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Scientific Roadmap for the Future of Animal-free Systemic Toxicity Testing Workshop - Biographical Sketches of Speakers

May 30-31, 2013
U.S. Food and Drug Administration's Wiley Building
5100 Paint Branch Parkway
College Park, Maryland 20740

  • Harvey Clewell is the Director of the Center for Human Health Assessment at the Hamner Institutes for Health Sciences.  He is a leading expert on the use of tissue dosimetry and mode-of-action information in chemical safety and risk assessment.  He has a Masters in Chemistry from Washington University, St. Louis, and a PhD in Toxicology from Utrecht University, NL.  His current research focuses on the development of methods for in vitro to in vivo extrapolation of cell-based assays and pharmacokinetic modeling of early life exposures. He is also conducting research on the use of genomic dose- and time-response information to inform chemical risk assessments for various chemicals including arsenic, nickel and naphthalene.  
  • David Dix is Acting Director of the Office of Science Coordination and Policy (OSCP) of the U.S. Environmental Protection Agency (EPA) in Washington DC. OSCP provides coordination, leadership, peer review, and synthesis of science and science policy for EPA’s Office of Chemical Safety and Pollution Prevention, assuring sound scientific decisions and coordinating emerging exposure and hazard assessment topics such as endocrine disruptors. Prior to OSCP, Dr. Dix was Deputy and then Acting Director of EPA’s National Center for Computational Toxicology in Research Triangle Park, NC, and led development of high throughput decision support tools for chemical exposure, hazard and risk. Dr. Dix joined EPA’s Office of Research and Development in 1995 as a scientist in reproductive, genomic and computational toxicology. He is an Adjunct Associate Professor in the Department of Environmental Sciences and Engineering at the University of North Carolina at Chapel Hill. He has a B.S. in Biological Sciences from the University of Illinois, a Ph.D. in Physiology from Rush University in Chicago, and postdoctoral training from the U.S. National Institute of Environmental Health Sciences. He has published over 115 articles, reviews, reports and book chapters, serves on several journal Editorial Boards, and presented at numerous national and international meetings on EPA science.
  • Dr. Alan Goldberg received his bachelor’s degree at the Long Island University-Arnold and Marie Schwartz College of Pharmacy in 1961 and his PhD from the University of Minnesota, Department of Pharmacology in 1966.  After postdoctoral work in microchemistry and a faculty appointment at Indiana University, he moved to the Johns Hopkins University in 1969, where he became Professor in 1978, and was an associate dean (research and technology transfer) from 1984-1999.  As a professor of toxicology, his area of focus was the nervous system, with his major contributions in fundamental aspects of cholinergic biology and radio-enzymatic assay for the measurement of the neurotransmitter acetylcholine.  In the late 1970s, Dr. Goldberg’s work began to focus on in vitro systems.  In 1981, he founded the Center for Alternatives to Animal Testing.

    The Center for Alternatives to Animal Testing is focused on working with industry and government to incorporate the latest technologies and the most humane science in decision-making.  The Center supports the development of new in vitro methods and refinement alternatives that contribute to basic research, product development, and regulatory decisions.  It also provides education to scientists on how one practices the most humane science, aka – the 3Rs of alternatives – refinement, replacement, reduction.

    As a Dean at the Johns Hopkins Bloomberg School of Public Health, Dr. Goldberg was responsible for technology transfer, conflict of interest, and working with the private sector. 

    Dr. Goldberg actively serves on the International Animal Welfare Advisory Boards of Shell, and Procter & Gamble (IAMS), consults with CeeTox (an in vitro toxicology CRO) and chairs their Scientific Advisory Board.  In the non-profit area, he is Chairman of the Management Board of Orange House Partnership (Brussels); has been appointed as a member of the Advisory Board of Faculty for the Department of Institutional Review Ethics and Administration in Nicholas Cardinal Cheong Graduate School for Life, The Catholic University of Korea, (South Korea); is a member of the Alexandra Foundation (Monaco); is a member of the Board of Directors of the Institute for Scientific Communication (ISC); and is on the Toxicology Panel of EFSA (European Food Safety Authority in Parma, Italy).

