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Session 7BC: Predicting Clinical Safety from Nonclinical Data: Case Studies
Session Chair(s)
Arthur A. Levin, PHD
Distinguished Scientist, Avidity Biosciences, 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)
Barbara Wilcox, PHD
Pharmacologist, OMPT, ODEI, DNP, OND, CDER, FDA, United States
Session Co-Chair
John A. Vest
Senior Director, Clinical Development, Alnylam Pharmaceuticals, Inc., United States
Using Nonclinical Data to Interpret Clinical Safety Signals
Andreas Dieckmann, PHD
Senior Principal Scientist, F. Hoffmann-La Roche , Switzerland
A Sensitive In Vitro Screening Approach to Assess the Hybridization-Dependent Toxic Potential of High Affinity Single Stranded Gapmer Oligonucleotides
Xuan Chi, PHD
Supervisory Pharmacologist, CDER, FDA, United States
Regulatory Application of a Nonclinical Database for Oligonucleotide Therapeutics at FDA
Panel Discussion
, All Session Speakers, United States
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