Scientific Program

SCIENTIFIC PROGRAM

The program of the 11th World Congress on Alternatives and Animal Use in the Life Sciences (WC11) will be virtual due to continued COVID-19 imposed restrictions, and will be spread over a two-week period, from 23 August - 2 September 2021.

The program below is subject to change. The final program will be available in June 2021.

Monday 23 August 2021 - Day 1

1.45 - 3.30 PM - Plenary sessions

1.45 - 2.15 PM

WC11 Virtual Opening Ceremony and Welcome Address

The official opening of the WC11 Virtual Congress with speeches from the Chair of the Local Organizing Committee, President of the Maastricht University and a representative of the European Commission. With a real Maastricht, the Netherlands flavor. 

2.15 - 3.15 PM

KEYNOTE: Dr. André Kuipers, European Space Agency

Born on 5 October 1958 in Amsterdam, the Netherlands, André Kuipers is married with three daughters and a son. He enjoys flying, scuba diving, skiing, hiking, traveling, and history.

In December 2002, André was assigned as a Flight Engineer for a Soyuz flight to the International Space Station. The DELTA mission was sponsored by the Dutch government in an agreement between ESA and the Russian Federal Space Agency and took place from 19–30 April 2004. The flight had three objectives: to exchange the Soyuz spacecraft that serves as Space Station lifeboat, to exchange the Station crew and for André to perform 21 experiments in human physiology, biology, technology and education.

In August 2009, André was assigned to Expedition 30/31, a long-duration mission to the International Space Station called PromISSe. Together with Russian cosmonaut Oleg Kononenko and NASA astronaut Don Pettit, André was launched on 21 December 2011 from Baikonur Cosmodrome in Kazakhstan. During his mission, he took part in around 50 experiments covering a wide range of disciplines. He was the prime crewmember for the rendezvous and docking of ESA’s third Automated Transfer Vehicle. He was also involved in berthing SpaceX’s Dragon ferry. André and his crewmates returned to Earth on 1 July 2012.

Read more about André Kuipers on the  website of the European Space Agency.

3:15 - 3.30 PM

Break and WC11 TV from the studio

3.30 - 5.30 PM - Parallel Session MO-1

3.30 - 5.30 PM

S21: Remove ATT, TABST & LABST. How far away we are to global harmonization for those safety tests? (Theme: Disease)

Many institutions and organization have been working independently or jointly to remove those obsolete safety testing from the production and batch release testing for human (ATT) and veterinary vaccines (TABST, LABST). Many regulatory agencies and international organizations have successfully removed or suggested the remove or the waiver of those tests. How far away are we from their global elimination?

Chair: L. Viviani, Humane Society International


Speakers:

Abstract ID 293 - Remove ATT, TABST & LABST. How far away are we to global harmonization for those safety tests?
L. Viviani, Humane Society International

Abstract ID 713 - REMOVE ATT, TABST & LABST. The journey of how they became obsolete
K. Schutte, EPAA - European Partnership for Alternative Approaches to Animal Testing

Abstract ID 1026 - Waiving the Target Animal Batch Safety Tests of veterinary vaccines. An industry perspective.
C. Philippe, Boehringer Ingelheim

Abstract ID 759- The interest to adopt a change on TABST & LABST in Brazil.
M. Vinicius de Santana Leandro, Ministry of Agriculture Brazil

Abstract ID 260 - The process for the deletion of ATT, TABST and LABST in India
B. Poojary, HSI

Abstract ID 1114 - Removal of Abnormal Toxicity Test from human vaccines in India: a successful approach
S.K. Goel, Serum Institute of India

3.30 - 5.30 PM

S200: Establishing a European Network of 3Rs Centers and 3Rs-Societies (Theme: Ethics, Welfare and Regulation)

Several 3Rs centers have recently been established around the world dealing with different aspects of replacement, reduction and refinement of animals used for scientific purposes. The session aims at providing an overview of the diversity and experiences the various centers may face within their countries. In addition, it will discuss possible synergies and collaborative activities that can help furthering the implementation of 3Rs at different levels such as research, education and dissemination.

Session chair and co-chair: H. Spielmann, EUSAAT (European Society for Alternatives to Animal Testing) and C. Chandrasekera, Canadian Centre for Alternatives to Animal Methods (CCAAM))


Speakers:

Abstract ID 76 - The EUSAAT initiative to establish a European Network of 3Rs Centers
W. Neuhaus, AIT Austrian Institute of Technology

Abstract ID 24 - Norecopa: A hub of international 3R resources
A. Smith, Norecopa

Abstract ID 75 - The Berlin-Brandenburg Research Platform BB3R - Research and Graduate Education since 2014
M. Schäfer-Korting, Freie Universität Berlin

Abstract ID 909 - Canadian Centre for Alternatives to Animal Methods
C. Chandrasekera, CCAAM

Abstract ID 80 - Asian Congress supported by the Japanese Society for Alternatives to Animal Experiments (JSAAE)
H. Kojima, JaCVAM

Abstract ID 77 - Promotion of the 3Rs consensus formation in China through transformation between academia and industry
S. Cheng, Shanghai Jiaotong

3.30 - 5.30 PM

S167: Replacing Fetal Bovine Serum (FBS) – Innovative Alternatives and Transition Strategies (Theme: Innovative Technologies)

Cell culture media are commonly supplemented with fetal bovine serum (FBS), obtained from the blood of unborn calfs, to ensure cell proliferation and maintenance. Its unknown composition and high lot to-lot variability can cause unintended outcomes and problems in experimental reproducibility. Furthermore, FBS production is subject to ethical and animal welfare concerns, as there are certain indications that fetuses are already capable of suffering. Alternatives are on the market, e.g. lysates of human blood platelets (hPL) or chemically defined media. The workshop aims to discuss the use and collection of FBS, performance of existing alternative media and demonstrates transition strategies.

Session chair and co-chair: T. Weber, German Animal Welfare Federation & Animal Welfare Academy and K. Groff, PETA International Science Consortium Ltd


Speakers:

Abstract ID 284 - Dam transportation, fetal suffering and legal objections - Why fetal bovine serum should be a thing of the past
Tilo Weber, German Animal Welfare Federation / Animal Welfare Academy

Abstract ID 88 - Replacing Foetal Bovine Serum: A piece of cake?
Jan Valk, 3Rs-Centre Utrecht Life Sciences, Utrecht University

Abstract ID 245 - Replacing Fetal Bovine Serum (FBS) - Innovative Alternatives and Transition Strategies
Karen Bieback, Institute of Transfusion Medicine and Immunology, Medical Faculty Mannheim, Heidelberg University; German Red Cross Blood Service Baden-Württemberg - Hessen

Abstract ID 480 - Towards the replacement of foetal bovine serum in cell culture application: the example of A549 cells
Aline Chary, Luxembourg Institute of Science and Technology

Abstract ID 534 - WHAT IS TRULY ANIMAL-FREE TESTING? MOVING TOWARDS ANIMAL-PRODUCT-FREE IN VITRO SYSTEMS
Carol Treasure, XCellR8 Ltd, Techspace One, Keckwick Lane, Daresbury, Cheshire WA4 4AB, UK

Abstract ID 1032 - A UNIQUE THREE DIMENSIONAL MULTIWELL PLATE FOR ANIMAL FREE EVALUATION OF TOXICITY
Stina Oredsson

3.30 - 5.30 PM

S161: Validation redefined: needs and opportunities for the validation of (r)evolutionary non-animal approaches for chemical safety assessment (Theme: Safety)

This workshop focuses on how to validate new paradigms for chemical risk assessment, e.g. Next Generation Risk Assessment (NGRA). This is perceived challenging because these paradigms are based on combinations of new approach methods (NAMs). Previous workshops on this topic concluded that a comprehensive evaluation of biological relevance, scientific validity and regulatory purpose of NAMs and assessment strategies is needed. Case studies that provide practical experience with NGRA were considered important to build up confidence to facilitate regulatory acceptance. In this workshop the topic will be presented from the angles of different stakeholders followed by an interactive panel discussion.

Session chair: M. Oelgeschlaeger, German Federal Institute for Risk Assessment (BfR) 


Speakers:

Abstract ID 92 - SETTING THE SCENE FOR A NEW PARADIGM FOR RISK ASSESSMENT: EVOLUTION VERSUS REVOLUTION
Aldert Piersma, RIVM

Abstract ID 668 - Validation in a regulatory context - a EURL ECVAM perspective on principles, practice and progress
Maurice Whelan, European Commission, Joint Research Centre (JRC)

Abstract ID 144 - Rethinking validation: Building confidence in human models through biologically based design
Rebecca Clewell, 21st Century Tox Consulting LLC

Abstract ID 121 - NEXT GENERATION RISK ASSESSMENT FOR CONSUMER SAFETY: WHAT DO WE NEED FROM VALIDATION?
Carl Westmoreland, Unilever SEAC

Abstract ID 429 - TOWARDS AN ANIMAL-FREE HUMAN HEALTH ASSESSMENT: WHAT ARE THE REGULATORYNEEDS?
Peter Bos

Abstract ID 787 - IMPROVEMENT OF IN SILICO MODELS FOR TOXICITY PREDICTION BY IDENTIFYING, CHARACTERISING AND REDUCING UNCERTAINTIES
Mark Cronin

3.30 - 5.30 PM

S149: Implementing openness: promoting transparency around animal research across regions (Theme: Ethics, Welfare and Regulation)

Transparency is an objective of Directive 2010/63 on the protection of animals used for scientific purposes. By creating greater compliance and accountability, along with trust and social acceptance, transparency promotes a level playing field and supports competitiveness. An increasing number of European states are supporting formal ‘transparency agreements’ around their use of animals in research. In this round-table session five speakers will talk from different perspectives about their experiences of implementing greater openness, highlighting the successes and the challenges. There will be opportunity of discussion and questions related to increasing transparency around the use of animals in research.

Session chair: B.Williams, Understanding Animal Research 


Speakers:

Abstract ID - 15 Openness in the UK since the Concordat
Wendy Jarrett, Understanding Animal Research

Abstract ID 4 - THE TRANSPARENCY AGREEMENT IN SPAIN: AN EXAMPLE OF SUCCESS
Javier Guillén, AAALAC International

Abstract ID 544 - Implementing Transparency in Portugal
Ana Santos, NOVA Medical School, NOVA University Lisboa; FELASA

Abstract ID 8 - Talking about harms
Barney Reed, RSPCA

Abstract ID 458 - Promoting transparency around animal research across regions
Susanna Louhimies, European Commission

3.30 - 5.30 PM

S79: Methods to enhance biotransformation capability for in vitro high throughput screening assays (Theme: Safety)

In vitro high-throughput screening (HTS) assays have been developed over the past decade for generating toxicity profiles for thousands of data-poor environmental compounds. Although highly successful, the effort has been limited by a lack of effective biotransformation capability in the standard cell types used in these in vitro assays. Thus, results from these assays may not accurately reflect in vivo activity. To address this problem, several laboratories are developing methods to provide metabolic activation capability to these in vitro systems. This symposium will highlight novel, ongoing approaches for providing biotransformation capability to HTS assays, with an emphasis on human-relevant metabolism.

Session chair: Kristine Witt, National Toxicology Program/NIEHS and Menghang Xia, SOT/National Center for Advancing Translational Sciences


Speakers:

Abstract ID 2 - Incorporation of a metabolic component into in vitro Tox21 high throughput screening assays
Menghang Xia, National Center for Advancing Translational Sciences, NIH

Abstract ID 87 - RETROFITTING AN IN VITRO TOX21 HIGH THROUGHPUT SCREENING ASSAY FOR P53 ACTIVATION WITH METABOLIC CAPABILITY: COMPARING RESULTS FROM HUMAN AND RAT LIVER MICROSOME PREPARATIONS
Kristine Witt, U.S. National Toxicology Program/NIEHS/NIH

Abstract ID 857 - A human xenobiotic metabolic system adapted to quantitative high-throughput screening processes
Ludovic LE HEGARAT, ANSES, French Agency for Food, Environmental and Occupational Health & Safety

Abstract ID 64 - Development of Metabolically Competent Human and Rat Spheroid Models and Application of High-throughput
Transcriptomics Towards 3R's strategy
Sreenivasa Ramaiahgari, Biomolecular Screening Branch, Division of National Toxicology Program, National Ins

Abstract ID 10 - Use of human cell lines with different bioactivation capacities to determine the genotoxic mechanism of action
Marc Audebert, INRAE TOXALIM

Abstract ID 598 - Deciding on an Assay Setup to Control Test Chemical Concentrations In Vitro
Nynke Kramer

5.30 - 7.00 PM - Plenary sessions

5.30 - 5.45 PM

Break and WC11 TV from the studio

5.45 - 6.45 PM

KEYNOTE: Dr. Russel Thomas, U.S. Environmental Protection Agency

Russell Thomas is the director of the Center for Computational Toxicology and Exposure at the U.S. Environmental Protection Agency. The Center is performing solutions-driven research to rapidly evaluate the potential human health and environmental risks due to exposures to environmental stressors and ensure the integrity of the freshwater environment and its capacity to support human well-being.

Dr. Thomas has a broad, multidisciplinary background and experience. Dr. Thomas’ formal academic training includes a B.A. in chemistry from Tabor College, an M.S. in radiation ecology and health physics from Colorado State University, and a Ph.D. in toxicology also at Colorado State.

Following his doctoral studies, Dr. Thomas performed postdoctoral research in molecular biology and genomics at the McArdle Cancer Research Laboratory at the University of Wisconsin. Following his academic training, Dr. Thomas performed bioinformatics and genomics research in the biotechnology sector and gained experience in high-throughput screening and in vitro assay development in the biopharma sector. Prior to coming to the U.S. EPA, Dr. Thomas worked as an investigator and senior manager at a non-profit research institute.

6.45 - 7.00 PM

Break and WC11 TV from the studio

7.00 - 9.00 PM - Parallel Session MO-2

7.00 - 9.00 PM

S71: Biomarker-based in vitro tools targeting early Alzheimer's in a human relevant fashion (Theme: Disease)

Decades of research using animal models for Alzheimer's disease did not translate into benefits for patients. Causes of failure are several: (i) animal models do not develop human pathology which challenges the human relevance of these models, (ii) traditionally, research focus has been on disease stages with irreversible brain damage and thus a low expected impact of novel therapies, and (iv) animal models represent <5% of the Alzheimer’s cases. Overall, there has been disproportional little attention for external risk factors driving the more frequent form of Alzheimer’s that develops later in life (> 60 years) (>95% of the cases).
This workshop intends to challenge the traditional paradigm and will advocate for the application of novel technologies which have shown successful in the field of oncology. These technologies include approaches for assessing in a human relevant way the impact of non-genetic risk factors and environment on initiation and early development of Alzheimer’s. Especially the use of miRNA profiles for peripheral diagnosis of non-clinical Alzheimer's is discussed.

Session chair: Erwin L Roggen, ToxGenSolutions BV


Speakers:

Abstract ID 19 - The current translational gap: Problems and solutions
Erwin L Roggen, ToxGenSolutions BV

Abstract ID - The impact of biomarkers on drug development in the area of Oncology
Carl Borreback, Lund University

Abstract ID 65 - lncRNAs AS NOVEL SOURCE OF DIAGNOSTIC APPLICATIONS FOR EARLY ALZHEIMER'S DISEASE AND OTHER DEMENTIA TYPES - ADDIA Consortium and ADKIT Consortium
Hüseyin Firat, Amoneta Diagnostics SAS

Abstract ID 251 - Mapping potential biomarkers for early sporadic Alzheimer's: Status of the Interreg VL-NL project 'Memories'
Jacco Briedé, Maastricht University

7.00 - 9.00 PM

S76: Sharing organs and tissues to reduce the lab animal usage – Current update on existing biobanks and sharing platforms (Theme: Ethics, Welfare and Regulation)

The reduction of lab animal usage can be achieved by e.g. improved statistical and experimental planning, in-depth pre-analysis in suitable cell culture models or conscious handling of biological resources and materials that are left during the animal experiments. Therefore, sharing of organs and tissues of animals sacrificed for scientific purpose, surplus animals or those used for organ collection under anesthesia or educational purposes provides the great opportunity to sustainably reduce the animal number in a short-term setup. Within the proposed symposium, we will give an overview on current existing projects providing an infrastructure for biobanking or an online platform to share organs and tissues.

Session chair: Annemarie Lang, Charité-Universitätsmedizin Berlin and Valerie Speirs, University of Aberdeen


Speakers: 

Abstract ID 222 - Update on innovative approaches to share organs and tissues in science
Annemarie Lang, Department of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin Berlin; AniMatch UG (haftungsbeschränkt)

Abstract ID 300 - SEARCHBreast: A virtual bioresource to facilitate the sharing of surplus animal materials derived from breast cancer studies
Valerie Speirs, University of Aberdeen

Abstract ID 488 - BUILDING AN INTERNAL INFORMATION INFRASTRUCTURE TO DISSEMINATE SURPLUS ANIMALS
Claudia Abramjuk, FEM, Charité Universitätsmedizin Berlin

Abstract ID 1014 - How to reduce Reduction to practice - an example
Beate Obermüller, University of Graz

Abstract ID 598 - Vital Tissue, an initiative to supply viable human materials to laboratories in The Netherlands
Evita van de Steeg

Abstract ID 495 - Implemetation of the 3Rs in Biomedical Research
Birgit Reininger-Gutmann

7.00 - 9.00 PM

S235: Industrial case studies using Microphysiological Systems (Theme: Innovative Technologies)

The Pharmaceutical industry has implemented a broad array of in vitro systems to support preclinical evaluation of new drug candidates. Microphysiological Systems (MPS) are considered to further improve prediction of safety and efficacy of new drug candidates prior to their use in humans. MPS-based assays are increasingly becoming part of the internal decision-making processes within Pharma and this session aims to present case studies of industrial adoption while discussing their impact on the 3R´s.

Session chair and co-chair: A. Roth, Hoffman La Roche and L. Ewart, Emulate Inc.


Speakers:

Abstract ID 95 - Introduction to the Session: Case studies from Industry using Microphysiological Systems 
L. Ewart, Emulate Inc.

Abstract ID 520 - Human immunocompetent Organ on Chip platforms allow safety profiling of tumor-targeted T-cell bispecific antibodies
N. Gjovreski and L. Cabon, Roche

Abstract ID 868 - A high-throughput, microfluidic platform for drug screening on vascularized 3d tissues
J. Joore, Mimetas

Abstract ID 204 - A human-derived proximal tubule-on-a-chip replicates ASO-induced kidney injury biomarkers
T. Nieskens, AstraZeneca

Abstract ID 876 - Organoids: less animal studies, more relevant data
R. Vries, Hubrect Institute

7.00 - 9.00 PM

S163: New Approach Methodologies (NAM)-supported Read-Across Approaches for Regulatory Purposes (Theme: Safety)

Read-across (RAx) is one of the most commonly used alternative approaches for data gap filling in registrations submitted under cosmetics safety assessment and REACH. New approach methodologies (NAM) have started to be deployed to reduce uncertainty and establish robust read-across.
In this session, the use of NAM-supported RAx will be introduced and exemplary case studies from the Cosmetics Europe Long-Range-Science-Strategy and the EU-ToxRisk project will be presented. The EU-ToxRisk advisory document will be described. A strong focus will be given on its regulatory foundation and future impact. Finally, the available approaches and tools for RAx-supported risk assessment will be discussed.

Session chair and co-chair: S. Hougaard Bennekou, National Food Institute, Technical University of Denmark and D. Kroese, TNO, Netherlands Organisation for Applied Scientific Research


Speakers:

Abstract ID 856 - Setting the scene: New Approach Methodologies (NAM)-supported Read-Across Approaches
Hennicke Kamp, BASF SE

Abstract ID 281 - A Case Study combining Read-Across and NAM, the Example of Propyl-paraben in Systemic Toxicity, from A to Z
Gladys Ouedraogo, Cosmetics Europe

Abstract ID 596 - From case studies to a regulatory guidance: the EU-ToxRisk NAM-assisted RAx advisory document
Bob van de Water, Leiden University

Abstract ID 650 - Regulatory Feedback on the EU-ToxRisk (NAM)-supported Read-Across Advisory Document
Matthias Herzler, German Federal Institute for Risk Assessment (BfR)

Abstract ID 301 - Advancing read-across practice and applications for the evaluation of data-poor environmental chemicals within the U.S. EPA PPRTV program
Lucina E. Lizarraga, US EPA

7.00 - 9.00 PM

S196: Barriers of Refinement Use in Practice (Theme: Ethics, Welfare and Regulation)

Refinement research has the potential to improve the lives of many animals. However, implementation of Refinement is often limited, even when Refinements are based on scientifically sound discoveries. Barriers to implementation may include: economical constraints, apprehensions about changes to data, limitations in products marketed by animal research suppliers and people (their cultural backgrounds, attitudes and beliefs towards animals). This workshop explores what is perceived as the potential barriers to implementation of Refinement, with the aim of highlighting paths forward for successful application. Real case studies will be presented to reveal existing barriers and as examples on ways to achieve change.

Session chair and co-chair: K. Hermann, Johns Hopkins University Bloomberg School of Public & Center for Alternatives to Animal Testing


Speakers:

Abstract ID 150 - Perceived barriers to implementing refinements in euthanasia for rodents
L. Amendola, University of British Columbia

Abstract ID 819 - Practical challenges and considerations in refining euthanasia methods in laboratory animal research in rodents – a pharmaceutical industry case study
S. Robinson, AstraZeneca

Abstract ID - Low stress handling of mice: challenges and solutions for implementation
J. Hurst, University of Liverpool

Abstract ID 366 - Education and training to fully Implement refinement methods in practice
K. Herrmann, Johns Hopkins Bloomberg School of Public Health & CAAT

7.00 - 9.00 PM

S111: Modern, Mechanistic Approaches to Cancer Risk Assessment (Theme: Safety)

For decades, risk assessors have relied on the rodent cancer bioassays to identify potential human carcinogens. The rodent bioassays are required by numerous regulatory authorities for carcinogenicity assessment. However, five decades of research have revealed more informative, human-relevant approaches to assess potential carcinogenic effects. Questions are being asked about how to modernize cancer risk assessment through the use of mechanistic approaches that reduce testing on animals and provide more health protective information to ensure chemical safety. During this session, experts will deliver presentations and a panel discussion providing insight into current challenges and opportunities in designing human-relevant chemical carcinogenicity assessment.

