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Click here to view the Q&A from Day 1 (February 28, 2024)
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Click here to view the recordings from Day 1 and Day 2 (February 28-29, 2024)
| Day 1 – February 28, 2024 |
| Session 1: Background and Introduction |
| Welcome & Workshop Objectives Gilbert J. Burckart, Pharm.D., US Food and Drug Administration |
| Patient Centric Pediatric Product Development: A Caregiver Perspective M. Petrea Cober, PharmD., BCNSP, BCPPS, FASPEN, Northeast Ohio Medical University, College of Pharmacy |
| Overview: Challenges in Pediatric Drug Product Development and Potential for Using Biorelevant Dissolution Testing Hardikkumar Patel, Ph.D., M.S., US Food and Drug Administration |
| Current Landscape of Pediatric Biorelevant In Vitro Dissolution Testing Sandra Klein, Ph.D., University of Greifswald |
| Biorelevant Dissolution Enabling Pediatric Formulation Selection/Optimization Andrea Moir, AstraZeneca |
| Session 2: Knowledge Gaps and Challenges in PBBM for Pediatric Oral Formulation Development |
| Pediatric Ontogeny Related to Pediatric Oral Drug Absorption [slides not available]Valentina Shakhnovich, MD, Ironwood Pharmaceuticals |
| Current Approaches Towards Leveraging PBBM to Predict Performance of Pediatric Formulation Across Different Age Groups [slides not available]David Good, Ph.D., Bristol Myers Squibb |
| PBBM to Assess Food Effect in Pediatric Patients Neil Parrott, M.Sc., F Hoffmann LaRoche |
| Session 3: Application of PBBM to Support Pediatric Oral Formulation Development |
| Physiologically Based Pharmacokinetic Absorption Modeling for Bioequivalence Evaluation in Adult and Pediatric Populations Fang Wu, Ph.D., US FDA |
| Evaluation of Absorption-Mediated Drug-Drug Interactions in the Pediatric Population [slides not available]Daniel Gonzalez, PharmD, Ph.D., Duke University |
| BREAKOUTS |
| Day 2 – February 29, 2024 |
| Welcome & Workshop Objective- Day 2/ Review of Day 1 Breakouts Andreas Abend, Ph.D., Merck & Co., Inc. |
| Session 4: Current Trends in Formulation Development |
| Trends and Challenges with the Development of Pediatric Formulations after the Implementation of the Current Regulations: Industry Perspective David Harris, Ph.D., Merck & Co., Inc. |
| Current Trends and Experience with the Development of New Pediatric Drugs after the Implementation of Regulations: Regulatory Perspective Lynne Yao, MD, U.S. Food and Drug Administration |
| “In-use” Dosing Practices: Risks and Opportunities/Food-Drug Design Space [slides not available] Nikoletta Fotaki, Ph.D., University of Bath |
| Session 5: Challenges in the Assessment of Pediatric Formulation Quality: In-use and Lifecycle Management |
| Current Regulatory Expectations of Assessing In-Use Stability of Solid Oral Dosage Forms to be Mixed with Foods Proposed in Product Label Julia Pinto, Ph.D., U.S. Food and Drug Administration |
| Unique Elements of the Pediatric Quality Target Product Profile (QTPP) Daniel Schaufelberger, Ph.D., NGT BioPharma Consulting LLC |
| Forging New Partnerships to Advance Pediatric Formulations Development: An Overview of NIH Resources Spanning the Formulation Development Lifecycle James E. Cummins, Jr., Ph.D, National Institutes of Health |
| Session 6: In-Silico Enabled Assessment of PK Performance and Pediatric Lifecycle Management |
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| BREAKOUTS |