Introduction for TestSmart--A Humane and Efficient Approach to Screening Information Data Sets (SIDS) Data

April 26-27, 1999
Hyatt Fair Lakes
12777 Fair Lakes Circle
Fairfax, VA 22033

A workshop of The Johns Hopkins Center for Alternatives to Animal Testing
TestSmart is a program of the Vision 20/20 forum
This workshop is partially funded through a grant by the Vira I. Heinz Endowment

SUMMARY/PRELIMINARY RECOMMENDATIONS

TOXIC IGNORANCE AND HPV TESTING--THE ISSUES AND THEIR RELATIONSHIPS TO TESTSMART
Karen Florini, Environmental Defense Fund (EDF)

OECD'S HPV PROGRAM--BACKGROUND AND OVERVIEW OF THE SIDS TEST BATTERY
Herman Koëter, Organization for Economic Cooperation and Development

HPV CHALLENGE PROGRAM--OVERVIEW, STATUS, AND ANIMAL WELFARE
Charles Auer, Environmental Protection Agency

CMA--COMMITMENT AND APPROACH
Marty Miller, Exxon Biomedical Sciences, Inc.

REFINEMENT OF ANIMAL PROCEDURES/HUMANE ENDPOINTS
Andrew Rowan, Humane Society of the United States

PREDICTIVE SAR MODELS: STATUS REPORT
Herbert Rosenkranz, University of Pittsburgh

TESTSMART APPROACH TO HPV ENDPOINTS
Sidney Green, Howard University
Alan Goldberg, Johns Hopkins Center for Alternatives to Animal Testing
Joanne Zurlo, Johns Hopkins Center for Alternatives to Animal Testing

ORIGINAL RECOMMENDATIONS FOR TESTSMART WORKING GROUP
Joanne Zurlo, Johns Hopkins Center for Alternatives to Animal Testing
Alan Goldberg, Johns Hopkins Center for Alternatives to Animal Testing
Sidney Green, Howard University

ICCVAM GUIDELINES FOR THE VALIDATION AND ACCEPTANCE OF NEW TEST METHODS
William Stokes, National Toxicology Program Interagency Center for the Evaluation of Alternative Methods, National Institute of Environmental Health Sciences

ECVAM GUIDELINES FOR THE VALIDATION AND ACCEPTANCE OF NEW TEST METHODS
Manfred Liebsch, Federal Institute for Health Protection of Consumers & Vetrinary Medicine (BgVV)

HIGH THROUGHPUT APPROACH TO TOXICOLOGY--GENERAL COMMENTS
Gihan Tennekoon, University of Pennsylvania

HUMAN CELLS IN CULTURE--CURRENT STATUS
James Yager, Johns Hopkins University

PARALLEL SESSIONS I

Ecotoxicology
Chair: Phil Sayre, Environmental Protection Agency
- Current Approaches and Potential Directions for Gathering SIDS Ecotoxicity Data
  Phil Sayre, Environmental Protection Agency
- Potential of QSAR Techniques to Predict Fathead Minnow LC₅₀ Values
  Kurt Enslein, Health Designs, Inc.
- Microtox® as a Substitute for Acute Fish Toxicity Testing
  Mark T.D. Cronin, John Moores University
- Comparison of Ciliate and Fish Acute Toxicity: Tetrahymena versus Pimephales
  Terry Schultz, University of Tennessee
- Utility of Xenopus Data from FETAX Assay for Prediction of Fish Acute Toxicity (or Fish Reproductive/Larval Toxicity
  Jack Bantle, Oklahoma State University
"Thoughtful Testing" Approaches--Repeat Dose with Reproductive, Developmental and In Vivo Metagenicity
Chair: Katherine Stitzel, Procter & Gamble
- Reflections on Development of the Initial SIDS Test Protocol
  John A. Moore, Institute for Evaluating Health Risks
- Evaluation of Chemical Toxicity Using Multiple Endpoint Studies
  Thomas Re, Cosmair Cosmetics Corp.
- Integration of Multiple Endpoints in Toxicological Studies: NTP Perspective
  Rajendra S. Chhabra, National Institute of Environmental Health Sciences
- Integration of Immunotoxicity Endpoints into Subchronic Tests
  Michael P. Holsapple, Dow Chemical Company
Cytotoxicity Assays
Chair: Rodger Curren, Institute for In Vitro Sciences
- An Examination of the MEIC Hypotheses and Results, Extending into the ECITTS-Project
  Erik Walum, Pharmacia/Upjohn (Sweden)
- A Proposal for the Practical Application of the MEIC Results in the HPV Challenge Program
  Bjorn Ekwall, Cytotoxicity Laboratory Uppsala (CTLU)
- Chemical Kinetics in Mammalian Systems -- Research Needs
  John M. Frazier, United States Air Force

