraL
EUROPEAN AND DEVELOPING COUNTRIES CLINICAL TRIALS PARTNERSHIP (EDCTP) - (NETHERLANDS)
February 2018 - July 2024
Dolutegravir in Pregnant HIV mothers and Neonates (DolPHIN2)
UNITAID (SWITZERLAND)
December 2016 - July 2023
Development and validation of an assay for quantitation of antiretrovirals in human breastmilk.
THE ACADEMY OF MEDICAL SCIENCES (UK)
January 2013 - July 2015
Population pharmacokinetic study of postnatal and breastfeeding women on antiretroviral therapy
WELLCOME TRUST (UK)
February 2015 - January 2021
Investigation into the relationship between pharmacological and immunological responses to tuberculosis treatment and risk of early death
THE BRITISH INFECTION ASSOCIATION (UK)
January 2013 - August 2014