Session chair: Gina Hilton, PETA Science Consortium International e.V.


Speakers:

Abstract ID 11 - Modernizing the NTP's Carcinogenicity Testing Program
Warren Casey, US National Toxicology Program

Abstract ID 72 - Towards replacing the two-year bioassay with short-term NAMs: genomic and nongenomic activation levels can
identify rat liver tumorigens
Chris Corton, Environmental Protection Agency; Center for Computational Toxicology and Exposure

Abstract ID 17 - Application of the key characteristics in carcinogen hazard identification
Kathryn Guyton, IARC

Abstract ID 44 - ReCAAP: Carcinogenicity waivers for food-use pesticide registration
Gina Hilton, PETA Science Consortium International e.V

Abstract ID 170 - Developing an Integrated Approach to Testing and Assessment for non-genotoxic carcinogens
Nathalie Delrue, Organisation for Economic Co-operation and Development

Abstract ID 63 - Advancing carcinogenicity assessment: a novel methodological approach to integrate information and further the
impact on the 3Rs
Federica Madia, European Commission, Joint Research Centre

9.00 - 10.00 PM - WC11 Talkshow live from the studio in Maastricht

9.00 - 10.00 PM

WC11 Talkshow live from the studio

tuesday 24 August 2021 - Day 2

2.30 - 3.00 PM - Plenary sessions

2.30 - 3.00 PM

WC11 TV - Live from the studio

3.00 - 5.00 PM - Parallel Session TUE-1

3.00 - 5.00 PM

S75: Modeling the muskuloskeletal system and related disorders in vitro – Cells, scaffolds and biomechanics (Theme: Disease)

The development of physiological relevant models to simulated parts of the musculoskeletal system such as bone or cartilage requires the combination of tissue engineering, cell biology and biomechanics. In the proposed symposium different aspects and approaches for this specific area will be presented including bone-, cartilage- or joint-on-a-chip technologies, macro-tissue and bioreactor approaches towards sophisticated tissue engineering and qualitative network models.

Session chair: Frank Schulze, German Centre for the Protection of Laboratory Animals (Bf3R) and Marcel Karperien, University of Twente, The Netherlands


Speakers:

Abstract ID 50 - THE EFFECT OF MECHANICAL LOADING IN A BONE-ON-A-CHIP
Frank Schulze, German Federal Institute for Risk Assessment; German Centre for the Protection of Laboratory Animals

Abstract ID 896 - Microfabrication technologies for engineering of a moving Joint-on-Chip
Marcel Karperien, University of Twente

Abstract ID 718 - In silico modelling as a way to prioritize experiments and reduce experimental testing for osteoarthritis drug target discovery
Raphaelle Lesage, Prometheus, Division of Skeletal Tissue Engineering, KU Leuven, Belgium; Biomechanics Section, KU Leuven

Abstract ID 236 - Developing an in vitro model of glucocorticoid-induced osteoporosis
Annemarie Lang, Department of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin Berlin; German Rheumatism Research Center

Abstract ID 167 - An in vitro 3D fracture gap model as a tool for preclinical testing procedures
Moritz Pfeiffenberger

3.00 - 5.00 PM

S244: Rehoming rodents, views and criteria (Theme: Ethics, Welfare and Regulation)

The EU directive 2010/63/EU and Astralian legislation state that rehoming of animals should be considered wherever possible, provided that the wellbeing of the animals is safeguarded. Rehoming schemes have largely focused on species such as dogs, cats, and non-human primates, with good results. But what about rodents? Should we promote that rodents are included in institutional rehoming schemes? Can we safely rehome rats and mice, and if so, how?
In this workshop, we will discuss the views on rehoming rodents and the criteria necessary for a successful rehoming scheme based on results from a Dutch and a Swiss initiative.

Session chair: M. Janssens, Netherlands National Committee for the protection of animals used for scientific purposes (NCad)


Speakers:

Abstract ID - Rehoming rodents - What's your opinion? 
M. Janssens, Utrecht University

Abstract ID 23 - Re-homing rodents - a university perspective
P. Jirkof, University of Zurich

Abstract ID 341 - Rehoming rodents - perspective and experience of an animal welfare organisation
J. Fitzi, Swiss Animal Protection

Abstract ID 336 - Re-homing rodents: opportunities and challenges
P. Van Loo, Utrecht University

Abstract ID 983 - Holding Animal-based Research to Our Highest Ethical Standards
Andrew Fenton

3.00 - 5.00 PM

S215: Emerging 3D organoid technology toward animal alternative testing (Theme: Innovative technologies)

The ability to generate 3D organoids or "mini-organs" that more closely mimic native tissue function has great potential for various applications, such as safety issues. Many strategies have been taken to build human relevant structures through developmental principles, self-guided assembly, and bioengineering. These efforts have resulted in the development of organ-specific human relevant models. However, effective implementation of these advances requires an understanding of their advantages and limitations for practical application. Here we bring together top scientists from regulatory, academia and industry to discuss the exciting challenges for engineering complexity into organ-like systems, their implementation, and future perspectives.

Session chair: Y. Kanda, National Institute of Health Sciences (NIHS) Japan


Speakers:

Abstract ID 306 - Human iPS cell-based models for predictive toxicology
Y. Kanda, National Institute of Health Sciences (NIHS) Japan

Abstract ID 268 - Metabolic maturation of human iPS cell-derived hepatocyte-like cells in multicellular spheroid culture
N. Kojima, Yokohama City University 

Abstract ID - 3D mini brain model for high-throughput screening
B. Anson, Stemonix

Abstract ID 57- Cell sheet-based myocardial tissue engineering for animal alternative
T. Shimizu, Tokyo Women's Medical University

3.00 - 5.00 PM

S126: Modern Regulatory Methods for Skin Sensitization: Bye-Bye Buehler? (Theme: Safety)

New approach methods (NAMs) for skin sensitization are accepted in regulatory and industry settings. Combining NAMs in defined or integrated approaches, predicts human skin sensitization hazard often better than in vivo methods. Yet, animal tests are still used to fulfill skin sensitization data requirements. The Buehler, in particular, not only impacts animal welfare but receives scientific criticism concerning sensitivity when compared to other methods. The goal of this workshop is to broach the controversial question: “Is the Buehler a redundant in vivo test?” and discuss how to build confidence in non-animal skin sensitization approaches for chemical hazard and safety decisions.

Session chair: J. Ezendam, National Institute for Public Health and the Environment 


Speakers:

Abstract ID 620 - WHERE ARE WE NOW: REPLACEMENT OF IN VIVO SKIN SENSITISATION ASSAYS
Emma Grange, Cruelty Free International

Abstract ID 137 - European Lessons learned from REACH submissions using NAM skin sentisisation data
Laura Rossi, Europea Chemicals Agency

Abstract ID 48 - A North American Regulatory Perspective on Skin Sensitization Risk Assessment
Nicole Kleinstreuer, NIEHS/NICEATM

Abstract ID 367 - Skin Sensitization Testing Strategy for Japan and Asia
Takao Ashikaga, National Institute of Health Sciences

Abstract ID 108 - Moderated Panel Discussion: Is it time to say "Bye Bye Buehler"?
Janine Ezendam, National Institute for Public Health and the Environment (RIVM)

3.00 - 5.00 PM

S114: Artificial Intelligence for Risk and Safety Assessment (Theme: Innovative Technologies)

Artificial Intelligence (AI) consists of an array of methodologies that are capable of extracting complex patterns from big data. The session will discuss the basic concept and methodologies of AI applied in predictive toxicology. The 21st century toxicology has increasingly used new tools, particularly alternative methodologies which generates new data streams. With examples from risk assessment and drug development, the guiding principle and best practice of applying AI in toxicology will be discussed with a specific emphasis on application for the new data streams.

Session chair and co-chair: W. Tong, NCTR/FDA and T. Hartung, Johns Hopkins University


Speakers:

Abstract ID 27 - Artificial Intelligence for drug safety and biomarker development
Weida Tong, NCTR/FDA

Abstract ID 952 - Artificial Intelligence for Safety in Drug Discovery
Stefan Platz, AstraZeneca

Abstract ID - Artificial intelligence and machine learning for chemical risk assessment
Thomas Hartung, Johns Hopkins University

Abstract ID 906 - Deep Learning for Predicting Molecular Properties
Djork-Arné Clevert, Bayer AG, Machine Learning Research

Abstract ID 902 - Reference-free Annotation for single-cell Transcriptomics using Graph Neural Network Model
Xiaohui Fan, College of Pharmaceutical Sciences, Zhejiang University

Abstract ID - InferBERT: A BERT-based causal inference framework for Improving AI interpretability
Z. Liu, NCTR/FDA 

3.00 - 5.00 PM

S156: Human relevance in both dose and effect for in vitro testing of respiratory toxicity (Theme: Safety)

Technical developments have resulted in systems that can be used to expose cells via the air to mimic inhalation exposure. Decisions on the exposure system and the cell model are dependent on the research question. However, results of the exposures need to be translated to human effects at some point. In this session, the translation of inhaled concentrations and effects in Air-Liquid-Interface (ALI) cultured cell models to human effects will be addressed.

Session chair: R. Vandebriel, RIVM and H. Braakhuis


Speakers:

Abstract ID 134 - Needs for application of Air-Liquid-Interface models in risk assessment of inhaled compounds
Yvonne Staal, RIVM

Abstract ID 492 - Applied and delivered dose determination for ALI acute inhalation toxicity testing of a petroleum-derived substance
Evelien Frijns, VITO NV (Flemish Institute for Technological Research)

Abstract ID 213 - In-Vitro Inhalation Experimentation Design and Dosimetry Considerations For In-Vitro To In-Vivo Prediction Of
Respiratory Toxicity
Detlef Ritter, Fraunhofer ITEM

Abstract ID 96 - EXPOSURE OF LUNG CELL MODELS TO COMPLETE UNFILTERED AND FILTERED EXHAUST FROM GASOLINE / DIESEL CARS AND COMPARISON WITH FINDINGS IN HUMANS
Barbara Rothen-Rutishauser, Adolphe Merkle Institute, University of Fribourg, Fribourg, Switzerland

Abstract ID 320 - ORGANOID-BASED EXPANSION OF AIRWAY EPITHELIAL CELLS FROM CLINICAL SAMPLES WITH LOW CELL NUMBERS FOR MODELLING EFFECTS OF CIGARETTE SMOKE EXPOSURE
Pieter Hiemstra, Department of Pulmonology, Leiden University Medical Center, Leiden, The Netherlands

Abstract ID 1089 - Use of cause-and-effect analysis to optimize the reliability of in vitro inhalation toxicity measurements using an air-liquid interface
Frank Stefan Bierkandt

5.00 - 6.30 PM - Plenary sessions

5.00 - 5.15 PM

Break and WC11 TV from the studio

5.15 - 6.15 PM

KEYNOTE: Dr. Donald Ingber, Harvard University

Donald E. Ingber, M.D., Ph.D. is the Founding Director of the Wyss Institute for Biologically Inspired Engineering at Harvard University, Judah Folkman Professor of Vascular Biology at Harvard Medical School and the Vascular Biology Program at Boston Children's Hospital, and Professor of Bioengineering at the Harvard John A. Paulson School of Engineering and Applied Sciences. He received his B.A., M.A., M.Phil., M.D. and Ph.D. from Yale University.

Ingber is a pioneer in the field of biologically inspired engineering, and at the Wyss Institute, he currently leads a multifaceted effort to develop breakthrough bioinspired technologies to advance healthcare and to improve sustainability. His work has led to major advances in mechanobiology, tumor angiogenesis, tissue engineering, systems biology, nanobiotechnology and translational medicine. Through his work, Ingber also has helped to break down boundaries between science, art and design.

Ingber has authored more than 450 publications and over 120 issued or pending patents, founded 5 companies, and been a guest speaker at more than 500 events internationally. He is a member of the National Academy of Medicine, National Academy of Inventors, American Institute for Medical and Biological Engineering, and the American Academy of Arts and Sciences. He was named one of the Top 20 Translational Researchers world-wide in 2012 (Nature Biotechnology), a Leading Global Thinker of 2015 (Foreign Policy magazine), and has received numerous other honors in a broad range of disciplines, including the Robert A. Pritzker Award and the Shu Chien Award (Biomedical Engineering Society), the Rous Whipple Award (American Society for Investigative Pathology), the Lifetime Achievement Award (Society of In Vitro Biology), the Leading Edge Award (Society of Toxicology), Founders Award (Biophysical Society) and the Department of Defense Breast Cancer Innovator Award.

One example of Ingber’s most recently developed technologies are Human Organs-on-Chips. These are microfluidic cell culture devices created with microchip manufacturing methods and lined by living human cells, which are being used to replace animal testing as a more accurate and affordable in vitro platform for drug development and personalized medicine. In 2013, Ingber’s work on Organs-on-Chips was honored by the NC3Rs Annual Award from the National Centre for the Replacement, Refinement, and Reduction of Animals in Research, London; in 2015, this technology was named Design of the Year by the London Design Museum and was also acquired by the Museum of Modern Art (MoMA) in New York City for its permanent design collection; and in 2016, they were named one of the Top 10 Emerging Technologies of 2016 by the World Economic Forum.

6.15 - 6.30 PM

Break and WC11 TV from the studio

6.30 - 8.30 PM - Parallel Session TUE-2

6.30 - 8.30 PM

S108: Pharmaceutical Industry initiatives driving the 3Rs (Theme: Disease)

There are a large number of initiatives underway within the pharma sector going beyond the legislative requirements for 3Rs. EFPIA recently published a brochure and would use a session to highlight sand out issues in the pharma sector - https://www.efpia.eu/media/412869/efpia-report-2019-putting-animal-welfare-principles-and-3rs-into-action_updated.pdf

Session chair: Kirsty Reid, EFPIA and Thierry Decelle - Sanofi


Speakers:

Abstract ID 62 - Integrated Research and Testing Strategy to go beyond the 3Rs
Thierry Decelle, Chief Veterinary Officer; Sanofi

Abstract ID 54 - 3R initiatives of the pharmaceutical industry
Kirsty Reid, EFPIA

Abstract ID 422 - REDUCING ANIMAL USE IN PHARMA BY INTEGRATING ELECTROENCEFALOGRAM, BEHAVIOR & CARDIO-HEMODYNAMIC READOUTS IN FREELY MOVING RODENTS
Francesca Pibiri

Abstract ID 279 - RETROSPECTIVE EVALUATION OF ANIMAL AND NON-ANIMAL MODELLING: EFFICACY-RELATED EXAMPLES INFORMING ORGANISATIONAL PRACTICES AND DRIVING IMPROVEMENTS
Maria Beaumont

Abstract ID 445 - BUILDING TRUST IN STEM CELL MODELS FOR COMPOUND SELECTION IN PHARMA; A TASK WORTH THE EFFORT
Ard Teisman

Abstract ID 1084 - 3D Human airway epithelial models to study SARS-CoV-2 pathogenesis
Samuel Constant

6.30 - 8.30 PM

S143: Open Science and Transparency in Animal-Based Research (Theme: Ethics, Welfare and Regulation)

Open Science is the umbrella term for efforts aimed at achieving more openness in science. In principle, results and data of publicly funded research should be made freely available at no cost. Especially in animal-based research, open science and transparency also have important ethical dimensions.
What responsibilities do funders, journal editors, and reviewers have to make this possible? What responsibility do scientists have to create more openness in science? In this session, we will ask different stakeholders to present their view on Open Science and Transparency in animal-based research and invite the audience to discuss with the experts.

Session chair: J-B. Prins, The Francis Crick Institute & Laboratory Animals Limited (LAL)


Speakers:

Abstract ID 110 - Communicating Animal Research: A PLOS ONE Perspective
Alejandra Clark, Public Library of Science

Abstract ID 351 - DORA DECLARATION, OPEN SCIENCE AND ITS IMPACT ON THE ASSESSMENT OF (ANIMAL)RESEARCH
Bas de Waard, ZonMw - The Netherlands Organisation for Health Research and Development

Abstract ID 586 - EDITORS' MORAL OBLIGATIONS - PROFIT, REGULATION AND VIRTUE
Gavin Jarvis, University of Cambridge

Abstract ID 1131 - Increasing transparency and reproducibility of animal research: focus on Open Science
A. Olssen, University of Porto

6.30 - 8.30 PM

S115: Scientific highlights in emulating human biology on chips (Theme: Innovative Technologies)

Microfluidic Microphysiological Systems (MPS, also referred to as organ-on-chip, multi-organ-chip, human body-on-chip or patient-on-chip tools) are considered an enabling technology for the development of approaches to reliably emulate human biology in vitro. Therefore, the value of such systems for basic and applied research of human biology becomes more and more evident. From human lung oedema and four-organ homeostasis on chips towards nerve growth, beating mini-hearts and microbiome on chips: MPS tools represent amazing opportunities to reduce and replace laboratory animals in human life science. The session aims for introducing discovery highlights using MPS.

Session chair and co-chair: J. van den Eijnden-van Raaij, hDMT and P. Loskill, Fraunhofer Institute for Interfacial Engineering and Biotechnology IGB & Eberhard Karls University Tübingen


Speakers:

Abstract ID 947 - SCIENCE, ETHICS AND ACCEPTANCE OF HUMAN MICROPHYSIOLOGICAL SYSTEMS - AN ULTIMATE ALTERNATIVE TO TESTING IN LABORATORY ANIMALS AND HUMAN VOLUNTEERS
Uwe Marx, TissUse GmbH; Technische Universität Berlin

Abstract ID 67 - BLOOD VESSELS IN ORGANS-ON-CHIPS
Andries Van der Meer, Applied Stem Cell Technologies, University of Twente

Abstract ID 109 - Eye-on-chips: Next-generation microphysiological in vitro models for ophthalmology research and ocular
toxicology
Peter Loskill, Faculty of Medicine, Eberhard Karls University Tübingen, Silcherstr. 7/1, 72076 Tübingen, Germany; Fraunhofer Institute for Interfacial Engineering and Biotechnology IGB, Nobelstraße 12, 70569 Stuttgart, Germany

Abstract ID 178 - Overview of Research Program for User-driven MPS Development in Japan
Hitoshi Naraoka, Stem Cell Evaluation Technology Research Association

Abstract ID - Quantitative in silico modelling of a diabetes micro-physiological system allows for translation to humans
G. Cedersund, Linköping University

6.30 - 8.30 PM

S13: Flexible, efficient and performance-driven in-house method validation responding to current regulatory challenges for identifying human thyroid disruptors (Theme: Safety)

The OECD has published the international guidance document on Good In Vitro Method Practices (GIVIMP) to support method developers and end-users working in academic, industry and government laboratories across all 36 OECD member countries and beyond in harmonisation efforts of the new generation of mechanistic in vitro methods responding to current regulatory challenges. Applying GIVIMP during the in vitro method development stage and in-house validation assessing the method's performance will help improve the quality and reliability of generated data needed to support safety decisions also in challenging fields like the thyroid disruptor field.
The European Commission is funding and coordinating a large scale efforts to obtain a set of mechanistically informative alternative methods to detect chemicals that disrupt normal thyroid hormone function, in collaboration with the European Union Network of Laboratories for the Validation of Alternative Methods (EU-NETVAL) and the method developers. An initial set of methods has been identified as candidates taking primarily into account the information reported in an OECD scoping document on in vitro and ex vivo methods for the identification of modulators of thyroid hormone signalling (OECD No. 207), but also an OECD Detailed Review Paper (OECD No. 178), and feedback received at various Expert Group meetings. Furthermore, research efforts are funded by the European and International funding programmes to support the necessary development of new methods and approaches in this particular field to complement the information gaps identified. The symposium will illustrate how global collaboration and harmonisation and interdisciplinary efforts and increasing common awareness of common agreed regulatory information needs can deliver methods and approaches responding to current regulatory challenges for identifying human thyroid disruptors.

1. STEREO PRESENTATION INTRODUCING and GIVING MAIN LEARNING OBJECTIVES OF THE SYMPOSIUM (10 min) with initial SURVEY (slido.com)
Sandra Coecke (EC JRC) and Patience Browne (OECD): Introduction/ goals symposium and overview of principal actors on behalf of the European Commission Joint Research Centre and the OECD

2. FLASH PRESENTATION BY METHOD DEVELOPER (10 min)
Renko Kostja (Le Charite, Berlin, Germany)
Actor: in vitro mechanistic method developer will give a short overview of the mechanistic methods and how OECD Good In Vitro Method Guidance Document (GIVIMP 2018) helps from laboratory bench to regulatory use.

