Current research projects

GRACIOUS - Framework for grouping and read-across of nanomaterials/nanoforms for regulatory risk assessment and safe-by-design

Funding: EU H2020 Jan 2018 - Jun 2021 - Euro's 6.9 million total (0.8 million to HWU)

Vicki Stone is project coordinator and PI

Background: Manufacturing and functionalising materials at the nanoscale can lead to a whole array of nanoforms (NFs) of a substance varying in e.g. size, morphology and surface characteristics. Due to financial, time and ethical consideration, safety testing for the risk assessment of every unique NF is virtually impossible. Grouping and read-across are currently used in a regulatory context to predict hazard and exposure information for data poor substances based on structural and chemical similarity with data rich substance.   

Goal: The main goal of GRACIOUS is to generate a highly innovative science-based Framework to enable practical application of grouping, leading to read-across and between NFs. In achieving this goal, GRACIOUS will streamline the risk assessment process for both regulatory and safe-by-design processes.

The GRACIOUS Framework is based on scientifically sound hypotheses that allow NFs, materials and substances to be grouped logically, subsequently facilitating read-across. The GRACIOUS Framework has 3 levels that facilitate initiation, development and justification of the hypothesis that encompasses information relevant to “Lifecycle environmental release and human exposure”, “What they are: physicochemical identity”, “Where they go: Environmental fate, uptake and toxicokinetics”, and “What they do: human and environmental toxicity”.  Based on the available data and information, each hypothesis may trigger specific tailored Integrated Approaches to Testing and Assessment (IATAs) that guide testing, modelling and assessment in a tiered manner, with the aim of generating the scientific evidence justifying the grouping and read-across. The IATAs will reduce, refine and replace (where possible) the need for animal testing by promoting the use of predictive modelling, in vitro and cell-free tests.  Stakeholders play an active role in the iterative cycle of design, testing and refinement to ensure that the Framework effectively meets the needs of both regulators and industry.

Impact:  The GRACIOUS Framework has been published in NanoToday (https://doi.org/10.1016/j.nantod.2020.100941).  The Framework is being used in case studies by the European Chemicals Agency (ECHA) with the European Commission (Joint Research Centre) and German competent authorities (e.g. Bfr), as well as Industry (BASF and The Zinc Industries consortium), consultants (e.g. Blue Frog) and international government bodies (e.g. US EPA, US NIOSH).  At an international level the GRACIOUS Framework will developed further by the Organisation for Economic Cooperation and Development (OECD) with Vicki Stone leading the project on behalf of the UK, along with the USA.

PATROLS  - Physiologically Anchored Tools for Realistic nanOmateriaL hazard aSsessment

Funding: EU H2020 Jan 2018 - Jun 2021  - Euro's 14 million total (1.2 million to HWU)

Vicki Stone is Work package leader and PI

Background:  An ever increasing array of nanomaterials, with varying physicochemical characteristics, surface modifications and applications makes it increasingly difficult to assess their safety.  It is not ethical nor financially feasible to test every new nanomaterial in animal models.  However, in vitro models are often criticised for being too simplistic and not sufficiently representative of complex biological tissues for the purpose of hazard assessment.

Goal: PATROLS will establish and standardise a battery of innovative, next generation hazard assessment tools that more accurately predict adverse effects caused by long-term (chronic), low dose NM exposure in human and environmental systems to support regulatory risk decision making.

Within PATROLS Vicki Stone leads the WP responsible for the development of 3D liver sheroid microtissue models, 3D models of different parts of the gastrointestinal tract and contributes to the development of 3D lung models able to predict fibrosis.  In addition, Vicki is contributing to work with zebrafish in order to use this model as an intermediate between human and environmental testing.

