This collaborative workshop was hosted by the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) and the U.S. Food and Drug Administration (FDA).
The presentation slides are available for download below, and the recordings of each presentation are accessible online.
FDA’s Division of Pediatrics and Maternal Health in collaboration with the Division of Anesthesiology, Addition Medicine, and Pain Medicine (DAAP) and the University of Maryland CERSI, hosted this two-day public workshop. The purpose of this public workshop was to discuss the current state of therapies to treat acute pain in children, identify data gaps, and consider methods to improve the current drug development paradigm for acute pain in patients under two years of age (e.g., use of pediatric extrapolation, and novel clinical trial designs). The workshop was designed to focus on drugs with well-established mechanisms of action (NSAIDs, acetaminophen, local anesthetics, opioids), rather than drugs with novel mechanisms of action.
Wednesday, October 13, 2021
10:00 a.m. – 1:30 p.m. ET
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Welcome & Introduction: Setting the Scene |
Lily Mulugeta, Pharm.D. |
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General Landscape of Extrapolation of Efficacy in Pediatric Drug Development and Ethical Considerations in Pediatric Drug Trials |
Beth Durmowicz, M.D. Office of Pediatric Therapeutics, FDA |
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Development of Nociception and Pain |
Suellen Walker, Ph.D. |
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Pain Epidemiology in Neonates and Infant Patients Types of pain encountered in each age cohort as compared to older pediatric patients, number of patients available for clinical trials, etc. |
Ricardo Carbajal, M.D. |
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Developmental Pharmacology of Analgesics What do we know about maturation of targets? Are there maturation-related changes to drug disposition or targets that may suggest need for lower or higher drug exposures in this age group to achieve response similar to older pediatric patients? |
Chris McPherson, Pharm.D. |
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Extrapolation of Adult Efficacy Data to Pediatric Patients Given the available data, is there a biological reason to believe that drugs with well-established MOA (or drugs with well-established MOAs [opioids, acetaminophen, and local anesthetics]) would be less effective at similar concentrations in pediatric patients less than two years of age compared to older children? If so, in which age group and what are the uncertainties? Assessment of PK and safety would be required in all age groups.
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John van den Anker, M.D. |
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Panelists: |
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Charles Berde |
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Thursday, October 14, 2021
10:00 a.m. – 3:00 p.m. ET
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Welcome & Introductory Remarks: Setting the Scene (DPMH) |
Lisa Wiltrout, M.D. |
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Trial Design Considerations for Acute Pain in Neonates and Infants |
Academic Perspective Industry Perspective Regulatory Perspective |
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Outcome Measures in Acute Pain Clinical Trials in Neonatal & Infant Populations |
Monique van Dijk |
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PTN COA Development and PTN/NICHD Trials for Off Patent Drugs |
Kanecia Zimmerman, M.D. |
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Brain-derived Approaches to Assess Neonatal & Infant Pain |
Rebecca Slater, Ph.D. University of Oxford |
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Innovative Trial Designs Including Bayesian Approaches |
Brian Anderson
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Lunch Break
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Considerations for PK/PD Studies |
Amy Cheung, Ph.D. Certara |
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Q&A and Moderated Panel Discussion |
Panelists:
Rigo Roca (FDA), Gerri Baer (FDA), Lynne Yao (FDA), Jinglin Zhong (FDA), James Yates (GSK), Ellen Fields, Edress Darsey (Pfizer), Dina Metwally (UMD), Gary Walco, Kanecia Zimmerman, Tamorah Lewis |
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Closing Remarks/Future Direction |
Lynee Yao, M.D.
FDA
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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 U01FD005946 totaling $25,000 with 100 percent 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.
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