    He is a leading authority on the creation, development, and validation of alternative toxicological methods and has served on numerous committees for national and international organizations charged with protecting public health. He is the recipient of several awards, including the inaugural Russell and Burch Award in 1991 from the Humane Society of the United States, the Society of Toxicology's Ambassador of Toxicology Award in 1998, the Society of Toxicology's 2001 Enhancement of Animal Welfare Award, and the 2001 Doerenkamp-Zbinden Foundation Award. He is the author of more than 150 scientific articles and editor of numerous books.  During the last several years, Dr. Goldberg was a member of the Pew Commission on the Impact of Industrial (US) Farm Animal Production (, on issues of public health, environment, animal welfare and social justice.  He is currently exploring issues of ethical (fair) foods.
  • Thomas Hartung, 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) with the portal AltWeb. CAAT hosts the secretariat of the Evidence-based Toxicology Collaboration (EBTOX) 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. He has authored more than 370 scientific publications.
  • Thomas Knudsen is a Developmental Systems Biologist at the US Environmental Protection Agency’s National Center for Computational Toxicology (NCCT), where he is a member of the ToxCast research team and leads the Virtual Embryo research project. He trained at Thomas Jefferson University, Children’s Hospital Research Foundation in Cincinnati, and Emory University. He held academic appointments at E Tennessee State University, Jefferson Medical College (tenured professor), and University of Louisville (tenured professor). Dr. Knudsen is a Past-President of the Teratology Society and is Editor in Chief of Reproductive Toxicology. His research on prenatal developmental toxicity and systems biology has led to over 100 scientific papers and book chapters. Dr. Knudsen is an Adjunct Professor at the University of Louisville Birth Defects Center, and is currently filling in as Acting Director of the EPA-NCCT.
  • James McKim graduated with high honors from the doctoral program in biochemical and molecular toxicology at Oregon State University and trained as a postdoctoral fellow at the University of Kansas Medical School. He is a diplomat of the American Board of Toxicology and has served as President of the Michigan Society of Toxicology.

    Dr. McKim has held many positions in his 20 years as a toxicologist. He was Assistant Professor at the University of Colorado School of Medicine where he researched mechanisms underlying liver diseases in children. He was awarded the DowCorning Technical Achievement Award for the research he led as Head of the Biochemical Molecular Toxicology Group on the biological effects of silicone products. At Pharmacia (later Pfizer) he was Director of the Global Center of Excellence for In Vitro Toxicology where he developed and patented algorithms assessing in vivo toxicity risk using in vitro data. Dr. McKim is the Founder and Chief Scientific Officer of CeeTox Inc, a leading CRO in the field of in vitro toxicity screening.

    Dr. McKim has published numerous scientific manuscripts, book chapters and reviews, and is a frequently-requested speaker at conferences and events in the US and around the world.
  • Grace Patlewicz is a chemist/toxicologist by training having obtained a degree in chemistry from the University of Manchester, UK, a Masters in Toxicology from the University of Surrey, UK and a Ph.D. in Organic Chemistry from the University of Santiago de Compostela, Spain.

    Early on in her career she joined Unilever, UK as a safety evaluation scientist before developing a keen interest in computational toxicology and moving to a role which involved providing modeling and chemistry expertise to Unilever’s businesses. As momentum grew in the potential regulatory application of (Q)SARs, she became involved in the OECD activities, such as the efforts to develop (Q)SAR Validation Principles. This prompted a move to the European Commission’s Joint Research Centre, Italy to continue in the development of guidance for the regulatory application of (Q)SARs and chemical categories. She was a lead player in the development of technical guidance for (Q)SARs and chemical categories under REACH. She also coordinated the technical development of software tools such as Toxtree (a tool which encodes the Cramer classification scheme for TTC amongst others) and Toxmatch (a tool for chemical similarity).

    In 2008, she made a return to Industry taking up a position within DuPont in the US. There she acts as the focal point and technical lead for all (Q)SAR, and read-across questions for regulatory purposes and product stewardship. She maintains involvement in the OECD Toolbox effort. As chair of the ACC Computational Profiling & Risk Assessment and Science Workgroup, she acts as the BIAC focal point for Industry’s activities on AOPs within the OECD programme. She also recently successfully chaired the ECETOC TF for read-across and co-organised on behalf of Cefic LRI a workshop on read-across in collaboration with ECHA.
  • Michael Schwarz is Professor of Toxicology and head of the Department of Toxicology in the Institute of Experimental and Clinical Pharmacology and Toxicology in the Medical School of the University of Tübingen, Germany. He has received his Ph.D. in Biology at the University of Tübingen and worked then for almost 20 years at the German Cancer Research Center in Heidelberg before he moved to the University of Tübingen in 1994. His main interest is in chemical carcinogenesis, in particular in the processes underlying tumor promotion. From 2004 onwards he became increasingly involved in projects on alternatives to animal testing. He was coordinator of ReProTect, a EU-framework program 6 funded project aiming to develop novel approaches to predict reproductive toxicity by use of in vitro, in silico and sensor technologies. Since 2004 he was, or still is, partner in the EU-framework program 7 projects CancerSys and ChemScreen, in the IMI-project MARCAR and in the EU/Cosmetic industry funded project COACH, which is a coordination action for the Seurat-1 cluster project working on alternatives to animal testing in the field of repeated dose systemic toxicity. Michael is member of the German MAK commission, which is responsible for the investigation of health hazards and exposure limit setting of chemical compounds in the work area. In 2013 he received the Toxicology Award of the German Society of Experimental and Clinical Pharmacology and Toxicology. 

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