Shaping the Future of Pediatric Formulation Development

About the Event

Recent progress and advancements in drug delivery technologies and formulation sciences have created new opportunities for developing better pediatric medicines. However, multiple challenges and hurdles need to be overcome before these technologies can become fully available to children. By bringing together the pediatric community including pharmaceutical scientists, regulators and clinical counterparts from diverse functions, this workshop is intended to shed light on the barriers to and opportunities for patient-focused pediatric formulations. Advancing pediatric formulations will require sharing and building on experiences from patients/caregivers, industry, academia, and regulators. It is hoped that the participants will better understand the principles, gaps, technical, and process challenges encountered during formulation and dosage product development as well as considerations for regulatory assessments and ultimately policy development.

Sessions

Patient-Centricity

Scope: Patient-centric product development in the context of pediatric formulation means using a user-focused approach that understands the physiological, developmental and psychological needs of the pediatric population that spans from neonates to adolescence. This translates into tailoring dosage forms to address factors such as dosing flexibility, taste-masking and swallowing abilities across this age group and ascertain that caregivers can deliver these medications where needed to ensure adherence to dosing regimen to impact health outcomes. This concept also applies to easing the burden of clinical studies and arriving at appropriate dosing regimens with minimal hardships on this vulnerable population. This session will present perspectives on some of these aspects to promote understanding and generate discussion on some of these key topics.

Formulation and Analytical Aspects of a Pediatric Dosage Form: Mini tablets

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.

Formulation and Analytical Aspects of a Pediatric Dosage Form: Excipients for Pediatric Formulations

Scope: This session features presentations on the assessment of excipients for pediatric formulations, including tools such as the IID and ELSA, delivered by FDA experts. Industry perspectives are provided through talks on challenges and considerations in selecting excipients for pediatric products, including the use of the PERA tool. Additional insights focus on excipient needs for special populations—such as neonates. The program concludes with a breakout session on the PARA tool and a forward-looking panel discussion on future needs, research priorities, and regulatory challenges in pediatric excipient development.

Imagining the Future of Pediatric Formulation Development

Scope: Since our last pediatric workshop in 2019, we have seen transformational innovations in drug delivery systems, the evolution of complex biologics, as well as new techniques for gene editing and gene therapy. Furthermore, recent advances in AI/ML methodologies, including agentic AI, are having a broad impact on drug discovery and development. In this session, we will discuss these recent trends and how they will shape the future of developing better drugs and delivery systems for children.

Collaboration for Kids (across Academia, Health Authorities, Industry, and Non-profit Organizations)

Scope: This session will look towards establishing potential collaboration opportunities through shared understanding of the work done by various organizations such as industry, academia, philanthropic organizations or governments. The distinguished panel members from each of these organizations will share their perspectives through panel discussion. Workshop participants are encouraged to share their questions even ahead of time to enable productive, focused discussion on key topics as they relate to pediatric formulation development.

Funding Statement

This workshop is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award to the Center of Excellence in Regulatory Science and Innovation, U01FD005946 totaling $10,000 funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. government.

