Workshop: Pediatric Drug Development

Friday, March 24, 2017 - 8:30 am to 5:15 pm
University of California, Washington Center

1608 Rhode Island Ave NW, Washington DC 20036

speaker panel addressing participants in classroom


Regulatory and development experts will engage with participants at this special one day pediatric workshop to acknowledge the unique challenges of pediatric drug development with focus on hot topics for successful pediatric drug development. This workshop will highlight innovative perspectives from top pediatric thought leaders in areas of toxicology, formulation, pharmacokinetics/pharmacodynamics, biostatistics, extrapolation, safety, regulation and operations. In addition, Dr. Lynne Yao, Director of the Division of the Pediatric and Maternal Health at US Food and Drug Administration, will give a “future horizons” keynote talk. This pediatric-focused workshop is open to interested professionals, particularly the medical product developer, reviewer, clinician, scientist, trialist, investor or payer who seeks a survey of innovative pediatric drug development reaching beyond the boundaries of traditional pharmaceuticals. It would be especially valuable to those who plan careers in the field or who work in pediatric drug development.



  • Opening Remarks

    Brian Tseng, MD PhD, Novartis Pharma Corp

  • The Role of Regulatory Policy on the Pediatric Therapies of Tomorrow
    Christina Bucci-Rechtweg, MD, Global Head, Maternal Health and Pediatric Regulatory Policy, Novartis Pharma Corp

  • Toxicology for Pediatric Drug Development
    Karen L. Davis-Bruno, PhD, Associate Director, Pharmacology/Toxicology Staff, Office of New Drugs, Center for Drug Evaluation and Research (CDER), United States Food and Drug Administration (US FDA)

  • Formulation Age-appropriate and Acceptable Pediatric Dosage Forms: Making Medicines Child Size
    Roy Turner, PhD, Technical Project Leader / CMC Leader, Actelion

  • Pediatric Pharmacokinetics/Pharmacodynamics in Drug Development
    Gilbert Burckart, PharmD, Associate Director for Pediatrics, Office of Clinical Pharmacology, CDER, US FDA

  • Panel Discussion
    Speakers above

  • Lunch Keynote - Pediatric Drug Development: Moving Toward the Best Pharmaceuticals for Children
    Lynne Yao, MD, Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER, FDA

  • Statistical Implications of Extrapolation in the Design and Analysis of Pediatric Clinical Trials
    Margaret Gamalo, PhD, Principal Research Scientist, Eli Lilly and Company

  • Extrapolation Modeling & Simulation- Enhancing Pediatric Drug Development Efficiency
    David Wesche, MD PhD, Consultant, Bill & Melinda Gates Foundation/Certara

  • Operational Challenges in Pediatric Drug Development
    Ronald J. Portman, MD FAAP FASN, Executive Director, Pediatric Therapeutic Area, Novartis Pharma Corp

  • Safety in Small Populations - It's a Big Deal: Monitoring Safety in Pediatric Studies and Beyond
    Lisa Bollinger, MD, Vice President, Regulatory Affairs – CMC, Biosimilars, Devices and Pediatrics, Amgen

  • Patient Perspective
    Joseph Akmajian, National Ambassador, Muscular Dystrophy Association

  • Panel Discussion & Conclusion
    Speakers above


How to register


Administrative details

  • No on-site registration; advance registration is required.

  • Enrollment is limited; we encourage you to register well in advance.

Each year, in addition to its course, ACDRS also presents a workshop that is open to all interested parties.

  • The workshop topic changes from year to year. (To be notified of new workshops, email with your request.)
  • It is scheduled so that it is convenient for current ACDRS participants to attend, but you don’t need to be enrolled in ACDRS to attend.

Previous workshop

Substantial Evidence in 21st Century Regulatory Science: Borrowing Strength from Accumulating Data


Please contact