Moxidectin for Women’s Health Equity
Model-Informed Drug Development is increasingly impacting public health and regulatory decision-making in support of global health initiatives. In this webinar, we will share a recent global health case study on the use of pharmacokinetic (PK) and physiologically based pharmacokinetic (PBPK) modeling of moxidectin to understand the impact of drug exposure on breastfed infants. We will discuss how these quantitative approaches, which complement clinical lactation data, offered insights for healthcare providers, policymakers, and regulatory bodies while laying the groundwork for scalable solutions in global health challenges.
Moxidectin, a groundbreaking drug 25 years in development, gained FDA approval in 2018 for treating onchocerciasis (river blindness) in individuals aged 12 and older. More recently, the Ghana Food and Drugs Authority (FDA) approved its marketing authorization application for moxidectin for the treatment of river blindness in adults and children aged 4 years and older. As a key component in mass drug administration (MDA) programs, addressing the needs of breastfeeding women is essential for equitable and effective care in endemic regions.
Breastfeeding is common in communities affected by onchocerciasis, and many women participate in MDA programs while lactating. Developing safe, scientifically informed dosing recommendations is vital to protecting maternal and infant health.
Key Takeaways
Global Health Impact: PK and PBPK modeling plays an influential role in ensuring safe, equitable care for understudied populations.
Scalable Framework: Model-Informed Drug Development (MIDD) provides a replicable approach to address underserved populations and advance equitable healthcare worldwide.
Lactation Safety: Data-driven guidance can support effective maternal and infant care.
Evidence-Based Dosing: Combining clinical and modeling data establishes safe, effective dosing, advancing health equity globally.
Stakeholder Empowerment: Actionable insights support prescribers, policymakers, and regulators in improving maternal and infant health outcomes during drug development.
What You’ll Learn
How MIDD influences public health and regulatory decision-making at local and global levels.
- The role of modeling in ensuring safe treatments for populations including breastfeeding and pediatric populations.
- Strategies for addressing drug-drug interactions and optimizing therapies in MDA programs.
- Broader applications of quantitative pharmacology in advancing global health initiatives.
- How to use quantitative evidence to accelerate regulatory approvals.
Summary
Through advanced quantitative pharmacology, the moxidectin program exemplifies how innovative approaches can address public health challenges at scale. By prioritizing data, safety, and accessibility, this framework supports equitable healthcare and establishes a model for tackling complex global health issues.
As the fight against onchocerciasis continues, this program demonstrates how model-informed strategies can transform outcomes for at-risk populations, setting the stage for scalable, inclusive solutions to global health priorities.
演讲嘉宾
Karen Rowland Yeo – SVP, Client and Regulatory Strategy, Certara
Dr. Karen Rowland Yeo is Senior Vice-President, Client & Regulatory Strategy 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 settings across most therapeutic areas and is currently driving advancement of PBPK modelling to enable evidence-based individualized dosing recommendations for therapeutics. Dr. Rowland Yeo served as the Chair of the Scientific Program Committee for the 2024 ASCPT meeting and is the Deputy-Editor-in-Chief of the CPT: Pharmacometrics & Systems Pharmacology journal.
Nolan Wood, PhD – VP, Consulting, Certara
Nolan Wood is a consultant and team lead in the clinical pharmacology and translational medicine group at Certara. Prior to joining Certara in 2017, Nolan worked for more than 25 years as a clinical pharmacologist in the pharmaceutical industry, supporting global development programs at all stages of development from first-in-human studies through to successful global regulatory approvals. Nolan has worked across a wide range of therapeutic areas, involving both small molecules and biological products.
Mark Sullivan – Managing Director, Medicines for Global Health
Mark Sullivan is clinical and regulatory scientist with comprehensive experience of the development of new medicines for infectious diseases. Founder and CEO/Managing Director of Medicines Development for Global Health (MDGH), he has personally run global phase I to IV clinical programs and was project leader for moxidectin through FDA approval. He also significantly contributed to three other successful global registrational programs: 3TC for HIV, lamivudine for chronic hepatitis B and adefovir dipivoxil for chronic hepatitis B. He is an Honorary Professor at the University of New South Wales, and is an Officer of the Order of Australia.
Craig Rayner – Director, Translational Medicine – Infectious Diseases Development, Moderna
Craig is the Director of Translational Medicine in Infectious Diseases Global Clinical Development at Moderna. Prior to this he has had executive and/or R&D leadership roles in Moderna, Certara, d3 Medicine, Roche and CSL. He is an Adjunct Professor and Distinguished Alumnus at Monash University. He has been a champion of contemporary medicine development approaches across his career, contributing to numerous medicine approvals and due diligences resulting in multi-100m transactions. He has >120 publications including in NEJM, Lancet, Science, CPT and advised WHO, UN, NGOs and government on product development and global health.