Development of Antihypertensive Therapies for Use in Pediatric Patients
Wednesday, July 15 and Thursday, July 16, 2026
Agenda & Speakers
Day 1: 9 a.m.-5 p.m.
Welcome & Introduction
9-9:10 a.m.
Welcome and Introduction
John Alexander, M.D., MPH
Deputy Director, Division of Pediatrics and Maternal Health (DPMH), U.S. Food and Drug Administration (FDA)
9:10-9:20 a.m.
Keynote Talk
Hylton Joffe, M.D.
Director, Office of Cardiology, Hematology, Endocrinology, and Nephrology (OCHEN), FDA
9:20-9:35 a.m.
Regulatory Framework for Drug Development in Children and Extrapolation of Safety and Efficacy Data from a Reference Population
Gilbert Burckart, Pharm.D.
Associate Director of Pediatrics, Office of Clinical Pharmacology, FDA
9:35-9:55 a.m.
Landscape of Drug Development for Management of Hypertension
Kirtida Mistry, M.D.
Medical Officer, Division of Cardiology and Nephrology (DCN), FDA
Session 1: Chronic Hypertension
9:55-10:25 a.m.
Overview of Pediatric Hypertension and Similarities/Differences in Hypertension in Adults and Pediatric Patients
Joshua Samuels, M.D. (virtual)
Professor; Director, Nephrology Fellowship Program; Director, Hypertension Program, McGovern Medical School, UTHealth
10:25-10:45 a.m.
Similarities and Differences in Response to Anti-hypertensive Agents in Adult and Pediatric Patients
Joseph T. Flynn, M.D.
Professor, Pediatrics, University of Washington School of Medicine
10:45-10:55 a.m.
BREAK
10:55-11:15 a.m.
Off-label Prescribing Practices
Douglas Blowey, M.D. (virtual)
Medical Director, Chief Clinical Integration Officer, Children’s Mercy Integrated Care Solutions
11:15-11:30 a.m.
Off-label Prescribing: Medication Errors and Formulation Related Limitations
Rachel Meyers, Pharm.D.
Clinical Professor, Ernest Mario School of Pharmacy, Rutgers University; Pediatric Clinical Pharmacist, Cooperman Barnabas Medical Center
11:30-11:45 a.m.
Considerations for Age-Appropriate Pediatric Formulations — Industry Perspective
Lourdes Paola Contreras Chavez, Ph.D. (virtual)
Associate Director, CMC, Paediatric SME, AstraZeneca
11:45 a.m.-12 p.m.
Q&A/Clarifying Questions
12-1 p.m.
Panel Discussion
Moderated by Mona Khurana, M.D.
Medical Team Leader, Division of Pediatrics and Maternal Health, FDA
Panelists:
Joshua Samuels, M.D. (virtual)
Professor; Director, Nephrology Fellowship Program; Director, Hypertension Program, McGovern Medical School, UTHealth
Joseph T. Flynn, M.D.
Professor, Pediatrics, University of Washington School of Medicine
Doug Blowey, M.D. (virtual)
Medical Director, Chief Clinical Integration Officer, Children’s Mercy Integrated Care Solutions
Rachel Meyers, Pharm.D.
Clinical Professor, Ernest Mario School of Pharmacy, Rutgers University; Pediatric Clinical Pharmacist, Cooperman Barnabas Medical Center
Lourdes Paola Contreras Chavez, Ph.D. (virtual)
Associate Director, CMC, Paediatric SME, AstraZeneca
Fraz Ismat, M.D.
Clinical Development, Mineralys
Kirtida Mistry, M.D.
Medical Officer, Division of Cardiology and Nephrology, FDA
1-2 p.m.
LUNCH
Session 2: Extrapolation and Trial Design Considerations — Chronic Hypertension
2-2:15 p.m.
Dose-Response and Extrapolation of Efficacy from Older Pediatric Patients
Sudharshan Hariharan, Ph.D.
Master Pharmacokineticist, Office of Clinical Pharmacology, FDA
2:15-2:30 p.m.
Safety Assessment and Pediatric Specific Considerations
Ricardo Fonseca Martins, M.D.
Senior Medical Manager, Pharmacovigilance, E. Lilly and Company
2:30-3 p.m.
Panel: Lessons Learned from Conducting Clinical Trials in Pediatric Hypertension, including Uncontrolled Hypertension
Moderated by Jennifer S. Li, M.D.
Professor of Pediatric Cardiology, Duke Department of Pediatrics
Panelists:
Monica Bengus, M.D. (virtual)
Principal Medical Director, Cardiovascular, Roche
Joshua Samuels, M.D. (virtual)
Professor; Director, Nephrology Fellowship Program; Director, Hypertension Program, McGovern Medical School, UTHealth
Joseph T. Flynn, M.D.
