2024 ACCP Virtual Journal Club Webinar: Model-Informed Approaches to Support Drug Development for Patients With Obesity: A Regulatory Perspective - On Demand

Live Session: Wednesday, October 30^th, 2024, from 1:00 to 2:00 PM ET

On Demand: October 30^th, 2024 to October 30^th, 2027

Why is this webinar important to your practice? 

This presentation incorporates the use of Model-Informed Drug Development (MIDD) approaches to address the unique challenges in drug development and regulatory decision-making for patients with obesity. Given the high prevalence of obesity in the general population, it is essential to identify appropriate drug development strategies with optimal dosing for this patient group. However, the unique physiological and pathological characteristics of the obese population may present hurdles in clinical development programs. This presentation will provide an overview of the impact of obesity on pharmacokinetics, pharmacodynamics and the efficacy of drugs and, more importantly, demonstrate how MIDD approaches are applied at various stages of drug development and regulatory review for patients with obesity, with a focus on dosing regimen optimization, through case studies from recent submissions.  

Target Audience:

Interprofessional team of MDs, PhDs, PharmDs and other health care professionals, including students, trainees and professionals at all levels, who are involved or interested in drug development for patients with obesity.

Learning Objectives

After completing this activity, the learner will be able to:

• Describe the impact of obesity on drug pharmacokinetics, pharmacodynamics and efficacy;
• Identify the unique challenges and opportunities in drug development for patients with obesity;
• Recognize the utility of model-informed drug development in facilitating clinical trial design and regulatory decision-making in patients with obesity.