3. SERIES OF FLASH PRESENTATIONS BY EU-NETVAL TEST FACILITIES (30 min)
Flash presentations from EU- NETVAL test facilities; Actor: GLP test facilities OECD MAD validating and implementing new generation of in vitro and Ex-vivo mechanistic methods for identifying thyroid disruptors representing the end-user community doing routine testing service for global safety assessment:
Barbara Birk (BASF, Germany)
Kristina Fant (RISE, Sweden)
Flavio Cinato (Accelera, Italy)
Silvia Dotti (Izler, Italy)
Marisa Meloni (Vitroscreen, Italy)

4. SERIES OF FLASH PRESENTATIONS BY INTERNATIONAL R&D COMMUNITIES (40 min)
4.1. Klára Hilscherová (RECETOX, Masaryk University, Czech Republic)
Actor representing alignment with H2020 activities in terms of chemical selection and ecotoxicology- given an overview of the synergies with H 2020 ERGO, SCREENED, ATHENA)
4.2. Annie Lumen (FDA, USA); Nynke Kramer (IRAS, The Netherlands); Alicia Piani (EC JRC, Italy);
Actors representing integration from kinetic point of view giving a trio presentation illustrating kinetic models for assessing mechanistic strategies for in vitro to in vivo extrapolation for environmental thyroid-active chemicals as implementation strategy of activities ongoing at OECD level to get integrative approaches accepted at regulatory level.
4.3. Juliette Legler (IRAS, UIPS, Utrecht; Brunel University of London, UK)
Actor expert scientific advice - Coordinator H2020 GOLIATH, EURION – representing the cluster of 8 endocrine disruptor projects presenting Global research needs and gap analysis towards research today and in the future

4. FINAL PUBLIC SURVEY (slido.com) AND FINAL CONCLUDING and INTEGRATIVE PRESENTATION
Aldert Piersma (RIVM, The Netherlands) (10 min)
Actor representing expert scientific advice (member EC ESAC) towards the need for test strategies identifying thyroid disruptors towards a paradigm shift in risk assessment approaches in the 21st century.

Session chair: S. Coecke, EURL ECVAM, European Commission Joint Research Centre


Speakers:

Abstract ID 473 - Global collaboration, harmonisation and interdisciplinary efforts deliver mechanistic methods and integrated approaches for identifying human thyroid disruptors
S. Coecke, EURL ECVAM, European Commission Joint Research Centre

Abstract ID 466 - In house GIVIMP method validation as a key process for accelerating thyroid in vitro methods from bench to regulatory use
K. Renko, Le Charite, Bfr, Berlin

Abstract ID 496 - European network of high quality laboratories assessing efficiently the relevance of fully animal-free thyroid mechanistic methods
B. Birk, BASF

Abstract ID 277 - Mechanistic and integrative strategies for identifying thyroid-active chemicals impacting environmental and human health
K. Hilscherová, RECETOX Masaryk University

Abstract ID 508 - Biokinetics and dose-response models to predict thyroid disruption effects
A. Lumen, The Food and Drug Administration (FDA)

Abstract ID 185 - Identifying human thyroid disruptors in the 21st century needs a real paradigm shift in risk assessment approaches
A. Piersma, RIVM National Institute for Public Health and the Environment

6.30 - 8.30 PM

S183: Alternative approaches and predictive methods to fish toxicity testing (Theme: Safety)

Fish, as representatives of one of the trophic levels, are key aquatic organisms for environmental risk assessment. However, they fall into the scope of several international regulations for the protection of animals used for scientific purposes. Replacing animal testing for the environmental safety assessment in various sectors therefore faces significant challenges when addressing issues such as short- and long-term toxicity to fish, endocrine modulation and bioaccumulation.

This session will present the promising methodologies and progress made in these areas over the past decade, and highlight issues associated with fish testing and the potential of alternative approaches to predict relevant endpoints.

Session chair and co-chair: V. Poulsen, L'Oréal and M. Paparella, Medical University of Innsbruck


Speakers:

Abstract ID - Celebrating 20+ years of development: The long way of fish cell line assays towards regulatory use
K. Schirmer, EWAG

Abstract ID 783 - The zebrafish embryo as alternative model for acute and chronic fish toxicity - Inclusion of additional endpoints to replace fish toxicity tests in the comparative assessment with Daphnia and algae
S. Scholz, UFZ

Abstract ID 409 - Current status of the oecd project on integrated approaches to testing and assessment for acute fish toxicity
C. Faβbender, PETA International Science Consortium Ltd

Abstract ID - Use of fish embryos to assess endocrine disruption
M. Leonard, L’Oréal

Abstract ID 339 - The biotransformation and bioaccumulation of ionizable organic compounds in rainbow trout cell lines
F. Balk,  Eawag, Swiss Federal Institute of Aquatic Science and Technology

6.30 - 8.30 PM

S205: A Virtual Human Platform for Safety Assessment

The Virtual Human Platform for Safety Assessment (VHP4Safety) is a new integrated approach for assessing safety, based on quantitative information of human biology, toxicology and exposure. The VHP4Safety will form an overarching platform integrating high quality data from existing data(bases) and algorithms, as well as new data acquired within the project. During this session we dive into the topic of predictive modelling, data science, exposure assessment and advanced human in vitro models, to design a platform that reflects the Virtual Human and address the emerging societal challenge towards transition to animal-free safety assessment completely based on human data.

Session chair: T. Hartung, John Hopkins


Speakers:

Abstract ID 1128 - In silico medicine: bringing the community together and the field forward
Liesbet Geris, University of Liege

Abstract ID 186 - (Q)SARs in the AOP-Wiki and OECD IATA Case Studies project: a brief snapshot
Lidia Ceriani

Abstract ID 1109 - Toxicological mechanistic inference from gene expression assays with MechSpy
Ruchir Shah

Abstract ID 463 - NETWORK INTEGRATION AND MODELLING OF DYNAMIC DRUG RESPONSES AT MULTI-OMICS LEVELS
Ralf Herwig

Abstract ID 1000 - Comparing and Interpreting Tox21 Data Analysis Approaches
Agnes Karmaus

6.30 - 8.00 PM

YOU-WC11 - Speed Collaborating

Wednesday 25 August 2021 - Day 3

2.30 - 3.00 PM - Plenary sessions

2.30 - 3.00 PM

WC11 TV - Live from the studio

3.00 - 5.00 PM - Parallel Session WED-1

3.00 - 5.00 PM

S93: Reproducibility in preclinical studies (Theme: Disease)

Reproducibility is an important topic of discussion at present, including a need for improved experimental design

A IMI project called EQIPD (https://quality-preclinical-data.eu/) could bring interesting input into the discussion for preclinical studies to improve implementation of 3Rs:
Some info on EQIPD/What are the key drivers for decision making in drug development?

The pharmaceutical industry and basic research depend on robust data and scientific rigor as key drivers for decision making. They determine the pace of knowledge gain and ultimately the time needed to make new drug treatments available to patients.

What factors impact the transition from preclinical to clinical testing?

Recent publications report challenges with regard to the robustness, rigor and validity of research data, which often impact the transition from preclinical to clinical testing.

How can we improve innovation and data quality to speed up drug development?

We seek to provide simple and sustainable solutions that facilitate data quality without impacting innovation and freedom of research. Our consortium will pool resources from both academia and industry to pilot this action in neuroscience and drug safety with applicability beyond these research areas.

Session chair: Kirsty Reid, EFPIA


Speakers:

Abstract ID 648 - IMPROVING REPRODUCIBILITY AND TRANSLATION OF ANIMAL RESEARCH - AN INDUSTRY PERSPECTIVE Thomas Steckler, Janssen Pharmaceutica NV

Abstract ID 353 - ACHIEVING REPRODUCIBILITY THROUGH RESPONSIBLE ANIMAL RESEARCH
Nicola Osborne, Responsible Research in Practice

Abstract ID 350 - NC3RS RESOURCES TO IMPROVE THE REPRODUCIBILITY OF IN VIVO AND IN VITRO EXPERIMENTS
Mark Prescott, National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs)

Abstract ID - SR and meta-analysis of animal studies
Malcolm Macleod, University of Edinburgh

Abstract ID 174 - More than 3Rs - the 3Vs and the ethics of animal research
Hanno Wuerbel, University of Bern

3.00 - 5.00 PM

S34: Systematic Review, Machine Learning and Data-Driven Alternatives (Theme: Ethics, Welfare and Regulation)

Systematic review (SR) is now a well-established method for promoting the 3Rs, with great potential to replace animal experiments. Scientists find the process time-consuming, so the application of machine learning (ML), for example text-mining, can help improve the process, both scanning text via algorithms, and also by applying machine-learning prediction to meta-analyses. This collaboration between the SR and ML will ensure enhanced accuracy, and make the process more "user-friendly" for the experimentalists, and thus encourage a move away from default animal models for fundamental research.

Session chair: Merel Ritskes-Hoitinga, Radbou UMC


Speakers:

Abstract ID 914 - Finding alternatives using text based article classification
Wynand Alkema, TenWise BV; Hanze University of Applied Sciences

Abstract ID 58 - A Machine-Learning and Systems Biology Strategy Requires Systematic Review to Develop Animal Replacement Alternatives.
Brett Lidbury, NCEPH, Research School of Population Health, The Australian National University, Canberra, Australia; SYRCLE, Department of Health Evidence, Radboud UMC, Nijmegen, The Netherlands

Abstract ID 915 - A funder's role in stimulating transparency in 3Rs research
Erica van Oort, ZonMw - The Netherlands Organisation for Health Research and Development

Abstract ID 889 - Challenges and opportunities for AI in systematic reviews - risk of bias and systematic maps
Rob de Vries, SYRCLE, Radboudumc (Netherlands); EBTC, JHU (USA)

3.00 - 5.00 PM

S152: Organoid technology for infectious diseases: from innovation to established models (Theme: Innovative technologies)

Various aspects of human organoid technology for infectious diseases will be highlighted to accelerate acceptance of human organoid technology as established models and replace animal models.

Session chair: D. Pajkrt, Academic Medical Center and K. Wolthers, Amsterdam UMC


Speakers:

Abstract ID 6 - How to improve training in an EU Organoid training network.
Dasja Pajkrt, AmsterdamUMC, location AMC

Abstract ID 417 - Building 3D human cell models for virology
Katja Wolthers, Medical Microbiology, Amsterdam UMC location AMC

Abstract ID 873 - Towards development of gene therapy for neurodegenerative diseases based on animal-free testing.
Pavlina Konstantinova, uniQure

Abstract ID 286 - Intestinal organoids to study infections of zoonotic and foodborne bacteria
Kees van der Ark, Amstterdam UMC, University of Amsterdam, Department of Medical Mycrobiology; Amsterdam UMC, University of Amsterdam, Amsterdam Institute for Global Health and Development

Abstract ID 629 - Translating animal model results to human disease
Giulia Moreni, Amsterdam UMC

3.00 - 5.00 PM

S70: Challenges of Non-Animal Approaches for Food Safety & Nutrition in the 21st Century: From Inception to Application (Theme: Safety)

This session proposal aims to discuss:
• Different applicable legislations for non-animal approaches in the food sector
• The way food scientists approach animal and animal-free studies
• Benchmarking of non-animal approaches in different industry sectors
• Real life risk assessment application in food safety and nutrition

Session chair: Marcel Leist, Center for Alternatives to Animal Testing in Europe (CAAT) - University of Konstanz


Speakers:

Abstract ID 705 - APPLICABLE LEGISLATION FOR NON-ANIMAL APPROACHES IN THE FOOD SYSTEM
Katrin Schutte, European Commission

Abstract ID 51 - Animal-free strategies in food safety & nutrition
Alie de Boer, Food Claims Centre Venlo, Campus Venlo, Maastricht University

Abstract ID 788 - THE WINDY ROAD TO THE USE OF NON-ANIMAL APPROACHES FOR REGULATIONS OF CHEMICALS
Robert Landsiedel, BASF SE

Abstract ID 1039 - What are the strategies that can be used now in food safety risk assessment avoiding animal testing?
Alan Boobis, National Heart & Lung Institute, Imperial College London 

Abstract ID 717 - In vitro coculture model (h-CLAT/RHE) composed of THP-1 cells and 3D reconstructed human epidermis to assess activation and maturation of dendritic cells
Brunhilde Blömeke, Trier University

3.00 - 5.00 PM

S164: Decision making in non-animal cosmetic safety assessment (Theme: Safety)

There has been significant progress globally over recent years in advancing the science that underpins non-animal cosmetic safety assessment that has facilitated the ability to perform cosmetic safety assessment while using no new animal data. The Animal-Free Safety Assessment (AFSA) Cosmetics collaboration between Humane Society International, industry partners and other interested groups was created to facilitate implementation of robust consumer safety decisions by government health authorities, manufacturers of cosmetic products and ingredients, CROs and service providers, and other stakeholders, with the objective of transitioning the global industry fully away from reliance on new animal data by 2023. Presentations in this session will introduce the project and cover several aspects of the risk assessment process, including established and developing science areas.

P. Russell, Unilever


 

3.00 - 5.00 PM

S33: Religion-based Cultural influences on ethics, animal welfare and use of animals in science

Asian part of the world has a rich heritage and gained popularity over diverse religions and cultures. During this innovation lab session our aim is to share the influence of different religion-based cultures on ethics, animal welfare and use of animals in scientific procedures with the applicable legislations. Hence, the perspectives of Buddhism, Hinduism and Islam from three Asian countries; Sri Lanka, India and Malaysia will be discussed. Whatever the religion, the importance of ‘Culture of care’ concept in the use of animals in scientific procedures will be highlighted at the end of the session.

Session chair: Suresh Poosala, University of Hyderabad and Vera Baumans,
Utrecht University


Speakers:

Abstract ID 69 - RELIGION-BASED CULTURAL INFLUENCES ON ETHICS, ANIMAL WELFARE AND USE OF ANIMALS IN SCIENCE
Mangala Gunatilake, Faculty of Medicine, University of Colombo, Sri Lanka

Abstract ID 53 - Hinduism and Cultural Differences and similarities in thinking about animal welfare and the use of animals in Science
VIJAY PAL SINGH, CSIR INSTITUTE OF GENOMICS AND INTEGRATIVE BIOLOGY

Abstract ID - The Islamic View and Humane Practice in Using Laboratory Animal by Malaysian Researchers
Lokman Muhammad, KULLIYYAH OF NURSING, IIUM Kuantan Campus

Abstract ID 872 - Alternatives for Animals in Drug Discovery Research: Religion Interface and Current Trends in Culture of Care and Alternatives to Experiments on Animals
Suresh Poosala, OncoSeek Bio Company, University of Hyderabad

3.00 - 5.00 PM

YOU-WC11 - Workshop 1

5.00 - 6.30 PM - Plenary sessions

5.00 - 5.15 PM

Break and WC11 TV from the studio

5.15 - 6.15 PM

KEYNOTE: Dr. Jason Ekert, GlaxoSmithKline

Dr. Jason Ekert has been head of the Complex In Vitro Models (CIVM) group for the last three years in the In Vitro In Vivo Translation department in the Research organization at GlaxoSmithKline. He leads an integrated enterprise strategy for sustained, portfolio driven growth in R&D applications of complex human-relevant and translatable complex in vitro models (eg Spheroids, Organoids, Microphysiological systems and bioprinting).

The CIVM group drives the coordination and prioritization of development and integrated use of complex in vitro technologies for target identification/validation, efficacy, safety and DMPK studies. He has led a cross-functional matrix team for the last three years at GSK that is a multi-disciplinary team (Scientists that span from target ID/validation, screening, lead optimization, safety, DMPK and the research units) which coordinates activities, collaborates externally and identifies ready soon platforms that can positively impact the portfolio. He’s the vice-chair elect for the IQ-MPS affiliate. Dr Ekert received his PhD in Medical Science from Adelaide University in Australia. He performed post-doctoral training at the University of California, Davis and Coriell Institute for Medical Research.

Before coming to GlaxoSmithKline Dr Ekert worked for 11 years at Janssen BioThereapeutics in early biotherapeutic drug discovery in target discovery, drug validation and mechanism of action studies applying 3D cell cultures, induced pluripotent stem cells and primary cells in complex cell-based assays across multiple therapeutic areas.

6.15 - 6.30 PM

Break and WC11 TV from the studio

6.30 - 8.30 PM - Parallel Session WED-2

6.30 - 8.30 PM

S105: The role of clinical research on the understanding and treatment of diseases (Theme: Disease)

Clinical-based research can, for example: explore specific genes, gene sequences or patterns that may be involved in the aetiology of a disease; perform neurological examinations to identify areas involved in specific diseases; describe the biochemical and physiological changes that occur during the development of a disease; or understand relevant psychological and epidemiological factors that can play a role in the development of a disease.
Better collection, sharing, and utilisation of human-based knowledge can improve the integration of multidisciplinary approaches, understanding of the pathophysiology of specific diseases and development and testing of new therapies, whilst limiting the use of other animals.

Session chair: Luisa Bastos, Eurogroup for Animals


Speakers:

Abstract ID 919 - USING HUMAN TO BENCH TO HUMAN CIRCULAR APPROACHES FOR HEALTH AND MEDICINES RESEARCH
Maria da Silva Lima, Universidade de Lisboa; Faculdade de Farmácia

Abstract ID 901 - Functionally Enigmatic Genes in Cancer: Are We Still Looking Under the Lamp Post for The Keys?
Alexandra Maertens, Johns Hopkins University Bloomberg School of Public Health

Abstract ID 703 - HUMAN SKIN STEM CELL-DERIVED HEPATIC CELLS AS A TOOL FOR TOXICITY TESTING AND DRUG DEVELOPMENT
Joost Boeckmans, Department of In Vitro Toxicology and Dermato-Cosmetology, Faculty of Medicine and Pharmacy, Vrije Universiteit Brussel

Abstract ID 854 - A 21st-century roadmap for biomedical research and drug discovery: recommendations
Lindsay Marshall, Humane Society International

6.30 - 8.30 PM

S16: Focus on Severe Suffering (Theme: Ethics, Welfare and Regulation)

All laboratory animal suffering is a concern, but the RSPCA believes that reducing and avoiding ‘severe’ suffering should be a top priority. There are a number of reasons to do this: (i) the ethical and animal welfare benefits of reducing suffering, (ii) the legal requirement to minimise suffering set out in legislation, and (iii) the scientific benefits – it is acknowledged that good science goes hand in hand with good welfare.

This symposium will focus on the work of the RSPCA to reduce and ultimately end severe suffering, as well as showcasing practical examples from invited speakers.

Session chair: P. Hawkins, RSPCA Animals in Science Department


Speakers:

Abstract ID 71 - Introduction - Focus on Severe Suffering
P. Hawkins, RSPCA

Abstract ID 849 - Combining mathematics with medicine to make better use of animal data: Sepsis case study
M. Nandi, King's College London

Abstract ID 22 - Potential refinement of animal models of neuropathic and inflammatory pain
K. Abelson, University of Copenhagen

Abstract ID 29 - Monitoring of severity and implementation of refinement measures in DSS induced colitis in mice
P. Jirkhof, University of Zurich

Abstract ID 260 - Humane endpoints, tailor made
N. Verhave, Universiteit Leiden

Abstract ID 39 - Avoiding mortality during procedures
P. Hawkins, RSPCA

6.30 - 8.30 PM

S160: Human Organs-on-Chips: Advancing Regulatory Science through Innovation (Theme: Innovative Technologies)

A growing number of assays based on microphysiological systems (MPS) are being adopted by the pharmaceutical industry to evaluate new drugs and therapies. Data generated by these types of systems are increasingly used in portfolio decision-making thus reducing the use of laboratory animals. Simultaneously, scientists working in regulatory authorities have been actively involved in MPS-based research. The session aims to provide a perspective of how regulatory bodies from US, Europe, China, Russia and South Korea towards the replacement of laboratory animal-based assays and guidelines by qualified MPS-based assays.

Session chair: S. Fitzpatrick, US Food and Drug Administration and S.Beken, Federal Agency for Medicines and Health Products (FAMHP)


Speakers:

Abstract ID 946 - DEVELOPING PERFORMANCE BASED QUALIFICATION CRITERIA FOR ORGANS ON A CHIP - US FDA PERSPECTIVE
Suzanne Fitzpatrick, US Food and Drug Administration, Center for Food Safety and Applied Nutrition

Abstract ID 892 - DEVELOPING PERFORMANCE BASED QUALIFICATION CRITERIA FOR ORGANS ON A CHIP - EU PERSPECTIVE
Sonja Beken, Federal Agency for Medicines and Health Products (FAMHP)

Abstract ID - The potential of microphysiological systems to enter the changing Russian drug approval regulation environment
A. Tonevitsky, Higher School of Economics

Abstract ID 943 - CHINESE PERSPECTIVE OF THE IMPLEMENTATION OF ORGAN-ON-CHIP-BASED ASSAYS INTO THE REGULATORY LANDSCAPE
Xiaobing Zhou, National Center for Safety Evaluation of Drugs, National Institutes for Food and Drug Control

Abstract ID - 3D Tissue Chips and Microphysiological Systems: Korean Efforts from Development to Regulatory Adaptation
S. Kim, Seoul National University Hospital

6.30 - 8.30 PM

S60: New Approach Methods in AgroChemical Development and Regulatory Decisions (Theme: Safety)

New approach methods are being designed and applied to answer risk assessment and risk management questions. They are also being developed to inform data needs for chemical safety evaluation. There is also the potential to eliminate redundant and unnecessary studies through waiving repeat dose studies when adequate information is available to assess human health risk. The symposium will present a framework for fit for purpose evaluation of new approach methods, the application of new approach methods for determining inhalation risk, a new approach method for predicting developmental toxicity, and the US EPA's successful program to waive repeat dose studies which has saved several hundred thousands of animals.

Session chair: Douglas Wolf, Syngenta Crop Protection and Monique Perron, United States Environmental Protection Agency


Speakers:

Abstract ID 855 - An Evaluation Framework for New Approach Methodologies (NAMs) for Human Health Safety Assessment
Alan Boobis, Imperial College

Abstract ID 887 - Application of new approach method for determining developmental toxicity
Richard Currie, Syngenta

Abstract ID 853 - An integrated approach to testing and assessment for evaluating inhalation risk.
Douglas Wolf, Syngenta

Abstract ID 68 - Waiving repeat dose studies while confidently protecting human health from exposure to agricultural
chemicals
Monique Perron, United States Environmental Protection Agency

6.30 - 8.30 PM

S173: Culture of Care - a culture driven, pro-active approach towards improving standards (Theme: Ethics, Welfare and Regulation)

The purpose of the workshop is to demonstrate that a culture driven approach will deliver more and better outcome in terms of continuously optimised animal welfare instead of a reactive approach of merely reacting to problems when they arise. Emphasis should be on examples of improved animal welfare because the initiative was driven by a Culture of care.

