Development of Antihypertensive Therapies for Use in Pediatric Patients

Day 1 Workshop Details | July 15, 2026

Welcoming and Introduction Workshop Moderators: Lily Mulugeta, PharmD Associate Director for Policy and Research Division of Pediatrics and Maternal Health (DPMH), U.S. Food and Drug Administration (FDA) Kirtida Mistry, MD Medical Officer, Division of Cardiology and Nephrology (DCN), FDA
9 AM – 9:10 AM Welcome and Introduction	Speaker: John Alexander, MD, MPH Deputy Director, Division of Pediatrics and Maternal Health (DPMH), FDA
9:10 AM – 9:20 AM Keynote	Speaker: Hylton Joffe, MD Director, Office of Cardiology, Hematology, Endocrinology, and Nephrology, FDA
9:20 AM – 9:35 AM Regulatory Framework for Drug Development in Children and Extrapolation of Safety and Efficacy Data from a Reference Population	Speaker: Gilbert Burckart, PharmD Associate Director of Pediatrics, Office of Clinical Pharmacology, FDA	Presentation (PDF)
9:35 AM – 9:55 AM Landscape of Drug Development for Management of Hypertension	Speaker: Kirtida Mistry, MD Medical Officer, Division of Cardiology and Nephrology (DCN), FDA	Presentation (PDF)
Session 1: Chronic Hypertension
9:55 AM – 10:25 AM Overview of Pediatric Hypertension and Similarities/Differences in Hypertension in Adults and Pediatric Patients	Speaker: Joshua Samuels, MD (Virtual) Professor; Director, Nephrology Fellowship Program; Director, Hypertension Program, McGovern Medical School, UTHealth	Presentation (PDF)
10:25 AM – 10:45 AM Similarities and Differences in Response to Anti-hypertensive Agents in Adult and Pediatric Patients	Speaker: Joseph T. Flynn, MD (Virtual) Professor, Pediatrics, University of Washington School of Medicine	Presentation (PDF)
10:45 AM – 10:55 AM	Break	Break
10:55 AM – 11:15 AM Off-label Prescribing Practices	Speaker: Doug Blowey, MD (Virtual) Medical Director, Chief Clinical Integration Officer, Children’s Mercy Integrated Care Solutions	Presentation (PDF)
11:15 AM – 11:30 AM Off-label Prescribing: Medication Errors and Formulation Related Limitations	Speaker: Rachel Meyers, PharmD Clinical Professor, Ernest Mario School of Pharmacy, Rutgers University; Pediatric Clinical Pharmacist, Cooperman Barnabas Medical Center	Presentation (PDF)
11:30 AM – 11:45 AM Considerations for Age-Appropriate Pediatric Formulations—Industry Perspective	Speaker: Lourdes Paola Contreras Chavez, PhD (Virtual) Associate Director, CMC, Paediatric SME, AstraZeneca	Presentation (PDF)
11:45 AM – 12:00 PM	Q&A/Clarifying Questions
12:00 PM – 1:00 PM Panel Discussion	Moderator: Mona Khurana, MD Medical Team Leader, Division of Pediatrics and Maternal Health, FDA Panelists: Joshua Samuels, MD (Virtual) Professor; Director, Nephrology Fellowship Program; Director, Hypertension Program, McGovern Medical School, UTHealth Joseph T. Flynn, MD (Virtual) Professor, Pediatrics, University of Washington School of Medicine Doug Blowey, MD (Virtual)Medical Director, Chief Clinical Integration Officer, Children’s Mercy Integrated Care Solutions Rachel Meyers, PharmD Clinical Professor, Ernest Mario School of Pharmacy, Rutgers University; Pediatric Clinical Pharmacist, Cooperman Barnabas Medical Center Lourdes Paola Contreras Chavez, PhD (Virtual) Associate Director, CMC, Paediatric SME, AstraZeneca Fraz Ismat, MD Clinical Development, Mineralys Kirtida Mistry, MD Medical Officer, Division of Cardiology and Nephrology, FDA
