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Predicting Drug Off-Target Protein Binding to Hypothesize Mechanisms for Safety Issues

Track:
Nonclinical and Translational Development/Early Phase Clinical Development

Day & Time:
June 18, 3:30PM - 5:00PM (Pacific Standard Time)

Session Number:
382

Room Number:
7B

Level:
Intermediate

Type:
Session

Title:
Predicting Drug Off-Target Protein Binding to Hypothesize Mechanisms for Safety Issues

Chair(s):
Keith K. Burkhart, DrMed
Senior Advisor, Medical Toxicology, OCP, CDER
FDA, United States

Description:
A new technology predicts a drug’s binding to protein ligands, potentially identifying off-target actions. Preclinical case studies and a postmarket analysis of drug-induced serotonin syndrome are presented.

Learning Objective(s):
Discuss new technology that predicts off-target drug-protein binding; Describe applications for use throughout a drug’s life cycle; Demonstrate a biological plausibility analysis for serotonin syndrome.

Presentation(s) & Speaker(s):
Use of In Silico Approach for Safety Assessment of Clinical Candidates: Mitigation and Management for Clinical Drug Positioning
Laszlo A. Urban, DrSc, MD, PhD
Global Head, Preclinical Safety Profiling
Novartis Institutes for BioMedical Research, Inc., United States

Predicting Secondary Pharmacology from Drug Off-Target Networks
Michael J. Keiser, PhD
Assistant Professor, UCSF; Founder
Seachange Pharmaceuticals Inc, United States

Use of In Silico Protein Binding Predictions in Postmarket Safety Signal Analysis and Biological Plausibility
Keith K. Burkhart, DrMed
Senior Advisor, Medical Toxicology, OCP, CDER
FDA, United States