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Clinical Trial Designs
Symposia

Symposium 4: Advances in Improving Pediatric Therapeutic Response

Sunday, September 8, 2024
3:30 PM – 5:00 PM ET
Location:Grand Ballroom A-D
CE: 1.5

Target Audience:

The target audience for this Symposium is clinical pharmacologists, pharmacokinetic/pharmacodynamic specialists, drug metabolism scientists, regulatory and pharma employees, and general pediatric practitioners.



Description:

Gaining insights into drug exposure-response relationships in pediatric patients is challenging for several reasons, including limited data from clinical trials during the drug development process and difficulties collecting objective response data, particularly in younger patients. The Symposium will present several new approaches for investigating exposure-response relationships in pediatrics, including new insights from an exposure matching, computer-engineering and clinical perspective into the consequences of variability in drug response in a clinical setting. Topics that will be covered will include exposure-response and disease similarity between adults and pediatrics in schizophrenia and Bipolar I disorder, machine learning and wearables related to predicting response to therapeutic interventions in children and adolescents with depression and disruptive behaviors, and model-informed precision dosing (MIPD) to individualize the dose to a target exposure to identify different responder phenotypes within a population of patients with Attention Deficit Hyperactivity Disorder.

Goals & Objectives:

Following the completion of this activity, the learner will be able to:
  • Identify the strengths and weaknesses of exposure-response modeling in children and adults;
  • Recognize the potential for wearable technology to assess therapeutic response;
  • Explain the potential for model-informed precision dosing to uncover discrete drug response phenotypes in patients.

Presentations:

  • Advances in Improving Pediatric Therapeutic Response: The Role of Exposure Matching

    Co-Chair & Faculty: Catherijne A.J. Knibbe, PharmD, PhD, FCP – St Antonius Hosp/Leiden Univ

  • Model-informed Drug Development for Pediatric Patients With Psychiatric Disorders

    Faculty: Hao Zhu, PhD (he/him/his) – US Food & Drug Administration

  • Application of Machine Learning & Wearable Devices to Predict Therapeutic Response in Children With Behavioral Disorders

    Faculty: Arjun Athreya, MS, PhD – Mayo Clinic

  • Exposure Escalation Studies to Identify Distinct Response Phenotypes in Attention Deficit Hyperactivity Disorder

    Co-Chair & Faculty: Steve Leeder, PharmD, PhD (he/him/his) – Children's Mercy Kansas City

  • Discussion, Questions & Answers, Learner Feedback & Evaluations