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Symposium 8: Harnessing a multidisciplinary approach to lactation pharmacology around the world

Tracks
Track 8
Tuesday, July 14, 2026
11:15 AM - 1:15 PM

Details

Breastfeeding is the most affordable, feasible, acceptable, sustainable and safe feeding option for infant and mother. Breastfeeding women are found in every society around the world, and more than half of these will require some form of medication whilst breastfeeding. For many medications, lactation pharmacology studies have not been performed and decisions on risks and benefits to the mother-infant dyad are made ‘in the dark’. This is unacceptable. In this symposium, we bring to together three leading consortia that use innovative clinical, analytical, pharmacometrics, and real-world evidence approaches to fill critical gaps in evidence. The MPRINT (Maternal Pediatric PRecision in Therapeutics) Hub, the ConcePTION Project (lactation related WP3) and the MILK (Maternal and Infant Lactation pharmacoKinetics) group explore infant exposure to medications through lactation. Efforts aim to support regulatory pathways and decisions, drug labelling, and to inform clinical therapy of lactating patients and their children.


Speaker

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Dr Sara Quinney
Professor
Indiana University School Of Medicine

MPRINT: Innovative study design, analyses, and research dissemination to support safe medication use in lactation

Abstract

Biography

Sara K. Quinney, Pharm.D., Ph.D., is a Professor in the Department of Obstetrics and Gynecology and Division of Clinical Pharmacology, Department of Medicine, at Indiana University School of Medicine, where she serves as the Director of the Indiana Clinical and Translational Sciences Institute (CTSI) Pharmacometric Modeling and Simulation Program. She received her Pharm.D. and Ph.D. in pharmacy practice from Purdue University and completed clinical pharmacology and bioinformatics fellowships at Indiana University. Dr. Quinney utilizes in vitro, preclinical, clinical, and bioinformatics data to develop quantitative pharmacology models to improve understanding of drug disposition and response in special populations, particularly in maternal and pediatric populations. She leads the Indiana University-Ohio State University Maternal and Pediatric Precision in Therapeutics (MPRINT) Hub Data and Model Knowledge Research Coordination Center (IU-OSU MPRINT DMKRCC), with a goal of enhancing maternal and pediatric pharmacotherapy through integrating data using innovative pharmacometric modeling approaches. Dr. Quinney also supports preclinical drug development efforts and serves as the clinical pharmacology and pharmacokinetic/ pharmacodynamic modeling expert for the IU Simon Comprehensive Cancer Center, Model Organism Development and Evaluation for Late-onset Alzheimer’s Disease (MODEL-AD) and the IU/Purdue Target Enablement to Advance Therapeutics for Alzheimer’s Disease (TREAT-AD) Preclinical Testing Cores. Dr. Quinney has served as a mentor to numerous students, residents, postdoctoral fellows, and junior faculty from a variety of disciplines.
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Prof Karel Allegaert
KU Leuven

Experience with an European Medicines Agency related qualification advice of a PBPK model to simulate lactation related medicine exposure: a personal reflection

Abstract

Biography

Karel Allegaert is a paediatrician (1999), neonatologist (2000) and clinical pharmacologist (2003), and is currently appointed at KU Leuven, departments of Development and Regeneration, and Pharmaceutical and Pharmacological Sciences as full professor, with an additional appointment as senior consultant (10%) at Erasmus MC, Rotterdam (Hospital Pharmacy). His research has its focus perinatal and pediatric clinical pharmacology and its co-variates (maturational, non-maturational, pharmacogenetics, disease-related). In a truly international and interdisciplinary connection and collaboration, this resulted in a rather extended scientific output (650 PubMed papers, H index 55, https://www.webofscience.com/wos/author/record/C-3611-2016), and about 50 textbook chapters. The most relevant science categories are pediatrics, pharmacology and pharmacy, medicine research, microbiology and microbiology, toxicology, and lactation-related drug exposure. Links to retrieve the scientific output, as accessible in the public domain: https://www.researchgate.net/profile/Karel-Allegaert. The commitment to create societal impact is reflected in advisory tasks within the field of pharmacology and medicine, like membership of the commission on human medicines; council member Royal Academy of Medicine Belgium (since 2015); member trial board, KCE Belgium. He is also member of the HCP-WP and member of the expert screening panel on medical devices, of the European Medicines Agency, and highly involved in different pediatric formularies (kinderformularium, Australasian neonatal formulary, MADAM).
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Prof Catriona Waitt
Nihr Professor Of Clinical Pharmacology & Global Health
University Of Liverpool/ Infectious Diseases Institute (Makerere)Makerere Univer

Maternal and Infant Lactation pharmacoKinetics (MILK): role of Community Engagement and Involvement in successful lactation pharmacology studies

Abstract

Biography

Catriona Waitt is a physician and NIHR Professor of Clinical Pharmacology and Global Heath at the University of Liverpool. Since 2015 she has been based at the Infectious Diseases Institute, Makerere University, Uganda where she established the Maternal and Infant Lactation pharmacoKinetics (MILK) research programme.
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Dr Aida Kawuma
Pharmacometrician
IDI Makerere University, PumasAI

Leveraging Pharmacometrics to Bridge Evidence Gaps in Lactation Pharmacology

Abstract

Biography

Aida Kawuma is a scientist at PumasAI specialising in pharmacometrics analyses across a diverse range of drugs, from small molecules to biologics. In addition, Aida is an active member of the MILK-Centre modelling group at the Infectious Diseases Institute, Makerere University, and the Uganda Chapter of Pharmacometrics Africa. 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.
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Assoc Prof Elora Sharmin
Bangladesh Medical University

Safety and effectiveness of COVID-19 vaccination in Bangladeshi pregnant women and neonates

Abstract

Biography

Dr. Elora Sharmin is an Associate Professor and Acting Chairman of the Department of Pharmacology at Bangladesh Medical University. She is a clinical pharmacologist with over 15 years of experience in pharmacovigilance, vaccine safety, toxicology, and clinical research capacity development. Dr. Sharmin established one of the first institutional pharmacovigilance centers in Bangladesh and has led multiple nationally funded research projects. She has received international training in poisoning management, regulatory science, and clinical trials, and is actively engaged in strengthening clinical trial infrastructure and translational research at her institution. Her work focuses on improving medicine safety, enhancing vaccine oversight systems, and building sustainable research capacity in low- and middle-income countries.

Session chair

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Catriona Waitt
Nihr Professor Of Clinical Pharmacology & Global Health
University Of Liverpool/ Infectious Diseases Institute (Makerere)Makerere Univer

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Francis Williams Ojara
GULU UNIVERSITY

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