LIVE WEBINAR
Wednesday, February 19th | 3pm ET
Duration: 1 hour
Can't make the live date? Register and we'll send you a link to the recording. ​

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. 

What You’ll Learn:

• 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. 

SPEAKERS

Karen Rowland Yeo
SVP, Client and Regulatory Strategy
Certara
 

Nolan Wood, PhD
VP, Consulting
Certara
 

Mark Sullivan
Managing Director
Medicines for Global Health
 

Craig Rayner
​Director, Translational Medicine - Infectious Diseases Development
Moderna