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  4. FDA Grand Rounds: Applied Regulatory Research to Address the Ongoing Opioid Crisis - 10/12/2023
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Webcast

Event Title
FDA Grand Rounds: Applied Regulatory Research to Address the Ongoing Opioid Crisis
October 12, 2023

Date:
October 12, 2023
Time:
12:00 PM - 1:00 PM ET
Image
FDA Grand Rounds 10/12/2023

About the Speakers

Lidiya Stavitskaya

Lidiya Stavitskaya, Ph.D.
Pharmacokineticist
Division of Applied Regulatory Science
Office of Clinical Pharmacology, Office of Translational Sciences
Center for Drug Evaluation and Research (CDER)

Dr. Stavitskaya received her Ph.D. in Pharmaceutical Sciences from the University of Maryland, Baltimore in 2011. She joined Division of Applied Regulatory Sciences (DARS) in Center for Drug Evaluation and Research (CDER), as a Computational Toxicologist in 2014. Dr. Stavitskaya has extensive research experience in the areas of medicinal chemistry and regulatory computational pharmacology and toxicology. Dr. Stavitskaya’s current focus is to improve FDA’s ability to predict drug safety issues and to expand the use of chemical informatics and predictive modeling in safety assessment.

Zhihua Li

Zhihua Li, Ph.D.
Pharmacokineticist
Division of Applied Regulatory Science
Office of Clinical Pharmacology, Office of Translational Sciences
Center for Drug Evaluation and Research (CDER)

Dr. Zhihua Li is the Principal Investigator of several computational biology and quantitative systems pharmacology projects at Division of Applied Regulatory Sciences (DARS). He has been leading the in silico workstream under a global effort to develop a new regulatory paradigm for cardiac safety. He also led the development of translational models to evaluate the effects of opioids and opioid antagonists that informed the development and regulatory decision making for some recent opioid antagonists products.


About the Presentation

According to preliminary data released by the Centers for Disease Control and Prevention, the nation set a new record of over 109,000 deaths from illicit and prescription drug overdose in 2022.  This presentation will focus on computational methods that have been developed to rapidly assess if newly emerging opioids are a risk to public safety and to evaluate dosing strategies for using opioid receptor antagonists.

Learning Objectives

  1. Describe the different computational methodologies that are being applied at the FDA to address the ongoing opioid crisis.
  2. Explain how model-informed approaches have facilitated assessment of newly emerging opioids and opioid antagonist drug development.

Event Materials

Activity Announcement for FDA Grand Rounds – October 12, 2023
Webcast Recording

 
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