Session chair and co-chair: S. Robinson, Astra Zeneca and T. Bertelsen - Novo Nordisk


Speakers:

Abstract ID 155 - A simple-to-use model to work purposeful and focused with culture of care
T. Bertelsen - Novo Nordisk

Abstract ID 815 - A five category framework for implementing culture of care
S. Robinson, Astra Zeneca

Abstract ID 678 - culture of care and governance: two sides of the same coin
J. Prins, The Crick Institute

Abstract ID 138 - Culture of care at novartis - the path for better science
B. Ledermann, Novartis

Abstract ID 846 - The Ongoing Journey to Champion and Enhance a Culture of Care
A. White, GSK

6.30 - 8.30 PM

S309: DNT (Theme: Safety)

Abstract ID 32 - ESTABLISHMENT OF A DEVELOPMENTAL NEUROTOXICANT SCREENING USING SOX1-GFP MOUSE EMBRYONIC STEM CELLS
Eui-Bae Jeung

Abstract ID 74 - An Integrated Approach Alternative for Screening Reproductive, Developmental and Endocrine Disrupting Activity with Ex Vivo Whole Rat Embryo Culture
Shui-Yuan Lu

Abstract ID 163 - An analysis of the limitations and uncertainties of in vivo developmental neurotoxicity testing and assessment to identify the potential for alternative approaches
Martin Paparella

Abstract ID 188 - Colinear Hox gene expression in the neural embryonic stem cell test (ESTn) defines its biological domain and reveals effects of compounds
Victoria de Leeuw

Abstract ID 1025 - In vitro screening for developmental neurotoxicity by using a human cell-based testing battery: A case study of flame retardants
Melanie Pahl

Abstract ID 1030 - AN INTER-LABORATORY CASE STUDY TO HARMONIZE ZEBRAFISH LIGHT-DARK TRANSITION TEST TO PREDICT DEVELOPMENTAL NEUROTOXICITY 
Celia Rodríguez

Thursday 26 August 2021 - Day 4

2.30 - 3.00 PM - Plenary sessions

2.30 - 3.00 PM

WC11 TV - Live from the studio

3.00 - 5.00 PM - Parallel Session THU-1

3.00 - 5.00 PM

S118: A global movement to improve science using animal-free antibodies (Theme: Disease)

We are on the brink of a sea change on antibody production. In Europe, the ECVAM Scientific advisory committee has endorsed the scientific validity of replacement methods not requiring animal immunization and the U.S. NICEATM aims to improve research quality and reproducibility by accelerating their development and use. No longer must we accept the scientific shortcomings of animal-derived antibodies. Considering the $80 billion scale of the antibodies industry, importance to all scientific disciplines, vast animal use and commitment by government authorities to the implementation of Directive 2010/63/EU, the landmark movement to animal-free sequence-defined antibodies will have an enormous global influence.

Session chair and co-chair: A. Gray, AFABILITY & University of Nottingham and K. Groff, PETA International Science Consortium Ltd


Speakers:

Abstract ID 118 - Barriers and Challenges Facing the Replacement of Animal-Derived Antibodies (ADAs)
Alison Gray, AFABILITY

Abstract ID 726 - Scientific Validity of Non-Animal-Derived Antibodies
João Barroso, European Commission, Joint Research Centre, Ispra (VA), Italy

Abstract ID 1 - Animal free multiclonal antibody generation as a replacement for polyclonal antibodies
Stefan Dübel, Technische Universität Braunschweig

Abstract ID 907 - Recombinant antibodies: a complete toolbox for academia
Pierre Cosson, University of Geneva, Faculty of Medicine

Abstract ID 127 - Recombinant antibody technology: taking antibodies from bench to bedside
Lia Cardarelli, Toronto Recombinant Antibody Centre; University of Toronto

Abstract ID 101 - STRATEGIZING TO OPTIMIZE THE DEVELOPMENT AND USE OF ANIMAL-FREE ANTIBODIES IN THE U.S.
Katherine Groff, PETA Science Consortium International e.V.

3.00 - 5.00 PM

S102: Refinement of pain & stress assessment to enhance animal welfare in rodents (Theme: Ethics, Welfare and Regulation)

Evidence-based pain and stress assessment is essential for accurately identifying, predicting, and preventing animal suffering. It is also central for informing harm-benefit assessment of animal experimentation, thus furthering both animal welfare and regulatory compliance. Reliable and sensitive assessment is also essential for implementing refinement measures and evaluating their effect. To fulfill these goals, scientists, animal care and veterinary personnel need reliable assessment tools for providing species-relevant measurements of the animals` physical and affective state.
In this session, we aim to highlight recent scientific advances in rodent health, welfare, pain and stress assessment, such as automated grimace score assessment or thermography with the potential to further both the 3Rs and scientific quality.

Session chair: Nuno Henrique Franco, i3S, University of Porto


Speakers:

Abstract ID 84 - TOWARDS AN AUTOMATED FACIAL EXPRESSION ANALYSIS IN MICE USING DEEP LEARNING
Katharina Hohlbaum, Institute of Animal Welfare, Animal Behavior, and Laboratory Animal Science, Department of Veterinary Medicine, Freie Universität Berlin

Abstract ID 690 - Assessment of acute stress and anxiety by infrared thermography
Nuno Henrique Franco, i3S - Instituto de Investigação e Inovação em Saúde, Universidade do Porto

Abstract ID 28 - Inter-laboratory variability in behavior-based severity assessment
Paulin Jirkof, University of Zurich

Abstract ID 599 - Pain assessment and management in bone-linked mouse models
Annemarie Lang, Department of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin Berlin; German Rheumatism Research Center

Abstract ID 310 - IDENTIFICATION OF APPROPRIATE METHODS FOR SEVERITY ASSESSMENT IN A WIDELY USED MOUSE MODEL OF ACUTE COLITIS
Christine Haeger 

3.00 - 5.00 PM

S177: Innovative approaches for CNS research - from brain organoids to new single cell culture methods (Theme: Innovative technologies)

A functioning central nervous system (CNS) is key for living, and ageing is a major risk factor of disfunction. With the increase in human lifespan the incidence of neurodegenerative diseases is rising. There is a demand for good models for neurodegenerative diseases, as current in vivo models have limitations and ethical concerns.
Modeling the CNS in vitro is, however, challenging. Recent discoveries in neuroscience, such as the breakthroughs of induced pluripotent stem cell technology, 3D-organotypic cultures and organs-on-chip, move the field forward. This workshop will overview how scientists are embracing new cutting-edge technologies and provide a guidemap for future developments.

Session chair: J. Bajramovic, Biomedical Primate Research Centre


Speakers:

Abstract ID 850 - From microphysiological to micropathophysiological systems to study neurotoxicity and CNS diseases
L. Smirnova, Johns Hopkins

Abstract ID 578 - Transcriptome guided approaches to mimic homeostatic adult microglia in culture
R. Timmerman, Biomedical Primate Research Centre

Abstract ID 1022 - New ways of neurotoxicity testing in pre-clinical drug development
S. Kustermann, Roche

3.00 - 5.00 PM

S222: Integrated Approach to Testing and Assessment of Chemicals: Occam’s razor for the integration of New Approach Methodologies into 21st Century Human Health Decision-Making (Theme: Safety)

The diverse array of in silico platforms, in vitro assays, ex vivo tissue models, and information databases and systems, collectively referred to as New Approach Methodologies (NAM), holds the potential to transform the field of toxicology and human health risk assessment. A proposed key to integrating NAM into human health evaluations of chemical risk is through use of an Integrated Approach to Testing and Assessment (IATA) that invokes fit-for-purpose modularity for data application. This session will provide an overview of how IATA may facilitate phased or tiered application of NAM data that advances public health decision-making associated with chemical exposures.

Session chair and co-chair: J. Lambert, U.S. Environmental Protection Agency and T. Barton-Maclaren, Health Canada, Existing Substances Risk Assessment Bureau


Speakers:

Abstract ID 722 - IATA as the Nexus of Traditional Bioassay and New Approach Methods data in Human Health Assessment in the 21st Century 
J. Lambert, U.S. Environmental Protection Agency

Abstract ID 723 - Opportunities for Use of IATA in Canada’s Chemicals Management Plan
T. Barton-Maclaren, Health Canada

Abstract ID 698 - Advancing IATA in European Chemicals Regulatory Decision-Making
M. Whelan, Joint Research Centre, European Commission

Abstract ID 46 - IATA as an opportunity for next generation risk assessment
G. Ouedraogo, L’Oreal Research and Innovation

3.00 - 5.00 PM

S195: Industry and public sector partnerships in education to foster the implementation of alternative methods (Theme: Ethics, Welfare and Regulation)

Newer alternative methods to animal tests in toxicology are increasingly using advanced techniques. These are sometimes more complex than historical animal tests and their appropriation by stakeholders, CROs, safety evaluators, regulatory bodies require new knowledge, equipment and also availability of the test systems. Their validation is a must but not always sufficient to be accepted everywhere. To be trusted and routinely used there is a need of communication and training at an international level for both current professionals and next generation of toxicologists.
In this context a number of initiatives involving private companies in partnership with educational/research institutions, learned societies and nonprofit organizations have emerged to organize theoretical as well as hands-on-training of human-relevant alternative methods. This allows students, scientists and toxicologists, to quickly become familiar with newer methods and to better understand how to use the results for GHS (global harmonization system) classification or risk assessment. In these approaches the notion of partnership is crucial. On one hand, private companies, such as methods providers or end-users, have expertise and access to technologies and methods. On the other hand, public establishments, academic institutions or learned society are representative of the intended population and have legitimacy in education.
After a short presentation of some examples involving private and public/nonprofit players conducted in Europe, South America, India or China this round table will discuss some of the barriers experienced (funding, mistrust...), definition of education and training good practices (mixing theory and practice, hosting laboratory...) and ways to improve the effectiveness and recognition of these courses (university partnership, certification, webinars...). Finally, the interest of coordination and generalization of this kind of partnerships to accelerate the spread of alternative methods to animal experimentation worldwide will be discussed.

Session chair and co-chair: Christian Pellevoisin from the Episkin Academy &  Vijay Pal Singh from CSIR-Institute of Genomics & Integrative Biology (India)575


Speakers:

Abstract ID 575 - Round Table: Industry and public sector partnerships in education to foster the implementation of alternative methods Alternatives to Animals in Education and Risk Assessment: An Overview with Special Reference to Indian Context
Akbarsha, Mohammad A., Society for Alternatives to Animal Experiments-India (SAAE-I)

Abstract ID 793 - BRAZIL is ON: Animal Testing Ban and Available OECD TG in Brazil
L. Balottin, National Institute of Metrology, Quality and Technology (INMETRO)

Abstract ID 496 - Ways to improve their effectiveness and recognition
F. Busquet, Altertox Acadamey 

Abstract ID 591 - The development of alternative methods in China and the role of the industries
C. Shujun, Shanghai Jiao Tong University

Abstract ID 670 - Feedback from 8 years of training to alternative methods in industrial and academic contexts
C. Pellevoisin, EPISKIN Academy

3.00 - 5.00 PM

S181: Use of New approach methodologies –NAMs- to derive Point(s) of departure; opportunities and limitations (Theme: Innovative Technologies)

Several initiatives have generated a wealth of non-animal data, « new approach methodologies » -NAMs-. In 2007, the American National Academy of Science called from moving away from measuring apical endpoints to considering upstream events. Regulatory changes like in the cosmetics sector in Europe incentivized such initiatives.
NAMs have been used in different decision-making contexts. Biological effects at the molecular, cellular and/or tissue level compared to internal concentrations based on use scenarios yielded PoDs protective of human health and conservative.
The session covers cases with PoDs from NAMs with a 30 min discussion highlighting opportunities and limitations of such approaches.

Session chair and co-chair: R. Thomas, NCCT - US EPA and G. Ouedraogo - L'Oreal


Speakers:

Abstract ID 742 - Screening to Assessment: Building confidence in Bioactivity Points of Departure at Health Canada
T. Barton Maclaren, Health

Abstract ID 52 - Cosmetic Europe case studies exploring alternatives to repeated dose systemic toxicity testing
C. Mahony, P&G

Abstract ID 604 - High throughput transcriptomics to derive mode-of-action and potency information to support read across approaches
B. van de Water, University of Leiden

Abstract ID 49 - Applying In Vitro to In Vivo Extrapolation to NAM-derived PODs
N. Kleinsteuer

Abstract ID: 444 - Application of newly validated route-specific in vitro genotoxicity assays to support the safety assesment of cosmetic ingredients
R. Fautz

5.00 - 6.30 PM - Plenary sessions

5.00 - 5.15 PM

Break and WC11 TV from the studio

5.15 - 6.15 PM

KEYNOTE: Prof. Dr. Malcolm McLeod, University of Edinburgh

Malcolm Macleod is Professor of Neurology and Translational Neurosciences at the University of Edinburgh, member of the UK Commission for Human Medicines and the UK Reproducibility Network. He also leads the European Quality in Preclinical Data IMI project and the SE Scotland Stroke Research Network. He was co-CI of the EuroHYP trial of brain cooling for acute stroke and is UK coordinator for the PRECIOUS trial of preventing complications following stroke.

Since founding the Collaborative Approach to Meta-analysis and Review of Animal Data form Experimental Studies (CAMARADES) in 2004 his research has largely focussed on how best to increase the value of biomedical research. This has included work with funders, journals (including randomised studies of different approaches to improve quality, and the proposed MDAR Minimum Standards Framework) and most recently with institutions (recently appointed Research Improvement lead at the University of Edinburgh).
He led the development and implementation of the SyRF platform (app.syrf.org.uk) which supports systematic reviews of in vivo research.

Warlow’s Stroke: Practical Management (ISBN: 978-1-118-49222-2)

6.15 - 6.30 PM

Break and WC11 TV from the studio

6.30 - 8.30 PM - Parallel Session THU-2

6.30 - 8.30 PM

S127: Implementing the 3Rs in Safety Assessment and Drug Development (Theme: Disease)

The 3Rs represent a framework for the advancement of animal welfare by supporting the Reduction, Refinement, and Replacement of animals within scientific research. While specific government regulations aim to ensure minimum animal welfare standards, the scientific community has a responsibility to actively investigate refinement and alternatives to animal use and to minimize the number of animals used, along with promoting animals’ wellbeing in the research environment and for procedures that are performed. Although animal use is often mandated or deemed necessary for research and safety testing, there are opportunities to implement 3Rs improvements within current toxicology testing strategies and individual study designs. Improvements in data quality and increased predictivity to human outcomes can facilitate the provision of new therapies to benefit patient health.

The main objective of this session is to highlight some of the different approaches used to advance the science of the 3Rs in drug development, bringing together global colleagues from various sectors and collaborative projects within the toxicology field. This session will summarize the current understanding, recent advancements and data from retrospective analyses and introduce emerging technologies to challenge you to consider how best to design your preclinical toxicology and efficacy studies to maximize data quality and clinical relevance whilst promoting animal welfare. We posit that a well-defined development strategy includes a suite of tools to help better predict clinical translatability. These may include in silico modeling or in vitro tests replacing animal experiments, or as a supplement to reduce subsequent animal use. Emerging technologies, digital and non-digital, provide an opportunity for identification of novel clinically relevant endpoints and increased understanding of animal models. When animal models are required, modifications in study designs including endpoints and real-time data access can limit animal use while maximizing scientific utility, whilst refinements in animal housing, welfare and data driven enrichment that decrease or eliminate pain and/or distress can improve data quality.

Session chair: D. W. Lee, Genentech 


Speakers:

Abstract ID 899 - INCREASE PREDICTIVITY AND TRANSLATABILITY FROM ANIMAL MODELS - UNDERSTANDING HOW DIFFERENT FACTORS CONTRIBUTE TO (IR)REPRODUCIBILITY 
Emily Sena, University of Edinburgh

Abstract ID 359 - Reimagining preclinical studies through digital transformation; leveraging computer vision, machine learning,
mixed reality & informatics platforms to maximize data quality and clinical relevance of preclinical studies
Szczepan Baran, Novartis Institutes for BioMedical Research (NIBR), Inc.

Abstract ID 732 - Advanced Human Cell Models to support Safety assessment of bi-specific Antibodies
Adrian B. Roth, Roche

Abstract ID 408 - Applying the 3Rs within Regulatory Toxicology Studies in Drug Development
Helen Prior, NC3Rs

Abstract ID 18 - 3Rs opportunities in preclinical safety testing: A CRO perspective
Gerhard Weinbauer, VP Global DART

Abstract ID - Improving the 3Rs in Drug Development Takes Collaborative Effort
Donna Lee, Genentech 

6.30 - 8.30 PM

S219: Rigor, Relevance and Reproducibility in (animal) research: when "Science's 3Rs" come into play (Theme: Ethics, Welfare and Regulation)

While one can think there is failure to improve experimental design and increase 3Rs principle uptake in the scientific community, this session aims at bridging science quality and the 3Rs:
- providing concrete scientific perspectives on how rigor, relevance and reproducibility foster the best use of research models and deliver scientific results that ultimately benefit the 3Rs;
- illustrating the continuity and complementarity in the use of non-animal and animal research models as the best approach to shift from animal to non-animal methods over time through knowledge sharing;
- ultimately aligning researchers and regulators to the same ultimate 3Rs goal.

Session chair and co-chair: S. Rao, SANOFI R&D and A. L Andreu, EATRIS


Speakers:

Abstract ID 890 - Rigor, relevance and reproducibility in the use of in vivo models in the pharmaceutical industry
S. Rao, Sanofi R&D 

Abstract ID 761 - Increasing the reliability of preclinical data: enabling approaches
I. Lefevre, Sanofi R&D

Abstract ID 112 - Reproducibility crisis in preclinical research
A. Andreu,  EATRIS

6.30 - 8.30 PM

S117: Personalized medicine through human organoid models (Theme: Innovative Technologies)

Adult- and induced pluripotent stem cells are unique sources of somatic human cells from patients and healthy individuals, challenging to obtain reproducibly in large numbers from primary tissue samples. Immune cells and inflammation are major disease triggers and identifying renewable sources of these cells would benefit attempts to model disease as in patients. These stem cell derivatives can be cultured in 2D or 3D and in single or multiple cell type combinations and thus form Micro-physiological Systems that can “stand alone” as research or drug screening models or may be incorporated into Organ-on-Chip models for inclusion of appropriate biophysical parameters.

Session chair: C. Mummery, LUMC C. Denning


Speakers:

Abstract ID 945 - HUMAN PLURIPOTENT STEM CELL MODELS FOR CARDIOTOXICITY
Chris Denning, University of Nottingham, Biodiscovery Institute, Faculty of Medicine & Health Sciences

Abstract ID 944 - GASTRULOIDS FROM STEM CELLS: MODELS OF EARLY DEVELOPMENT.
Alfonso Martinez Arias, University of Cambridge, Department of Genetics

Abstract ID 908 - BUIDING VESSELS ON A CHIP TO MODEL GENETIC VASCULAR DISEASES USING PATIENT-SPECIFIC INDUCED PLURIPOTENT STEM CELLS 
Valeria Orlova, Leiden University Medical Center

Abstract ID 948 - A standardized platform for miniaturized cortical organ
Steven Kushner, Department of Psychiatry, Erasmus Medical Center Rotterdam

6.30 - 8.30 PM

S231: Building confidence in Next Generation Risk Assessment (Theme: Safety)

Next Generation Risk Assessment (NGRA) is an exposure-led, hypothesis-driven approach that uses new approach methodologies (NAMs) to ensure the chemical safety without the use of animal data. Whilst some NAMs have been validated and adopted by regulators (e.g. OECD test methods for skin sensitization) there is a need amongst both industry and regulatory risk assessors for more examples to demonstrate the utility of NAMs for decision-making on effects that are associated with systemic exposure to chemicals. This symposium will increase awareness and confidence in the use of NAMs for decision-making, by showcasing several of the components of an NGRA framework

Session chair and co-chair: C. Westmoreland, Unilever and M. Varçin, Cosmetics Europe


Speakers:

Abstract ID 677 - Perspectives on the Use of High Throughput Profiling Assays in Next Generation Risk Assessment
J. Harrill, US Environmental Protection Agency (EPA)

Abstract ID 628 - Predictive value of PBK-model predictions based on in vitro and in silico input data as essential tool in next generation (animal-free) risk evaluations
A. Punt, Wageningen Food Safety Research (WFSR)

Abstract ID 851 - In silico approaches to link adverse outcomes to molecular initiating events through AOPs
T. Allen, University of Cambridge

Abstract ID 262 - An industry perspective on strategies for integrating new approach methodologies for NexGen Risk Assessment: coumarin as a case study
M. Baltazar, Unilever

Abstract ID 337 - Integrating toxicokinetics and toxicodynamics for decision-making in an NGRA context: 2 Cosmetics-Europe case studies
G. Ouedraogo, L’Oreal

6.30 - 8.30 PM

S230: The in3 project: An integrated interdisciplinary approach to animal-free nanomaterial and chemical safety assessment (Theme: Ethics, Welfare and Regulation)

in3 is a EU's Marie Skłodowska-Curie Action - Innovative Training Network project funded by the EU Horizon 2020 under grant no. 721975. In3 focuses on research and training of 15 PhD students in utilising integrated in silico and in vitro tools for animal-free toxicity assessment. There is a particular interest in the project on utilising human induced Pluripotent Stem Cells (hiPSC) differentiated to toxicologically relevant target tissues such as brain, lung, liver, vasculature and kidney, but also anchoring this information to mechanistic toxicology and utilising read across and adverse outcome pathways.

