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EUROTOX 2018, Brussels, Belgium | Programme, April, 2018 1 Sunday, 2 September, 2018 08h00 - 21h00 Congress registration 16h00 – 21h00 Exhibition 10h30–16h00 Continuing Education Courses (CEC), including coffee & lunch breaks 10h30–16h00 Meeting Stu- dio 311 CEC1 Exposure, hazard and risk assessment of mixtures of pesticides/chemicals in food using the tools developed in the EuroMix project Chairs: Hubert Dirven, Norway | Jacob van Klaveren, The Netherlands Risk assessment of chemical mixtures – Regulatory requirements and current scientific approaches Roland Solecki, BfR, Germany Opportunities and Pitfalls in Risk Assessment of Co-exposures Heli Hollnagel, DOW chemical, Switzerland Real-life dietary exposures to pesticides: An exposure driven test strategy Jacob van Klaveren, RIVM, The Netherlands Case study: combining dietary and non-dietary pesticide exposure Marc Kennedy, Fera Science Limited, United Kingdom Case study: Aggregate and cumulative consumer exposure to bisphenols Cecilie Karrer, EHTZ, Switzerland Case study: Exposure to mixtures of chemicals in a human study and verification of models using real-life data Hubert Dirven, Norwegian Institute of Public Health, Norway 10h30–16h00 Meeting Stu- dio 312 CEC2 Introduction to benchmark dose modelling using the PROAST software Chairs: Wout Slob, The Netherlands |Allen Davis, United States Difference between NOAEL and BMD approach Wout Slob, RIVM, The Netherlands

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Page 1: Sunday, 2 September, 2018 - eurotox-congress.com 20… · EUROTOX 2018, Brussels, Belgium | Programme, April, 2018 1 Sunday, 2 September, 2018 08h00 - 21h00 Congress registration

EUROTOX 2018, Brussels, Belgium | Programme, April, 2018

1

Sunday, 2 September, 2018

08h00 - 21h00 Congress registration 16h00 – 21h00 Exhibition

10h30–16h00 Continuing Education Courses (CEC), including coffee & lunch breaks

10h30–16h00

Meeting Stu-

dio 311

CEC1

Exposure, hazard and risk assessment of mixtures of pesticides/chemicals in food using the tools developed in the EuroMix project

Chairs:

Hubert Dirven, Norway | Jacob van Klaveren, The Netherlands

Risk assessment of chemical mixtures – Regulatory requirements and current scientific approaches

Roland Solecki, BfR, Germany

Opportunities and Pitfalls in Risk Assessment of Co-exposures

Heli Hollnagel, DOW chemical, Switzerland

Real-life dietary exposures to pesticides: An exposure driven test strategy

Jacob van Klaveren, RIVM, The Netherlands

Case study: combining dietary and non-dietary pesticide exposure

Marc Kennedy, Fera Science Limited, United Kingdom

Case study: Aggregate and cumulative consumer exposure to bisphenols

Cecilie Karrer, EHTZ, Switzerland

Case study: Exposure to mixtures of chemicals in a human study and verification of models using real-life data

Hubert Dirven, Norwegian Institute of Public Health, Norway

10h30–16h00

Meeting Stu-

dio 312

CEC2

Introduction to benchmark dose modelling using the PROAST software

Chairs:

Wout Slob, The Netherlands |Allen Davis, United States

Difference between NOAEL and BMD approach

Wout Slob, RIVM, The Netherlands

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EUROTOX 2018, Brussels, Belgium | Programme, April, 2018

2

Introduction to the BMD method

Wout Slob, RIVM, The Netherlands

Differences between EPA and EFSA approach

Allen Davis, MSPH, United States

Presentation of the PROAST webtool

Jose Cortinas Abrahantes, EFSA, Italy

Practical exercises with the PROAST webtool: data table generation

Bas Bokkers, RIVM, The Netherlands

Practical exercises with the PROAST webtool: Presentation of case studies and modelling of provided datasets

Philip Bellion, DSM Nutritional Products, Switzerland

10h30–16h00

Meeting Stu-

dio 313

CEC3

Application of non-animal (toxico)kinetic data and tools in risk assessment from basic research to practice Supported by European Partnership for Alternative Approaches to Animal Testing

Chairs:

Alicia Paini, Italy | Cecilia Tan, United States

Incorporating TK data and tools to support regulatory decision making – from the perspectives of EPA

Cecilia Tan, EPA, United States

Incorporating TK data and tools to support regulatory decision making – from the perspectives of cosmetic industry

