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Specific Populations
Symposia

Symposium 3: Assessing the Impact of Obesity During Drug Development: What Can We Do Better?

Sunday, September 8, 2024
1:30 PM – 3:00 PM ET
Location:Grand Ballroom A-D
CE: 1.5

Target Audience:

The target audience for this Symposium is clinical researchers (Phase 1 through 4) and regulatory professionals (PhD, PharmD, MD, RN, MS) involved in clinical trial design and conduct and clinical care (MD, PA, NP, RN) involved in patient care that treat obese individuals.



Description:

Obesity remains a national health crisis and a growing concern worldwide. Concerningly, obese individuals are at an increased risk for comorbid diseases that include, but are not limited to, hypertension, diabetes, cardiovascular disease and cancer. In addition, beyond the risk for developing these conditions, obesity may also impact the pharmacological activity of the therapies being used to treat them and other disease states. The pharmacokinetics, pharmacodynamics, safety and efficacy of therapies, both currently marketed and under clinical development, may be directly impacted by the alteration in body composition and physiology that can occur secondary to chronic excess body weight. This Symposium will address several important viewpoints, clinical, clinical drug development, modeling & simulation and regulatory sciences, that play a direct role in our understanding of this disease state and its importance in drug development and clinical care.

Goals & Objectives:

Following the completion of this activity, the learner will be able to:
  • Define obesity, common comorbidities and physiological changes relevant to drug disposition and describe the current approach to drug dosing in obesity in the clinic;
  • Discuss the current state of US FDA labeling related to obesity and explain how US FDA Guidance affects the inclusion of obese patients in drug development clinical trials;
  • Explain the historical overview of obese population inclusion in clinical studies, the importance of including obese patients in clinical drug development and how mechanistic modeling approaches can be applied.

Presentations:

  • Assessing the Impact of Obesity During Drug Development: A Clinical Perspective

    Faculty: Walter K. Kraft, MD (he/him/his) – Thomas Jefferson Univ

  • Application of Mechanistic Modeling for Assessment of Pharmacokinetics in Obese Patients

    Faculty: Karen Rowland Yeo, PhD – Certara UK Ltd

  • Panel Discussion 1

    Co-Chair & Faculty: Kenneth T. Moore, PhD (he/him/his) – Janssen Scientific Affairs LLC, a Johnson & Johnson Co

  • Regulatory Guidance Impacting the Inclusion of Obese Patients in Clinical Trials

    Faculty: Gilbert J. Burckart, PharmD – US Food & Drug Administration

  • Inclusion of Obese Participants in Clinical Studies

    Co-Chair & Faculty: Suneet Shukla, PhD (he/him/his) – Boehringer Ingelheim Pharmaceuticals Inc

  • Panel Discussion 2

    Co-Chair & Faculty: Suneet Shukla, PhD (he/him/his) – Boehringer Ingelheim Pharmaceuticals Inc

  • Discussion, Questions & Answers, Learner Feedback & Evaluations