Session chair: M. Culot, Universitè d’Artois


Speakers:

Abstract ID 938 -The in3 project - An integrated interdisciplinary approach to animal-free nanomaterial and chemical safety assessment
P. Jennings, Vrije Universiteit Amsterdam

Abstract ID 837 - Study the effect of Cycloporin A on functionality of endothelial cells differentiated from induced pluripotent stem cells as in vitro toxicity model
Z. Mazidi, Evercyte GmbH

Abstract ID 809 - Exploiting the use of iPSC derived renal proximal tubular like cells to investigate megalin mediated aminoglycosides toxicity
V. Chandrasekaran, Vrije Universiteit Amsterdam

Abstract ID 654 - iPSC-derived human BrainSpheres: a multifaceted and powerful 3D model for
neurotoxicity testing
C. Nunes, Université de Lausanne

Abstract ID 768 - Probabilistic modelling of an Adverse Outcome Pathway network for developmental neurotoxicity
N. Spinu, John Moores Liverpool University

Abstract ID 608 - New read across modules for safer chemicals
A. Caballero, Istituto di Ricerche Farmacologiche Mario Negri

6.30 - 8.30 PM

S85: A walk through 10 years of CAAT-Europe’s highlights

The Center for Alternative to Animal Testing in Europe (CAAT-Europe), housed at the University of Konstanz, coordinates transatlantic activities to promote the development of new and improved methods in toxicology, to provide a platform for different stakeholders for exchanging ideas, and to support the 3R’s principle of human science. CAAT-Europe is going to celebrate the 10th anniversary of its foundation, with a session focused on the most relevant CAAT articles that have been published in the last years. The presentations will cover several topics, as in vitro regulatory, systemic and investigative toxicology, including the application of omics, microphysiological systems and good practice guidance for supporting a human-centered toxicity testing paradigm change. Each speaker will introduce a single publication to tell the story behind its compilation and to discuss its implication and impact on the actual and future discussion in the 3Rs field.

M. Leist, CAAT-Europe/ University of Konstanz

6.30 - 8.00 PM

YOU-WC11 - Quiz Night

Friday 27 August 2021 - Day 5

2.30 - 3.00 PM - Plenary sessions

2.30 - 3.00 PM

WC11 TV - Live from the studio

3.00 - 5.00 PM - Parallel Session FRI-1

3.00 - 5.00 PM

S208: Application of new-approach methodologies to assess the safety of medical devices (Theme: Disease)

The safety assessment of medical devices traditionally relies heavily on animal testing, which represents a significant portion of global animal use. However, a paradigm shift to replace and complement these animal tests with new processes is taking place. These processes include improved and detailed analytical chemistry and new approach methodologies (NAMs). When an adverse biological effect is also of interest to other sectors (e.g., industrial chemicals), adaptation of established NAMs is very promising. However, when the adverse effect is medical device-specific, new NAMs need to be developed. The proposed workshop will introduce this emerging, but important field for application of NAMs to medical devices by presenting successes and promising ongoing projects. These include: (1) the validation and acceptance of in vitro irritation testing using reconstituted human epidermis (RhE) models, (2) an overview of in vitro methods for skin sensitization testing that use RhE and cell-based models, (3) an in vitro thrombogenicity assessment method where fresh human blood is used to replace in vivo models, and (4) the application of the monocyte activation test as an alternative to current in vivo pyrogenicity assays.

Session chair and co-chair: S. Hoffmann, seh consulting + services and K. Coleman, Medtronic


Speakers:

Abstract ID 365 - In Vitro Irritation Testing for Medical Devices: Validation and Acceptance
K. Coleman, Medtronic plc

Abstract ID 669 - In vitro assays for skin sensitization of medical devices
C. Pellovoisin, Episkin

Abstract ID 312 - The monocyte activation test (MAT) for medical devices: an alternative test method for the detection of pyrogen- and material-induced immune activation
S. Stoppelkamp, Universitätsklinikum Tübingen

Abstract ID 700 - In vitro methods to assess thrombogenicity of medical devices and materials: effects of donor specificity
W. van Oeveren, CEO Haemoscan

3.00 - 5.00 PM

S113: Wildlife research and the 3Rs principles (Theme: Ethics, Welfare and Regulation)

Wildlife research is considered crucial for successful species conservation in the midst of current biodiversity loss, but often includes invasive research practices. Wildlife research can thus result in a fundamental conflict between individual animal welfare and the welfare of the population or ecosystem, which could be significantly minimized if the 3Rs principles were more broadly implemented. The purpose of this session is to invite the audience of the World Congress to share their experiences in integrating the 3Rs principles in wildlife research, present solutions that can promote broader implementation of these principles, and define priorities for the near future.

Session chair: M. Zemanova, Centre for Compassionate Conservation, University of Technology Sydney & Animalfree Research, Switzerland 


Speakers:

Abstract ID 153 - APPLYING THE 3RS PRINCIPLES IN WILDLIFE RESEARCH THROUGH NON-INVASIVE METHODS
Miriam Zemanova, Centre for Compassionate Conservation, University of Technology Sydney

Abstract ID 25 - Is wildlife research "second-rate science"? What can lab animal and field scientists learn from one another?
Adrian Smith, Norecopa

3.00 - 5.00 PM

S67: Using the Sematic Web for Rapid Integration of Publicly Available Biological Information (Theme: Innovative technologies)

The diversity of publicly available biological data, and the variety of methods used to store online resources in different formats, provides a challenge for researchers in the integration and analyses of these data. This workshop will discuss novel methods of data conversion and integration used to capture and link biological data. Challenges and benefits will be explored by a panel of experts in relation to capturing information related to toxicological adverse health outcomes using computational methods.

Session chair: Penny Nymark, Karolinska Institutet and Alison Motsinger-Reif, NIEHS


Speakers:

Abstract ID 859 - US EPA Adverse Outcome Pathway Database (AOP-DB) Semantic Integration and Workshop Opening Remarks 
HOLLY MORTENSEN, US EPA

Abstract ID 283 - SEMANTIC MODELLING OF ADVERSE OUTCOME PATHWAYS AND THE IMPLEMENTATION IN REPRODUCIBLE WORKFLOWS
Marvin Martens, Department of Bioinformatics - BiGCaT, NUTRIM, Maastricht University, Maastricht, The Netherlands

Abstract ID 861 - TOWARDS BIOLOGICAL PLAUSIBILITY USING LINKED OPEN DATA
Egon Willighagen, Maastricht University

Abstract ID 490 - Towards building harmonized and interoperable e-infrastructures for reproducible new approach toxicology -
the OpenRiskNet concept
Thomas Exner, Seven Past Nine

Abstract ID 1115 - Adverse Outcome Pathways and data integration
Penny Nymark, Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden

Abstract ID 1118 - EPA ORD NAKNOWBASE (NKB): NANOMATERIAL DATABASE SEMANTIC WEB INTEGRATION FOR ACCESS AND COLLABORATION
Weston Slaughter, Oak Ridge Institute for Science and Education (ORISE) appointee at Office of Research and Development, US Environmental Protecti

3.00 - 5.00 PM

S65: Diving into the scientific knowledge big data looking for alternatives (Theme: Innovative Technologies)

The implementation of a new method or model by life science researchers is based on six phases: 1) access to scientific knowledge; 2) theoretical familiarisation; 3) experimental reproduction; 4) adaptation to their own specific research paradigm; 5) internal validation and 6) deployment.
In this view, easy access to scientific knowledge is the gatekeeping phase towards final deployment (and enhanced uptake) of non-animal models and methods, because it empowers not only researchers, but also regulators, ethical approval boards and those responsable for project/animal licence approvals to discover already available alternatives, importantly reducing duplication of efforts, and boosting the horizontal use and cross-validation in different fields of application.
Improving, or facilitating, informed access to scientific knowledge means that all these stakeholders know how to search for publications of interest and, on the other side, implies that key publications are easy findable.
Our experience tells us that literature search skills in these communities often need improvement and additionally, increasing visibility of non-animal methods could improve familiarity with, and uptake of such methods and could therefore reduce animal use. It is also true that, for identifying key publications, the precise nature of the models and/or methods must be better highlighted in titles/abstracts when drafting scientific documents.
The overall aim of this workshop is to improve literature search skills for the disparate groups of stakeholders who are required to maintain currency with developments in non-animal methodologies. We will provide tips for highlighting non-animal alternatives when drafting a document, consider how and where to search for reliable sources of information and also describe how automated, deep learning methods could be employed to create and update libraries.

Session chair: Laura Gribaldo, European Commission JRC and Adelaide Dura, European Commission JRC


Speakers:

Abstract ID 20 - How to better highlight your research by using the right keywords in titles and abstracts
Lindsay Marshall, The Humane Society of the United States/Humane Society International

Abstract ID 673 - Good Practice: Key experimental details to highlight when drafting your research article
Fabrizio  Rossi, FRESCI by Science&Strategy SL

Abstract ID 93 - Mind the gap: improving literature search skills to access the most relevant scientific and tech knowledge.
David Straccia, FRESCI by SCIENCE&STRATEGY SL

Abstract ID 258 - Data Access and EU institutions
Francois Busquet, altertox

Abstract ID 637 - Advancing machine learning and artificial intelligence techniques for use in (semi-)automatic literature reviews
Krystof Dibusz, EcoMole

Abstract ID 1117 - NAMmed: DEVELOPMENT OF AN ARTIFICIAL INTELLIGENCE DATABASE TO COLLECT AND STRUCTURE NON-ANIMAL METHODS IN USE FOR BIOMEDICAL RESEARCH
Marco Straccia, FRESCI by SCIENCE&STRATEGY SL

3.00 - 5.00 PM

S138: The Animal Welfare Body - how are we doing? (Theme: Ethics, Welfare and Regulation)

Every establishment designated under Directive 2010/63/EU must have an Animal Welfare Body (AWB), which has important tasks, including advising on animal welfare and the Three Rs. This workshop reflects on the implementation of the AWB, including what works well; how to address any outstanding challenges; and the activities of AWB networks. It will focus on Replacement, including what it is realistic to expect from the AWB, and how the AWB can create a culture that encourages effective searches for alternatives. We will combine talks and discussion, share ideas, and identify areas where further support may be needed for the AWB.

Session chair and co-chair: P. Hawkins, RSPCA Animals in Science Department and N. Stockhofe-Zurwieden, Wageningen University and Research


Speakers:

Abstract ID 459 - ANIMAL WELFARE BODY - TASKS AND ROLE
Susanna Louhimies, European Commission

Abstract ID 40 - The Animal Welfare Body - how are we doing
Norbert Stockhofe-Zurwieden, Wageningen UR

Abstract ID 38 - INTERACTIVE DISCUSSION - HOW ARE WE DOING?
Penny Hawkins, RSPCA

Abstract ID 898 - Creating a culture that promotes Replacement
Reinoud Gosens, University of Groningen

Followed by an interactive discussion in 4 breakout rooms (each with 15 people)

Feedback and wrap-up
Penny Hawkins, RSPCA

3.00 - 5.00 PM

S213: Documentary Film and Alternatives Room

The Documentary Film and Alternatives Room showcases a number of new and recent documentary films that address animal experimentation and the innovative, humane methods being implemented in education and training, research and testing. Each film’s producers will be available for questions and answers after the showings. The room will also feature demonstrations and footage of a range of education and training tools, from virtual reality models for comparative anatomy practical classes to advanced synthetic cadavers for medical and veterinary surgery training.

Nick Jukes, InterNICHE

3.00 - 5.00 PM

EPAA training session on Skin sensitisation

15:00-15:10 Welcome & introduction/house-keeping rules by the moderator
François Busquet

15:10-15:30 Introduction on Skin sensitisation NAMs and Defined Approaches current status
Nicole Kleinstreuer

15:30-16:00 BASF/Givaudan GHS IATA Case study

16:00-16:30 Cosmetics Europe NGRA IATA Case study

16:30-17:00 Live Q&A

3.00 - 5.00 PM

YOU-WC11 - Workshop 2

5.00 - 8.30 PM - Plenary sessions

5.00 - 6.00 PM

Pre-poster warm up sessions live from the studio

6.00 - 7.30 PM

Poster session and possibility to ask questions to poster presenters

7.30 - 8.30 PM

WC11 TV - Talk show

Monday 30 August 2021 - Day 6

2.30 - 3.00 PM - Plenary sessions

2.30 - 3.00 PM

WC11 TV - Live from the studio

3.00 - 5.00 PM - Parallel Session MO-1

3.00 - 5.00 PM

S122: Biomed 2.0 -Non-animal Models for Biomedical Research (Theme: Disease)

Animal models have been traditionally used in biomedical research to recapitulate human disease features and develop new drugs, as they are generally supposed to resemble some of the major hallmarks of human diseases. However, these animals do not develop the disease as it occurs in humans, and their use has not paved the way to the development of drugs effective in human patients for many highly prevalent non-communicable diseases, such as Alzheimer disease. Indeed, despite conspicuous research and economical endeavours, the clinical failure rate in drug development still remains very high, with an overall likelihood of approval from Phase I of about 9.6%. On the other hand, enhanced human clinical trials utilising micro- dosing, and more representative study populations and durations, as well as surrogate human tissues, advanced imaging modalities and human epidemiological, sociological and psycho- logical studies, may increase our understanding of illness aetiology and pathogenesis, and facilitate the development of safe and effective pharmacologic interventions. Particularly when human tissues are used, non-animal models may generate faster, cheaper results, more reliably predictive for humans, whilst yielding greater insights into human biochemical processes. A first effort to gather existing knowledge about non-animal models of highly prevalent human diseases has been made by the Joint Research Centre of the European Commission. The final goal is to disseminate and improve knowledge sharing on potentials and limitations of human based models at different levels: scientific communities, universities and secondary schools, national committees for animal welfare and the public at large.
Additionally, project proposals in translational research based on the use of both animal and/or non-animal approaches have been extensively funded at European level. Notwithstanding, defining indicators to measure return on investment of research funding strategies is necessary to retrospectively assess public health trends, and readdress funding strategies when needed.

The session aims to shed light on the concepts, challenges and perspectives for implementation of innovative alternative non-animal methods in biomedical research. Literature reviews and meta-analyses of non-animal approaches as key tools to advance this area of science will be discussed, as well as possible indicators that could be suitable to measure return on investment in biomedical research.

Session chair and co-chair: L. Gribaldo, EURL-ECVAM, F3 Unit, JRC,EC and M. Straccia, FRESCI


Speakers:

Abstract ID 662 - AN INVENTORY OF NON-ANIMAL METHODS TO STUDY ALZHEIMER'S AND PARKINSON'S DISEASE
Liesbeth Aerts, VIB Center for Brain & Disease Research, VIB, Belgium; KU Leuven - University of Leuven, Leuven, Belgium

Abstract ID 7 - Available and emerging non-animal models for human respiratory tract diseases. 
Lindsay Marshall, Humane Society International

Abstract ID 113 - What is the analysis of biomedical research literature teaching us about the use of non-animal models?
Marco Straccia, FRESCI by SCIENCE&STRATEGY SL

Abstract ID 5 - The need to address human relevance and measure impact and innovation of biomedical research
Francesca Pistollato, European Commission, Joint Research Centre, Ispra, Italy

Abstract ID 140 - INNOVATIVE STRATEGIES IN BIOMEDICAL RESEARCH: WHICH MODELS?
Laura Gribaldo, JRC-EC

3.00 - 5.00 PM

S136: How to avoid polarization in dealing with uncertainties in public, scientific and regulatory debate (Theme: Ethics, Welfare and Regulation)

Letting go of old habits and (false) certainties is a challenging process.Implementing animal-free innovations instead of, or alongside, animal-driven research is a complex transformation. Such a transformation process benefits from a fair, open-minded debate. There are many uncertainties, and a recurring pattern in transformation processes with different stakeholders is that uncertainties are used in the discussion to invalidate or ridicule arguments from other stakeholders. This leads to a destructive, increasingly polarizing discussion potentially paralyzing the transformation process. In this session we explore how to learn from previous experiences with complex transformation processes, and some successful drivers of transformation will speak.

Session chair and co-chair: Prof. Dr. J-B, Francis Crick Institute  & Leiden University Medical Centre and Dr. W. de Leeuw, Head of Animal Welfare Body, University Utrecht, The Netherlands


Speakers:

Abstract ID - Transition: an evolutionary revolution
Jan Rotmans, Erasmus University

Abstract ID 900 - Communicating uncertainty about facts, numbers, and science in a polarized debate
Anne Marthe van der Bles, University of Groningen

Abstract ID - Moving Beyond Animal Testing from a scientific point of view
D. Diavatoupoulos, Moving Beyond Animal Testing from a scientific point of view

Abstract ID - Moving Beyond Animal Testing from a regulatory point of view
F. Musuamba, European Medicine Agency

3.00 - 5.00 PM

S162: Novel cell-based technologies for predicting drug-induced liver injury (Theme: Innovative technologies)

Drug-induced liver injury remains the most common cause of the safety-related withdrawal of drugs from the market, and this despite extensive animal testing and in vitro testing. Therefore, there is a great need for better in vitro predictive models. During this session, the speakers will address progress made in different aspects of in vitro liver models that should enhance drug toxicity prediction. This includes different cells of origin (primary and pluripotent stem cell-derived liver cells), as well as advanced technologies to create tissue mimetics (laser-guided printing, fully defined hydrogel scaffold-based spheroids, organoid or spheroid formation) as well as multi-organ-on-a-chip systems.

Session chair: C. Verfaillie, Katholieke Universiteit Leuven 


Speakers:

Abstract ID - Biology-inspired microphysiological systems: The asset of multi-organ co-cultures
E. Dehe, TissUse GmbH

Abstract ID 867 - A New In Vitro Model for Interrogating DILI Susceptibility for Patients with Benign Fatty Liver Disease 
Katarzyna Sanchez, InSphero AG

Abstract ID - Liver organoids to toxicity studies
H. Clevers, Hubrecht Institute

Abstract ID 897 - Complex in-vitro models: Synthetic matrices for pluripotent stem cells (PSC) derived multi-cellular 3D liver
organoid
Manoj Kumar, Stem Cell Institute, KU Leuven

Abstract ID - Development of a bioprinted liver tissue model and its evaluation for drug toxicity testing
F. Guillemot, Poietis 

3.00 - 5.00 PM

S104: AOPs, MOAs, and KCs - Mutually Informative, Not Mutually Exclusive (Theme: Safety)

Adverse Outcome Pathways (AOPs) are frameworks for organizing and integrating diverse, and sometimes abundant, toxicological data. AOPs include identification of the initial chemical-biological interaction (the molecular initiating event), a complete sequence of biological events (key events), and relationships between events that lead to an adverse outcome of actionable concern. AOPs evolved from mode-of-action (MOA) and other preceding concepts and have expanded on this groundwork by more precisely defining the level of knowledge required to link a molecular interaction to an apical effect. AOPs are now part of the lexicon of modern toxicology and are well beyond the proof of concept phase, yet to date, application of AOPs to chemical safety decision making has been limited. This may be due in part to the substantial resource investment required to research, author, and review a “complete” AOP. In the cases where all key events are known and there are non-animal methods to test these events, testing strategies may be sufficiently predictive of the apical response to replace the need for in vivo data (e.g. skin sensitisation). However, for circumstances that do not achieve this high standard, a variety of other strategies that do not require as complete an understanding of the biological events between molecular interactions and apical effects have been successfully deployed for chemical safety decision making. For example, evaluating the hazard of chemicals that may interact with vertebrate endocrine systems requires data on the chemical’s MOA and an adverse effect in an animal but to date, complete AOPs (from MIE to apical adverse outcome) are not available for most types of endocrine toxicity. This has not prevented regulatory agencies from using pathway-based models in chemical prioritization and hazard screening, and to replace the need for some in vivo testing. Another recent approach has been to interrogate, assemble and evaluate the relevant evidence on various cancer mechanisms according to defined key characteristics (KC), chemical and biological properties of established carcinogens identified by the WHO's International Agency for Research on Cancer (IARC). An approach based on the KCs does not require an a priori hypothesis concerning the biological mechanisms or signaling that initiates the toxic effect or all events leading to carcinogenesis, but nonetheless can contribute to protecting human health, in some cases, in the absence of animal experiments. In other scenarios, AOP frameworks can be used to identify candidate assays to fill regulatory data gaps, even for circumstances where the intermediate events linking the molecular initiating event and apical effect may not be well understood. For example, chemicals that interfere with retinoid pathway signalling are associated with some of the most common human birth defects. Rather than designing a new in vivo method to investigate retinoid signaling, in vitro and in silico mechanistic tests can help identify environmental chemicals that may act through this pathway. This session will focus on the lessons learned from these different approaches, highlighting examples for integrating evidence that are used in regulatory decision making and involve varying degrees of understanding of the biological sequelae linking mechanistic effects to adverse outcomes. The presentations will address the strengths and limitations of each of these approaches, and where the different approaches may be mutually informative, improve chemical safety hazard identification, and reduce the need for animal testing.

Session chair: Patience Browne, OECD


Speakers:

Abstract ID 47 - Building an AOP-Driven Defined Approach Guideline
Nicole Kleinstreuer, NIEHS/NICEATM

Abstract ID 103 - AOPS FOR ENDOCRINE DISRUPTORS
Sharon Munn, DG-JRC European Commission

Abstract ID 16 - The key characteristics of carcinogens
Kathryn Guyton, IARC

Abstract ID - Modeling the retinoid system in biology and toxicology
Tom Knudsen, US Environmental Protection Agency

Abstract ID 524 - KCs, MOAs and AOPs - Mutually Informative, Not Mutually Exclusive
Patience Browne, OECD

Abstract ID 652 - Classification of Human Reference Data and their Use for Evaluating Defined Approaches for Skin Sensitisation
Matthias Hezler, The German Federal Institute for Risk Assessment (BfR)

3.00 - 5.00 PM

S59: Innovative technologies integrating standardised regulatory test methods: challenges and perspectives (Theme: Innovative Technologies)

Modern technologies supported by good science are progressively bringing innovative solutions to the need to move away from systematic animal testing. Innovation has a cost for companies who invest in research and development, and the resulting intellectual proterty need to be protected. At the same time, the regulatory community requires reliable and transparent methodologies that they can rely upon for the safety assessment of chemicals. In the OECD context of Mutual Acceptance of data, another layer of complexity is added by the need for the methods to be broadly available and transferable. The presentations in this session will illustrate some of the challenges faced and solutions implemented to allow protected elements in test methods to integrate Test Guidelines used in regulatory contexts.

