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Thursday, June 20 • 8:00am - 9:00am
#407: Leveraging Statistical Approaches in Drug Safety Analysis

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-683-L04-P; CME 1.00; RN 1.00

Safety analyses play a pivotal role in drug development, ensuring the protection of patients while advancing innovative pharmaceuticals to market. This statistical session will discuss the critical aspects of safety analysis including the shortcomings of the way we estimate safety signals today focusing on the incorporation of advanced statistical methodologies for signal detection and wider evaluation of specific events such as adverse events of special interest. Additionally, the session will delve into regulatory considerations and best practices for presenting safety analyses to regulatory agencies. Understanding the expectations and requirements of regulatory bodies is essential for successful drug development, and the session will provide valuable guidance in this regard.

Learning Objectives

Describe key aspects in planning safety analyses, and their pivotal role in ensuring the safety of pharmaceutical products; Discuss regulatory considerations and best practices for presenting safety analyses to regulatory agencies; Identify quantitative assessment and characterization of adverse events of special interest (AESIs) in the drug lifecycle; Discuss the shortcomings of the way we currently estimate safety outcomes and a call to action to change that.

Chair

George Kordzakhia, PhD

Speaker

Industry Update
Melvin Slaighter Munsaka, PhD, MEd, MS

Industry Update
Michael A. Fries, PhD, MA

FDA Update
Cesar Daniel Torres, PhD, MS


Speakers
GK

George Kordzakhia

Statistical Sciences Senior Director, AstraZeneca, United States
M.S Applied Mathematics, Purdue University, 1998 Ph.D. Statistics, University of Chicago, 2003 VIGRE Assistant Professor, UC Berkeley, 2003-2006 Mathematical Statistician, FDA, 2006-2021 Statistical Sciences Senior Director, Astra Zeneca, 20022-2024
MF

Michael Fries

Head, Biostatistics, CSL Behring, United States
Michael has been the head of biostatistics at CSL Behring since 2022. He has worked in the industry since 1999. He has also held several academic appointments, including a Visiting Assistant Professor at the School of Computer Science and DePaul University. Michael is a workstream... Read More →
avatar for Melvin Munsaka

Melvin Munsaka

Senior Director, Head Safety Statistics, AbbVie, United States
Melvin S. Munsaka is a Senior Director and Head of the Safety Statistics at AbbVie in the Statistical Sciences and Analytics Department. He has a PhD in Mathematical Statistics from Queen’s University in Canada. He has been in the industry for more than 25 years. He co-leads the... Read More →
avatar for Cesar Torres

Cesar Torres

Senior Mathematical Statistician, OB, OTS, CDER, FDA, United States
Cesar received his B.S. in Probability & Statistics at the University of California, San Diego, before completing his graduate studies at the University of Washington’s Department of Biostatistics. He now works at the FDA’s Center for Drug Evaluation and Research as a reviewer... Read More →

Thursday June 20, 2024 8:00am - 9:00am PDT
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  01: ClinSafety-PV, Session |   11: Statistics-Data Science, Session