2010 In Vitro Alternatives Forum Held in Old Town Alexandria, Virginia, USA

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In the Spotlight

2010 In Vitro Alternatives Forum Held in Old Town Alexandria, Virginia, USA

Rodger Curren & Erin Hill, Institute for In Vitro Sciences, Inc.

Published: December 8, 2010

The Institute for In Vitro Sciences (IIVS), Inc. hosted its third In Vitro Alternatives Forum on October 18-19, 2010 in Old Town Alexandria, Virginia, USA. Over 90 scientists from industry, academia, regulatory agencies and animal protection organizations attended. The Forum, which has become the de facto US national meeting on alternatives to animal testing, provided the opportunity for extended discussions of the important in vitro and in silico technology issues facing toxicologists today. The program addressed four main topics: new regulatory chemical testing issues, advances in assessing skin sensitizers, the use of three-dimensional tissue models, and several new and innovative commercially available technologies.

The Forum began by addressing a pervasive new activity that has tremendous international impact – the extraordinary expansion of hazard assessments for new and existing chemicals. The push to conduct more extensive testing has already surfaced in Europe’s REACH program and will likely extend to the US via revision to the Toxic Substances Control Act (TSCA). The necessary integration of in vitro and in silico information into these reforms was discussed by a cross-section of interested constituencies.

This first session was opened by James Jones (U.S. Environmental Protection Agency [EPA]), who discussed details of the potential TSCA revisions and how EPA is developing ways to utilize non-animal approaches to obtain information which can be used in their decision making process. His presentation was followed by extended comments from three stakeholders (Sara Amundson, Humane Society Legislative Fund; Richard Becker, American Chemistry Council; and Douglas Fratz, Consumer Specialty Products Association) addressing how their constituencies viewed the potential new legislation.

Continuing with the theme of how to efficiently investigate the potential toxicity of the thousands of chemicals that will be assessed in these new testing programs, Thomas Hartung (Center for Alternatives to Animal Testing) addressed how experiences from the validation of non-animal methods over the last decade can be applied as we try to bring the tools of 21st Century Toxicology to bear on the problem. Robert Kavlock (EPA) then demonstrated how EPA’s ToxCast program is developing high throughput cell-based methods and the necessary data analysis software that can hopefully provide EPA staff with much of the required chemical toxicity information without the use of whole animals. Chihae Yang (Altamira) then described advances in another important tool for chemical toxicity evaluation, computational methods.

The last three presentations of the first day covered an overview of EPA’s activities with animal alternatives (Tina Levine, EPA), a specific EPA program to allow in vitro ocular data to be used for the registration of anti-microbial cleaning products (Rodger Curren, IIVS), and the informatics and computational safety programs being developed and used by Food and Drug Administration’s Center for Drugs (R. Daniel Benz, FDA). It was clear from the first day’s presentations that US regulatory agencies are serious about incorporating non-animal test methods—be they cell based or computational—into the toolbox of approaches that will be used in the safety evaluation of drugs, chemicals and products.

Following the first day’s formal presentations, Erin Hill (IIVS) and Kristie Sullivan (Physicians Committee for Responsible Medicine) announced the formation of a new scientific society – the American Society for Cellular and Computational Toxicology (ASCCT). One impetus for forming this organization was the existence of several societies within Europe focusing on emerging non-animal testing methods, and the lack of a single similar society within the US. The ASCCT will provide an organized forum for discussion of cellular and computational toxicology approaches to the safety of chemicals and products, especially as replacements for animal-based toxicology methods. Information about the society, including how to become a member, can be found by visiting http://www.ascctox.org or emailing info@ascctox.org.

The second day began with a comprehensive look at the remarkable advances being made in the area of in vitro methods to identify skin sensitizers. With the 2013 deadline for the banning of animal tests for skin sensitization imposed by the EU’s Seventh Amendment to the Cosmetics Directive approaching, optimism is building that a combination of tests may be available to address a number steps in the cutaneous immune response. Moderator Robert Landsiedel (BASF) started the session by reviewing the chain of events leading to skin sensitization and then introduced Anthony Gaspari (University of Maryland), Frank Gerberick (Procter & Gamble), David Basketter (head of ECVAM’s Science Advisory Committee), Pierre Aeby (representing COLIPA), Hiroshi Sakaguchi (Kao Corporation), and William Stokes (U.S. Interagency Coordinating Committee on the Validation of Alternative Methods) who reported on translating human allergic contact dermatitis processes to in vitro systems, peptide reactivity assays, the progress of the ECVAM sensitization prevalidation studies, the Colipa in vitro research program, progress with the h-CLAT assay in Japan, and new LLNA methods.

The Forum then shifted to the various ways that three-dimensional (3-D) tissue models and ex vivo systems are currently being used for hazard identification and risk assessment within industry. Ann De Smedt (Johnson & Johnson), Rodger Curren, James Jester (University of California), Marilyn Aardema (consultant), Erwin van Vliet (Johns Hopkins University), and Marianna Gaça (British American Tobbacco) discussed integrating in vitro models into risk assessment, the role of 3-D tissue models in 21st Century toxicology, histopathology approaches for eye irritation, 3-D models in genotoxicity testing, 3-D brain cell cultures, and in vitro approaches for inhalation toxicology.

The Forum’s final session explored a few of the new, commercially available technologies that are designed to assist toxicologists in evaluating the safety of their chemicals and products. Martin Yarmush (Hurel Corporation) presented a microfluidic system for in vitro testing using human cell and tissues, Elizabeth Donley (Stemina Biomarker Discovery) described combining stem cells with metabolomics to predict developmental toxicity, and Jayashree Srinivasan (Accelrys Contract Research) outlined how their (Q)SAR systems can help predict compound toxicity.

An additional highlight of the Forum was the presentation of the Alternatives Research and Development Fund (ARDF) William and Eleanor Cave Award to the well-known and respected journal Alternatives to Laboratory Animals (ATLA). Michael Balls, long time editor of ATLA, traveled on short notice from the UK to accept the Award presented by Sue Leary, President of ARDF. Ms. Leary praised ATLA for being a beacon of hope for non-animal testing through years when it seemed like progress was very slow and that significant changes might never be realized.

IIVS would like to warmly thank this year’s speakers, supporters and attendees who helped to make the 2010 Forum a memorable event.


Contact Information

Institute for In Vitro Sciences
30 W. Watkins Mill Rd., Ste. 100
Gaithersburg, MD 20878
Email: info@iivs.org