Session chair: Anne Gourmelon, OECD and Joao Barroso, EURL ECVAM Joint Research Center


Speakers:

Abstract ID 171 - Innovative technologies integrating standardised regulatory test methods: challenges and perspectives
Anne Gourmelon, OECD

Abstract ID 297 - Integrating innovative methods to predict a regulatory hazard endpoint: a regulatory perspective
Monique Perron, U.S. EPA

Abstract ID 331 - TRANSFERABILITY CHALLENGES WITH MODERN TECHNOLOGY AND HOW TO OVERCOME THEM - A CASE STUDY OF THE GARD ASSAYS FROM A TEST METHOD DEVELOPER'S PERSPECTIVE
Axel Sjöblad, SenzaGen AB

Abstract ID 624 - Auditing for GLP compliance, a regulatory study that relies heavily on computerised prediction models and complex in vitro techniques, where are the pitfalls and issues to care about
Martijn Baeten, Sciensano GLP Monitoring Authorithy Belgium

Abstract ID 808 - Establishing scientific credibility of NAMs. To what extent is transparency, interpretability and explainability
necessary?
João Barroso, European Commission, Joint Research Centre, Ispra (VA), Italy

Abstract ID 644 - STopTox: An in-silico alternative to animal testing for acute Systemic and TOPical TOXicity
Anne Kienhuis, RIVM

3.00 - 5.00 PM

S124: Connecting experts with TPI.tv

To connect professionals working in the chain of animal-free innovations - from scientific discovery to market access - we have developed TPI.tv. This is a cloud-network of professionals with supply or demand of information, knowledge and data. It connects professionals who want to enter into a dialogue on the transition to animal-free innovation. Because dialogue is key to the development and application of innovations that will increase efficacy and safety of medicines, food, cosmetics and chemicals, whilst making the use of animal tests redundant.

In this session we will:
1. Present:
a. an animation on the why, how and what of TPI.tv (10 min)
b. an Instructive video how to make an effective and mobilizing video-abstract (10
min)
c. the channel TPI.tv with individual browsing time (10 min)
2. Have an interactive part with and a real-time poll (30 min)
3. Have an online panel discussion on sharing content on TPI.tv (30 min)

 

H. Heusinkveld, RIVM

5.00 - 6.30 PM - Plenary sessions

5.00 - 5.15 PM

Break and WC11 TV from the studio

5.15 - 6.15 PM

KEYNOTE: Dr. Ger Janssen, Philips

Ger Janssen has a PhD in Applied Physics from Eindhoven University of Technology in the Netherlands. He joined Philips in 2001 and in all his responsibilities in the company computational modelling is a recurring theme, in which he has now over 20 years of experience.

He is currently head of the Digital Twin department in Philips Research and since 2018 also Program Manager Patient Digital Twin. In these roles he is shaping the digital twin activities of Philips from R&D to operational and clinical space. For these activities the guiding principle is that all Philips solutions should address the quadruple aim: better health outcome, better patient and staff satisfaction against lower costs.

6.15 - 6.30 PM

Break and WC11 TV from the studio

6.30 - 8.30 PM - Parallel Session MO-2

6.30 - 8.30 PM

S84: Beyond the 3Rs: Expanding the Use of Human-Relevant Replacement Methods in Biomedical Research (Theme: Disease)

The current landscape of alternative methods calls for a strategic focus on (1) biomedical research (where many human disease processes remain unclear), (2) replacement methods (given the myriad types of models now available (e.g., organs-on-a-chip)), and (3) human relevance (given problems with the current translatability of models). This roundtable will reflect this strategic focus by addressing the use of human relevant models in several areas of biomedical research, including cardiovascular disease, Alzheimer disease, autism, and cancer.

Session chair: Martin Stephens, Johns Hopkins Bloomberg School of Public Health and Kathrin Herrmann, Johns Hopkins Bloomberg School of Public Health


Speakers:

Abstract ID 21 - Overview of new approaches in biomedical research - the BioMed21 collaboration
Lindsay Marshall, The Humane Society of the United States/Humane Society International

Abstract ID 696 - In-silico trials for drug safety and efficacy assessment
Cristian  Trovato, University of Oxford

Abstract ID 3 - The need to prioritize 'Replacement' in Alzheimer's disease research
Francesca Pistollato, European Commission, Joint Research Centre, Ispra, Italy

Abstract ID 689 - Applications of brain-model technology to study chemical induced neuro(developmental) disorders
Helena Hogberg, Center for Alternatives to Animal Testing (CAAT), Johns Hopkins Bloomberg School of Public Health

Abstract ID 513 - Mini Me - Tissue-on-a-chip as a mimic for patient response
John Greenman, University of Hull

Abstract ID 1116 - Applications of brain-model technology to study neurodevelopmental disorders
Cleber Trujillo, StemoniX, a Vyant Bio Company

6.30 - 8.30 PM

S120: 3Rs in vaccines Development (Theme: Disease)

This session will review how 3R can be use in Vaccines development, from early development strategy to launch . The presentation will focus on success stories of recent developed vaccines and future trends.

Session chair and co-chair: S. Shaid, GSK and C. Stirling, Zoetis


Speakers:

Abstract ID 525 - MENINGOCOCCAL GROUP B VACCINE: A JOURNEY TOWARDS A COMPLETE ANIMAL TEST FREE RELEASE PROCESS
Orazio Oliverio, GSK

Abstract ID 695 - REGULATORY CONSEQUENCES OF THE VALIDATION OF REPLACEMENT IN VITRO TOXICITY AND ANTIGENICITY ASSAYS FOR CLOSTRIDIUM SEPTICUM VACCINE ANTIGENS
Marie-Emmanuelle Behr-Gross, EDQM Council of Europe

Abstract ID 860 - NIH REPLACEMENT FOR HUMAN RABIES VACCINE: METHOD DEVELOPMENT AND STRATEGY FOR IMPLEMENTATION OF NEW ELISA FOR COMMERCIAL PRODUCT
Audrey Toinon, Sanofi Pasteur

6.30 - 8.30 PM

S221: Implementing the Three Rs in the creation and breeding of Genetically Altered Animals (GAAs)s (Theme: Ethics, Welfare and Regulation)

The use of Genetically Altered animals in scientific procedures in EU accounts for around one-third of all uses, and continues to increase year on year. In some countries the use of GA mice and zebra fish exceed the use of conventional animals.
The session will concentrate on current issues relating to different methods used in the creation and breeding of GA animals and consider, in particular, how animal numbers & degree of suffering can be minimised. Although GA mice are the most commonly used species, the session will also consider the impact of GA technologies on other commonly used species.

Session chair: D. Anderson, Pentlands Management Systems


Speakers:

Abstract ID 456 - Genetically altered animals (GAA) – Why the Three Rs are important
S. Louhimies, European Commission

Abstract ID 437 - EU expert working group proposals for common guidance on the creation and breeding of genetically altered animals (gaas)
D. Anderson, PMS

Abstract ID 935 - Application of the 3Rs in creation of GAA mice - the challenges of new technologies
B. Jerchow, Novartis Institutes for BioMedical Research, Novartis Pharma AG, Basel, Switzerland

Abstract ID 659 - Three R challenges in the breeding of GA rodents
A. Zintzsch, University of Basel

Abstract ID 12 - Animal welfare assessment of genetically altered Göttingen Minipigs
L. Mikkelsen, Ellegard

6.30 - 8.30 PM

S135: Advancing Three Rs education and training under a European Parliament Pilot Project (Theme: Ethics, Welfare and Regulation)

European Parliament Pilot project promoting alternatives and the Three Rs in education and training facilitates the development of six interactive, open access e-learning modules on critical aspects of Directive 2010/63/EU and the development and uptake of non-animal alternatives, to aid today's users and method developers. Furthermore, the Education and Training Platform for Lab Animal Science (ETPLAS) is developing Learning Outcome assessment criteria and tools for competence assessment. Finally, targeting future generations, EURL ECVAM is preparing learning resources and guidance for educators on how to include the Three Rs in a curriculum for high schools, universities and for early career scientists.

Session chair: K. Schütte, European Commission


Speakers:

Abstract ID 355 - ADVANCING THREE RS UNDER A EUROPEAN PARLIAMENT PILOT PROJECT
Katrin Schutte, European Commission

Abstract ID 37 - E-LEARNING RESOURCES TO SUPPORT TRAINING FOR PROJECT EVALUATION, PROJECT AND PROCEDURE DESIGN, AND SEVERITY ASSESSMENT FRAMEWORK
Paul Flecknell, Flaire Consultants Ltd

Abstract ID 614 - Advancing Three Rs education and training under a European Parliament Pilot Project
Judith van Luijk, Radboudumc

Abstract ID 407 - A European Commission funded project to develop Learning Outcomes and Assessment tools to facilitate harmonisation of LAS education and training in Europe
Jan-Bas Prins, Leiden University Medical Centre ; The Francis Crick Institute

Abstract ID 603 - Advancing Three Rs Education and Training under a European Parliament Pilot Project at EURL ECVAM
Marcelle Holloway, European Commission, Joint Research Centre (JRC)

6.30 - 8.30 PM

S245: hands-on experience with the application of NAMs in intelligent testing strategies under regulatory programs

Chemical regulations, like REACH (European Regulation on Registration, Evaluation, Authorisation and restriction of CHemicals), are requiring extensive datasets and increased granularity in the data submitted to eventually help manage the potential risk related to exposure to chemicals. To progress towards a more sustainable approach to hazard and risk assessment, we should take the unique opportunity that REACH provides to promote alternative methodologies in order to reduce the reliance on testing in vertebrate animals on each of the three “Rs”. In practice however, (regulatory) uptake of the application of these methodologies has been slow. Hands-on experience from different actors in the front line (regulators, academia, industry), will highlight both the challenges to overcome and opportunities we have going from development to increased practical application. Presentations will be short, to set the scene for an interactive panel debate with the aim to further contribute to the “3Rs in transition; from development to application”.

Session chair and co-chair: H. Ketelslegers, European Petroleum Refiners Association (Concawe) and K Schutte, European Commission


Speakers:

Abstract ID 755 - Hands-on experience with the application of NAMs for the registration of petroleum substances under REACH
P. Boogaard, Shell International/Wageningen University

Abstract ID 706 - Use of NAM under REACH and globally
M. Rasenberg, European Chemicals Agency (ECHA)

Abstract ID 290 - The OECD IATA Case Studies Project – Five years of shared experience in the integration of new methods in a regulatory context
P. Browne, OECD

Abstract ID 619 - Integration of in silico and in vitro NAM approaches to support read across: the EU-ToxRisk experience
B. van de Water, Leiden Academic Centre for Drug Research (LACDR)/Leiden University

Abstract ID 766 - Potential application of NAMs to improve regulatory acceptance of Read-across
M. Pereira, Humane Society International

Abstract ID 847 - Promoting non-animal approaches within the EU Chemicals Strategy for Sustainability
K. Schutte, European Commission, DG Environment

6.30 - 8.30 PM

S151: Transition management on animal-free testing

Animal-free innovation is not easy. It can accelerate in a climate where trust and transparency are the norm. Therefore some pragmatic tools and conditions are being created in the Netherlands that could help accelerate animal-free innovation. Such as the logistics and rules for the use of human waste material (vital tissue).

In this session we will:
1. Present several video’s on tools like:
• Masterclass Helpathon,
• Beyond Animal testing Index (BATi),
• Vital Tissue and Research
• preclinical trial register.
• reporting of In Vivo Experiments
2. Have a real-time poll on trust and transparency
3. Have an online panel discussion on the presented tools and requirements

6.30 - 8.30 PM

YOU-WC11 - Workshop 3

Tuesday 31 August 2021 - Day 7

2.30 - 3.00 PM - Plenary sessions

2.30 - 3.00 PM

WC11 TV - Live from the studio

3.00 - 5.00 PM - Parallel Session TUE-1

3.00 - 5.00 PM

S228: Of mice and men and predictive biology: what would it take to ingrain the 3Rs in biomedical research? (Theme: Disease)

In the third decade of the 21st century, it is paradoxical that we know more about animal biology than human biology. While translational failure is at an all-time high, human biology-based investigations have fallen out of favour with scientists, funding agencies, and reviewers alike in hypothesis-driven basic biomedical research. A paradigm shift where human biology serves as the gold standard in basic research is needed to accelerate bench-to-bedside success. This workshop will address critical factors limiting the widespread adoption of the 3Rs in basic research and collate information to craft a human-centred predictive biology strategic roadmap for biomedical research.

Session chair and co-chair: C. Chandrasekera, Canadian Centre for Alternatives to Animal Methods and P. Rorsman, University of Oxford


Speakers:

Abstract ID 858 - Of mice and not men: Lessons from academia
P. Rorsman, University of Oxford

Abstract ID - Where is the animal model? Reviewer bias in upholding the 3Rs
D. Flower, Nature Publishing Group

Abstract ID 812 - Law and order: Policies and legislation (or lack thereof) for the 3Rs in research
E. Baker, Physicians Committee for Responsible Medicine

Abstract ID - Predictive basic research: Applying lesson from toxicology
T. Hartung, Center for Alternatives to Animal Testing, Johns Hopkins University

Abstract ID 910 - Beyond animal research: Human biology as the gold standard
C. Chandrasekera, Canadian Centre for Alternatives to Animal Methods, University of Windsor

3.00 - 5.00 PM

S121: 3R in vaccines batch release: Progress and future strategies (Theme: Disease)

This session will review what is the situation on the use of animal in vaccine batch release and how 3R could be integrated in the acceleration and simplification of vaccines batch release process. It will also to present cross industry initiative and success stories leading to animal reduction in Batch release.

Session chair and co-chair: S. Shaid, GSK and S. Uhlrich, Sanofi Pasteur


Speakers:

Abstract ID 937 - Vaccine batch to vaccine batch comparison by consistency testing (VAC2VAC)
Hilde Depraetere, European Vaccine Initiative

Abstract ID 533 - 3Rs approach for potency testing of human combined DTaP vaccines: current status and next steps
Emmanuelle Coppens, Sanofi Pasteur

Abstract ID 441 - TECHNOLOGY IS MOVING GSK TOWARDS THE SUBSTITUTION OF ANIMAL-TESTING
Shahjahan SHAID, GSK Biologicals - Vaccines

Abstract ID 893 - A VIEW FROM THE VETERINARY SECTOR ON 3R'S IN BATCH RELEASE
Catrina Stirling, Zoteis Inc.

Abstract ID 912 - Regulatory Acceptance for the Substitution of In Vitro for In Vivo Vaccine Potency and Safety Assays for Batch
Release: Science Versus the Fear Factor
Dean Smith, Health Canada

Abstract ID 421 - IMPROVED PRODUCT CHARACTERIZATION USING NON-ANIMAL METHODS: DEVELOPMENT OF AN IMMUNOASSAY FOR DIPHTHERIA AND TETANUS VACCINES
Paul Stickings

3.00 - 5.00 PM

S128: Lessons Learned and Practical Considerations for the Use of In Vitro Exposure Systems to Assess Respiratory Toxicity

Inhalation is a major route of human exposure to airborne substances and interest in developing efficient testing approaches based on mechanisms of human toxicity have led to significant investment in the advancement of in vitro approaches to assess respiratory toxicity. Studies have shown the use of cells or tissue models grown at the air-liquid interface to be a promising model to predict the effects of substances on the human respiratory tract, and equipment for the exposure of cells grown in vitro has been developed. Laboratories using in vitro exposure systems have developed extensive expertise in the use of these systems and an understanding of factors that need to be considered.

In this session, speakers will discuss practical considerations and lessons learned through hands-on experience with in vitro exposure systems. The session will include speakers from laboratories testing different types of substances (e.g., direct solids or liquids, aerosols, gases or vapors) and provide insights into how the physical form of the test substance impacts the equipment and protocols used. The presentations will also cover selection of the test system (cell or tissue type), relevant biological endpoints, and assays to use, depending on the test substance and purpose of the study. Practical experience will be shared on critical aspects of equipment choice and experimental design, including methods for ensuring and quantifying test substance exposure, evaluating dosimetry, physical conditions of the exposure system, such as flow rate, temperature, humidity, as well as worker safety considerations.

This session will be useful to researchers considering the purchase of an in vitro exposure system or current users. A discussion of the critical factors to standardize and compare results from different laboratories and different equipment will be included. Attendees will leave with real-world information about the selection, set-up, and troubleshooting of in vitro inhalation exposure systems and the remaining hurdles that need to be overcome to facilitate widespread adoption of in vitro approaches to assess the effects of inhaled substances on the respiratory tract.

Session chair and co-chair: A. Clippinger, PETA Science Consortium International e.V. and Dr L. Milchak - 3M Company


Speakers:

Abstract ID 287 - Key learnings from in vitro vapor and direct liquid exposure studies for acute respiratory toxicity
Lawrence Milchak, 3M Company

Abstract ID 66 - Air-liquid interface exposure for inhalation testing: case studies
Sandra Verstraelen, VITO NV (Flemish Institute for Technological Research), Unit HEALTH

Abstract ID - Use of a Novel In Vitro Exposure System with Various Human Primary Bronchial Epithelial Cell Cultures to Assess Respiratory Toxicity
M. Higuchi, US Environmental Protection Agency Office of Research and Development

Abstract ID 884 - USING A DRY POWDER VITROCELL SYSTEM TO EXPOSE RESPIRATORY EPITHELIAL MODELS
Vicki Stone, Heriot-Watt University

Abstract ID 882 - Advanced human 3-dimensional test systems paired with modern exposure systems: progress toward recreating
physiological-like inhalation exposures
Holger Behrsing, IIVS, Inc.

3.00 - 5.00 PM

S26: “Proof in animals”: Has journal editorial policy fallen behind advances in human-based approaches? (Theme: Ethics, Welfare and Regulation)

Biomedical scientists using the growing toolbox of human-derived, non-animal technologies have been questioned by peer reviewers or journal editors as to whether their findings have been corroborated in an animal model. Demands for a animal data to “validate” human-based approaches reinforce the dubious gold standard status of animal models for humans, and run contrary to the 3R principle that the scientific mainstream purports to embrace. This round table will bring together science leaders and journals’ editors to critically examine this topic, and to draw a path forward that embraces human-focused technologies as the new mainstream.

Session chair: Marcia Triunfol, Humane Society International


Speakers:

Abstract ID -
To be provided
Steve Carney, Editor - Drug Discovery Today 

Abstract ID 895 - Role of biomedical journals' policies in promoting the dissemination of the 3Rs
Laura Gribaldo, JRC, European Commission

Abstract ID 936 - Human Organ Chips: From experimental models to clinical mimicry
Donald Ingber, Wyss Institute for Biologically Inspired Engineering at Harvard University

Abstract ID 580 - WHAT CAN WE LEARN FROM PUBMED ON THE USE OF ANIMALS IN ALZHEIMER'S RESEARCH?
Marcia Triunfol, Humane Society International

Abstract ID - To be provided
Nicole Kleinstreuer , National Institutes of Health

Abstract ID 683 - CONFRONTING PUBLISHING BIAS AGAINST IN VITRO APPROACHES
Catharine Krebs, Physicians Committee for Responsible Medicine

3.00 - 5.00 PM

S150: Beyond animal welfare policy – how other areas of policy can boost non-animal alternative

Transitions are long-term processes. What is the current state of the transition towards animal-free innovation? The phase TPI is in is characterized by dynamics of build-up. What are the different push and pull factors to build up a new practice with the use of human knowledge and data and without the use of animals?
Interactive pdf to share:
. Review on TPI 2018-2020 Download 'Review of TPI'
. Policy line of reasoning (work in progress)

In this session we will:
1. Present an interview video with characterization of the current state of the transition
towards animal-free innovation and with the Dutch TPI-partners and their coming
promising actions.
2. Ask the participants in a real-time poll to share their motives for development and
acceptance animal-free models and methods.
3. Have an online panel discussion on motivations for animal-free innovation.

3.00 - 5.00 PM

S313: ROADMAP (Theme: Safety)

Abstract ID 340 - ANIMAL-FREE TESTING OF CELL-BASED MEDICINAL PRODUCTS
Jan Willem van der Laan

Abstract ID 514 - Scientific workshop on non-animal approaches for chemical safety in China: Current Progress and Outlook
Carl Westmoreland

Abstract ID 622 - REACH AND THE 3RS – REINVIGORATING EFFORTS TOWARDS THE AVOIDANCE OF VIVO TESTING 
Emma Grange

Abstract ID 693 - ANIMAL-FREE TESTING OF CELL-BASED MEDICINAL PRODUCTS
Jan Willem van der Laan

Abstract ID 1008 - Improving alternative method adoption through tools and resources to support community knowledge
Shannon Bell

Abstract ID 1101 - EXPERIMENTAL MODELS IN RESEARCH: A EU-WIDE SURVEY
Lorenzo Del Pace

5.00 - 6.30 PM - Plenary sessions

5.00 - 5.15 PM

Break and WC11 TV from the studio

5.15 - 6.15 PM

Poster session and possibility to ask questions to poster presenters

6.15 - 6.30 PM

Break and WC11 TV from the studio

6.30 - 8.30 PM - Parallel Session TUE-2

6.30 - 8.30 PM

S69: Promoting the use of 3Rs through partnership: EPAA (Theme: Ethics, Welfare and Regulation)

The session will highlight the contribution of EPAA as a cross-sector European partnership between industry and regulators to promote development and acceptance of alternative approaches. The progress of some important collaborative projects and communication activities will be presented.

