JSM 2012 Online Program

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*542 !**	Wed, 8/1/2012, 2:00 PM - 3:50 PM	CC-Room 22
Progress in Pre-Clinical Safety Biomarker Qualification in the Predictive Safety Testing Consortium (PSTC): An FDA Critical Path Initiative — Invited Papers
Biopharmaceutical Section
Organizer(s): Xiaoyu Jiang, Novartis Institutes for BioMedical Research
Chair(s): Xiaoyu Jiang, Novartis Institutes for BioMedical Research
2:05 PM	Observational Study to Determine Reference Ranges for Novel Renal Biomarkers in Healthy Volunteers — Jaromir Mikl, Boehringer Ingelheim Pharmaceuticals, Inc.
2:25 PM	Statistical Methods for Biomarker Performance Evaluation — David Raunig, ICON Medical Imaging
3:05 PM	Kidney Toxicity Biomarker Qualification: A Journey Along the Critical Path — Dan Holder, Merck Research Laboratories
3:25 PM	Lessons Learned from the Carcinogenicity Working Group: From Biomarker Discovery to Predictive Modeling — Alex Adai, Asuragen, Inc.
3:35 PM	Discussant: Sue-Jane Wang, FDA
3:45 PM	Floor Discussion

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