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Global Health (GH) and Regulatory Science (RS) Communities

Thursday, January 13, 2022

11:15 AM – 12:15 PM ET

Network and Community Chair(s)

Priya Jayachandran, PharmD

Pfizer
Kendra K. Radtke, PharmD, PhD

Post-doctoral Fellow
University of California San Francisco
Lakshmi Vasist, PharmD

Director, Clinical Pharmacology Modeling & Simulation
GlaxoSmithKline

Handouts
Zhu Zhou, PhD

Assistant Professor
City University of New York

Network and Community Speaker(s)

Hye Lynn Choi

Technical Officer
World Health Organization
Vikram Gota, MD

Professor of Clinical Pharmacology
Advance Centre for Treatment Research & Education in Cancer (ACTREC), Tata Memorial Centre
Martina Penazzato, MD, PhD

GAPf team lead
World Health Organization
Mark Sullivan, BSc

CEO
Medicines Development for Global Health

Session Description

Pediatric drug development is a global effort that has made tremendous progress across the past few decades. This progress, however, is unequal between the developing and developed world, which has become more evident during the COVID-19 pandemic. The World Health Organization reported that two regions, Sub-Saharan Africa and Central and Southern Asia, accounted for half of the under-age 5 mortality rate in 2019. Infectious diseases represent one of the leading causes of these deaths. Lack of access to safe, effective, and quality-assured medicines is another inequality that leads to preventable childhood deaths. These statistics underscore the unequivocal importance of pediatric drug development and availability of high-quality medicines as part of the solution. In this session, attendees will hear global perspectives from various experts sharing experiences and learnings across clinical pharmacology, chemistry-manufacturing-control, and regulatory science to shine a light on the inequities of access to safe and high-quality medicines to children around the globe and how, as clinical pharmacologists, we can help accelerate pediatric drug development in low- and middle- income countries.

Learning Objectives

1. To explore recent successes and challenges and the role of clinical pharmacology in addressing the needs of global pediatric drug development and access including for diseases with a high burden in resource limited settings.

2. To discuss how to strengthen global partnerships across regulatory agencies, the pharmaceutical industry, and academia for the advancement of pediatric drug development.

Session Schedule

11:15 AM - 11:25 AM ET
Opening Remarks and Case Study 1
Priya Jayachandran, PharmD, Lakshmi Vasist, PharmD and Mark Sullivan, BSc

11:25 AM - 11:29 AM ET
Case Study 2
Hye Lynn Choi

11:29 AM - 11:40 AM ET
Case Study 3
Vikram Gota, MD and Zhu Zhou, PhD

11:40 AM - 11:51 AM ET
Case Study 4
Martina Penazzato, MD, PhD and Kendra K. Radtke, PharmD, PhD

11:51 AM - 12:15 PM ET
Panel Discussion, Live Q&A and Closing Remarks
All Speakers