Session chair: Rob Roggeband, EPAA and Vera Baumans, Utrecht University


Speakers:

Abstract ID 203 - A PUBLIC PRIVATE PARTNERSHIP FACILITATING DEVELOPMENT AND UPTAKE OF 3R APPROACHES
Giacomo Mattino’ (European Commission, DG GROW)

Abstract ID 98 - NEW IDEAS FOR SYSTEMIC TOXICITY: OUTCOME OF AN EPAA BLUE SKY WORKSHOP
George Daston, Procter & Gamble

Abstract ID 354 - HARMONISATION OF THE THREE RS IN BIOLOGICALS
KATRIN SCHUTTE, EU Commission

Abstract ID 363 - OPTIMAL DURATION OF SAFETY STUDIES WITH MONOCLONAL ANTIBODIES
Peter van Meer, Medicines Evaluation Board

Abstract ID 183 - TOOLS TO SUPPORT APPLICATION OF PHYSIOLOGICALLY-BASED KINETIC MODELLING IN SAFETY ASSESSMENT Judith Madden, School of Pharmacy and Biomolecular Sciences, Liverpool John Moores University, Byrom St, Liverpool, L3 3AF, UK

Abstract ID 195 - EPAA EFFORTS TO PROMOTE AND BUILD CONFIDENCE ON THE USE OF 3Rs 
Rob Roggeband, Procter & Gamble

6.30 - 8.30 PM

S62: Bridging the gap between 3R development and application, one-on-one

6.30 - 8.30 PM

S300: 3D MODEL 1 (Theme: Innovative Technologies)

Speakers:

Abstract ID 135 - MICROPHYSIOLOGICAL SYSTEM COCULTURE APPROACH FOR BRONCHIAL LUNG AND LIVER MODELS FOR SUBSTANCE EXPOSURE STUDIES
Katharina Schimek

Abstract ID 347 - DEVELOPMENT OF A HUMAN BONE-ON-A-CHIP TO MODEL INTRAMEMBRANOUS OSSIFICATION IN BASIC SCIENCE AND TOXICOLOGY
Julia Scheinpflug

Abstract ID 728 - A 3D-PRINTED MICROPLATE INSERT FOR HIGH-THROUGHPUT AND ULTRA LONG TERM HIGH RESOLUTION IMAGING OF LIVE HUMAN BRAIN ORGANOIDS: A new platform to replace animal models in brain cancer research
Guillermo Alberto Gomez

Abstract ID 842 - Human immunocompetent Choroid-on-chip: a promising tool for studying ocular side effects of biological drugs
Madalena Cipriano

Abstract ID 931 - A 3D AUTOLOGOUS IPSC-DERIVED HAIR BULB MODEL
Oussama EL BARAKA

Abstract ID 1107 - MULTI-ORGAN-CHIP DEVELOPMENTS: TOWARDS A PARADIGM SHIFT IN DRUG DEVELOPMENT
Ilka Maschmeyer

6.30 - 8.30 PM

S301: Animal welfare in practice (Theme: Ethics, Welfare and Regulation)

Abstract ID 85 - IMPLEMENTING CUP AND TUNNEL HANDLING IN A (LARGE) PHARMACEUTICAL RODENT FACILITY
Maria Kiersgaard

Abstract ID 139 - AN INTERNATIONAL DATA CROWDSOURCING PROJECT TO UNDERSTAND AND MINIMISE AGGRESSION IN GROUP-HOUSED MALE LABORATORY MICE
Mark Prescott

Abstract ID 191 - A Refinement Wiki
Adrian Smith

Abstract ID 230 - Clicker/Target Training of Research Animals as a Refinement
Kathryn Bayne

Abstract ID 504 - The Animal Protection Quality Certificate. Key figures for the improvement of animal welfare
Roberto Plasenzotti

Abstract ID 817 - UPDATING PAIN RECOGNITION AND MANAGEMENT APPROACHES IN LABORATORY MICE AND RATS
Patricia Turner

6.30 - 8.30 PM

S302: BMP (Theme: Safety)

Abstract ID 227 - Engineering a Dynamic Model of the Alveolar Interface for the Study of Aerosol Deposition 
Roberta Nossa

Abstract ID 292 - MODELING BLOOD-BRAIN BARRIER PERMEATION IN THE AUTOLOGOUS STEM CELL-DERIVED CHIP4 
Leopold Koenig

Abstract ID 324 - Optimization of an in vitro placental transfer assay for screening purposes
Barbara Birk

Abstract ID 680 - TOWARDS A REGULATORY APPLICATION OF CACO-2 ADVANCED INTESTINAL BARRIER MODEL
Isabella De Angelis

Abstract ID 844 - SECRETOME CHARACTERIZATION OF 3D BRONCHIAL EPITHELIAL CULTURES TO STUDY THE ROLE OF PROTEIN CORONA ON THE FATE AND LONG-TERM EFFECTS OF NANOPARTICLES
Daniel Sanchez-Guzman

Abstract ID 1050 - Particle deposition and effects in an air-liquid interface lung model: an interlaboratory comparison study
Rob Vandebriel

6.30 - 8.30 PM

S303: CANCER (Theme: Disease)

Abstract ID 55 - 3D scaffold-based neuroblastoma model for evaluating cytotoxic and miRNA-targeted therapeutics 
Olga Piskareva

Abstract ID 107 - MIMICKING HUMAN LUNG TUMOUR COMPLEXITY IN 3D IN VITRO TUMOROIDS CULTURED AT THE AIR-LIQUID INTERFACE FOR PREDICTING THE EFFICACY OF INHALED ANTI-CANCER DRUGS IN NSCLC PATIENTS
Dania Movia

Abstract ID 142 - CELLULAR CROSS-TALK-INDUCED SECRETION OF INTERLEUKIN-10 (IL-10) IN AN ORGANOTYPIC HUMAN MELANOMA MODEL DIRECTS MONOCYTE DIFFERENTIATION TO AN M2-LIKE PHENOTYPE
Elisabetta Michielon

Abstract ID 156 - All-human, dynamic, in vitro, 3D blood brain barrier models for drug delivery and cancer metastasis studies; basal laminae protein types define TEER and transient opening can be demonstrated, reflecting human xenograft model findings.
Geoffrey John Pilkington

Abstract ID 506 - MULTI OMICS DATA INTEGRATION TO STUDY THE RELEVANCE OF IN VITRO DISEASE MODELS THROUGH THE CREATION OF GENOMIC INTERACTION NETWORKS 
Tim Kuijpers

6.30 - 8.30 PM

YOU-WC11 - Workshop 4

Wednesday 1 September 2021 - Day 8

2.30 - 3.00 PM - Plenary sessions

2.30 - 3.00 PM

WC11 TV - Live from the studio

3.00 - 5.00 PM - Parallel Session WED-1

3.00 - 5.00 PM

S154: NASH, the liver disease of the 21st century? Alternative technology in the spotlights (Theme: Disease)

Non-alcoholic fatty liver disease (NAFLD) encompasses a spectrum of disease stadia related to the excessive accumulation of lipids in the liver. The NAFLD prevalence, which is strongly associated to lifestyle, is estimated on 33.5% of the global adult population by 2030 [1]. The first stage in NAFLD, simple steatosis, is mainly benign and implies no detrimental consequences. However, 5-10% of patients suffering from steatosis progress to non-alcoholic steatohepatitis (NASH), which is accompanied by hepatic inflammation. NASH is considered the tipping point to advanced stages of NAFLD, such as fibrosis, cirrhosis and hepatocellular carcinoma. The disease can be managed to a certain degree by diet and lifestyle modifications, however, these treatments have a low success rate and are generally poorly appreciated by the patients [2]. Despite the enormous prevalence of NASH and its central role in disease progression, no FDA-approved anti-NASH drug is available yet [3].
Animal models have been widely employed in NAFLD research. Rodents fed with a methionine- and choline deficient- or high fat diet are most frequently used as NASH models. These pathogenic stimuli mimic only to a limited extent the human NASH pathogenesis. Differences in the development of intracellular lipid accumulation, hepatic inflammation and mitochondrial abnormalities have been reported [4]. For example, administration of PPAR-α agonists (i.e. one of the molecular targets of elafibranor, a clinical phase III anti-NASH compound [5]) to rodents evokes peroxisome proliferation and hepatocellular carcinoma, yet this does not happen in humans [6].
Human-based models can overcome these interspecies differences as well as most of the ethical issues related to animal models. However, NASH modelling is challenging because of the involvement of multiple pathogenic stimuli and consequently the need for multi-disciplinary approaches. As such, the understanding of the human NASH pathogenesis using novel (computational) approaches such as systems biology in combination with human-based tools could facilitate the understanding of the mechanisms behind this disease and therefore accelerate anti-NASH drug development [7].
The proposed symposium for the 11th World Congress on Alternatives and Animal Use in the Life Sciences therefore focusses on (i) the difficulties in unraveling the human NAFLD pathogenesis, (ii) the progress that has been made in human-based anti-NASH drug testing and (iii) possible future therapies.

References:
[1] C. Estes et al. “Modeling the epidemic of nonalcoholic fatty liver disease demonstrates an exponential increase in burden of disease,” Hepatology, vol. 67, no. 1, pp. 123–133, 2018.
[2] V. Ratziu et al. “Novel Pharmacotherapy Options for NASH,” Dig. Dis. Sci., vol. 61, no. 5, pp. 1398–1405, 2016.
[3] S. L. Friedman et al. “Mechanisms of NAFLD development and therapeutic strategies,” Nat. Med., vol. 24, no. 7, pp. 908–922, 2018.
[4] J. Willebrords et al. “Strategies, models and biomarkers in experimental non-alcoholic fatty liver disease research,” Prog. Lipid Res., vol. 59, pp. 106–125, 2015.
[5] V. Ratziu et al. “Elafibranor, an Agonist of the Peroxisome Proliferator-Activated Receptor-α and -δ, Induces Resolution of Nonalcoholic Steatohepatitis Without Fibrosis Worsening,” Gastroenterology, vol. 150, no. 5, pp. 1147–1159, 2016.
[6] M. Rakhshandehroo et al. “Peroxisome Proliferator-Activated Receptor Alpha Target Genes,” PPAR Res., vol. 2010, no. 612089, pp. 1–20, 2010.
[7] J. Boeckmans et al. “Human-based systems: mechanistic NASH modelling just around the corner?,” Pharmacol. Res., vol. 134, no. 30, pp. 257–267, 2018.

Session chair and co-chair: V. Rogiers, Innovation Centre-3Rs (IC-3Rs) and S. Malany, University of Florida


Speakers:

Abstract ID 770 - A HUMAN HEPATOCYTE-LIKE CELL BASED IN VITRO MODEL FOR HEPATIC INSULIN-DRIVEN DE NOVO LIPOGENESIS
Filip Beirinckx, Galapagos NV

Abstract ID 760 - HUMAN HEPATIC IN VITRO MODELS REVEAL DISTINCT ANTI-NASH POTENCIES OF PPAR AGONISTS
Joost Boeckmans, Department of In Vitro Toxicology and Dermato-Cosmetology, Faculty of Medicine and Pharmacy, Vrije Universiteit Brussel, Laarbeeklaan 103, 1090 Brussels, Belgium

Abstract ID 266 - PHENOTYPIC HIGH THROUGHPUT SCREENING IN A HUMAN IPSC-DERIVED HEPATOCYTE MODEL OF STEATOSIS REVEALS INHIBITORS OF ER-STRESS INDUCED  LIPID ACCUMULATION
Siobhan Malany, University of Florida

3.00 - 5.00 PM

S237: Application of an in vitro testing battery for developmental neurotoxicity (DNT) assessment in a regulatory context (Theme: Safety)

Recently, an increased prevalence of neurodevelopmental disorders, including autism, is observed. While these disorders result from a combination of multiple factors, exposure to environmental chemicals could contribute to developmental neurotoxicity (DNT). Currently, there is limited information on DNT effects and this data gap cannot be overcome with the current in vivo testing.
The talks will present the recent international efforts led by EFSA, OECD, JRC and US EPA to develop a in vitro testing strategy to improve the current DNT regulatory assessment including the efforts to develop an OECD Guidance Document on the use of alternative methods for DNT evaluation.

Session chair: A. Bal-Price, European Commission Joint Research Centre


Speakers:

Abstract ID 164 - The international regulatory roadmap to enhance developmental neurotoxicity testing
M. Sachana, Organisation for Economic Co-operation and Development (OECD)

Abstract ID - A DNT in vitro testing battery in light of an OECD Guidance Document
E. Fritsche, IUF - Leibniz Research Institute for Environmental Medicine

Abstract ID 894 - Examples of How Data from in vitro Developmental Neurotoxicity Assays Could be Used to Make Decisions About Chemicals
T. Schafer, Biomolecular and Computational Toxicology Division Center for Computational Toxicology and Exposure US EPA 

Abstract ID 9 - An adverse outcome pathway (AOP)-informed integrated approach to testing and assessment (IATA) as a tool to conduct a developmental neurotoxicity (DNT) hazard characterization
A. Bal-Price, European Commission Joint Research Centre 

3.00 - 5.00 PM

S23: Asia: A place ripe for the development of 21st century science (Theme: Safety)

This 90min round table will invite key regulators & government agencies from India, China, South Korea and Japan to present the strategies for investment into human biology-centric new approach methodologies in research & toxicology. Having made major progress in the regulatory aspect with respect to animal testing prohibition for cosmetics in some countries, reduction and replacement of animals for pesticide regulations in others, the stage is set for these countries to increase investment into non animal methodologies.The anticipated outcomes of the session would be to gain new insights on working towards increased investment into NAMs after regulatory acceptance of alternatives.

Session chair: C. Willet, Humane Society International


Speakers:

Abstract ID 790 - Asia is a ripe place for alternatives to animal testing: status and potential in India
S. Parvatam, Centre for Predictive Human Model Systerms (AIC - CCMB) India

Abstract ID 1110 -  Promoting alternatives to animal testing methods through stakeholder collaboration.
S. Borami,  Humane Society International India

Abstract ID 767 - Toxicity Pathway- and Mechanism-Based Risk Assessment of Chemical-Induced Mitochondrial Toxicity 
J. Guo 

Abstract ID 484 - Safety sciences towards non-animal tests in China: current status and perspectives
X. Qu, The Society of Toxicity Testing and Alternative Methods, Chinese Environmental Mutagen Society China

Abstract ID 390 - 21st-Century Toxicology and Regulatory Testing: An Update from Japan
H. Kojima, National Institute of Health Sciences Japan

3.00 - 5.00 PM

S176: Continuous training of Animal Welfare Body members (Theme: Ethics, Welfare and Regulation)

Within this session we would like to exchange ideas on how the active members of animal welfare bodies can enhance their training in order to increase their impact on the scientific community.
Questions that will be addressed:
• What should be basic training?
• What life long learning aspects could be important to ensure continuous advise on 3R implementation?
• Should all competencies be acquired by all members, even in bigger organisations?
• How can we organize the training to achieve a level playing field within Europe?

Session chair: P. Flecknell, Flaire Consultants


Speakers:

Introduction of the subject (training of AWB members)
Pieter Verbost and Ivo Tiebosch, session chairs

Abstract ID 439 - distance learning resources to support training of animal welfare body members
P. Flecknell, Flaire Consultants

Abstract ID 344 - Continuous training of animal welfare body members - an education program for oversight on welfare and care of laboratory animals
C. Kunne, TNO

Abstract ID 633 - Animal Welfare Bodies: Initial Training and continuing professional development
N. Linklater, University of Marburg

Abstract ID 569 - IACUC FUNCTION AND MEMBERSHIP TRAINING IN KOREA: THE FIRST TWELVE YEARS
Gwi Hyang Lee

General Discussion
Ivo Tiebosch, University of Utrecht

3.00 - 5.00 PM

S304: 3D MODEL 2 (Theme: Innovative Technologies)

Abstract ID 237 - Combining in vitro and in silico modelling to study cytokine-driven cartilage degradation
Annemarie Lang

Abstract ID 455 - BIOPRINTING OF HUMANIZED LIVER AND LUNG MODELS FOR INFECTION STUDIES
Jens Kurreck

Abstract ID 667 - Think big and scale down: Development of a “skin allograft on-a chip model” emulating immune cell-skin interactions
Juliane Hübner

Abstract ID 730 - Automating Multi-Organ-Chip assays and analysis for improved standardization and reproducibility
Juliane Hübner

Abstract ID 807 - ENDOTHELIUM RESPONSE TO IRON NANOMEDICINE IN STATIC VERSUS DYNAMIC IN VITRO VASCULAR MODEL
Niusha Nikravesh

Abstract ID 1093 - DEVELOPMENT OF A PUMPLESS MULTI-ORGAN MICROPHYSIOLOGICAL DEVICE TO DETECT DRUG TOXICITY
Mridu Malik

3.00 - 5.00 PM

S306: Corporate social responsibility (Theme: Ethics, Welfare and Regulation)

Abstract ID 86 - CRITICAL INCIDENT REPORTING SYSTEM IN LABORATORY ANIMAL SCIENCE - CIRS-LAS
Sabine Juliane Bischoff

Abstract ID 131 - CARING FOR THOSE CARING FOR RESEARCH ANIMALS: DEVELOPING A GLOBAL CORPORATE RESILIENCY BUILDING PROGRAM
Judy Murray

Abstract ID 630 - Iron Fist & Velvet Glove: Expanding the Implementation of the 3Rs
John R Baumann

Abstract ID 746 - Promoting transparency in preclinical research: preregistration of animal studies on an online platform
Aina Cervera i Barea

Abstract ID 883 - Beyond Program Review/Post Approval Monitoring: Developing and Implementing a Quality Improvement Program for Laboratory Animal Research Program 
John Baumann

Abstract ID 972 - The Beyond animal testing index: how to assess your institutes contribution to animal free innovation and the 3R’s?
Judith van Luijk

3.00 - 5.00 PM

YOU-WC11 - Workshop 5

5.00 - 6.30 PM - Plenary sessions

5.00 - 5.15 PM

Break and WC11 TV from the studio

5.15 - 6.15 PM

KEYNOTE: Dr. Tharanga Thoradeniya, University of Colombo

Tharanga Thoradeniya is a Senior Lecturer at the Department of Biochemistry and Molecular Biology, Faculty of Medicine, University of Colombo, Sri Lanka. Dr. Thoradeniya has a multidisciplinary background and has broad research interests and experience in metabolism and functionality of micronutrients, nutrition modulation of chronic disease risk, food systems, animal welfare and alternatives. Dr. Thoradeniya obtained her Bachelor of Veterinary Science (B.V.Sc) degree from the Faculty of Veterinary Medicine and Animal Science, University of Peradeniya, Sri Lanka an her Ph.D. in Nutritional Biochemistry from the University of Colombo, Sri Lanka.

She is a Commonwealth Fellow and has received many awards including the President’s Awards for scientific research. Dr. Thoradeniya is a past president of the Sri Lanka Association for Laboratory Animal Sciences and Sri Lankan Academy of Young Scientists, and currently the Vice-president of the Sri Lanka College of Biochemists.

She has extensive experience in animal welfare and ethics and is playing a leading role in conducting training on animal welfare and ethics locally and in the region. She was awarded the 2020 Global Animal Welfare Award by the World Veterinary Association (WVA) and Ceva Santé Animale (Ceva) for her outstanding service and dedication in promoting animal welfare.

6.15 - 6.30 PM

Break and WC11 TV from the studio

6.30 - 8.30 PM - Parallel Session WED-2

6.30 - 8.30 PM

S199: Can non-animal models identify environmental endocrine disruptors? (Theme: Innovative Technologies)

Non-animal test systems are widely used in toxicology to characterize the biological properties of chemicals. In particular, in vitro assays allows identifying mechanisms of action, including endocrine activity, that are relevant for humans. The new European regulation on the identification of endocrine disruptors requires that potential endocrine properties of chemicals are investigated with regard to both human health and the environment. However, in vitro test systems are rarely available to investigate endocrine activity in non-mammalian environmental species (e.g., fish, amphibians, birds). As a consequence, the implementation of the new European regulation on endocrine disruptors results in the use of huge numbers of animal in testing. Recently, embryo assays have been developed as non-animal alternatives to chronic tests on fish and amphibians. The workshop will address various aspects of the use of non-animal tests for the identification of environmental endocrine disruptors including the latest technological developments, advantages and limitation of non-animal tests, regulatory acceptance of embryo assays, and the societal demand for reducing tests on animals.

