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embryonic stem cells differentiating to definitive and primitive endoderm and further toward the hepatic lineage. Stem Cell Develop. 2010; 19, 961-78. 12. Leite SB, Teixeira AP, Miranda JP, et al. Merging bioreactor technology with 3D hepatocyte-fibroblast culturing approaches: Improved in vitro models for toxicological applications. Toxicol In Vitro. 2011 [Epub ahead of print]. Patent Applications Filed 1. Integration of a Cytochrome P450 induction assay on primary human hepatocytes to the Pharmacelsus portfolio. 2. Integration of the (pre-validated) method for Cytochrome P450 induction on the HepaRG cell line to the Pharmacelsus portfolio. 3. A novel population of hepatocytes derived via definitive endoderm (DE-hep) from human blastocysts derived stem cells. Patent filed July 2007 – US60/935,003 by Cellartis AB. Partners Co-ordinator Carl-Fredrik Mandenius Linköping University Division of Biotechnology, IFM 581 83 Linköping, Sweden cfm@ifm.liu.se Elmar Heinzle Saarland University Saarbrücken, Germany Inger Johansson Karolinska Institute Stockholm, Sweden Manuel Carrondo Instituto de Biología Experimental e Tecnológica (IBET) Oeiras, Portugal Görg Gerlach Charité University Hospital Berlin, Germany Petter Björquist Cellartis AB Göteborg, Sweden Christine Batzl-Hartmann Pharmacelsus GmbH Saarbrücken, Germany Tommy B. Andersson AstraZeneca AB Mölndal Mölndal, Sweden Sandra Coecke European Commission Joint Research Centre (ECVAM) Ispra, Italy Christophe Chesne BioPredic International Rennes, France 194 PROGRESS REPORTS FROM EU-FUNDED PROJECTS Progress Report 2011 & AXLR8-2 Workshop Report
PROGRESS REPORTS FROM EU-FUNDED PROJECTS Progress Report 2011 & AXLR8-2 Workshop Report 195
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ALTERNATIVE TESTING STRATEGIES PROG
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ALTERNATIVE TESTING STRATEGIES PROG
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TABLE OF CONTENTS 1. 2. EXECUTIVE S
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Update on EPA’s ToxCast Programme
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challenges, needs, and priorities f
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1INTRODUCTION It is the aim of the
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and progress of these multidiscipli
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Table 2. Members of the AXLR8 Scien
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• OECD Joint Meeting Special Sess
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ACuteTox Optimisation & Pre-Validat
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to robotic screening platforms; and
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ased on functional parameters inclu
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Table 1. Outliers identified by com
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showed that for some compounds the
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Computer-based prediction of metabo
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three reference compounds revealed
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a calibration curve constructed. Th
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cell lines) or 48 hours (A704 cells
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multivariate CART results did not c
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probability) ~50% of the substances
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Publications 2010-11 Hoffmann S, Ki
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Per Artursson Uppsala University Up
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their genotoxic and carcinogenic po
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Table 1. Overview of carcinoGENOMIC
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D12.23 3 monthly Project M42 √ Bo
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annual carcinoGENOMICS meeting in N
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M3.5 Decision of most M40 Postponed
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M3.4 Identification of most suitabl
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WP1 with input from other partners
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Partners Project Co-ordinator Jos K
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combine knowledge of critical proce
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defined and published in the form o
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WP6 is devoted to the setup of a so
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Partners Co-ordinator Bart van der
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obustness, comparing results obtain
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6. Candéias S, Pons B, Viau M, et
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ESNATS Embryonic Stem Cell-Based No
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Table 1. List of deliverables due i
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D3.3.1 Toxicity gene expression sig
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Table 2. List of milestones due in
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Table 3. Test systems corresponding
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Publications 2010-11 1. Peters SJ,
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Marcel Leist Universität Konstanz
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The most significant achievements o
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Figure 3. The Sensor Dish Reader (S
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LIINTOP Optimisation of Liver & Int
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cells express most of the functions
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Figure 3. Scheme of lentivirus gene
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Figure 5. Co-culture set-up. Functi
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Figure 9. Phalloidin-TRITC staining
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Table 1. Values are expressed as pe
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formed with mannitol, atenolol, pro
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Figure 14. Comparison of Digoxin an
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By using the new technology of HCA
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Figure 17. (Left panel) Phalloidin-
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limited amount of data could be pro
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André Guillouzo Institut National
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Objectives The overall aim of this
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Table 2: Milestones achieved in 201
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detected iron (µg/ml) 80 70 6
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in the following order: uncoated ma
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analysis of leukocytes, expression
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2011 the automated protocols will b
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OpenTox Promotion, Development, Acc
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Results The OpenTox Framework The O
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Figure 1. ToxPredict: OpenTox Appli
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scientifically sound manner, so as
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Figure 4. Creating a QPRF report wi
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Figure 7. MaxTox model-building app
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Figure 8. Bioclipse interaction wit
Page 144 and 145: and model predictions, which they m
Page 146 and 147: Publications 2010-11 1. Hardy B, Do
Page 148 and 149: In vitro toxicology using isolated
Page 150 and 151: (2C-Glo-CYP2C, 3A-Glo-CYP3A) while
Page 152 and 153: neuronal models 2D (primary culture
Page 154 and 155: 10 and 14 days. The liver-specific
Page 156 and 157: Frédéric Bois Institut National d
Page 158 and 159: Figure 1. The Sens-it-iv sphere. 2.
