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Symposia

Symposium 12: Towards Optimal Dosing in Malnutrition: Innovations for Improved Health Outcomes

Tuesday, September 10, 2024
8:00 AM – 9:30 AM ET
Location:Grand Ballroom A-C
CE: 1.5

Target Audience:

The target audience for this Symposium is graduate students, postdoctoral fellows/trainees and early-stage career professionals, as well as advanced professionals working in clinical trial design, implementation, execution and analysis. The Symposium is interdisciplinary for all healthcare professions and across work settings for academia, industry, regulatory agencies and clinical settings.



Description:

Malnutrition, specifically undernutrition, is a major public health problem, mostly affecting the global south. Current estimates from the World Health Organization suggest that approximately 462 million adults worldwide are underweight, while an estimated 155 million children under the age of 5 years are suffering from stunting. Malnutrition is associated with physiological changes affecting drug disposition and pharmacokinetics. Specifically in pediatrics, malnutrition as a comorbidity in diseases such as tuberculosis, HIV and cancer has been linked to poor disease outcomes. Given that drug dosing guidelines for most diseases have been established from evidence generated from clinical trials conducted in the global north countries, where such populations with malnutrition might be fewer and since clinical trials often exclude this vulnerable population, optimizing treatment in this population remains a challenge, particularly in the context of low-income countries. Clinical pharmacology studies and modeling & simulation approaches can help characterize pharmacokinetics (PK) of drugs and optimize dosing in malnourished patients. This Symposium will highlight some of the current impactful research done in this area and will bring together stakeholders from the clinical pharmacology community to discuss the challenges associated with providing optimal dosing for this population.

Goals & Objectives:

Following the completion of this activity, the learner will be able to:
  • Identify the importance of clinical evaluations to characterize the PK and optimize dosing in malnourished populations;
  • Apply novel model-informed methodology, such as population PK analysis, and physiologically-based PK modeling which could prospectively provide dosing recommendations for key drugs utilized in this population.

Presentations:

  • Drug Dosing in Malnourished Patients: Unmet Need & Current Practices

    Co-Chair & Faculty: Meenakshi Srinivasan, PharmD (she/her/hers) – GSK plc

  • Assessing the Impact of Malnutrition on Pediatric Dosing Needs through Population PK: Lessons from Global Health & Infectious Diseases

    Faculty: Rada Savic, PhD (she/her/hers) – Univ of California San Francisco

  • Informing Dosing in Malnourished Pediatrics by Applying Physiologically-based Pharmacokinetic Modeling

    Faculty: Erik Sjögren, PhD – Pharmetheus ab

  • Integrated Pharmacokinetic-Pharmacodynamic-Metabolomic Approaches to Evaluate the Impact of Malnutrition in Childhood Cancers: A Perspective from South Asia

    Co-Chair & Faculty: Vikram Gota, MD – Advance Ctr for Treatment Research & Education in Cancer, Tata Memorial Ctr

  • Discussion, Questions & Answers, Learner Feedback & Evaluations