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 AgendaApril 8th, 2011
Federal Research Center at White Oak
U.S. Food and Drug Administration
| 8:30 | Welcome Loftus Lucas, Leadscope |
| 8:45 | A 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 |
| 09:45 | Break: Refreshments and Posters |
| 10:15 | Supporting Safety Assessment of Drug Impurities Using the Ames Assay (Q)SAR Model Kevin Cross, Leadscope and Luis Valerio, FDA/CDER |
| 10:45 | Consensus (Q)SAR Predictions Andreas Czich, Sanofi-Aventis |
| 11:15 | Predicting Phospholipidosis Naomi Kruhlak, FDA/CDER |
| 11:45 | Lunch and Round-Table Discussion: Working Towards a Consensus on Standards for (Q)SAR Regulatory Submissions Dan Benz, FDA/CDER |
| 13:00 | Tox21: An Overview Hongmao Sun, NIH/NHGRI |
| 13:30 | The NIEHS Integrated Prediction Service Glenn Myatt, Leadscope |
| 13:45 | Overview of EU SEURAT-1, Including ToxBank Glenn Myatt, Leadscope |
| 14:00 | Break: Refreshments and Posters |
| 14:30 | SEND and ToxML: A Comparison of Data Formats Lauren Mihalcik, FDA/CDER and David Bower, Leadscope |
| 15:30 | New Leadscope (Q)SAR Carcinogenicity Models Kevin Cross, Leadscope and Edwin Matthews, FDA/CFSAN |
| 16:00 | Leadscope R&D and Future Products Glenn Myatt and Kevin Cross, Leadscope |
| 16:30 | Adjourn |
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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