Development of Antihypertensive Therapies 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
Lily Mulugeta, Pharm.D.
Associate Director for Policy and Research, DPMH, ORPURM, CDER, FDA
9:10-9:20 a.m.
Keynote Talk
Hylton Joffe, M.D.
Director, OCHEN, CDER, 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
Lily Mulugeta, Pharm.D.
Associate Director for Policy and Research, DPMH, ORPURM, CDER, FDA
9:35-9:55 a.m.
Landscape of Drug Development for Management of Hypertension
Kirtida Mistry, M.D., FASN
Medical Officer, DCN, CDER, 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., MPH
Professor; Director, Nephrology Fellowship Program; Director, Hypertension Program, McGovern Medical School, UTHealth Houston
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., M.S.
Professor, Pediatrics, University of Washington School of Medicine; Chief, Division of Nephrology, Seattle Children's
10:45-10:55 a.m.
Break
10:55-11:15 a.m.
Off-label Prescribing Practices
Douglas Blowey, M.D.
Medical Director, Chief Clinical Integration Officer, Children’s Mercy Integrated Care Solutions
11:15-11:30 a.m.
Considerations for Age-Appropriate Pediatric Formulations — Industry Perspective
11:30-11:45 a.m.
Off-label Prescribing: Medication Errors and Formulation Related Limitations
Rachel Meyers, Pharm.D., BCPS, BCPPS, FPPA
Clinical Professor, Ernest Mario School of Pharmacy, Rutgers University; Pediatric Clinical Pharmacist, Cooperman Barnabas Medical Center
11:45 a.m.-12 p.m.
Q&A/Clarifying Questions
12-1 p.m.
Panel Discussion
Moderated by Mona Khurana, M.D.
Pediatric Team Leader, DPMH, ORPURM, OND, CDER, FDA
Panelists:
Kirtida Mistry, M.D., FASN
FDA-Liaison, CDER, FDA
Joshua Samuels, M.D., MPH
Professor; Director, Nephrology Fellowship Program; Director, Hypertension Program, McGovern Medical School, UTHealth Houston
Joseph T. Flynn, M.D., M.S.
Professor, Pediatrics, University of Washington School of Medicine; Chief, Division of Nephrology, Seattle Children's
Douglas Blowey, M.D.
Medical Director, Chief Clinical Integration Officer, Children’s Mercy Integrated Care Solutions
Rachel Meyers, Pharm.D., BCPS, BCPPS, FPPA
Clinical Professor, Ernest Mario School of Pharmacy, Rutgers University; Pediatric Clinical Pharmacist, Cooperman Barnabas Medical Center, Livingston NJ
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, OCP, FDA
2:15-2:30 p.m.
Safety Assessment and Pediatric Specific Considerations
Ricardo Fonseca Martins, MBA
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.
Pediatric Cardiologist, Duke Children’s Cardiology Creekstone
Panelists:
Monica Bengus, M.D.
Principal Medical Director, Cardiovascular, Roche
Joseph T. Flynn, M.D., M.S.
Professor, Pediatrics, University of Washington Schoolof Medicine; Chief, Division of Nephrology, Seattle Children's
Tammy McLoughlin Brady
Joshua Samuels, M.D., MPH
Professor; Director, Nephrology Fellowship Program; Director, Hypertension Program, McGovern Medical School, UTHealth Houston
3-3:10 p.m.
Break
3:10-3:25 p.m.
Dose Prediction and Modeling and Simulation — Industry Perspective
3:25-3:40 p.m.
Innovative Trial Designs and Leveraging Existing Data
3:40-4:40 p.m.
Panel and Stakeholder Discussion
Moderated by Kirtida Mistry, M.D., FASN
Medical Officer, DCN, CDER, FDA
Panelists:
Aliza M. Thompson, M.D., M.S.
Director, DCN, CDER, FDA
Sudharshan Hariharan, Ph.D.
Master Pharmacokineticist, OCP, FDA
Ricardo Fonseca Martins, MBA
Senior Medical Manager, Pharmacovigilance, E. Lilly and Company
4:40-4:50 p.m.
Closing Remarks — Day 1
Day 2: 9-11:30 a.m.
Welcome
9-9:10 a.m.
Welcome and Summary of Day 1
Session 3: Management of Uncontrolled Hypertension
9:10-9:25 a.m.
Treatment of Uncontrolled Hypertension: Similarities/Differences Adult and Pediatric Patients Across Age Spectrum
Carissa M. Baker-Smith, M.D., MPH, M.S.
Cardiologist, Director, Nemours Preventative Cardiology Program, Nemours Children’s Hospital
9:25-9:40 a.m.
Evaluation of Response — Treatment of Uncontrolled Hypertension in Adults Versus Pediatric Patients Across Age Spectrum
9:40-10 a.m.
Break
10-11:20 a.m.
Panel Discussion
Panelists:
Tammy McLoughlin Brady
Carissa M. Baker-Smith, M.D., MPH, M.S.
Cardiologist, Director, Nemours Preventative Cardiology Program, Nemours Children’s Hospital
11:20-11:30 a.m.
Closing Remarks
Aliza Thompson, M.D., M.S.
Director, DCN, CDER, FDA
