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.
The OpenTox AI Framework
Barry Hardy (Edelweiss Connect)
In this presentation I will discuss principles supporting the successful development, deployment and use of applications in predictive toxicology and risk assessment supporting safer product design and societal well being. We take an initial perspective based on the OpenTox framework and its principles originally formulated and published in 2010 (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).
We propose an extended set of principles, including ones for new applications based on Artificial Intelligence (AI), increased use of a variety of modelling and in vitro approaches often currently described as Novel or New Approach Methods (NAMs), and their integration into integrated approaches such as Integrated Approaches to Testing and Assessment (IATAs) Next Generation Risk Assessment (NGRA) and Safe and Sustainable by Design (SSbD) workflows.
We review developments over the past fifteen years with regards to technical and scientific developments related to predictive toxicology and risk assessment. Many of the challenges and issues presented in the original OpenTox article (e.g., access to quality data, improved well-documented models, transparency, interoperability, ontology, applicability domain, validation, interpretation) remain valid today. We discuss the developments that have taken place over this period and also important challenges that remain.
Increasingly, with the increasing use of AI in a variety of applications, we are faced as a community with a variety of challenging issues including human and social factors, trust, ethics, legal factors, and a complex set of societal values and decisions. We include discussion of these issues and principles as important components of our framework.
The main purpose of the OpenTox AI Framework is to develop and communicate an updated well-formulated set of principles that can help guide effective application design, development, adoption and impact, particularly with a focus on open science and innovation approaches and best practices supporting product design, predictive toxicology and risk assessment.