Page 160 and 161: Figure 2. The updated modular struc
Page 162 and 163: Technology Module The aim of techno
Page 164 and 165: Table 1: The final compound list. R
Page 166 and 167: Table 2. The Sens-it-iv Toolbox. N
Page 168 and 169: Figure 4. A gene profile for identi
Page 170 and 171: Figure 7. In vitro T cell priming a
Page 172 and 173: sessions at congress and meetings (
Page 174 and 175: 7. Gibbs S, van Montfrans C, Kroeze
Page 176 and 177: vitro assessment of allergens. Eds:
Page 178 and 179: S.F. Martin Universitätsklinikum F
Page 180 and 181: idging the gap to human volunteer s
Page 182 and 183: combinations of transcriptomics, me
Page 184 and 185: normal animals who usually exhibit
Page 186 and 187: Workshop proposals Concepts of data
Page 188 and 189: VITROCELLOMICS Reducing Animal Expe
Page 190 and 191: esulting of the project was the abi
Page 192 and 193: Figure 3. Four-compartment artifici
Page 196 and 197: 196 3AXLR8-2 WORKSHOP REPORT
Page 198 and 199: Workshop participants were divided
Page 200 and 201: 08.45 - 09.15 ACuteTox Annette Kopp
Page 202 and 203: 3.3 Workshop Presentations 202
Page 204 and 205: Table 1. A sampling of current toxi
Page 206 and 207: Table 2. EPA activities: a timeline
Page 208 and 209: Why is a Consortium Needed While th
Page 210 and 211: the development of new more relevan
Page 212 and 213: in particular for fundamental resea
Page 214 and 215: compared to controls. Most interest
Page 216 and 217: epidermis to known allergens and UV
Page 218 and 219: The Virtual Liver Spatial-Temporal
Page 220 and 221: A B C D E Figure 2. Tissue reconstr
Page 222 and 223: Figure 4. Mechanisms of how hepatoc
Page 224 and 225: in rat liver in vivo (Figure 5A). H
Page 226 and 227: The IMI eTOX Project Efforts to Dev
Page 228 and 229: deliverables, which can only be ach
Page 230 and 231: A series of publications related to
Page 232 and 233: Update on EPA’s ToxCast Programme
Page 234 and 235: Phase I of ToxCast involved the eva
Page 236 and 237: Endpoint Brief Description of Bioac
Page 238 and 239: includes approximately 150 chemical
Page 240 and 241: information. For each slice, distan
Page 242 and 243: Judson RS, Houck KA, Kavlock RJ, et
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Embryonic Stem Cell Approaches Towa
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perhaps be tested efficiently in al
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compared gene and protein expressio
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cost and time, allowing more chemic
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Toxicol Appl Pharmacol. 2011; 251,
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functions, establish relationships
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cellular behaviours are captured fr
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assay. PLoS One. 2011; 6, e18540. 7
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learning algorithm called Support V
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Compound Potency Vehicle Concentrat
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mediated inhibition of RXR function
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References Basketter DA, Evans P, F
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When considering consumer exposure,
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in the induction of skin sensitisat
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has reacted, when the peptide deple
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of presentations and discussions, t
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Contact Dermatitis. 2005; 53. 16. S
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the development of in vitro assays.
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Although the mechanisms underlying
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skin sensitisation, it will aid in
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Figure 3. Scatter plot of robust li
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7. De Smedt A, Van Den Heuvel R, Va
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The OECD Adverse Outcome Pathway Ap
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the AOP can be used in qualitative
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Table 1. Summary of the experimenta
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the significance of type 1 versus t
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plus the key events that occur acro
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Dimitrov, S.D., Low, L.K., Patlewic
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[Supporting information and databas
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Figure 1. Strategic R&D of chemical
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The Bhas 42 system can sensitively
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Table 1. Established reporter cell
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elated genes (Hand1, ADAM19, Cmyal,
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Publications Carcinogenicity Tanaka
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Case Study Approaches for Implement
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assay results together with CSBP mo
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them to support multi-day testing i
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CSBP models for both receptor-media
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Hamner Presentations in 2011 • Ch
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human health risk assessment. Risk
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There is a significant scientific c
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phototoxicity and eye irritation, f
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allergy risk assessment rather than
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‘toolbox’ of non-animal methods
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332 3.4 Breakout Group Reports
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Figure 1. An illustration of the me
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methods, and the generally poor und
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3.4.3. Break-Out Group 2: Reproduct
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- Deep-sequencing of birth defect p
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Figure 2. Specific stages of the ma
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3.4.4 Break-Out Group 3: Skin Sensi
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for further progress. Better tools
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sure doses is not straightforward.
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3.5 AXLR8 Scientific Panel Recommen
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Workshop participants underlined th
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could be co-ordinated in a focused
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focusing on scientific excellence a
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Directory of Projects & Co-ordinato
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Glossary of Terms 2D/3D 3Rs CARDAM/
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362
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