Day 1 Workshop Details | June 24, 2026

Opening Session: Why Are We Here & Session 1A: Patient-Centricity Session Leads: Dr. Trupti Dixit, Dr. Mona Khurana Scope: Patient-centric product development in the context of pediatric formulation means using a user-focused approach that understands the physiological, developmental and psychological needs of the pediatric population that spans from neonates to adolescence. This translates into tailoring dosage forms to address factors such as dosing flexibility, taste -masking and swallowing abilities across this age group and ascertain that caregivers can deliver these medications where needed to ensure adherence to dosing re gimen to impact health outcomes. This concept also applies to easing the burden of clinical studies and arriving at appropriate dosing regimens with minimal hardships on this vulnerabl e population. This session will present perspectives on some of these aspects to promote understanding and generate discussion on some of these key topics
7:45 AM – 8:35 AM Speaker Introductions	Speaker: Mona Khurana, MD Lead Physician, DPMH, ORDPURM, OND, CDER, FDA	Presentation (PDF)
9:40 AM – 10:10 AM Pediatric Patient and Family Perspective	Patient and Family Representatives International Children’s Advisory Network (ICAN)	Presentation (PDF)
10:10 AM – 10:30 AM Compounding 101: Regulatory Framework for Human Drug Compounding	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 Events	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	Moderator: Trupti Dixit, PhD, MBA Workshop Program Chair, Independent Consultant, Dixit Consulting Panelists: Mona Khurana, MD Lead Physician, DPMH, ORDPURM, OND, CDER, FDA 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
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	Speaker Introductions: Elizabeth Galella, MS Acting Supervisor, DPQA VI, OPQA I, OPQ, CDER, FDA	Presentation (PDF)
1:05 AM – 1:25 AM Minitablets and Drug Product Nomenclature	Speaker: Minitablets and Drug Product Nomenclature Director, Oral Product Development, Bristol Myers Squibb, UK	Presentation (PDF)
10:40 AM – 11:00 AM Linking In Vitro Dissolution to In Vivo Performance of Extended-Release Drug Products	Speaker: Yihong Qiu, PhD Chief Technical Director, QPD Solutions	Presentation (PDF)
11:00 AM – 11:20 AM Understanding In Vitro Dissolution and Clinical Performance for High-Risk IR Products	Speaker: Sanjaykumar Patel, PhD Senior Principal Scientist, Merck & Co., Inc.	Presentation (PDF)
11:20 AM – 11:40 AM Development of a Dissolution Control Strategy and BE Safe-Space for a Solid-Dispersion Drug Product	Speaker: David Sperry, PhD Executive Director, Synthetic Molecule Design & Development, Eli Lily
11:40 AM – 11:45 AM Session 2 Summary	Speaker: Haritha Mandula, PhD Acting Supervisor, DPQA VI, OPQA I, OPQ, CDER, FDA	Presentation (PDF)
11:45 AM – 12:45 PM	Lunch Break
Session 3: Medium Risk Drug Products-How to Use Biopharmaceutics Tool to Understand and Mitigate Risk? (Video) Session Leads: Dr. Emilija Fredro-Kumbaradzi, Dr. Duxin Sun, Dr. Hailing Zhang, Dr. Ahmed Zidan Scope: This session addresses products where in vivo dissolution and absorption are governed by drug substance properties and are likely impacted by GI physiological conditions. The focus will be on developing dissolution methods, including biorelevant methods that mimic and may therefore be, indicative of in vivo performance, the potential for these methods to exist separately from QC dissolution methods, and their use in mitigating BA/BE requirements for lifecycle management. Discussions will center on what data and scientific justifications are required to potentially downgrade, rather than just mitigate, the risk from medium to low from a regulatory perspective and therefore, reduce the dissolution testing requirements throughout the product’s lifecycle
12:45 PM – 12:50 PM Speaker Introductions	Speaker: Duxin Sun, PhD Associate Dean for Research, The Charles R. Walgreen Jr. Professor of Pharmacy & Pharmaceutical Sciences, College of Pharmacy, The University of Michigan	Presentation (PDF)
12:50 PM – 1:10 PM The Tale of Truqap Dissolution: The Apex of Science vs. Compliance	Speaker: James Mann, MSci, PhD Principal Scientist, In Vitro Product Performance, AstraZeneca	Presentation (PDF)
1:10 PM – 1:30 PM Capturing Fasting Gastric Motility and pH Variability In Vitro to De-Risk Development of Oral Medicines	Speaker: Dorota Danielak, PhD, dr hab Senior R&D Specialist, Physiolution	Presentation (PDF)
1:30 PM – 1:50 PM Biopharmaceutic Risk Assessment of a Neutral BCS Class IV Drug: A Generic Industry Perspective	Speaker: Emilija Fredro-Kumbaradzi, PhD Director, Biopharmaceutics & Statistics, R&D, Apotex, Inc	Presentation (PDF)
1:50 PM – 2:10 PM Defining and Managing Medium-Risk Drug Products Within the Risk-Based Biopharmaceutics Framework: An FDA Perspective	Speaker: Hailing Zhang, PhD Division Director, DPQA XII, OPQA II, OPQ, CDER, FDA	Presentation (PDF)
2:10 PM – 2:15 PM Session 3 Summary	Speaker: Ahmed Zidan, PhD Senior Pharmacologist, DPQR V, OPQR, OPQ, CDER, FDA	Presentation (PDF)
Breakout Sessions: Framework, High Risk, Medium Risk
2:15 PM – 2:20 PM	Transition to Breakout Session Rooms
2:20 PM – 2:30 PM Introduction to Breakout Sessions Topic A and B	Breakout Session by Moderators
2:30 PM – 3:30 PM	Breakout Session A: Implementing Biopharmaceutics Risk Assessment Framework: Practical Strategies for Drug Development and Regulatory Decision-Making. Breakout Session B: A Framework for Biopharmaceutics Risk Characterization and Mitigation Strategies for High-Risk Drug Products with Emphasis on Clinical Relevance
3:30 PM – 3:45 PM	Break
3:45 PM – 3:50 PM	Transition to Breakout Session Rooms
3:50 PM – 4:00 PM Introduction to Breakout Sessions Topic C and D	Breakout Session by Moderators
4:00 PM – 5:00 PM	Breakout Session C: What Biopharmaceutics Characteristics Differentiate a Medium Risk Product from a Low or High Risk Product? Breakout Session D: What Would be the Appropriate Control Strategy for Medium Risk Products to Ensure Bioperformance
5:00 PM – 5:15 PM Day 1 Closing Remarks	Speaker: Helena Engman, PhD Senior Principal Scientist, ADME Sciences, Seda Pharmaceutical Development Services	Presentation (PDF)

Top