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Clinical Drug Development & Investigations
Symposia

Symposium 3: Novel Approaches for the Prediction of Drug Effects in Children

Sunday, September 10, 2023
1:30 PM - 5:00 PM PT
Location:Grand Ballroom E-H
CE: 3.0

This Symposium will benefit clinical pharmacologists and those working with drugs used in children from both pharmaceutical/biotechnology companies and regulatory agencies, pharmacometricians, clinical researchers and drug development scientists who have an interest in applying and/or currently apply principles of clinical pharmacology to innovate and accelerate optimal drug therapy for pregnant patients. The target audience would include clinical and research faculty from schools and colleges of medicine, pharmacy and nursing, as well as pharmacologists, pharmacists, clinicians or graduate/postgraduate trainees wishing to better understand drug exposure in children.

Goals & Objectives:

Following the completion of this activity, the learner will be able to:
  • Discuss novel approaches that can be used to improve efficiency and feasibility of pediatric studies;
  • Review the challenges and opportunities in pediatric drug development from a preclinical and clinical pharmacology perspective;
  • Demonstrate how preclinical and clinical data together can inform and predict drug effects in children.

Presentations:

  • Novel Approaches for the Prediction of Drug Effects in Children: Can We Move from Pharmacokinetic to Pharmacodynamic Modeling?

    Co-Chair & Faculty: Catherijne J. Knibbe, PharmD, PhD – Leiden Univ

  • Advances in Pharmacodynamic Modeling of Pain & Sedation in Children: Applications of Item Response Theory & Repeated Time to Event Modeling

    Faculty: Elke Krekels, PhD – Leiden Univ

  • How to Proceed to Modelling of Prediction of Effects in Children
  • How Can Partnerships Between Industry, Regulatory & Academia Innovate Drug Development in Children?

    Faculty: Jeffrey Barrett, PhD – Aridhia Digital Research Environment

  • Quantifying Exposure in Breastfeeding Infants to Maternal Medications Using Physiologically-based Pharmacokinetics

    Faculty: Andrea Edginton, PhD – Univ of Waterloo

  • What Do We Need to Optimize Trial Design in Neonatology & Pediatrics: Role of Industry, Academia & Regulatory
  • Faculty Panel Discussion, Questions & Answers, Learner Feedback & Evaluation