2025 ACCP Virtual Journal Club Webinar-June | Driving Efficiency: Leveraging Model-Informed Approaches in 505(b)(2) Regulatory Actions - Live
Includes a Live Web Event on 06/10/2025 at 12:00 PM (EDT)
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2025 ACCP Virtual Journal Club Webinar: Driving Efficiency: Leveraging Model-Informed Approaches in 505(b)(2) Regulatory Actions - LIVE
Live Session: Tuesday, June 10th, 2025, from 12:00 to 1:00 PM ET
On Demand: June 10th, 2025 to June 10th, 2028
Why is this webinar important to your practice?
This webinar will explore how model-informed drug development (MIDD) techniques are being used to support regulatory approval of new products through the 505(b)(2) pathway. Through detailed case studies, learners will gain practical insight into how the US Food & Drug Administration has accepted model-based justifications for dosing, safety and efficacy, using examples involving fixed-dose combinations, high-potency opioid antagonists and dose optimization in renal or hepatic impairment. Learners that complete this event will understand the significance of model-informed approaches in drug development and regulatory decisions associated with 505(b)(2) submissions.
Target Audience:
Interprofessional team of Physicians, Pharmacists, PhDs and other healthcare professionals interested in the application of MIDD in regulatory applications.
Learning Objectives
After completing this activity, the learner will be able to:
- Describe applications of model-informed approaches that have been utilized to provide evidence of effectiveness;
- Explain how model-informed approaches have been applied to optimize dosing in patient subgroups;
- Explain how a model-informed approach has been used to inform policy.
Vishnu Sharma
Staff Fellow, Pharmacometrics
US Food & Drug Administration
Vishnu Sharma is a Staff Fellow in the Office of Clinical Pharmacology at the US Food and Drug Administration. His research interests include leveraging quantitative model-based platforms in diverse therapeutic areas such as neuroscience, rare diseases, cardiology, nephrology, hepatology and gastroenterology. Prior to his current role, he served as a senior scientist in quantitative pharmacology at EMD Serono (as part of Merck KGaA in Germany) and contributed as a postdoctoral fellow at the University of Florida. He holds a Ph.D. in Pharmaceutical Sciences from Temple University and a Graduate Certificate in Statistics from Texas A&M University.
Jiexin Deng
Yellow-River Scholar
Henan University
Jiexin (Jason) Deng received a PhD in pharmacometrics from the University of Florida Center for Pharmacometrics & Systems Pharmacology. After completing a PhD, Dr. Deng worked for 5 years in Pfizer's clinical pharmacology group for rare diseases. Currently, he is a Yellow-River scholar at Henan University in Kaifeng, China, which is a research position for attracting high-level talent from outside Henan University. Apart from serving as a member of the Education Committee at ACCP, Dr. Deng also serves as a member of the Quantitative Pharmacology Professional Committee of the Chinese Pharmacological Society.
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