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The Consortium

Principal Investigator

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Thomas Hartung, MD PhD is Professor of Toxicology (Chair for Evidence-based Toxicology), Pharmacology, Molecular Microbiology and Immunology at Johns Hopkins Bloomberg School of Public Health, Baltimore, and University of Konstanz, Germany. He also is Director of their Centers for Alternatives to Animal Testing (CAAT, http://caat.jhsph.edu) with the portal AltWeb (http://altweb.jhsph.edu). CAAT hosts the secretariat of the Evidence-based Toxicology Collaboration (http://www.ebtox.com) and the industry refinement working group. As PI, he heads the Human Toxome project funded as an NIH Transformative Research Grant. He is the former Head of the European Center for the Validation of Alternative Methods (ECVAM), Ispra, Italy and has authored more than 370 scientific publications.

Co-Investigators

Melvin E. Andersen, PhD, DABT, CIH, is The Charles Hamner Distinguished Fellow and Associate Director, The Institute of Chemical Safety Sciences at The Hamner Institutes for Health Research, Research Triangle Park, NC. Over a 40-year toxicology career, he has worked in the federal government (US Navy, Department of Defense and EPA), private industry (ICF Kaiser) and academia (Colorado State University). He has over 400 published papers and book chapters in a research career that has primarily focused on computational modeling approaches for dose response and human health risk assessments for environmental chemicals. In June 2002, the Institute for Scientific Information recognized Dr. Andersen was as a highly cited scientist in Pharmacology/Toxicology. Increasingly, his programs at The Hamner are aligned to accelerating implementation of in vitro toxicity testing approaches outlined by the 2007 NAS report, “Toxicity Testing in the 21st Century: A Vision and A Strategy” through the use of case studies with specific toxicity pathways.   He has a PhD in Biochemistry and Molecular Biology from Cornell.  His current research programs related to toxicity pathways and human health safety assessments are noted on The Hamner website.

Kim Boekelheide, MD PhD, is professor of pathology and laboratory medicine at the Brown University. His career has been devoted to understand how the mammalian testis functions and the underlying mechanisms responsible for toxicant-induced testicular dysfunction. Hormones, paracrine signaling factors, signal transduction processes, and intracellular response pathways are the key cellular and molecular regulators of this wonderfully complex system responsible for spermatogenesis. With expertise in high throughput techniques, and the biology and toxicology of endocrine disruption, he is excited to contribute to this breakthrough in toxicity testing. As a member of the National Academy of Sciences committee that produced Toxicity Testing in the Twenty-first Century: A Vision and a Strategy, thought long and hard about toxicity testing, and know that a transformative change is inevitable. We currently rely on 20th century technologies that are too slow, too expensive, and fail to take advantage of the ongoing revolution in biology. With the new technologies and bioinformatics tools implemented in this project, we can shift the paradigm of toxicity testing by using the example of endocrine active chemicals to fully characterize the responsible toxicity pathways, and develop a robust mechanistic explanation of toxicant action.

Albert J. Fornace Jr., MD, is the Molecular Cancer Research Chair at Lombardi Comprehensive Cancer at Georgetown, was previously Director of the John B. Little for the Radiation Sciences and Environmental Health at Harvard, and earlier led the Gene Response Section at NCI. He is a highly cited researcher in stress-signaling mechanisms including discovery of the gadd gene group of growth-arrest and DNA-damage inducible genes such as GADD45A, and characterization of pathways involved in cell cycle control, tumor suppression, and apoptosis. His group has pioneered the use of transcriptomics and more recently metabolomics approaches for stress signaling applications with relevance to radiobiology, oncology, and molecular toxicology. In case of the latter, his laboratory has developed a transcriptomics approach for assessment of genotoxicity of pharmaceuticals and environmental agents, and this approach has been favorably reviewed at the FDA.

Russell S. Thomas, PhD,  is the director of the National Center for Computational Toxicology at the U.S. Environmental Protection Agency. Dr. Thomas’ academic training includes a B.A. in chemistry from Tabor College, an M.S. in radiation ecology and health physics from Colorado State University, and a Ph.D. in toxicology also at Colorado State. Following his doctoral studies, Dr. Thomas performed postdoctoral research in molecular biology and genomics at the McArdle Cancer Research Laboratory at the University of Wisconsin. Prior to coming to the U.S. EPA, Dr. Thomas was the director of the Institute for Chemical Safety Sciences at The Hamner Institutes for Health Sciences. Dr. Thomas also maintains an adjunct faculty appointment in the Division of Pharmacogenomics and Individualized Therapy at the University of North Carolina at Chapel Hill. Academic and professional honors of Dr. Thomas include the Agilent Thought Leader Award (2011), Society of Toxicology Achievement Award (2009), Honorable Mention for Society of Toxicology Board of Publications Best Paper Award (2009), Best Papers Advancing the Science of Risk Assessment by the Risk Assessment Specialty Section (2007, 2008, and 2011).

Michael V. Rosenberg, Ph.D. is a Director of Bioinformatics at Agilent Technologies Inc. where his responsibilities include development of analyses and visualizations tools for GeneSpring, Agilent premier bioinformatics software package, scientific collaborations and strategic planning. Prior to joining Agilent Dr. Rosenberg held several research and management positions in biotechnology and pharmaceutical industry. He served as Director of Professional Services at Rosetta Inpharmatics LLC, a wholly owned subsidiary of Merck and Co. Inc., Head of Bioinformatics at Biogen IDEC and Head of Sequencing Bioinformatics at Sanofi Aventis. Dr. Rosenberg earned his M.Sc. in physical chemistry and Ph.D. in biophysics of enzyme catalysis. He completed his postdoctoral training in molecular and developmental genetics at Brandeis University, Whitehead Institute and Massachusetts General Hospital where he developed novel genome mapping technologies, participated in sequencing human Y chromosome as part of Human Genome project and cloned several disease-associated genes in humans and model organisms. Dr. Rosenberg authored a number of scientific publications and patents, his interests are focused on developing novel computational biology tools enabling high-throughput omics research.

James Yager, PhD, is an expert on the mechanisms of estrogen carcinogenesis. His laboratory has focused on investigation of the mechanisms of estrogen carcinogenesis since 1978. These studies began with studies on the mechanisms of ethinyl estradiol (EE) induced hepatocarcinogenesis stimulated by the reports of the appearance of hepatocellular tumors in women who had taken the first generation of oral contraceptives containing EE. Since the mid 1990s his laboratory has focused on the mechanisms of sporadic breast cancer associated with estrogen exposure. Over the course of these investigations Dr. Yager and colleagues made a number of significant observations pertaining to the multiple mechanisms involved in estrogen carcinogenesis. Their studies provided strong support for a direct role of the estrogen receptors in the induction of mitochondrial gene expression through import into mitochondria and the enhanced activation of ER signaling via MAPK by cadmium. These studies contributed significantly to understanding the complexity of estrogen receptor mediated signaling processes. Dr. Yager’s research has also addressed the role of the oxidative metabolism of estradiol to catechols and then genotoxic quinones that cause oxidative DNA damage and the formation of depurinating adducts with adenine and guanine, as risk factors for breast cancer. Dr. Yager has served on a variety of research-related advisory boards and review panels, including various NIH grant, program project, center and doctoral training program review panels. He was a member of the National Academies of Science Committee on ‘Toxicity Testing and Assessment of Environmental Agents’ that published two reports, the second of which, “Toxicity Testing in the 21st Century: A Vision and A Strategy” presented a new, innovative paradigm for the toxicity testing process in the context of risk assessment.