Development of Antihypertensive Therapies for Use in Pediatric Patients

Day 1 Workshop Details | July 15, 2026

Welcome 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 Ta	Speaker: Keynote Talk Hylton Joffe, MD Director, Office of Cardiology, Hematology, Endocrinology, and Nephrology, F	Presentation (PDF)
9:10 AM – 9:05 AM Pediatric Formulations: What is Needed?	Speaker: John Alexander, PhD Supervisory Physician, DPMH, ORDPURM, OND, CDER, FDA	Presentation (PDF)
9:05 AM – 9:35 AM The Evolution of Pediatric Product Development: Progress, Remaining Gaps, and Future Directions	Joanna Koziara, PhD Executive Director, Technical Development Strategy and Operations, Gilead; Co-chair IQ Pediatric Working Group	Presentation (PDF)
9:35 AM – 9:40 AM Speaker Introductions	Speaker: Mona Khurana, MD Lead Physician, DPMH, ORDPURM, OND, CDER, FDA
9:40 AM – 10:10 AM Pediatric Patient and Family Perspective	Speaker: International Children’s Advisory Network (ICAN)	Presentation (PDF) Presentation (PDF)
10:10 AM – 10:30 AM Compounding 101: A Regulatory Framework	Speaker: Dominic E. Markwordt, JD, MBA Regulatory Counsel, OCQC, OC, CDER, FDA	Presentation (PDF)
10:30 AM – 10:45 AM	Break	Break
10:45 AM – 11:05 AM Pediatric Compounded Medication Safety: Examining Error-Related and Spontaneous Adverse Event	Speaker: Shannon Glueck, PharmD Branch Chief, DC II, Branch 6, OCQC, OC, CDER, FDA	Presentation (PDF)
11:05 AM – 11:25 AM Welcome to the Jungle: Real World Challenges with Pediatric Dosage Forms	Speaker: Rachel Meyers, PharmD Clinical Professor, Ernest Mario School of Pharmacy, Rutgers University, Cooperman Barnabas Medical Center	Presentation (PDF)
11:25 AM – 12:00 PM Panel Discussion	Moderator: Trupti Dixit, PhD, MBA Workshop Program Chair, Independent Consultant, Dixit Consulting Mona Khurana, MD Lead Physician, DPMH, ORDPURM, OND, CDER, FDA Panelists: Patient and Family Representatives International Children’s Advisory Network (ICAN) Dominic E. Markwordt, JD, MBA Regulatory Counsel, OCQC, OC, CDER, FDA Shannon Glueck, PhD Branch Chief, CB 6, DC II, OCQC, OC, CDER, FDA Rachel Meyers, PharmD Clinical Professor, Ernest Mario School of Pharmacy, Rutgers University; Pediatric Clinical Pharmacist, Cooperman Barnabas Medical Center Alyssa Hager, PharmD, BCPPS Department of Pharmacy Informatics, Children’s National Hospital	Video
12:00 PM – 1:00 PM	Lunch	Lunch
Session 2A: Formulation and Analytical Aspects of a Pediatric Dosage Form Mini Tablets Session Leads: Ms. Elizabeth Galella, Dr. David Tan Scope: This session will focus on key aspects of developing mini tablets as a dosage form for pediatrics. This session will provide a forum to discuss acceptability of mini tablets across pediatric age groups, inconsistencies in nomenclature, manufacturing and packaging challenges and limitations, and strategies for identifying appropriate food vehicles.
1:00 PM – 1:05 PM Speaker Introductions	Elizabeth Galella, MS Associate Director, Oral Product Development, Bristol-Myers Squibb	Video
1:05 AM – 1:25 PM Minitablets and Drug Product Nomenclature	Speaker: Stuart Charlton, PhD Director, Oral Product Development, Bristol Myers Squibb, UK	Presentation (PDF)
1:25 PM – 1:45 PM Mini Tablet Manufacturing Challenges	Speaker: Dosage Form Nomenclature LCDR Jibril Abdus-Samad, PharmD Nomenclature and Labeling Policy Lead, COSS, OPPQ, OPQ, CDER, FDA	Presentation (PDF)
1:45 PM – 2:05 PM Minitablet (Granule) Development and Manufacturing Considerations	Speaker: Katie Metzler, MS Director, Vertex Pharmaceuticals	Presentation (PDF)
2:05 PM – 2:25 PM Precision Packaging for Pediatric Drug Products	Speaker: Kirsten O’Brien, BS Director, Packaging Development, Gilead Sciences	Presentation (PDF)
2:25 PM – 2:45 PM Food Selection, Compatibility and Testing Strategies	Speaker: Anna Externbrink, PhD Associate Principal Scientist, Analytical R&D, Merck	Presentation (PDF)
2:45 PM – 3:05 PM Oral Drug Product Administration via Enteral Feeding Tubes: In Vitro Testing	Speaker: Yemin Liu, PhD Senior Principal Research Scientist, AbbVie Inc	Presentation (PDF)
3:05 PM – 3:25 PM Will Children Actually Take It? User Perspectives on Acceptability of Minitablet vs Conventional Small Tablet	Speaker: Smita Salunke, PhD Chief Scientific Officer, EuPFI	Presentation (PDF)
3:25 PM – 3:40 PM	Break	Break
3:40 PM – 4:40 PM Panel Discussion	Moderators: Elizabeth Galella, MS Associate Director, Oral Product Development, Bristol-Myers Squibb David Tan, PhD Senior Director, Vertex Pharmaceuticals Inc. Panelists: Stuart Charlton, PhD Director, Oral Product Development, Bristol Myers Squibb, UK Katie Metzler, MS Director, Vertex Pharmaceuticals Kirsten O’Brien, BS Director, Packaging Development, Gilead Sciences LCDR Jibril Abdus-Samad, PharmD Nomenclature and Labeling Policy Lead, COSS, OPPQ, OPQ, CDER, FDA Anna Externbrink, PhD Associate Principal Scientist, Analytical R&D, Merck Yemin Liu, PhD Senior Principal Research Scientist, AbbVie Inc. Smita Salunke, PhD Chief Scientific Officer, EuPFI	Video
4:40 PM – 5:00 PM	Day 1 Summary
5:00 PM – 6:30 PM	Networking / Posters	Predicting Weight Variability in Mini-Tablets: Impact of Particle Size and Tablet Punch Size Development of a Novel Paediatric Belumosudil Oral Suspension Advancing Pediatric Patient Care Through Oral Thin Film Compounding Sensory Analysis of 160 Investigational Drugs: A Framework for Assessing Taste-Masking Difficulty Machine Learning-Driven Quality by Design Framework for Predicting Dose Recovery in Enteral Feeding Tube Administration Co-designing MATE (Medicines Administered Through Enteral Tube)- Industry & Regulatory Perspectives MATE for Safer Medication Administration via Enteral Feeding Tubes to Children. Part I – Healthcare Professional Viewpoint

Development of Antihypertensive Therapies for Use in Pediatric Patients

Day 1 Workshop Details | July 15, 2026

Welcome and Introduction

Session 2A: Formulation and Analytical Aspects of a Pediatric Dosage Form Mini Tablets