PARALLEL SESSIONS II

High Throughput Screening Assays
Chair: Neil Wilcox, Food and Drug Administration
- Application of Protein-Based Mechanistic Information to the Selection of Markers and Cellular Systems for High-Throughput Toxicity Screening
  Sandra Steiner, Large Scale Biology Corporation
- High Content Screening to Extract Deep Biological Information from Multi-Parameter, Cell-Based Assays to Measure Compound Effects
  Jeff Pasley, Cellomics
- Considerations for Regulatory Applications of Emerging Molecular Toxicology Systems
  Frank Sistare, United States Food and Drug Administration
Non-Invasive and Monitoring Techniques
Chair: Martin Stephens, Humane Society of the United States
- Refinement of Animal Models for Drug Development by Non-Invasive Monitoring of Bioluminescent Reporters
  Pamela Reilly Contag, Xenogen Corporation
- Non-Invasive Monitoring of the Stress Response in Rats
  Bernie Doerning, Procter & Gamble Co.
- The Neurobehavioral Screening Battery as a Non-Invasive Monitor to Neurological Function in Rats
  Ginger Moser, Environmental Protection Agency
- Urinary Biomarkers as Humane Endpoints in Toxicology Research
  Raymond Poon, Health Canada
In Vitro Developmental Toxicity
Chair: Thomas Flynn, Food and Drug Administration
- Getting the Most Out of FETAX Developmental Toxicity Data
  John A. Bantle, Oklahoma State University
- Using Research from In Vitro Development Toxicity Assays for Risk Assessment: Challenges and Successes
  Elaine Faustman, University of Washington
- Prevalidation of the Embryonic Stem Cell Test (EST) and Status of the ECVAM Validation on Three In Vitro Embryotoxicity Tests
  Manfred Liebsch, BgVV

PARALLEL SESSIONS III

"Thoughtful Testing" Approaches - All Available Data - A Weight of Evidence Approach
Chair: Katherine Stitzel, Procter and Gamble Company
- Concepts in Safety Evaluation of HPV Food Substances
  Ian Munro, CanTox, Inc.
- Applying an Understanding of Toxicological Mechanisms to the Assessment of the Safety of Chemicals
  Lois D. Lehman-McKeeman, Procter & Gamble Company
- Guidance Principles for Exclusion of HPV Chemicals for Toxicity Testing
  Michael P. Holsapple, Dow Chemical Company
Specific Use of Human Cells in Culture
Chair: Charlene McQueen, University of Arizona
- Human Cells: Pluses and Minuses
  Charlene McQueen, University of Arizona
- The Development and Use of Human Cell-Lines for Toxicity Testing: Introduction of Critical Enzymes for the Activation of Xenobiotics
  Charles Crespi, Gentest Corp.
- Use of Human Cells in High Throughput Screening
  Paul Silber, In Vitro Technologies, Inc.
- The Use of Human Hepatocytes for Drug Metabolism and Testing
  Stephen Strom, University of Pittsburgh
In Vitro Reproductive Toxicity
Chair: Bernard Robaire, McGill University
- Leydig Cells, Endocrine Disrupters
  Gerald M. Cooke, Health Canada
- Seroli Cells, Early Germ Cells
  Kim Boekelheide, Brown University
- Epididymal Cells and Sperm Maturation
  Bernard Robaire, McGill University
- Sperm-Egg Interactions and Early Post Fertilization Events
  Sally Perreault, United State Environmental Protection Agency
High Throughput Screening Assays
Chair: Neil Wilcox, Food and Drug Administration
- High Throughput, Non-Invasive Animal Models for Target Discovery and Validation Drug Development and Toxicology
  Pamela Reilly Contag, Xenogen Corporation
- Entering the Era of Toxicogenomics with DNA Microarrays
  J. Christopher Corton, Chemical Industry Institute of Toxicology
- High Throughput Toxicity Testing
  Oliver Flint, Bristol-Myers Squibb Co.