Martina Klaric, Cosmetics Europe, Belgium

Developing TK databases and tools to support food safety assessment

Jean Lou Dorne, EFSA, Italy

Incorporating TK data and tools to support regulatory decision making – a European perspective

Minne Heringa, RIVM, The Netherlands

Predictive tools and databases for TK

Judith Madden, LJMU, United Kingdom

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3

RVis: a freely available modelling platform

George Loizou, HSE’s Health & Safety Laboratory, United Kingdom

10h30–16h00

Hall 300

CEC4

Organ-specific in vitro modelling: state-of-the-art

Chairs:

Mathieu Vinken, Belgium |Arno Gutleb, Luxembourg

Liver-based in vitro models for toxicity testing

Vinken Mathieu, Vrije Universiteit Brussels, Belgium

Kidney-based in vitro models for toxicity testing

Paul Jennings, Innsbruck Medical University, Austria

Lung-based in vitro models for toxicity testing

Samuel Constant, Epithelix Sàrl, Switzerland

Stem cell-based in vitro models for toxicity testing

Joery De Kock, Vrije Universiteit Brussels, Belgium

Tridimensional models for in vitro toxicity testing

Arno Gutleb, Luxembourg Institute of Science and Technology, Luxembourg

Dynamic organ-on-chip models for in vitro toxicity testing

Yaakov Nahmias, The Hebrew University of Jerusalem, Israel

10h30–16h00

Meeting Stu-

dio 314+316

CEC5

Read-across in REACH and its assessment

Chairs:

David Bell, Finland | Sabine Van Miert, Belgium

Read-across in REACH and the read-across assessment framework

Agnes Kovari, ECHA, Finland

Scientific considerations for assessing read-across between multi-constituent or UVCB substances

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4

Eric Stilgenbauer, ECHA, Finland

Scientific issues that need to be addressed for a successful read-across prediction

Mark Cronin, Liverpool John Moores University, United Kingdom

Use of novel and alternative methods to support read-across

Bob van de Water, University of Leiden, Netherlands

Key issues for successful read-across – a user's guide

Nicholas Ball, Dow Europe GmbH, Switzerland

HALF DAY

13h00–16h00

Meeting Stu-

dio 315

CEC6

Creating quantitative Adverse Outcome Pathways (AOPs)

Organized and supported by OECD

Chairs:

Anne Gourmelon, France | Magdalini Sachana, France

Introduction and best practices in building AOPs

Anne Gourmelon, OECD, France

Running Effectopedia for the first time

Searching and exploring Effectopedia content

Creating an AOP in Effectopedia

Magdalini Sachana, OECD, France

Add quantitative information to a key event and derive key event relationship within an AOP

Transforming test data (in-vitro to in-vivo)

Using in-silco models (R or MATLAB)

Hristo Aladjov, OECD, France

13h00–16h00

Meeting Stu-

dio 211+212

EU-ToxRisk: status quo of the Horizon2020 flagship project on non-animal toxicology

17h00–19h00

GOLD Hall

Opening Ceremony

Chair: Mumtaz Iscan, president of EUROTOX, Turkey

including

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Keynote lecture: Consumer toxicology: Natural is good, synthetic is bad Michael Siegrist, Switzerland

Chair: Dominique Lison, president of the EUROTOX 2018 congress, Belgium

and EUROTOX Merit Award

Chair: Mumtaz Iscan, president of EUROTOX, Turkey

19h00-21h00 Welcome Reception in the Exhibition Area Grand Hall 1+2

Monday, 3 September, 2018

07h30 - 19h30 Congress registration 09h00 – 18h00 Exhibition Grand Hall 1+2

08h30–09h30

GOLD Hall

Keynote lecture

Chair: Saadia Kerdine-Römer, France

Nrf2 and its future

Masayuki Yamamoto, Tohoku University Graduate School of Medicine and Tohoku Medical Megabank Organization, Japan

09h30–10h00 Coffee Break, Exhibition & Poster Viewing 1

10h00–12h00

GOLD Hall

Session 1

Organs on a chip in toxicology - is the end of animal testing near?

Chairs: Adrian Roth, Switzerland | Vera Rogiers, Belgium

The potential of organs on chips to impact drug safety assessment

Adrian Roth, Roche Innovation Center Basel, Switzerland

The role of cross-species microphysiological systems in understanding target organ toxicity in oncology drug projects

Lorna Ewart, Astra-Zeneca, United Kingdom

Organs on chips for toxicity testing: lung-thrombosis-chip as a practical example.

