ToxHQ develops and applies latest innovative methods in Safety Assessment

A Perspective on launching ToxHQ, by Barry Hardy (Douglas Connect)

The overarching goal of ToxHQ is to develop an innovative organization, offering services and products in hazard and exposure modelling, predictive toxicology and integrated testing strategies supporting safety assessment. The target industries produce products requiring health and environmental assessment and include pharmaceuticals, consumer products, chemicals, pesticides, biocides, food and product materials (including advance complex materials such as obtained from nanotechnology).

To achieve its goals, ToxHQ engages in interactions with industry, regulators and the research community. Together we define case studies describing a set of work tasks carrying out a substantial piece of work advancing innovative safety assessment methods. We define use cases contributing to such case studies against which our method and knowledge infrastructure is developed.

In initiating ToxHQ, we have undertaken numerous discussions with stakeholders. These discussions have motivated our support of Integrated Approaches to Testing and Assessments (IATAs), Integrated Testing Strategies (ITS), Read Across, Risk Assessment against Adverse Outcome Pathways (AOPs), and integration of the OpenTox and Risk21 concepts (Risk21-OpenTox). We have also seen the need for better support on practical work such as data management and search, quality assurance and supporting the workflows of knowledge workers with better tools.

One significant challenge to adoption of our solutions is the regulatory acceptance of new alternative evidence generation methods as developed by ToxHQ. We are currently participating actively in case study development activities, such as the current Read Across and Adverse Outcome Pathway (AOP) risk assessment activities on SEURAT-1 and EuToxRisk, jointly led by industry, regulatory representatives such as from the European Chemicals Agenca (EChA) and OECD, and research insititutions. We have also been active leaders in developing the OpenTox framework and community forward, which is a key contribution to our interoperability approach and our scientific and business ecosystem model. Such activities are ensuring that the ToxHQ design is closely matching to emerging industry and regulatory requirements.

Finally, the inclusion of a case study specifically designed with validation and regulatory goals by Safer Medicines Trust (SMT), and involving regulators including the US FDA and US EPA, provides a strong case study geared towards industrial application. The study also provides the opportunity to transfer drug knowledge to health and environmental goals of other sectors while also advancing the societal goal of safer medicines. For example, drug compound pairs can provide a convincing test of predictions, based on known observed human adverse effects.

The future development of ToxHQ will be strongly driven by the requirements of case studies which are led by industry case study partners with an additional strong input from regulatory authorities on use cases based on existing relationships. This combined input enables the design of applications which will be fit-for-purpose for broad industrial use and satisfying regulatory thinking on emerging practice and information requirements.