Dr. Barry Hardy is the Chief Executive Officer (CEO) at Edelweiss Connect where he is leading its team supporting the development of new integrating solutions in industrial product design and safety assessment and the translation of research methods to industrial practice. Example recent commercial developments include the creation of the SaferWorldbyDesign platform (https://www.saferworldbydesign.com/), and the development of the SaferSkin (https://saferworldbydesign.com/saferskin/) and EdelweissData products (https://saferworldbydesign.com/edelweissdata/). He is currently leading the development of risk assessment knowledge infrastructure and solutions, including new approach methods, SaferbyDesign, sustainability and next generation risk assessment solutions (https://www.risk-hunt3r.eu).
He coordinated the OpenTox project in predictive toxicology and is currently President of the OpenTox Association, founded in 2015 as an international non-profit organisation promoting an open knowledge community approach to new methods in predictive toxicology and the 3Rs principles of the refinement, reduction and replacement of animal experiments. Previously, he led the infrastructure development for the IMI EBiSC stem cell banking project, the eNanoMapper project developing solutions supporting nanotechnology safety assessment, OpenRiskNet infrastructure development supporting risk assessment, and knowledge infrastructure development for ACEnano, NanoCommons and EU-ToxRisk.
Dr. Hardy obtained his Ph.D. in 1990 from Syracuse University working in computational science. He was a National Research Fellow at the FDA Center for Biologics and Evaluation, a Hitchings-Elion Fellow at Oxford University and CEO of Virtual Environments International. He was a pioneer in the 1990s in the development of Web technology applied to virtual scientific communities and conferences. He has developed technology solutions for internet-based communications, tutor-supported e-learning, laboratory automation systems, and computational science and informatics. In recent years he has also been active in the field of knowledge management as applied to supporting innovation, communities of practice, and collaboration, with a particular focus on developing new evidence-based methods in predictive toxicology and safety assessment.
RISK-HUNT3R Knowledge Infrastructure Supporting Next Generation Risk Assessment Workflows
Barry Hardy*, Krzysztof Maciejczuk, Tomaz Mohoric, Daniel Burgwinkel, Divanshu Anand, Neza Mohoric, Nora Kleisli, Haris Rašidagić, Ghada Tagorti (Edelweiss Connect); Ugis Sarkans (EMBL-EBI); Swapnil Chavan (RISE); Sergey Sosnin, Gerhard Ecker (UNVIE); Manuel Pastor, Karolina Kopańska (UPF); Tanja Burgdorf (BfR); Eva Bay Wedebye (DTU); Mark Cronin (Liverpool John Moores University); Barira Islam (Certara); Andrew White (Unilever); Marcel Leist (University of Konstanz)
*Presenter at OpenTox 2024 Virtual Conference, corresponding author for article to OpenTox special issue of In Vitro Toxicology
In this presentation and article, we describe the knowledge resources and infrastructure developed within the RISK-HUNT3R project to provide trusted knowledge to next generation risk assessment workflows for specific problem formulations. We attempted to follow original OpenTox principles (1) but also more recent elaborations for New Approach Methods, FAIRness and Artificial Intelligence (2,3). These resources include:
(a) Harmonised Data Template for organising data generated on the project according to OpenTox and FAIR principles;
(b) Approach to collected data including harmonisation, referencing and integrity goals;
(c) Compound database including approach to compound ids, properties, project and case study annotation, linked biological data, batch upload, curation, search and user interface;
(d) ToxTemp (4) Methods database organising the description and review of test methods extended to having a readiness level and review process;
(e) Knowledge graph connecting compounds, studies, publications, authors and biological data;
(f) Data analysis tools including web notebooks;
(g) Visualisation tools;
(h) Dashboard documenting workflows;
(i) Knowledge sharing repository for Case Studies including templates;
(j) Knowledge management inventory;
(k) Deployment infrastructure;
(I) FAIR Modelling approach (5);
(l) Knowledge sharing portal.
We worked to achieve trusted integrity across the above resources based on the OpenTox principles of interoperability, harmonisation and ontology. Workflows are designed based on case study formulations providing a sequence of tasks and decision points to which trusted knowledge is provided from the knowledge resources (6,7). We have explored the concept of FAIR knowledge supporting FAIR AI (2) and tested it with case study work on hypothesis-based modelling of biological networks and qAOPs (8).
