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7:30-8:15 Breakfast Workshop or Morning Coffee
(Additional Sponsorships Available. Contact Nicolas Shostak, Manager, Business Development at 781-972-5479 or nshostak@healthtech)


8:30-8:35 Chairperson’s Opening Remarks

8:35-9:05 An Array FDA Efforts in Toxicogenomics
Weida Tong, Ph.D., Director, Center for Toxicoinformatics, National Center for Toxicological Research, FDA
Toxicogenomics (TGx) is identified in the FDA Critical Path document as a major opportunity for advancing medical product development and personalized medicine. An array of TGx efforts has been initiated in FDA to realize the TGx technologies, specifically DNA microarrays, in the regulatory application. In this presentation, the integrated nature of the following FDA efforts will be discussed: (1) The Voluntary Genomics Data Submission (VGDS) program; (2) The Best Practice document; (3) The FDA genomic tool, ArrayTrack; and (4) The MicroArray Quality Control (MAQC) project. VGDS is established to facilitate the communication between the FDA and private sectors on the application of TGx technology in drug development and regulation. MAQC is a community support project and has led by the FDA to address various issues associated with DNA microarrays. The lessens learned from both VGDS and MAQC pave the way for developing the Best Practice document for future voluntary submissions, as well as regular submission of genomic data in FDA. ArrayTrack is an integral part of VGDS and MAQC as a bioinformatics infrastructure to support data management, analysis and interpretation. Importantly, ArrayTrack serves as a vehicle to translate the Best Practice document into the real-world application.

9:05-9:35 To be Announced 

9:35-10:05 Preclinical Biomarkers of Hepatotoxicity: What’s new?
Frances Clemo, DVM, Ph.D., Research Fellow, Drug Safety Research & Development, Pfizer Inc.
In past years, limited biomarkers have been validated for monitoring of hepatotoxicity in animals; therefore, the standard blood biomarkers for liver damage and dysfunction (ALT, AST, ALP, GGT, Tbil, coagulation) are continued to be used. In this presentation, an update on emerging biomarkers for hepatotoxicity will be reviewed. 

10:05-11:00 Coffee Break with Poster and Exhibit Viewing


11:00-11:30 Biomarkers and Barn-Raising: C-Path’s Predictive Safety Testing Consortium as a Community Approach to Assay Validation and Translation
William B. Mattes, Ph.D., Director, Toxicology, The Critical Path Institute
Over recent years, many new biomarkers and pre-clinical assays of drug-induced toxicity have been described in the scientific literature. An unknown number have been developed in companies through internal research. However, the robust application of such biomarkers in both drug development and regulatory decision-making processes depends upon both scientific consensus on and regulatory acceptance of the validity and applicability of such biomarkers. Both these achievements require the development of a large set of data where the biomarker and its assay are examined in a number of studies. This is an endeavor that lends itself to a community effort, indeed, a formal venue for sharing data, assays and samples across multiple pharmaceutical companies; a process for the review of qualification study protocols and data at the FDA; and entry points for application of qualified biomarkers in regulatory decision making. The Predictive Safety Testing Consortium (PSTC) has been organized through the C-Path Institute as a venue for sharing and critically evaluating qualification data from studies using model as well as proprietary compounds. In collaboration with the FDA, the PSTC will share data to support the development of a process for review and acceptance of biomarkers, as well as to define potential regulatory applications of accepted biomarkers. The Consortium has already made progress developing data supporting the use of novel preclinical assays of drug-induced liver, kidney, and vascular injury, as well as carcinogenicity. With a clear understanding of their performance in pre-clinical models the PSTC is now moving towards examining these assays in a clinical setting.

11:30-12:00 Discovery and Validation of Toxicity Biomarkers through Application of Correlation Networks and Canonical Pathways
Alan Higgins, Ph.D, Senior Director, Translational Medicine, Cogenics, Inc., a division of Clinical Data Inc.
The project is taking place under a NIST Advanced Technology Program (ATP) grant involving a partnership between IO Informatics and Icoria (a division of Clinical Data, Inc.). This case study describes how experimental data from multiple sources is analyzed and visualized to detect coherent responses to experimental conditions as correlation networks connecting different (‘omics) analytical modalities. This provides an innovative method for detection and understanding of biomarker activity for toxicity in a systems biology environment. Integration, query and representation of data and knowledge from internal and external sources will be described.

12:00-1:30 Lunch (on your own)


1:30-2:00 NMR Metabolomics: Metabolites, Mechanisms, and Pathways
Qiuwei Xu, Ph.D., Merck Research Laboratories
With a drive to identify novel therapeutic targets, drug development faces a demanding challenge to minimize toxicity. The application of metabolomics to toxicity screening and investigation provides a new paradigm of molecular toxicology. It can contribute to efforts to understand underlying mechanisms of toxicity and reduce failure in late stage drug development. We will discuss NMR-based metabolomics with emphasis on metabolite identification and pathway-oriented mechanistic investigations.

2:00-2:30 Characterization of Multi-Age Rodent Pediatric Models of Toxicity
Laura K. Schnackenberg, Ph.D., Staff Fellow, Division of Systems Toxicology, National Center for Toxicological Research, Food and Drug Administration
Sprague-Dawley (SD) rats (10, 25, 40, 80 days old) at ages that are equivalent to human infants, toddlers, young and mature adults were treated daily with gentamicin (50 or 100 mg/kg, s.c., for 6 or 14 days) or cisplatin (1, 3, or 6 mg/kg, s.c., 1 day) to identify potential differences in pediatric vs. adult susceptibility to renal toxicity. There was an age-dependent sensitivity to gentamicin with 10 and 80>40>25 days old and to cisplatin was 80 and 40>25 and 10 days old. The magnitude of change in gene expression level of a set of nephrotoxicity biomarkers in animals treated with gentamicin and cisplatin correlated with the extent and severity of renal pathology. The levels of urinary biomarkers of nephrotoxicity and evaluation of metabonomic data indicated a distinctly separate and unique pattern for each drug and each age group. These findings indicate that metabonomic studies in multi-age animal models could be used as a means for predicting pediatric drug safety in pre-clinical and clinical studies. 

2:30-3:00 NMR-Based Metabolomics of Immunosuppressant Toxicity After Organ Transplantation
Natalie J. Serkova, Ph.D., Associate Professor, Anesthesiology and Radiology, Cancer Center MRI/MRS Core, University of Colorado Health Sciences Center
In clinical renal transplantation, four distinguished complications occur after organ transplantation: (i) delayed graft function (DGF, due to ischemia/reperfusion injury); (ii) acute rejection; (iii) chronic rejection; (iv) immunosuppressant (cyclosporine) nephrotoxicity. Using high-resolution 1H-NMR (nuclear magnetic resonance) metabolomics on urine and blood of animal models and renal recipients, metabolic markers of early graft dysfunctions versus cyclosporine toxicity were distinguished and validated. Uric acid pathway was a highly specific marker for ischemia/ reperfusion (IR) injury, in addition to a well known medulla injury marker TMAO. In contrast to IR injury after transplantation, the major immunosuppressant cyclosporine, which is known to be nephrotoxic, increased lactate and decreased glutathione blood concentrations, with slightly increased TMAO level. Due to the enormous capability of metabolomics for defining metabolic pathways and detecting metabolic biomarkers, it could soon become a reliable tool to assess graft function and to distinguish between pathophysiologies in clinical transplantation.

3:00 Close of Conference


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