1:00 PM – 2:00 PM	Lunch	Lunch
Session 2: Extrapolation and Trial Design Considerations—Chronic Hypertension
2:00 PM – 2:15 PM Dose-Response and Extrapolation of Efficacy from Older Pediatric Patients	Speaker: Sudharshan Hariharan, PhD Master Pharmacokineticist, Office of Clinical Pharmacology, FDA	Presentation(PDF)
2:15 PM – 2:30 PM Safety Assessment and Pediatric Specific Considerations	Speaker: Ricardo Fonseca Martins, MD Senior Medical Manager, Pharmacovigilance, E. Lilly and Company	Presentation (PDF)
2:30 PM – 3:00 PM Panel: Lessons Learned from Conducting Clinical Trials in Pediatric Hypertension	Moderator: Jennifer S. Li, MD Professor of Pediatric Cardiology, Duke Department of Pediatrics Panelists: Monica Bengus, MD (Virtual) Principal Medical Director, Cardiovascular, Roche Joshua Samuels, MD (Virtual) Professor; Director, Nephrology Fellowship Program; Director, Hypertension Program, McGovern Medical School, UTHealth Joseph T. Flynn, MD (Virtual) Professor, Pediatrics, University of Washington School of Medicine; Chief, Division of Nephrology, Seattle Children's Tammy McLoughlin Brady, MD, PhD Medical Director, Pediatric Hypertension Program, Children’s National Hospital Fraz Ismat, MD Clinical Development, Mineralys	Presentation(PDF)
3:10 PM – 3:10 PM	Break	Break
3:10 PM – 3:25 PM Dose Prediction and Modeling and Simulation—Industry Perspective	Speaker: Maria Learoyd, PhD (Virtual) Clinical Pharmacology & Safety Sciences, AstraZeneca	Presentation (PDF)
3:25 PM – 3:40 PM Innovative Trial Designs and Leveraging Existing Data	Speaker: Christine Ferrara-Cook, MD, PhD, MAS Executive Director, Diabetes Clinical Design, Eli Lilly	Presentation (PDF)
3:40 PM – 4:40 PM Panel and Stakeholder Discussion	Moderator: Lynne Yao, MD Director, Division of Pediatrics and Maternal Health, FDA Panelists: Aliza Thompson, MD, MS Director, Division of Cardiology and Nephrology, FDA Sudharshan Hariharan, PhD Master Pharmacokineticist, Office of Clinical Pharmacology, FDA Ricardo Fonseca Martins, MD Senior Medical Manager, Pharmacovigilance, E. Lilly and Company Jennifer S. Li, MD Professor of Pediatric Cardiology, Duke Department of Pediatrics Monica Bengus, MD (Virtual) Principal Medical Director, Cardiovascular, Roche Joshua Samuels, MD (Virtual) Professor; Director, Nephrology Fellowship Program; Director, Hypertension Program, McGovern Medical School, UTHealth Joseph T. Flynn, MD (Virtual) Professor, Pediatrics, University of Washington School of Medicine Tammy McLoughlin Brady, MD, PhD Medical Director, Pediatric Hypertension Program, Children’s National Hospital Christine Ferrara-Cook, MD, PhD, MAS Executive Director, Diabetes Clinical Design, Eli Lilly Maria Learoyd, PhD (Virtual) Clinical Pharmacology & Safety Sciences, AstraZeneca	Presentation(PDF)
4:40 PM – 4:50 PM Closing Remarks	Speaker: Lynne Yao, MD Director, Division of Pediatrics and Maternal Health, FDA	Presentation(PDF)

Development of Antihypertensive Therapies for Use in Pediatric Patients

Day 1 Workshop Details | July 15, 2026

Welcoming and Introduction

Session 1: Chronic Hypertension

Session 2: Extrapolation and Trial Design Considerations—Chronic Hypertension