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Shareen Doak
Professor at Swansea University

Shareen Doak is Professor of Genotoxicology and Cancer in Swansea University Medical School where she leads the In Vitro Toxicology Group. Shareen is a UK and EUROTOX Registered Toxicologist, an invited Fellow of the Royal Society of Biology (FRSB) and an elected Fellow of the Learned Society of Wales (FLSW).

Shareen sits on the UK Government Committee on Mutagenicity (COM), and is the Nanomaterials Working Group Co-Leader for the International Genetic Toxicology Technical Committee (GTTC). She is also Editor-in-Chief for Mutagenesis.

Shareen Coordinates the €13 Million H2020 PATROLS project ( and is Director of the €12Million Celtic Advanced Life Science Innovation Network (CALIN), an Ireland-Wales INTERREG operation established to build a innovation bridge between Wales and Ireland in life sciences (

Shareen’s research interests focus on the genotoxic profiles of engineered nanomaterials, the mechanisms underlying their DNA damaging potential and subsequent consequences upon human health. Her interests extend to the development of advanced 3D culture models and mechanism-based bioassays for safety assessment to reduce the need for animal testing.  While her prostate cancer research focuses on understanding the molecular basis of progression to invasive, aggressive disease; with an ultimate aim of identifying a prognostic biomarker panel for improved clinical management of patients.

OpenTox Virtual Conference 2022

Implementing New Approach Methodologies (NAMs) in nanomaterial safety science to promote regulatory change

The European Horizon2020 project PATROLS has delivered improved nanomaterial hazard characterisation models and New Approach Methodologies (NAMs) to help address concerns over the use of animals in chemical testing and to provide more reliable tests that are accessible for use in industry. Such approaches are important to deliver the European Commission's chemicals strategy for sustainability and the development of safe and sustainable chemicals. However, an important challenge is the provision of sufficient data and method validation to regulators to encourage use of NAMs for regulatory risk assessment purposes. To address this issue, PATROLS undertook a variety of approaches to work towards reducing the uncertainty around use of new testing approaches. This involved a series of targeted stakeholder workshops to present the NAMs to a variety of key sectors including industry, risk assessors, regulators and policy makers. Stakeholder engagement was an important activity allowing end-users to understand the future benefits the NAMs offer; they enabled key stakeholder communities to provide input into the method development phases ensuring the novel hazard testing tools developed were fit-for-purpose; and targeted training days both encourage end-user uptake and future validation exercises. The training workshops guided stakeholders through the NAMs  developed and demonstrated how they can be accessed by stakeholders for their own use. This was coupled to a suite of training tools in several different formats, including open-access videos, detailed Standard Operating Procedures (SOPs) and virtual training events. Inter-laboratory trials have been undertaken to demonstrate transferability and reproducibility of the testing systems. Additionally, the protocols have been disseminated to other European projects, such as RiskGONE, where further inter-laboratory testing is being conducted.

To help deliver policy and regulatory challenges such as those highlighted by the European Commission's chemicals strategy for sustainability, new tools will be needed. However, for NAMs to be utilised for hazard characterisation purposes to achieve change, significant extensive engagement and validation data is required, which can take decades prior to implementation. To encourage uptake, close collaboration and open dialogue between policymakers, regulators, scientists and industry is required to facilitate a greater understanding of what has been already achieved scientifically, to facilitate earlier integration into current regulatory frameworks.