Monicah Otieno, Janssen Pharmaceuticals Research & Development, United States of America

A microfluidic intestinal model to investigate altered drug behaviour under disease condition

Annie Moisan, Roche Innovation Center Basel, Switzerland

Adult stem cell patient derived toxicology models in organoids

Robert Vries, Hubrecht Institute, The Netherlands

10h00–12h00 Session 2

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6

COPPER Hall Ensuring validity of in vitro replacements: what is needed for regulatory decision making?

Chairs: Heather Wallace, United Kingdom | Ruth Roberts, United Kingdom

The current paradigm on data requirements: what is possible and what is not

Diane Benford, Food Standards Agency, United Kingdom

In vitro alternatives: progress, challenges and opportunities

Ian Kimber, University of Manchester, United Kingdom

A framework of a fit for purpose evaluation of non-animal methods

Alan Boobis, Imperial College London, United Kingdom

Case study 1: chemicals

Hans Ketelsegers, ConCawe, Belgium

Case study 2: agrichemicals

Phil Botham, Syngenta, United Kingdom

Case study 3: personal care or pharmaceuticals

Carl Westmoreland, Unilever, United Kingdom

Panel discussion

all speakers

10h00–12h00

SILVER Hall

Session 3

Chemical-induced immunosuppression in the 21st century

Chairs: François Huaux, Belgium | Emanuela Corsini, Italy

Future direction in immunotoxicology: immunosuppression as key player

François Huaux, Université catholique de Louvain, Belgium

Pesticide-induced immunotoxicity: the experience at EFSA

Andrea Terron, EFSA, Italy

Chemical-induced immunotoxicity: the experience at NTP

Dori Germolec, NIEHS, United States of America

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EUROTOX 2018, Brussels, Belgium | Programme, April, 2018

7

Immunosuppression mediated by enzymes that degrade tryptophan

Benoît Van den Eynde, Univeristé catholique de Louvain, Belgium

The aryl hydrocarbon receptor in immunity: tools and potential

Charlotte Esser, Leibniz Research Institute for Environmental Medicine (IUF), Germany

10h00–12h00

The Arc

Session 4

Non-clinical pharmacology and toxicology assessment of monoclonal antibodies supporting human clinical trials

Chairs: Annick Cauvin, Belgium| Thomas Weiser, Switzerland

Current strategies in the safety assessment of monoclonal antibodies

Sven Kronenberg, Roche, Switzerland

The general relevance of NHP models for safety assessment of mAbs

Gerhard Weinbauer, Covance, Germany

In vitro pharmacology and safety testing of monoclonal antibodies

Andrea Kiessling, UCB, United Kingdom

The use of in vitro and in vivo pharmacology and safety data to set safe starting doses for FIH studies with monoclonal antibodies

Lolke De Haan , Medimmune, United Kingdom

10h00–12h00

Hall 100

Symposium: Optimising drug discovery by investigative toxicology: scientific advancements and case studies (Part I)

Chairs: Francois Pognan, Switzerland| Andreas Czich, Germany

In silico prediction of off-targets - drug and metabolites

Jim Harvey, GSK, United Kingdom

In vitro off-target profiling: impacting drug design and guiding quantitative translation risk assessments

Jean-Pierre Valentin, UCB, Belgium

2D & 3D hepatocyte cell model screens (setting a benchmark for Adv models -mps)

Dominic Williams, AstraZeneca, United Kingdom

Early identification of potentially translatable compound-induced neurotoxicity and associated biomarkers utilizing 2D & 3D prima-

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8

ry and iPSC-derived microbrain models

Eric McDuffie, Janssen, United States of America

Mechanistic de-risking using 3D organoids: addressing human relevance of rat goblet cell expansion

Cristina Bertinetti , Roche, Switzerland

10h00–12h00

Hall 300 Short oral communications 1

12h00 –13h00

GOLD Hall

EUROTOX-SOT Debate: Adverse Outcome Pathways are the future for regulatory toxicology

Chairs: Heather Wallace, president-elect of EUROTOX, United Kingdom | Ron Hines, vice-president of SOT, United States of Ameri-

ca

EUROTOX speaker: Brigitte Landesmann, European Commission, Italy

SOT speaker: Daniel Villeneuve, US Environmental Protection Agency, United States of America

13h00-14h00 Lunch break, exhibition & poster viewing 1

13h00-14h00

The Arc

Industry session by CiToxLAB

Details will be announced soon Industry session

14h00–16h00

GOLD Hall

Session 5

Oligonucleotides – do they warrant specific safety assessment?

