Published on April 25, 2014
Center for Alternatives to Animal Testing (CAAT) Johns Hopkins University, Baltimore, USA – University of Konstanz, Germany Francois Busquet, PhD Toxicology for the 21st century in USA
WHO I WORK FOR?
ANIMAL TESTING HISTORICAL RETROSPECTIVE
Vth B.C. Hippocrate Aristotle IInd B.C. Galen XVIIth Descartes XIXth Darwin Bernard XVIIIth Bentham V. Bauman; Gene Therapy (2004) 11, S64–S66 & 2004 Nature Publishing Group XXth Russel & Burch
CHALLENGING THE 3000Yrs OF TRADITION WORLDWIDE
SOME US FIGURES
•85 to 100 M Vertebrates used worldwide – EU (11.5M) •$3 billions Tox studies regulates $10 trillions products •Tox21 Budget $hundredsM (ongoing) •US Federal R&D budget Y13: $133 billions
US REGULATORY FRAMEWORK
AWA - 76
US PERSPECTIVES - Tox21Tools
An atmosphere of departure in toxicology 2007 New technologies from biotech and (bio-)informatics revolution Mapping of pathways of toxicity (PoT) NAS vision report Tox-21c “Traditional toxicological testing is based largely on the use of laboratory animals. However, this approach suffers from low throughput, high cost, and difficulties inherent to inter-species extrapolation - making it of limited use in evaluating the very large number of chemicals with inadequate toxicological data. “
"The Tox21 collaboration will transform our understanding of toxicology with the ability to test in a day what would take one year for a person to do by hand." “In FY 2014, the EPA will continue the multi-year transition away from the traditional assays used in the endocrine disruptor screening program through efforts to validate and use computational toxicology and high throughput screening methods. This is expected to allow the agency to more quickly, efficiently, and cost-effectively assess potential chemical toxicity.” “The NTP recognized that the dramatic technological advances in molecular biology and computer science offered an opportunity to use in vitro biochemical- and cell-based assays and non-rodent animal models for toxicological testing.”
LOW COST & TIME =X $10 millions US + 5 years time X = $10,000 US + 2 weeks vs. 6 months
TOX21 REG. OUTPUTS
Tox-21c Reg. Outputs ToxCast Substance s HTP assay s Phase 1 2007-2009 300 500 Phase 2 2010-2013 2000 700
EDSP20 $6 millions / ingredient EDSP21 = in vitro HTS in silico Full replacement for Tier 1 $30,000 / ingredient
http://en.wikipedia.org/wiki/Organ-on-a-chip C. Zhang et al. (2009), “Towards a human-on-chip: Culturing multiple cell types on a chip with compartmentalized microenvironments” Human on a Chip Approach Opportunities from countermeasures to bioterrorism $200 million funding program
INTERNATIONAL CONTEXT & THE BAN
Shampoo Perfume Sunscreen Anti- wrinkle Sao Paulo ??next??
WHY AREN’T WE DONE WITH ANIMAL TESTING?
•3000 YEARS OF TRADITION = HUGE KNOW HOW •LACK OF CROs (CONTRACT RESEARCH ORGANISATION) •28 REGULATORY AGENCIES •SHORTCOMINGS FOR IN VITRO MODELS – DIFFICULT ENDPOINTS •MANPOWER - R&D INVESMENTS
EU FUNDING IN ALTERNATIVES TO ANIMAL TESTING
•MEMBER STATES DUTIES REGARDING ARTICLE 47 - DIRECTIVE 2010/63/EU •13 MEMBER STATES ONLY •AAT vs. national R&D investments: 0.001 to 0.035%...
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