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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?
20101981
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 Substances
HTP assay
s
Phase 12007-2009
300 500
Phase 22010-2013
2000 700
EDSP20
$6 millions / ingredient
EDSP21 =
in vitro HTSin 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
ShampooPerfume
SunscreenAnti-wrinkle
Sao Paulo
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WHY AREN’T WE DONEWITH 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%...