Chairs: Yann Tessier, Denmark | Annemieke Aartsma-Rus, The Netherlands

Overview of ways oligonucleotides can be exploited as therapeutics

Annemieke Aartsma-Rus, Leiden University Medical Center, The Netherlands

How do ADME properties of oligonucleotides influence their therapeutic index?

Steve R. Hood, Glaxosmithkline, United Kingdom

Antisense oligonucleotides – recent advances in preclinical safety assessment

Matthias Festag, F. Hoffmann-La Roche, Switzerland

Non-clinical aspects of oligonucleotide drug development: a regulator's perspective

David Jones, The Medicines & Healthcare Products Regulatory Agency, United Kingdom

14h00–16h00

COPPER Hall

Session 6:

Microphysiological human stem cell systems for toxicity testing

Chairs: Tamara Vanhaecke, Belgium | Sandra Coecke, Italy

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9

New developments in human stem cell-based models for toxicity testing

Jan Hengstler, Leibniz Institut für Arbeitsforschung an der Technischen Universität Dortmund - IfADo, Germany

Human skin-derived precursors and their applications in hepatic toxicology

Robim Marcelino Rodrigues, Vrije Universiteit Brussels, Belgium

A human brain microphysiological iPSC-derived system to study neurotoxicity

Helena Hogberg, United States of America

Stem cell derived human organ cells for toxicity testing in microfluidic devices

Carl-Fredrik Mandenius, Linköping University, Sweden

Good in vitro method practices as (the) key for regulatory acceptance of stem cell-derived toxicity methods

Sandra Coecke, EURL-ECVAM, Italy

14h00–16h00

SILVER Hall

Session 7

Detecting immunotoxicity of nanomaterials: from in vitro to rapid predictive testing

Chairs: Diana Boraschi, Italy | Albert Duschl, Austria

In vitro models for assessing nanomaterial functional interaction with human immunological and non-immunological barriers

Claus-Michael Lehr, Helmholtz Institute of Pharmacological Research Saarland, Germany

Advanced models and detection systems for evaluating immunotoxicity of nanomaterials in health and disease

Yvonne Kohl, Fraunhofer Institute for Biomedical Engineering, Germany

Immune response-on-chip: microfluidic systems for detecting human immune and inflammatory response to nanomaterials

Peter Ertl, Technical University Vienna, Austria

Towards realistic in vitro models for prediction of nanomaterials’ immunotoxicity and impact on immune system development

Inge Nelissen, Vlaamse Instelling voor Technologisch Onderzoek (VITO), Belgium

14h00–16h00

The Arc

Session 8

Systems-biology-based 3R methods in toxicology

Chairs: Angela Mally, Germany | Katrin Schutte, Belgium

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10

Single cell imaging for quantitative systems toxicology of hepatoxicity

Bob van de Water, Leiden Academic Centre for Drug Research (LACDR), The Netherlands

Integration of mechanism-based in vitro methods and quantitative in vitro-in vivo extrapolation (QIVIVE) modelling for prediction of

nephrotoxicity

Angela Mally, University of Würzburg, Germany

A 3R systems biology strategy for human neurotoxicity hazard, risk and safety assessment

Remco Westerink, Utrecht University, Institute for Risk Assessment Sciences, The Netherlands

Gaining confidence in replacing animal tests: a case study of the endocrine disruption program at the US EPA

Richard Judson, US EPA, National Center for Computational Toxicology, United States of America

14h00–16h00

Hall 300

Session 9

Open Source Platforms in chemical risk assessment: means to translate 21st century research and tools to the risk assessment

community?

Chairs: Harvey Clewell, United States of America| Jean Lou Dorne, Italy

In vitro models and opensource toxicokinetic databases to support quantitative in vitro to in vivo extrapolation for human risk as-

sessment

Harvey Clewell, ScitoVation, United States of America

Advancing risk assessment of cosmetics using in silico modelling and the COSMOS database

Alicia Paini, JRC-ECVAM, Italy

Reconnecting exposure, toxicokinetics and toxicity in food safety: opendfoodtox and TKplate for human health, animal health and

ecological risk assessment

Jean Lou Dorne, EFSA, Italy

Opensource repositories for the integration of aggregated exposure pathways and adverse outcome pathways

