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Session 7BC: Predicting Clinical Safety from Nonclinical Data: Case Studies
Session Chair(s)
Arthur A. Levin, PhD
Senior Consultant
Levin BioScience, United States
The most fundamental goal of toxicity studies is to predict the safety of drugs in clinical trials. This session will focus on some case-studies of how nonclinical data are being used to avoid adverse effects in clinical trials and how nonclinical data can be used to understand safety signals from clinical trials. In addition, the session features a discussion of the Agency’s database of oligonucleotide therapeutics how the data are collected and being used.
Learning Objective :
Speaker(s)
Session Co-Chair
Barbara Wilcox, PhD
FDA, United States
Pharmacologist, OMPT, ODEI, DNP, OND, CDER
Using Nonclinical Data to Interpret Clinical Safety Signals
John A. Vest
Alnylam Pharmaceuticals, Inc., United States
Senior Director, Clinical Development
A Sensitive In Vitro Screening Approach to Assess the Hybridization-Dependent Toxic Potential of High Affinity Single Stranded Gapmer Oligonucleotides
Andreas Dieckmann, PhD
F. Hoffmann-La Roche , Switzerland
Senior Principal Scientist
Regulatory Application of a Nonclinical Database for Oligonucleotide Therapeutics at FDA
Xuan Chi, MD, PhD
CDER, FDA, United States
Supervisory Pharmacologist
Panel Discussion
All Session Speakers, United States