Professor, Pediatrics, University of Washington Schoolof Medicine; Chief, Division of Nephrology, Seattle Children's
Tammy McLoughlin Brady, M.D., Ph.D.
Medical Director, Pediatric Hypertension Program, Children's National Hostpital
Fraz Ismat, M.D.
Clinical Development, Mineralys
3-3:10 p.m.
BREAK
3:10-3:25 p.m.
Dose Prediction and Modeling and Simulation — Industry Perspective
Maria Learoyd, Ph.D. (virtual)
Clinical Pharmacology & Safety Sciences, AstraZeneca
3:25-3:40 p.m.
Innovative Trial Designs and Leveraging Existing Data
Christine Ferrara-Cook, M.D., Ph.D., MAS
Executive Director, Diabetes Clinical Design, Eli Lilly
3:40-4:40 p.m.
Panel and Stakeholder Discussion
Moderated by Lynne Yao, M.D.
Director, Division of Pediatrics and Maternal Health, FDA
Panelists:
Aliza M. Thompson, M.D., M.S.
Director, Division of Cardiology and Nephrology, FDA
Sudharshan Hariharan, Ph.D.
Master Pharmacokineticist, Office of Clinical Pharmacology, FDA
Ricardo Fonseca Martins, M.D.
Senior Medical Manager, Pharmacovigilance, E. Lilly and Company
Jennifer S. Li, M.D.
Professor of Pediatric Cardiology, Duke Department of Pediatrics
Monica Bengus, M.D. (virtual)
Principal Medical Director, Cardiovascular, Roche
Joshua Samuels, M.D. (virtual)
Professor; Director, Nephrology Fellowship Program; Director, Hypertension Program, McGovern Medical School, UTHealth
Joseph T. Flynn, M.D.
Professor, Pediatrics, University of Washington School of Medicine
Tammy McLoughlin Brady, M.D., Ph.D.
Medical Director, Pediatric Hypertension Program, Children's National Hospital
Christine Ferrara-Cook, M.D., Ph.D., MAS
Executive Director, Diabetes Clinical Design, Eli Lilly
Maria Learoyd, Ph.D. (virtual)
Clinical Pharmacology & Safety Sciences, AstraZeneca
4:40-4:50 p.m.
Closing Remarks
Lynne Yao, M.D.
Director, Division of Pediatrics and Maternal Health, FDA
Day 2: 9-11:30 a.m.
Session 3: Management of Uncontrolled Hypertension
9-9:10 a.m.
Welcome
John Alexander, M.D., MPH
Deputy Director, Division of Pediatrics and Maternal Health, FDA
9:10-9:25 a.m.
Uncontrolled Hypertension: Similarities/Differences Adult and Pediatric Patients Across Age Spectrum
Carissa M. Baker-Smith, M.D., MPH
Professor, Cardiologist, Director, Nemours Preventative Cardiology Program, Nemours Children’s Hospital, Professor of Pediatrics
9:25-9:40 a.m.
Evaluation of Response — Treatment of Uncontrolled Hypertension in Adults Versus Pediatric Patients Across Age Spectrum
Tammy McLoughlin Brady, M.D., Ph.D.
Medical Director, Pediatric Hypertension Program, Children's National Hospital
9:40-10 a.m.
BREAK
10-11:20 a.m.
Panel Discussion
Moderated by Kirtida Mistry, M.D.
Medical Officer, Division of Cardiology and Nephrology, FDA
Panelists:
Shamir Tuchman, M.D., MPH
Acting Deputy Director for Safety, Division of Rare Diseases and Medical Genetics
Carissa M. Baker-Smith, M.D., MPH
Professor, Cardiologist, Director, Nemours Preventative Cardiology Program, Nemours Children’s Hospital
Tammy McLoughlin Brady, M.D., Ph.D.
Medical Director, Pediatric Hypertension Program, Children’s National Hospital
Joshua Samuels, M.D. (Virtual)
Professor; Director, Nephrology Fellowship Program; Director, Hypertension Program, McGovern Medical School, UTHealth
Joseph T. Flynn, M.D.
Professor, Pediatrics, University of Washington School of Medicine; Chief, Division of Nephrology, Seattle Children's
Gilbert Burckart, Pharm.D.
Associate Director of Pediatrics, Office of Clinical Pharmacology, FDA
Fraz Ismat, M.D.
Clinical Development, Mineralys
11:20-11:30 a.m.
Closing Remarks
Aliza Thompson, M.D.
Director, Division of Cardiology and Nephrology, FDA