Cecilia Tan, US-EPA, United States of America

14h00–16h00

Hall 100

Symposium: Optimising drug discovery by investigative toxicology: scientific advancements and case studies (Part II)

Chairs: Thomas Steger-Hartmann, Germany | Harrie Boonen, Denmark

Investigations into the mechanisms underlying the severe toxicity of novel pathway inhibitors of the spindle assembly checkpoint

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11

(SAC) pathway – evidence for the involvement of mitochondrial dysfunction

Jon Raschke, Bayer, Germany

Challenges in the assessment of reproductive toxicology of anti-obesity drugs: non-clinical safety assessments of anti-obesity drug

candidates are performed in lean, healthy animals

Florian Bolze, Novo Nordisk, Denmark

Case study: application of high content biology and toxicogenomics in safe drug design and selection

Jorrit Hornberg, AstraZeneca, Sweden

Induction of hemangiosarcoma in mice after chronic treatment with S1P-modulator siponimod appears irrelevant to rat and human

Francois Pognan, Novartis Pharma AG, Switzerland

Application of systems biology to guide quantitative translation risk assessments

Jay Mettelal, AstraZeneca, United States of America

16h00-16h30 Coffee break, exhibition & poster viewing 1

16h30–18h30

GOLD Hall

Session10

Mechanism-based mitochondrial toxicity testing for chemical safety evaluation

Chairs: Bob van de Water, The Netherlands | Philippe Vanparys, Belgium

Target tissue specific activation of transcriptional programmes by mitotoxicants

Marcel Leist, University of Konstanz, Germany

Mechanism-based high throughput screening of mitotoxicity in the Tox21 program

Steve Simmons, National Center for Computational Toxicology / U.S. EPA Office of Research and Development, United States of

America

Quantitative assessment of mitochondrial toxicity and oxidative stress interaction in Adverse Outcome Pathways

Bob van de Water, Leiden University, The Netherlands

In silico modelling of mitochondrial toxicity and oxidative stress to define the tipping point between adaptive and adverse effects

Andrew White, Safety & Environmental Assurance Centre / Unilever, United Kingdom

16h30–18h30

COPPER Hall

Session 11

Nrf2 and inflammation

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Chairs: Saadia Kerdine-Römer, France| Masayuki Yamamoto, Japan

The bright and the dark sides of Nrf2 in skin biology and pathology

Sabine Werner, ETH Zurich, Switzerland

Nrf2/ARE signaling pathway is a key factor for colorectal cancer

Laurence Huc, TOXALIM Research Center in Food Toxicology, France

Nrf2 pathway controls ROS-induced skin fibrosis

Frédéric Batteux, INSERM, Institut Cochin, France

Physiology, pharmacology and toxicology of the Nrf2 pathway

Ian Copple, University of Liverpool, United Kingdom

16h30-18h30

SILVER Hall

Session 12:

Old drugs in new guises: the toxicology of repurposing

Chairs: Ruth Roberts, United Kingdom | Miranda Cornet, Belgium

Repurposing of new medicines: opportunities and challenges

Ruth Roberts, University of Birmingham, United Kingdom

Potential reuse of oncology drugs in the treatment of rare diseases

Weida Tong, FDA NCTR, United States of America

Rethinking immunotherapy for neurodegenerative diseases

Ron Tjalkens, Colorado State University, United States of America

New opportunities for psychoactives in psychiatry

Paul Duffy, ApconiX, United Kingdom

16h30–18h30

The Arc

Session 13

Air pollution over and beyond the classical risk factors

Chairs: Tim Nawrot, Belgium | Jordi Sunyer, Spain

European air pollution models

Gerard Hoek, Utrecht University, The Netherlands

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13

Traffic exposure and health effects in persons with asthma

Paul Cullinan, Imperial College London, United Kingdom

Carbon load in airway macrophages as a biomarker of chronic exposure to air pollution

Ben Nemery, University of Leuven, Belgium

Early life time windows of environmental neurotoxicity

Jordi Sunyer, CREAL, Spain

Air pollution stress and the ageing phenotype

Tim Nawrot, Hasselt University, Belgium

16h30–18h30

Hall 300

16h30–17h30

Industry session by Cosmetics Europe:

5 Years after the ban: can regulatory safety assessment of cosmetics ingredients be performed based on non-animal methods &

approaches?

Chair: tbc.

