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Biomarker Assay Development - Main Conference

Conference Proceeding CD Now Available
  • Speaker Presentations
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Day 1 | Day 2 | Day 3

Monday, January 31, 2011


Main Conference

12:00 -1:45 pm Main Conference Registration

1:45 Welcoming Remarks

Tanuja Koppal, Ph.D., Conference Director



1:50 Chairperson’s Opening Remarks

William Mattes, Ph.D., Principal Consultant, PharmPoint Consulting

2:00 Pre-Clinical Hepatotoxicity Biomarker Discovery

William Salminen, Ph.D., DABT, Director of the Center for Hepatotoxicity, U.S. FDA National Center for Toxicological Research

This presentation will provide an overview of a multiple -omics (genomics, proteomics, and metabolomics) approach being applied at the US FDA NCTR to facilitate the identification of idiosyncratic hepatotoxicants. It is hypothesized that by using more sensitive multiple -omics endpoints, biomarkers will be identified that allow better prediction of idiosyncratic hepatotoxicants in pre-clinical species. The results from this study will be published in the public domain to facilitate the identification of new biomarkers.

2:30 Alzheimer's Disease Biomarkers: Impact from Drug Discovery through Phase III

Mary J. Savage, Ph.D., Research Fellow, Molecular Biomarkers, Merck & Co.

The amyloid peptide biomarker has advanced several drug discovery targets including secretase inhibitors and immunotherapy approaches into clinical trials.  This peptide manifests in several forms, both monomer and multimer and the nature of the toxic species is still not fully understood, nor is the mechanism by which it participates in the etiology of Alzheimer's Disease.  Several clinical trials have initiated and some have stopped, affecting this biomarker to varying degrees.  Data will be presented to describe some pitfalls in using the amyloid peptide as a biomarker to measure either acute drug responses or as a surrogate for efficacy in the clinic.  The evolution of this peptide measure as a prognostic marker will also be discussed.

3:00 Networking Refreshment Break with Exhibit and Poster Viewing


Safety Biomarkers in Action: Pre-Clinical to Clinical Translation

Calvert Louden, M.D., Senior Director of Pathology, Johnson & Johnson Pharmaceuticals

In toxicology (safety) the paradigm of mechanisms, models and markers is relevant to both safety and efficacy. However, the challenges for safety are significant and there is a strong emphasis to develop and employ new Safety Biomarkers (SBM). These new SBMs could contribute significantly to these challenges and be more informative if they can (1) distinguish between adaptive and toxic response (injury); (2) be predictive as well as diagnostic for injury that is minimal, progressive or reversible; (3) influence the selection of monitorable safety biomarkers for Phase 1 and beyond; (4) provide insights into the possible mode of action/mechanism of toxicity.



Topic 1:  To be Announced

Moderator:  Calvert Louden, M.D., Johnson & Johnson Pharmaceuticals


Topic 2:  Mass Spectrometry-based Biomarker Assays in the CLinical Lab: Pro or Con

Moderator:  Samir Hanash, M.D., Ph.D., Fred Hutchinson Cancer Research Center


Topic 3:  Quantifying and Validating Biomarkers in Biofluids that Lack ENdogenous Controls

Moderator:  William Salminen, Ph.D., DABT, U.S. FDA National Center for Toxicological Research


Topic 4:  Biomarker Uses:  Internal Decision-Making Only, or for Regulatory Use?

William Mattes, Ph.D., Principal Consultant, PharmPoint Consulting


Topic 5:  Biomarkers for Development of Biologics

Moderator:  Thomas Bocan, Ph.D., Senior Director, Head of BioImaging Center, Pfizer, Inc.

5:30 Opening Reception with Exhibit and Poster Viewing

6:30 pm End of Day One


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