Session chair: L. Lagadic, Bayer AG


Speakers:

Abstract ID 594 - Identification of endocrine disrupting chemicals in fish embryos
S. Scholz, Helmholz Zentrum für Umweltforschung (UFZ)

Abstract ID 607 - Use of non-animal models for the hazard identification of endocrine disrupting properties: a regulatory perspective
M. Arena, European Food Safety Authority (EFSA)

Abstract ID - REDUCING, REPLACING AND REFINING AQUATIC VERTEBRATE TESTING IN THE
IDENTIFICATION OF ENDOCRINE DISRUPTORS
H.Prior, NC3Rs

Abstract ID 255 - reducing, replacing and refining aquatic vertebrate testing in the identification of endocrine disruptors
B. Labram, NC3Rs

Abstract ID 610 - The use of non-animal models in regulatory evaluation of environmental endocrine disruptors - An industry perspective
L. Lagadic, Bayer AG, Crop Science Division

Followed by two panel discussions

6.30 - 8.30 PM

S56: Breakthroughs towards animal free innovations

We are proud that the World congress is visiting our country again. The first time the World Congress was organized in The Netherlands we reached Nature and Science due to our Dutch lead in alternatives (teaching of the future generation of biomedical scientists, animal experimentation committees, training, activities in national policy and international legislation). I think we have something special again to show the world this time.
Boosting better biomedical research by high technical innovations from adjacent disciplinary fields. “Better” means in this context with a smaller extrapolation gap from animals to men, by stimulating over disciplinary walls cross fertilization with new innovations in tissue cultures, like human cell based organoid, 3D tissues, big data analysis from human population (healthy versus pathology), biotechnology breakthroughs, -omics responses with micro doses interventions, system approaches connecting human microbiome with metabolic syndrome (diabetic & cholesterol) and mental diseases. This we regard as a second route next to traditional animal based basic research for which the 3 Vs are most important to minimize suffering and reducing numbers of animals.
This time we can show the international community a joint initiative of two humane foundations, Stichting Bouwstenen voor dierenbescherming (Hugo van Poelgeest Prijs voor Alternatieven since 1987) and the Stichting Proefdiervrij (the last years active in co-financing above mentioned research projects) to boost high technical initiatives in human based biomedical research. After two years of background research on the best way to stimulate such constructive animal friendly and biomedical boosting research, we decided to focus on the young talent, within 8 years after their master degree, who are currently under pressure to become scientific nomads due to poor governmental funding, inducing also a brain drain for The Netherlands, as well as in other countries. The World congress will be the place where 6 nominated researchers in two categories (e.g. organoids and big data analysis of citizens and patients, or wider: in-vitro and in-silico) will present their outstanding results and their personal qualities by short 5 minutes clips, followed by the announcement of the two winners, selected by an independent scientific jury (receiving some money and a piece of art with inscription).
The goal for the initiators is not the price, this is just the vehicle, but the exposure of these young talents to the world: all six movies will be connected to relevant media platforms, inspiring the public, high school students, the upcoming generation of biomedical students. And being supportive in the strong competition of Post-doc grants or short visiting grants worldwide, and thus intensifying and broadening the knowledge network of their research group.
As it is well known, for the Dutch researchers, currently this initiative is in line with new governmental policy Transitie Proefdiervrije Innovatie, which is also an unique policy in the world.
What we like to ask from the organizers of the World Congress, is to think in line with our initiative, which is rooted in the same values as your audience, i.e. for good and reliable alternative models for animals experiments, and provide us exposure of these 6 talented post-docs to the relevant audience.
We were informed, that there are in principle several options available: 1) an center stage for out-of-the-box presentations. 2) a scheduled dynamic session of 90-120 minutes in which the nominated post-doc’s present their innovations and the prices will be awarded. 3) a satellite meeting at the day before the opening of the congress. Each option has its pros and cons, e.g. price, exposure to laboratory science community, access of journalists and media, space ( supporters as family and research team are much motivated to join the nomination session).
We hope that you feel sympathy for this typical Dutch presentation on the international World Congress. Typical in the way that The Netherlands show again that societal organizations, scientific departments and government are able to join together in order to realize in a constructive way good science with less animals and shorter routes to medical applications.
Sincerely yours,
Prof.dr. Tjard de Cock Buning (Stichting Bouwstenen, Hugo van Poelgeestprijs for Alternatives)
Debbie Weijers (Director Proefdiervrij)

For further information and discussion regarding the options you could contact directly with Prof.dr. Tjard de Cock Buning
Tel: +31 628809591
e-mail: Tjard.de.CockBuning@vu.nl

Session chair: Tjard de Cock Buning, Foundation Bouwstenen + Proefdiervrij


Speakers:

Abstract ID 593 - Cartilage-on-chip: towards improved models of Osteoarthritic disease
Carlo Alberto Paggi, University of Twente, Department of Developmental BioEngineering; University of Twente, Applied Microfluidics for BioEngineering Research

Abstract ID 949 - TOWARDS ANIMAL-FREE IN VITRO NEUROTOXICITY TESTING AND SEIZURE LIABILITY ASSESSMENT
Anke Tukker, IRAS, Utrecht University, Utrecht, The Netherlands; School of Health Sciences, Purdue University, West Lafayette, Indiana, USA

Abstract ID 276 - Qualification of cardiac microphysiological models for drug screening
Berend van Meer, Leiden University Medical Center

6.30 - 8.30 PM

S64: skills4science

Young researchers dedicate rightfully most of their time to core knowledge production via laboratory experiments, reading peer-review literature, publishing own
results, attending conferences whenever possible as well as undertaking trainings on writing grants, papers among many other activities However, the promoter argue
here that restricting them to this unique set of activities is jeopardizing creativity and reducing awareness of a more complex picture in science. Other fields linked
with social sciences, including scientometrics and epistemological areas covered during conferences and continuous education, may contribute to a more productive
working environment for young researchers. This session would be the opportunity to kick-off the discussion and tackle some of these "secondary" topics. This was first covered in the following article "The use of social media in scientific research and creative thinking" by Busquet & Vinken https://doi.org/10.1016/j.tiv.2019.04.006

Session chair: Francois Busquet, Altertox and Nuno Franco, i3s - University of Porto


Speakers:

Abstract ID 257 - Smart use of social media in 3Rs
Francois Busquet, Altertox

Abstract ID 916 - Data Management in a Changing Toxicity Testing Paradigm
Nynke Kramer, Utrecht University

Abstract ID 111 - From research to innovation: business in life sciences.
Marco Straccia, FRESCI by SCIENCE&STRATEGY SL

Abstract ID 641 - 3Rs leadership for young researchers
Nuno Henrique Franco, i3S, Universidade do Porto

Abstract ID 848 - Regulatory science: industry, research and innovation for the testing of substances
David Demortain, INRAE, Laboratoire Interdisciplinaire Sciences Innovations Sociétés

Abstract ID 235 - Gender inequality in science - Finding the end of the rainbow
Annemarie Lang, Department of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin Berlin

6.30 - 8.30 PM

S109: Computational Synthesis and Integration for Systems Toxicology in the Animal-free Zone (Theme: Safety)

Human cell-based assays are providing vast in vitro data to profile chemical effects, but systems-based approaches are needed to tie these data to biological understanding (genetic signals & responses; tissue microphysiology; multiscale simulation; and computational prediction). Case studies will connect chemistry, toxicokinetics and toxicodynamics to animal-free prediction of developmental toxicity. Abstracts on in vitro data and in silico models are invited as well, especially AI-based methodologies for computational intelligence.

Session chair: Thomas Knudsen, US EPA and George P. Daston - Procter & Gamble Co.


Speakers:

Abstract ID 852 - Computational intelligence: opening DART's 'black-box' with agent-based models.
Thomas Knudsen, US EPA

Abstract ID 99 - Cheminformatics and gene expression data: linking chemical-biological interaction to outcome
George Daston, Procter & Gamble Co.

Abstract ID 866 - Quantitative prediction of developmental toxicity by modelling the DARTable genome.
Richard Currie, Syngenta

Abstract ID 73 - VIRTUAL MODELS FOR HUMAN DEVELOPMENTAL TOXICOLOGY DRIVEN BY NEW APPROACH METHODOLOGIES
Aldert Piersma, RIVM

Abstract ID 13 - Accelerating regulatory use of alternatives in DART testing: how to build confidence
Manon Beekhuijzen, Charles River

Abstract ID 881 - Multi-Scale, Virtual-Tissue Simulations of Developmental Toxicity and Toxicology as an Approach to Minimize the
Required Number of Animal Experiments
James Glazer, Indiana University

6.30 - 8.30 PM

S305: 3D MODEL 3 (Theme: Innovative Technologies)

Abstract ID 151 - BIOENGINEERED 3-DIMENSIONAL LUNG ORGANOIDS AS AN ALTERNATIVE TO PATIENT-DERIVED XENOGRAFT MODELS OF SMALL CELL LUNG CANCER 
Chandani Sen

Abstract ID 588 - Human liver-pancreas-heart microphysiological system for studying cardio-metabolic disorders
Liisa Vilén

Abstract ID 636 - Establishment of a human multi-organ-chip platform to replace animal transplant models for preclinical evaluation of Treg cell therapies
Isabell Durieux

Abstract ID 684 - Exploring 3D Bioprinting Technology for the Development of Complex Reconstructed Skin Model with Hair Follicle Structure and Automation of the Fabrication of Hair Follicle Spheroids 
Carolina Motter Catarino

Abstract ID 797 - Enhancing preclinical predictions for neurodegenerative diseases using brain-on-chip models
Alex Bastiaens

Abstract ID 869 - CRACK IT: 3D hiPSC-derived laminated retinal model as a tool for toxicology and drug discovery studies
Cathy Vickers

6.30 - 8.30 PM

S307: DISEASE MISC (Theme: Disease)

Abstract ID 205 - Serum microRNA signatures as "liquid biopsies" for interrogating hepatotoxic mechanisms and liver pathogenesis
Julian Krauskopf

Abstract ID 229 - The human-based in vitro 3D arthritic joint model for preclinical drug testing
Alexandra Damerau

Abstract ID 716 - Replacing the need for bovine blood products in early stage optimisation of cardiac assist devices: improving the international standard
Antony P McNamee

Abstract ID 748 - Understanding nanomaterial risks in pulmonary infection: Effects of graphene related materials on healthy and Streptococcus pneumoniae infected 3D reconstituted human lung cells
Savvina Chortarea

Abstract ID 940 - A human iPSC-based microphysiological model of the liver to study the impact of hepatic stellate cells on NASH development
Martin Raasch

Abstract ID 1035 - Tissue engineered models of fibrotic cardiac tissue for preclinical validation of therapies
Valeria Chiono

6.30 - 8.30 PM

S312: QIVIVE (Theme: Safety)

Abstract ID 303 - The integration of in vitro chemical transplacental passage into a generic PBK model for pregnancy 
Styliani Fragki

Abstract ID 442 - In Vitro to In Vivo Extrapolation for Developmental Toxicity Potency of Valproic Acid Analogues
Xiaoqing Chang

Abstract ID 658 - IN VITRO-IN SILICO BASED ASSESSMENT OF SPECIES DIFFERENCES IN KINETICS: TOWARDS HARMONIZATION OF IN VITRO CLEARANCE STUDIES
Jochem Louisse

Abstract ID 780 - Bottom-up physiologically-based toxicokinetic modelling of perfluorooctanoic acid
James Chun Yip Chan

Abstract ID 781 - VALIDATION OF A BOTTOM-UP PBPK MODEL PREDICTION OF HEPATIC CONCENTRATIONS OF ROSUVASTATIN
Shawn Tan

Abstract ID 918 - Comparing model predictions and analytically determined test chemical distributions in vitro
Nynke Kramer

Thursday 2 September 2021 - Day 9

2.30 - 3.00 PM - Plenary sessions

2.30 - 3.00 PM

WC11 TV - Live from the studio

3.00 - 5.00 PM - Parallel Session THU-1

3.00 - 5.00 PM

S234: Reverse Translation: Maximizing clinical relevance while reducing the need for preclinical data (Theme: Disease)

The concept of reverse translation brings patient derived knowledge in the center and has a potential to revolutionize drug discovery and/or risk assessment of industrial and environmental chemicals. The symposium will discuss new biomarker based approaches to study drug induced organ injuries and inflammatory bowel disease. The goal of the symposium is to spark interest in application of novel biomarkers and discuss progress in their regulatory acceptance.

Session chair: J. Aubrecht, Takeda


Speakers:

Abstract ID - Reverse translation: a patient centric approach to drug development
J. Wagner, ForsiteCapital

Abstract ID - Development of novel biomarkers to accelerate drug development 
J. Sauer, Critical Path Institute

Abstract ID - Calprotectin in IBD: "new tricks of an old dog" 
J. Aubrecht, Takeda

Abstract ID - Metabolomic signatures reveal complex interactions of microbiomae and host in health and disease
H. Li, Georgetown University

3.00 - 5.00 PM

S216: Animal Experimentation: Working Towards a Paradigm Change (Theme: Ethics, Welfare and Regulation)

New human biology-based tools should facilitate a strong shift away from animal experimentation. However, in research, animals are still widely seen as the default option, even though interspecies differences compromise translation to the humans. In this workshop we discuss some of the obstacles and driving forces of change. We address the vague public policy provisions regarding animal replacement; the limited education and training possibilities on human-relevant approaches; insufficient funding for the development of non-animal models; psychological lock-in and entrenchment in science; and public misinformation about animal experimentation, as well as how education, funding redeployment, and political action can drive change.

Session chair and co-chair: M. Stephens, Johns Hopkins Bloomberg School of Public Health And K. Herrmann, Johns Hopkins Bloomberg School of Public Health


Speakers:

Abstract ID 738 - Barriers to the Implementation of Animal-free Alternatives and How to Overcome Them
K. Taylor, Cruelty Free International

Abstract ID 832 - Educating Future Scientists and Raising Public Awareness on Animal-free Experimentation
K. Herrmann, Johns Hopkins Bloomberg School of Public Health

Abstract ID 721 - Political Campaigning: Where Scientific and Ethical Arguments Meet Public Policy
E. McIvor, People for the Ethical Treatment of Animals (PETA)

Abstract ID 810 - Stakeholder Collaboration to Implement Regulatory and Policy Change for Drug Development
E. Baker, Physicians Committee for Responsible Medicine (PCRM)

Abstract ID 518 - Breaking the lock-in to animal research within academia
P. Pound, Safer Medicines Trust

Abstract ID - Research and Testing Without Animals: Where Are We Now and Where Are We Heading?
T. Hartung, Johns Hopkins Bloomberg School of Public Health

3.00 - 5.00 PM

S185: Harnessing the power of data to improve systemic toxicity prediction: multisectorial perspectives (Theme: Safety)

Over the last decade, triggered by the fast development of IT technologies, especially through the explosion of calculation power and data generation/storage capacity, a data revolution has been happening. Today outcomes of this ongoing revolution can be seen in almost all industrial sectors: health, car, beauty, fashion, game & entertainment while little by little, big data, algorythms, artificial intelligence do reveal the power lying in data capture and exploitation.
At the same time, in the toxicology field (whatever the industrial sector or the geographical region) the need for better toxicity prediction has never been so high. In the Pharma industry, a low drug development success rate of 2% raises questions about factors (including low toxicity prediction) at the origins of such innovation crisis. In the Cosmetics industry, the animal testing ban which took place in 2013 in Europe for its final phase left the safety discipline with a tool gap and the uncapacity in specific circumstances to predict systemic toxicity and develop new ingredients. In the chemical sector, much attention has been placed recently on data-poor chemicals that are already in commerce and may have potential contributions to human diseases. Hence there is a high need to better substantiate toxicity profiles of new or already marketed chemicals.
In several industrial and public sectors, various initiatives have been fostering the development of information systems providing access to databases, computational tools and workflows for better toxicity prediction. Some initiatives have explored open innovation paths combining resources from industrial and public sectors. eTox, under the auspices of Innovation Medicines Initiative, paved the way to pharma industry proprietary non-clinical data sharing on a large scale supporting the development of toxicity prediction algorythms. Research initiatives are integrating IT tools like Cosmos from SEURAT1, CE-ToxGPS from Cosmetics' Europe Long Range Science Strategy. SEURAT1 gathered data from cosmetics and led to the establishment of cosmetics ingredients safety database. In the chemical sector, similar considerations are made in different initiatives like CEFIC's chemoinformatic platform and the US EPA's chemistry dashboard. The AMBIT system was built and includes data from the EU REACh and the Openfood databases from the European food safety agency.
Learning on those 1st steps, some 2nd generation initiatives have been designed in order to harness even more the power of data, leading to better & smarter use of (non-)/animal data and improved toxicity prediction. This session will open windows on those cutting edge initiatives, share their progress and explore how they could be beneficial across sectors.

Session chair: S. Dhalluin, L'Oréal


Speakers:

Abstract ID 41 - Exploiting safety data shared by pharmaceutical industry: the eTRANSAFE project
M. Pastor, University Pompeu Fabra

Abstract ID 31 - Towards Virtual Control Groups for Animal Toxicity Studies – an eTRANSAFE Initiative
T. Steger-Hartmann, Bayer AG

Abstract ID 45 - Enabling chemical substance data integrative analysis and applications
N. Jeliazkova, Ideaconsult Ltd

Abstract ID 785 - Data driven computational modelling to support safety assessment of cosmetics ingredients
M. Cronin, Liverpool John Moore University

Abstract ID 30 - Systemic Toxicity Predictions Using In Vivo and In Silico Approaches
R. Judson, NCCT – US

Abstract ID 275 - EVALUATION OF A NEW APPROACH METHODOLOGY TOOLBOX FOR THE NEXT GENERATION
RISK ASSESSMENT OF SSYTEMIC TOXICITY
Sophie Cable

3.00 - 5.00 PM

S308: DISEASE NAM (Theme: Disease)

Abstract ID 207 - THE CLINICAL TRANSLATION OF HIGH-PROFILE ANIMAL-BASED RESEARCH REPORTED IN THE UK NATIONAL PRESS
Jarrod Bailey

Abstract ID 464 - A MICROPHYSIOLOGICAL SYSTEM OF HUMAN PANCREATIC ISLET MICROTISSUES AND LIVER SPHEROIDS FOR MODELLING DIABETES MELLITUS
Sophie Bauer

Abstract ID 745 - Exploration of an animal-free drug development approach for tomorrow’s medicine
Roeland Hanemaaijer

Abstract ID 920 - Investigating epilepsy using a combination of mathematical modelling and voluntary human data as a viable replacement for animal models
Andre Peterson

Abstract ID 991 - ROLE OF NON-ANIMAL TECHNOLOGIES IN COVID-19 RESEARCH
Dilyana Filipova

Abstract ID 1083 - Model of immune cell extravasation and migration using a microfluidic hydrogel barrier
Lisette van Os

3.00 - 5.00 PM

S310: Education & Training: Global views (Theme: Ethics, Welfare and Regulation)

Abstract ID 246 - “My Animal Research: Experimental Design”: a personalized, practice-based learning track for PhD students
Ivo Tiebosch

Abstract ID 813 - IMPLEMENTATION OF THE 5R’S (REPLACEMENT, REDUCTION, REFINEMENT, RESPONSIBILITY AND RESPECT) IN LABORATORY ANIMAL SCIENCE EDUCATION & TRAINING COURSES IN THE UNIVERSITY OF CAPE TOWN, SOUTH AFRICA
Janet McCallum

Abstract ID 822 - A COMPARISON OF TRAINING STANDARDS AMONGST INTERNATIONAL COLLEGES OF LABORATORY ANIMAL MEDICINE
Patricia Turner

Abstract ID 829 - Highlighting Modern Approaches Through Education and Training
Kristie Sullivan

Abstract ID 1066 - Promote the consensus of 3Rs in China through translational of the academic and industries
Tingting Luo

Abstract ID 1105 - THE EDUCATION & TRAINING PLATFORM FOR LABORATORY ANIMAL SCIENCE (ETPLAS) – A REFERENCE FOR LABORATORY ANIMAL SCIENCE AND 3R TRAINING
Nuno Henrique Franco

3.00 - 5.00 PM

S311: Good research practice (Theme: Ethics, Welfare and Regulation)

Abstract ID 81 - Systematic reviews to validate alternatives to specific animal models
Cathalijn Leenaars

Abstract ID 143 - DO WE ACT LIKE CAR SALESMEN OR AIRLINE PILOTS? PREPARING FOR ROBUST AND HUMANE RESEARCH
Adrian Smith

Abstract ID 212 - SENSITIVITY OF MOUSE BEHAVIOURAL TESTS OF ANXIETY TO ANXIOLYTIC DRUGS APPROVED FOR TREATMENT OF ANXIETY IN HUMANS: A SYSTEMATIC REVIEW
Marianna Rosso

Abstract ID 244 - Criterion guided interviews to validate competence in designing animal experiments
Ivo Tiebosch

Abstract ID 289 - SATORI-BTR: DEVELOPING PRELIMINARY GUIDANCE ON EVALUATING QUALITY AND HUMAN RELEVANCE OF IN VITRO STUDIES IN BRAIN TUMOUR RESEARCH
Karen Pilkington

Abstract ID 1113 - AN URGENT CALL FOR FULLY XENO-FREE STEM CELL CULTURE CONDITIONS AND CERTIFICATION IN DISEASE MODELING 
Eizleayne M. Edrosa

5.00 - 8.00 PM - Plenary sessions

5.00 - 5.15 PM

Break and WC11 TV from the studio

5.15 - 6.15 PM

KEYNOTE: Prof. Joseph Wu, Stanford Cardiovascular Institute

Joseph C. Wu, MD, PhD is Director of the Stanford Cardiovascular Institute and Simon H. Stertzer, MD, Professor of Medicine and Radiology at the Stanford School of Medicine. Dr. Wu received his MD from Yale University School of Medicine. He trained in internal medicine and cardiology at UCLA followed by a PhD in the Dept of Molecular Pharmacology.

His lab works on biological mechanisms of patient-specific and disease-specific induced pluripotent stem cells (iPSCs). The main goals are to (i) understand basic cardiovascular disease mechanisms, (ii) accelerate drug discovery and screening, (iii) develop “clinical trial in a dish” concept, and (iv) implement precision cardiovascular medicine for prevention and treatment of patients.

Dr. Wu has received numerous awards, including National Institutes of Health (NIH) Director’s New Innovator Award, NIH Roadmap Transformative Award, American Heart Association (AHA) Innovative Research Award, Presidential Early Career Award for Scientists and Engineers given out by President Obama, AHA Established Investigator Award, Burroughs Wellcome Foundation Innovation in Regulatory Science Award, AHA Merit Award, and AHA Distinguished Scientist Award. Dr. Wu serves on the Scientific Advisory Board for the Keystone Symposia, FDA Cellular, Tissue, and Gene Therapies Advisory Committee, AHA National Board of Directors, Chair of the AHA Basic Cardiovascular Science Council, and Chair of the AHA National Research Committee.

Dr. Wu is an elected member of American Society of Clinical Investigators (ASCI), Association of University Cardiologists (AUC), American Institute for Medical and Biological Engineering (AIMBE), American Association for the Advancement of Science (AAAS), American Association of Physicians (AAP), and National Academy of Medicine (NAM).

6.15 - 6.30 PM

Break and WC11 TV from the studio

6.15 - 7.15 PM

Björn Ekwall Memorial Fund (BEMF) Award

6.30 - 7.15 PM

WC11 - Award ceremony

7.15 - 8.00 PM

WC11 TV - Closing ceremony live from the studio