The Way Forward

The Way Forward essays are a series of invited expert commentaries exclusively available on the AltTox website.

Many sections of AltTox conclude with one or more of the invited The Way Forward essays, which were written by technical or policy experts in the field covered in that section. The writers, whose brief biographical sketches follow their essays, were all asked to express their views on how best to accelerate progress on developing, validating, and gaining regulatory acceptance of non-animal methods in the topics under consideration. These "Way Forward" commentaries address specific fields of toxicity testing (e.g, neurotoxicity testing), types of non-animal technology applied to toxicity testing (e.g. (Quantitative) Structure-Activity Relationships), and stakeholder policies or programs (e.g., the Interagency Coordinating Committee on the Validation of Alternative Methods). Also included are more broadly focused essays on Overarching Challenges and Opportunities. The commentators were under no obligation to address all aspects of a topic; indeed, many chose to address a few salient aspects of the subject matter. Their views do not necessarily reflect those of the AltTox Management Team.

Readers are invited to discuss these commentaries in The AltTox Forum. Also, readers interested in writing a Way Forward commentary, or in nominating a colleague, should contact the Management Team at info@alttox.org. We would especially welcome offers to write commentaries on topics that currently have few or no commentaries. Moreover, we will regularly post new commentaries and archive older ones.

Author Guidelines for The Way Forward Essays

Toxicity Endpoints & Tests

Acute Systemic Toxicity

• The ACuteTox Testing Strategy: The Way Forward to Replace the Animal Tests Used Today in the Field of Acute Systemic Toxicity by Cecilia Clemedson
• Opportunities and Barriers to the Replacement of Animals in Acute Systemic Toxicity Testing by Troy Seidle

Ecotoxicity

• Animal Alternatives in Environmental Science by Scott Belanger

Eye Irritation/Corrosion

• The Way Forward for Eye Irritation Testing by Chantra Eskes, Valerie Zuang & Thomas Hartung
• In Vitro Ocular Toxicology - The Way Forward by Monica Berry

Genotoxicity/Carcinogenicity

• Use of Genetic Toxicology Testing for Predicting Carcinogenicity: A Multi-Stakeholder Approach by Marilyn Aardema
• Use of In Silico Evaluation of Chemical Genotoxicity by Makoto Hayashi
• Genotoxicity and Carcinogenicity: Which Alternative Strategy(ies)? by Gladys Ouedraogo
• Animal Use in Genetic Toxicity Tests for Identifying Potential Carcinogens by Errol Zeiger
• New Developments in Genetic Toxicology - Development of a novel 3D Human Reconstructed Skin Micronucleus Assay by Marilyn Aardema & Rodger Curren
• Alternative Approaches for the Identification of Carcinogens are Closer than Usually Thought, but the Present Strategies and Regulations Need to be Updated by Romualdo Benigni

Immunotoxicity

• The Way Forward: Applying Non-Animal Approaches to the Assessment of Immunotoxicity by Emanuela Corsini

Neurotoxicity

• Alternative Methods for Neurotoxicity by William Mundy
• Why In Vitro Neurotoxicity Approaches Are Not Formally Validated and Used for Regulatory Purposes: The Way Forward by Sandra Coecke & Anna Price
• Neurotoxicity - The Way Forward by Evelyn Tiffany-Castiglioni
• Brain Aggregate Cell Cultures as an in vitro Model for Neurotoxicity Testing by Paul Honegger, Florianne Monnet-Tschudi & Marie-Gabrielle Zurich
• Neurotoxicity Testing Using Microelectrode Arrays (MEAs): A Growing Trend by Timothy J. Shafer

Pharmacokinetics & Metabolism

• Roles of Quantitative In Vitro ADME in Toxicology and Risk or Safety Assessment by Hugh Barton
• Animal-Alternative Approaches to Understand Pharmacokinetics and Metabolism by Kannan Krishnan
• Replacing Animals in Absorption, Distribution, Metabolism & Excretion Studies by Gill Langley

Repeated Dose/Organ Toxicity

• In Vitro Evaluation of Human Xenobiotic Toxicity: Scientific Concepts and the Novel Integrated Discrete Multiple Cell Co-culture (IdMOC) Technology by Albert Li
• Alternate Methods for Assessing Respiratory Toxicity Using Non-animal Methods by Mark Riley
• Human Proximal Tubular Cells as an In Vitro Model for Drug Screening and Mechanistic Toxicology by Lawrence H. Lash
• The COSMOS Project: A Foundation for the Future of Computational Modelling of Repeat Dose Toxicity by Mark T.D. Cronin, Judith C. Madden, and Andrea-Nicole Richarz

Reproductive & Developmental Toxicity

• Alternatives in Reproductive Toxicity: A Way Forward by George Daston
• How Well do Animal Teratology Studies Predict Human Hazard? – Setting the Bar for Alternatives by Jarrod Bailey
• Developmental Toxicity Testing in the 21^st Century: An Opportunity to Take a New Pathway by Ed Carney
• Way Forward Essay on Current and Future State of Developmental Toxicology Assays by Cindy X. Zhang, Julie Panzica-Kelly, and Karen Augustine-Rauch