Note: This work is also being submitted as a full article for peer review in the special OpenTox issue of In Vitro Toxicology
References
- Hardy, B., Douglas, N., Helma, C. et al. Collaborative development of predictive toxicology applications. J Cheminform 2, 7 (2010). https://doi.org/10.1186/1758-2946-2-7. www.jcheminf.com/content/2/1/7.
- Barry Hardy, Daniel Burgwinkel, Tomaz Mohoric, Asmaa Ali, Jeff Wiseman (Edelweiss Connect), AI-assisted Next Generation Risk Assessment and Safe and Sustainable Design Workflows enabled by FAIR Data and Knowledge, ECETOC Workshop on “Integrating AI into chemical safety assessment – Opportunities, challenges, and the path forward , 16-17 October 2024. And sister paper in workshop session Erik Schultes (GoFair Foundation) “FAIR data and data that are fully AI-Ready” https://www.ecetoc.org/wp-content/uploads/2024/03/05_Hardy.pdf
- Asmaa Ali, Daniel Burgwinkel, Barry Hardy (Edelweiss Connect) and collaborators, OpenTox 2.0 – A Perspective on the Principles for Predictive Toxicology and Risk Assessment Applications enabled by New Approach Methods, Computational Modelling and Artificial Intelligence, OpenTox 2024 Virtual Conference and article submission for peer review in OpenTox special issue of In Vitro Toxicology (2024). https://opentox.net/events/virtual-conference-2024/AsmaaAli
- Krebs A, Waldmann T, Wilks MF, Van Vugt-Lussenburg BMA, Van der Burg B, Terron A, Steger-Hartmann T, Ruegg J, Rovida C, Pedersen E, Pallocca G, Luijten M, Leite SB, Kustermann S, Kamp H, Hoeng J, Hewitt P, Herzler M, Hengstler JG, Heinonen T, Hartung T, Hardy B, Gantner F, Fritsche E, Fant K, Ezendam J, Exner T, Dunkern T, Dietrich DR, Coecke S, Busquet F, Braeuning A, Bondarenko O, Bennekou SH, Beilmann M, Leist M. Template for the description of cell-based toxicological test methods to allow evaluation and regulatory use of the data. ALTEX. 2019;36(4):682-699. doi: 10.14573/altex.1909271. Erratum in: ALTEX. 2020;37(1):164. doi: 10.14573/altex.1909271e. PMID: 31658359.
- Cronin MTD, Belfield SJ, Briggs KA, Enoch SJ, Firman JW, Frericks M, Garrard C, Maccallum PH, Madden JC, Pastor M, Sanz F, Soininen I, Sousoni D. Making in silico predictive models for toxicology FAIR. Regul Toxicol Pharmacol. 2023 May;140:105385. doi: 10.1016/j.yrtph.2023.105385. Epub 2023 Apr 8. PMID: 37037390.
- ASPA workflows for Risk Assessment, https://www.risk-hunt3r.eu/aspa/
- Barry Hardy, Tomaz Mohoric, Thomas Exner, Joh Dokler, Maja Brajnik, Daniel Bachler, Ody Mbegbu, Nora Kleisli, Lucian Farcal, Krzysztof Maciejczuk, Haris Rašidagić, Ghada Tagorti, Pascal Ankli, Daniel Burgwinkel, Divanshu Anand, Ugis Sarkans, Awais Athar, Knowledge infrastructure for integrated data management and analysis supporting new approach methods in predictive toxicology and risk assessment, Toxicology in Vitro, Volume 100, 2024, 105903, ISSN 0887-2333, https://doi.org/10.1016/j.tiv.2024.105903.
- Jeff Wiseman, Daniel Burgwinkel, Tomaz Mohoric, Asmaa Ali, Barry Hardy (Edelweiss Connect) and collaborators, Development and Testing Strategies for Mechanistic Toxicology Models supported by Knowledge Graphs and AI Methods, OpenTox 2024 Virtual Conference and article submission for peer review in OpenTox special issue of In Vitro Toxicology (2024). https://opentox.net/events/virtual-conference-2024/Jeffrey-Wiseman