Building confidence in non-animal methods and regulatory acceptance: the example of collaboration between regulators, re-

searcher and industry to expand the TTC database

Carl Westmoreland, Unilever, United Kingdom

Refining the testing strategies for genotoxicity taking into account human exposure: example of the 3D Micronucleus and Comet

assays and their use for safety assessment

Stefan Pfuhler, Procter & Gamble, United States of America

From bench to OECD guideline - How to integrate methods and reach regulatory acceptance

Nathalie Alépée, L’Oréal, France

17h30–18h30

Industry sessions

18h30-19h30

Specialty section meetings:

Meeting Studio 311 Carcinogenesis SS

Meeting Studio 312 ERAS Risk Assessment SS

Meeting Studio 314 ITCASS Immunotoxicology SS

Meeting Studio 316 Molecular Toxicology SS

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Tuesday, 4 September, 2018

07h30 - 18h30 Congress registration 09h00 – 18h00 Exhibition

08h30–09h30

GOLD Hall

Bo Holmstedt Memorial Fund Lecture

Chairs: Mumtaz Iscan, president of EUROTOX, Turkey | Hermann Autrup, Denmark

Metabolism, inflammation and cancer

Nigel J Gooderham, Imperial College London, UK

09h30 - 10h00 Coffee Break, Exhibition & Poster Viewing 2

10h00–12h00

GOLD Hall

Session 14

Ecotoxicology and toxicology: bridging the gaps | models and frameworks

Chairs: Dries Knapen, Belgium |Alan Boobis, United Kingdom

Example 1: pathway approaches

Ecotoxicology

Lucia Vergauwen, University of Antwerp, Belgium

Toxicology

Mathieu Vinken, Vrije Universiteit Brussels, Belgium

Example 2: mixtures

Ecotoxicology

Ad Ragas, University of Nijmegen, The Netherlands

Toxicology

Jean-Lou Dorne, EFSA, Italy

Panel discussion

All speakers

10h00–12h00

COPPER Hall

Session 15:

Developing safe medicines for children – non-clinical considerations

Chairs: Luc De Schaepdrijver, Belgium |Miranda Cornet, Belgium

Postnatal development of organ systems – species comparison

Steven Van Cruchten, University of Antwerp, Belgium

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Developmental changes in drug disposition and response: the challenges

Jean-Marie Nicolas, UCB Biopharma, Belgium

What can we do better in bringing safe medicines to children – an industry perspective

Georg Schmitt, Roche, Switzerland

Non-clinical safety considerations to support pediatric drug development – a regulatory update

Paul Baldrick, Covance, United Kingdom

10h00–12h00

SILVER Hall

Session 16

Innovative medicinal products – challenges for the safety assessment of adverse immune effects

Chairs: Marc Pallardy, France | Peter Hoet, Belgium

Nanomedicinal products and immunotoxicity: pitfalls in testing and the regulatory framework

Christina Giannakou, University Maastricht/RIVM, The Netherlands

Immunotoxicity assessment of biotech products and small molecules

Marc Pallardy, INSERM, University Paris-Sud, France

Industry perspective on the challenges and opportunities of the safety assessment of biologicals

Sjeng Horbach, Genmab, The Netherlands

Regulatory view on immunotoxicity assessment of biomedical and biotechnology applications

Ruben Pita, PharmD, LLM, United Kingdom

10h00–12h00

The Arc

Session 17

Adverse Outcome Pathways and development of alternative methods

Supported by ECETOC

Chairs: Bennard van Ravenzwaay, Germany | Aldert Piersma, The Netherlands

Introduction and use of AOP in the European Union

Maurice Whelan, EU, JRC – ECVAM, Italy

Respiratory sensitization: in absence of an appropriate animal study, how can an AoP approach help

Ian Kimber, University of Manchester, United Kingdom

Ontologies and AoP in developmental toxicity

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Thomas Knudsen, USA- EPA, United States of America

AoP development at OECD – state of the art

Magdalini Sachana, OECD, France

10h00–12h00

Hall 300 Short oral communications 2

12h00–13h00

GOLD Hall

SOT Merit Award Lecture

Robert Kavlock, US Environmental Protection Agency, United States of America

Chair: Ron Hines, vice-president of SOT, United States of America

13h00–14h00 Lunch break, exhibition & poster viewing 2

13h00–14h00

The Arc

Industry Session by RTC S.p.a.

Details will be announced soon Industry session

14h00–16h00

GOLD Hall

Session 18

Ecotoxicology and toxicology: bridging the gaps | contemporary challenges

supported by UMICORE

Chairs: Mark Martens, Belgium | Chair 2: tbc.