Skin Irritation/Corrosion

• The Way Forward for In Vitro Skin Irritation Testing by Patrick Hayden
• The Way Forward for In Vitro Skin Irritation and Corrosion Testing – 2010 Update by Helena Kandárová, Yulia Kaluzhny, Mitchell Klausner & Patrick Hayden

Skin Sensitization

• Skin Sensitization: What is it? Why is it important? What are the challenges? by Ian Kimber & G. Frank Gerberick
• Sens-it-iv: A Pathway Towards In Vitro Assessment of the Sensitising Potency of Proteins and Chemicals by Erwin L. Roggen
• Applying Non-Animal Approaches to the Assessment of Skin Sensitization by Emanuela Corsini
• Novel Testing Strategies for In Vitro Assessment of Allergens by Erwin L. Roggen

Emerging Technologies

-Omics, Computational Biology, & Bioinformatics

• The Way Forward for the Three Rs and Systems Biology by Nirmala Bhogal
• Computational Toxicology by Robert Kavlock
• A Way Forward Commentary by Gilman Veith & Gerald Ankley
• Novel Tests for Preclinical Toxicity from Toxicogenomics Gene Expression Studies by Jennifer Fostel

Cell-based Technologies

• Unifying the Effort Behind In Vitro Alternative Method Development by Frank Barile
• Micro Cell Culture Analogs and What They Can Contribute to the Drug Screening Process by Michael L. Shuler & Mandy B. Esch
• Recombinant Antibody Technology for the Production of Antibodies Without the Use of Animals by Michelle Echko & Samantha Dozier
• Application of Medium and High Throughput Screening for In Vitro Toxicology in the Pharmaceutical Industry by Willem G.E.J. Schoonen, Walter M.A. Westerink & G. Jean Horbach

Integrated Testing Strategies & Risk Assessment

• Replacement Alternative Methods and the Need for New Approaches to Risk Assessment in Relation to Chemicals and Chemical Products by Michael Balls & Bob Combes
• Risk Assessment: The Art and Science of Using Fewer Animals by Kristie Stoick

(Q)SAR

• The Way Forward: (Q)SAR by Grace Patlewicz
• A Choral Strategy for (Q)SAR Models for Regulatory Purposes by Emilio Benfenati
• The Way Forward in Using (Q)SAR in Toxicology – A Personal Commentary by Mark Cronin
• (Q)SAR: A Way Forward Commentary by Gilman Veith
• The Way Forward in Non-Animal Toxicity Testing Approaches: Towards Regulatory Acceptance of (Q)SAR Methodologies by Bob Diderich

Programs & Policies

United States

• Some Considerations as ICCVAM Moves Forward by Martin Stephens
• Ruminations on ICCVAM/NICEATM and the Draft NICEATM-ICCVAM Five-Year Plan (2008-2012) by Leonard Schechtmann
• The NICEATM-ICCVAM Five-Year Plan (2008-2012) by Neil Wilcox
• Animal Welfare in the US EPA’s Chemical Assessment and Management Program and the Extended High Production Volume Program by Chad Sandusky

European Union

• First Evaluation of the Use of "Non-animal" Methods to Meet the Requirements of the EU Chemicals Directive REACH by Horst Spielmann
• REACH and Alternatives to Animal Testing: Experience So Far by Nicholas Ball

International

• Proposal for a Brazilian Centre on Alternative Test Methods by Chantra Eskes, Jadir Nunes, Octavio Presgrave, Dermeval de Carvalho, Ekaterina Rivera, Thomas Hartung, Sandra Coecke, Philippe Masson, Joachim Kreysa, and Vanessa de Moura Sá-Rocha

Overarching Challenges & Opportunities

• RISK ASSESSMENT + NEW TECHNOLOGIES: Opportunities to Assure Safety Without Animal Testing and Better Protect Public Health? by Julia Fentem & Carl Westmoreland
• Toxicity Testing in the 21^st Century by Melvin Andersen, Daniel Krewski, Ellen Mantus & Lauren Zeise
• Food for Thought ... on Validation by Thomas Hartung
• The Way Forward: Alternatives – The Future is Now! by Andrew Rowan
• A Paradigm Shift in Toxicity Testing Is Inevitable by Kim Boekelheide
• Tox21: Putting a Lens on the Vision of Toxicity Testing in the 21st Century by Christopher Austin, Robert Kavlock & Raymond Tice
• ASAT: Reversing the Paradigm in Toxicity Testing! by Bart Sangster
• A New Perspective on the Past, Present and Future of Toxicity Testing by Sunita Shukla
• Toxicity Testing and Safety Assessment in the 21^st Century: Creating a Research Program to Accelerate Change by Melvin E. Andersen
• Looking Beyond Replacements: One Company's Approach for Continuing the Progress by Mark Lafranconi
• 21^st Century Safety Science and Non-Animal Approaches at Unilever by Carl Westmoreland, Paul Carmichael, Ian Malcomber, Gavin Maxwell, Oliver Price & Julia Fentem