FDA Symposium: On the Use of Leadscope Tools, QSAR Models and Databases at FDA/CDER Federal Research Center at White Oak U.S. Food and Drug Administration

Tentative Agenda
April 8th, 2011
Federal Research Center at White Oak
U.S. Food and Drug Administration

8:30Welcome
Loftus Lucas, Leadscope
8:45A Brief History of (Q)SAR Computational Toxicology at FDA/CDER
Dan Benz, FDA/CDER
9:15 am(Q)SAR Approaches for Drug Impurities
Mark Powley, FDA/CDER
09:45Break: Refreshments and Posters
10:15Supporting Safety Assessment of Drug Impurities Using the Ames Assay (Q)SAR Model
Kevin Cross, Leadscope and Luis Valerio, FDA/CDER
10:45Consensus (Q)SAR Predictions
Andreas Czich, Sanofi-Aventis
11:15Predicting Phospholipidosis
Naomi Kruhlak, FDA/CDER
11:45Lunch and Round-Table Discussion: Working Towards a Consensus on Standards for (Q)SAR Regulatory Submissions
Dan Benz, FDA/CDER
13:00Tox21: An Overview
Hongmao Sun, NIH/NHGRI
13:30The NIEHS Integrated Prediction Service
Glenn Myatt, Leadscope
13:45Overview of EU SEURAT-1, Including ToxBank
Glenn Myatt, Leadscope
14:00Break: Refreshments and Posters
14:30SEND and ToxML: A Comparison of Data Formats
Lauren Mihalcik, FDA/CDER and David Bower, Leadscope
15:30New Leadscope (Q)SAR Carcinogenicity Models
Kevin Cross, Leadscope and Edwin Matthews, FDA/CFSAN
16:00Leadscope R&D and Future Products
Glenn Myatt and Kevin Cross, Leadscope
16:30Adjourn

Email Us if you would like to attend.


The FDA is very pleased to sponsor this gathering of experts to discuss promising new scientific methodologies; however, the meeting should not be construed as an announcement of FDA guidance or regulations, or a FDA endorsement of Leadscope, Inc. products.
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