Example 1: nanomaterials

Ecotoxicology

Jérome Rose, CEREGE, France

Toxicology

Hans Bouwmeester, University Wageningen, The Netherlands

Example 2: metals

Ecotoxicology

Erik Smolders, Katholieke Universiteit Leuven, Belgium

Toxicology

Violaine Verougstaete, Eurométaux, Belgium

Panel discussion

All speakers

14h00–16h00

COPPER Hall

Session 19

Translational safety biomarkers: current and future trends

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Chairs: Andre da Costa, Belgium|Alain Verstraete, Belgium

Evaluation of emerging safety biomarkers for major organ toxicities

Heidrun Ellinger-Ziegelbauer, Bayer Pharma AG, Germany

Recent advances on novel translational kidney safety biomarkers and their use in the value chain

Jean-Charles Gautier, Sanofi R&D, France

Taking safety biomarkers 'out of the box': biomarker panels and drug induced injuries

Stephanie Glineur, UCB BioPharma, Belgium

Transformative mechanism-based biomarkers of drug-induced liver injury and their application in precision toxicology

Daniel Antoine, University of Liverpool, United Kingdom

14h00–16h00

SILVER Hall

Session 20

Tools, trends, and technologies in modern CNS safety assessment: mind your brain!

Chairs: Marie-Luce Brodzinski-Rosseels, Belgium | Andrea Greiter-Wilke, Switzerland

3Rs-favorable CNS evaluation: integration of safety pharmacology endpoints in toxicology studies

Will Redfern, Astra Zeneca, United Kingdom

Seizures and dreams in non-clinical drug development: from brain slices to EEG

Simon Authier, CiToxLAB, Canada

Do we neglect peripheral Neuropathy? Pathophysiology, assessment and translational aspects

Joseph Arezzo, Albert Einstein College of Medicine, United States of America

Exciting challenges in the regulatory field of preclinical abuse liability testing of novel CNS-active drug candidates:

can we cope?

Greet Teuns, Janssen Pharmaceutical N.V., Belgium

14h00–16h00

The Arc

Session 21

New insights in the role of innate immunity in immunotoxicology

Chairs: Raymond Pieters, The Netherlands | Marc Pallardy, France

Role of innate immunity in drug induced hepatotoxicity

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Hartmut Jaeschke, University of Kansas Medical Centre, United States of America

Monocytes in particle-induced lung fibrosis

Francois Huaux, Université catholique de Louvain, Belgium

Neutrophil activation in contact allergy

Saadia Kerdine-Römer, Université Paris Sud, France

Neutrophil-monocyte interplay in drug induced liver injury

Raymond Pieters, IRAS - Utrecht University, The Netherlands

14h00–16h00

Hall 300 Industry sessions

16h00 - 16h30 Coffee break, exhibition & poster viewing 2

16h30–18h30

GOLD Hall

Session 22

Mode of action as a key in risk assessment of chemical carcinogens

Chairs: Dieter Schrenk, Germany | Jan Vondracek, Czech Republic

Predictability of carcinogenesis

A. Wallace Hayes, Michigan State University, United States of America

Current approaches to risk assessment of carcinogens

Dieter Schrenk, University of Kaiserslautern, Germany

Mode of action and human relevance of rodent liver tumours produced by nongenotoxic CAR and PPARα activators

Brian G. Lake, University of Surrey, United Kingdom

Multiple modes of action converge in carcinogenicity of polycyclic aromatic hydrocarbons

Jan Vondracek, Institute of Biophysics CAS, Czech Republic

16h30–18h30

COPPER Hall

Session 23

Breeding IATAs for predicting DART by fusing high-dimensional data with biological knowledge

Chairs: Aldert Piersma, The Netherlands | Philippe Vanparys, Belgium

Developmental and reproductive toxicity testing – the next generation

Manon Beekhuijzen, Charles River Laboratories Den Bosch B.V., The Netherlands

AOP-informed tiered testing to predict DART risks during new chemical R&D

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Richard Currie, Syngenta Limited, United Kingdom

Building an AOP based prenatal developmental toxicity ontology

Aldert Piersma, National Institute for Public Health and the Environment RIVM, The Netherlands

Integrative modelling and AOP-based simulation of developmental toxicity

Thomas Knudsen, National Center for Computational Toxicology, US EPA/ORD, United States of America

16h30–18h30

SILVER Hall

Session 24

Cardiac safety: current state of the art

Chairs: Mark Holbrook, United Kingdom | Ester Lovsin-Barle, Switzerland

Current challenges and opportunities in cardiac safety: a clinical perspective

Philip Sager, Stanford University, School of Medicine, United States of America

Developing solutions to detect and avoid cardiovascular toxicity in the clinic

Jean-Pierre Valentin, UCB Biopharma, Belgium

Ion channel profiling of stem cell-derived cardiomyocytes: Useful reagents for automated patch-clamp?

Michael Morton, ApconiX, United Kingdom

Cardiac Safety: A regulatory perspective

Krishna Prasad, MHRA London, United Kingdom

16h30–18h30

The Arc

Session 25

Developmental immunotoxicity

Chairs: Unni C. Nygaard, Norway |Ingo Bichlmaier, Finland

Mechanisms of adult and developmental immunotoxicity

Rodney Dietert, College of Veterinary Medicine, Cornell University, United States of America

Adversity of changes in immune parameters and findings in developmental immunotoxicity studies

Ellen Hessel, RIVM, The Netherlands

Skin sensitisation and developmental immunotoxicity - are there any links?

Katarzyna Malkiewicz, Swedish Chemicals Agency, Sweden

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Regulatory aspects under REACH relating to the developmental immunotoxicity (DIT) cohort in the extended one-generation re-

productive toxicity study (EOGRTS)

Ingo Bichlmaier, ECHA, Finland

16h30-18h30

Hall 300 Industry sessions

18h00 Closure of the exhibition

19h30 - 24h00 Congress dinner at AUTOWORLD Brussels

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Wednesday, 5 September, 2018

07h30 - 13h00 Congress Registration

08h30–09h30

COPPER Hall

Keynote Lecture

Chair : Miranda Cornet, Belgium

Drug discovery: if you want to see different results do things differently

Ruth Roberts, University of Birmingham, United Kingdom

09h30–10h00 Coffee Break

10h00–12h00

COPPER Hall

Session 26

Success of toxicology applications in society: from science to regulation and to implementation

Chairs: Jyrki Liesivuori, Finland | Aristidis Tsatsakis, Greece

How modern toxicology serves the society?

Thomas Hartung, Johns Hopkins Bloomberg School of Public Health, United States of America

Is EU chemical policy reaching its goals?

Björn Hansen, European Commission, Belgium

How effectively toxicology saves environment and consumers?

Vito Buonsante, Client Earth, Italy/Belgium

Successful implementation of toxicology in occupational health?

Jukka Takala, International Commission on Occupational Health, Singapore

10h00–12h00

SILVER Hall

Session 27

Integrating epidemiology and experimental toxicology to understand the risk of endocrine disrupting chemical mixtures on chil-

dren

Chairs: Mattias Öberg, Sweden | Corinne Charlier, Belgium

To use epidemiological data for identification of EDC mixtures correlated to adverse health outcomes on growth and metabolism,

neurodevelopment, and sexual development

Carl-Gustaf Bornehag, Karlstad University, Sweden

Identification of mechanisms underlying adverse health outcomes related to EDC mixtures using experimental animal and cell

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models

Barbara Demeneix, Centre National de la Recherche Scientifique (CNRS), France

Mixture effects on mesenchymal stem cell differentiation in relation to low birth weight and obesity later in life

Joëlle Rüegg, Karolinska Institutet, Sweden

Transcriptomic and epigenomic profiling of human embryonic stem cells (hESC) during differentiation into neural progenitors ex-

posed to EDC mixtures

Giuseppe Testa, The European Institute of Oncology, Italy

10h00–12h00

The Arc

Session 28

Cytokine release assays: future directions

Supported by ILSI Health and Environmental Sciences Institute (HESI)

Chairs: Lynn O'Donnell, United States of America |Brigitte Molinier, France

Reference reagents for a better harmonisation of cytokine release assays

Sandrine Vessillier, National Institute for Biological Standards and Control, United Kingdom

Utility of humanized mice for assessment of potential cytokine release Lynn O'Donnell, Pfizer, United States of America

Translational aspects of the cytokine release assay

Daniel Weinstock, Janssen R&D, United States of America

Regulatory perspective of cytokine release assays in particular with respect to co-administered biotherapeutics

Gabriele Reichmann, Paul-Ehrlich-Institute, Germany

10h00–12h00

Hall 300 Short oral communications 3

12h00–13h00

COPPER Hall

HESI CITE Lecture

Chair: tbc.

Details will be announced soon.

13h00–13h30

COPPER Hall Closing Ceremony and Awards presentation