BIORIMA - BIOmaterial RIsk MAnagement

Funding: EU H2020 Nov 2017- Oct 2021  - Euro's  million total (250k to HWU)

Vicki Stone is PI

Background: Currently nano-biomaterials are used in a wide range of advanced medicines and medical devices.  The current regulatory frameworks require risk assessment for approval.  While a range of regulations exist that are applicable to

Goal: To develop an Integrated Risk Management Framework for Nano-Biomaterials used in Advanced Medicine and Medical Devices

BIORIMA will develop an Integrated Risk Management Tool.  HWU will contribute to the development of this tool by building an Integrated Approach to Testing and Assessment (IATA) in order to guide and streamline the hazard testing, in order to improve effeciency and reduce animal usage.

SAVE:  Single-Administration Vaccine Enhancement

Funding:  BBSRC June 2018 - May 2021 £740k

Vicki Stone is CoI  (PI Ferry Melchels)

Background:  In order to ensure a vaccine is effective in the long term, delivery of a vaccine booster is required at a predefined time (usually several months) after delivery of the initial vaccine.  Delivery of a booster for farm animals requires recollection of the animals and a second expensive visit by the vet.  By co-adiministration of the initial dose and the booster simultaneously the cost and effeciency is greatly enhanced.  This is relevant for a vareity of diseases such as Bovine tuberculosis (TB). In future, if successful, this approach can also be used in humans, especially in remote locations where booster take-up is low.

Goal:  To improve the efficiency of vaccinating farm and wild animals by administration

of vaccines and their boosters simultaneously through use of a biodegradable, low toxicity implant the bursts to release the vaccine booster payload at a predefined time.

Vicki Stone's role is to lead the biocompatibility assessment of the implant.

Developing Alternative Models to Evaluate the Impact of Nanomaterials on Neutrophils during the Stimulation and Resolution of Inflammation

Funding: NC3Rs  Nov 2016 - Oct 2019  £447

Vicki Stone is CoI  (PI Helinor Johnston)

Background: Alternative methods to the use of animals are required to address legislative requirements for mandatory chemical and nanomaterial safety assessment.

Goal:  To develop sensitive and relevant alternative (non-rodent) methods for assessing the stimulation and resolution of inflammation via evaluation of neutrophil responses. Neutrophil functions that reflect key processes in the initiation, progression and resolution of inflammation will be identified and used to select evidence based, sensitive endpoints (bio-indicators) that can be developed into standardised protocols to screen inflammogenicity using alternative models. The models used will include:

1. Blood derived primary human neutrophils

2. The neutrophil-like HL60 human promyelocytic cell line

3. Transgenic zebrafish (ZF) embryos (e.g. with fluorescent neutrophils)

Synthetic layered silicate toxicity testing

Funding:  BYK Altana May 2016 - Nov 2019  £101k

Vicki Stone is PI

Background: Synthetic layered silicates are used in a wide variety of commercial products ranging from cosmetics and personal hygiene products, to medical devices, foods and coatings.

Goal:  To compare the relative hazard of a range of man-made synthetic layered silicates varying in their composition, size and charge.

I graduated from the University of Leeds in 1991 with a 1st class honours degree in Physiology. At the University of Leeds I was the recipient the University of Leeds Centenary Medal. My PhD was completed at Birmingham University in Toxicology in 1994 supervised by Prof Roger Coleman and Prof Kevin Chipman. While studying in Birmingham I was awarded the British Toxicology Society Young Investigator Award. I am an elected Fellow of the Royal Society of Edinburgh, the Royal Society of Chemistry and the Royal Society of Edinburgh, as well as an Honorary Principal Scientist at the Institute of Occupational Medicine.  I have provided expert advice on particle toxicology to the World Health Organisation, the Royal Society/Royal Academy of Engineering and to the Royal Commission. I was a member of the Department of Health’s Committee on the Medical Effects of Air Pollution (COMEAP), and in the past have worked as an executive member of the International Council on Nanotechnology (ICON) and Consultant to the Olympic Medical Association. I have been an invited speaker at conferences in Australia (Perth and Sydney), Asia (China, Taiwan and Japan), USA (San Francisco, North Carolina, Florida, Miami) and Europe (Denmark, France, Spain, Germany, Italy, Switzerland).Collaborators spread across Europe (more than 40 institutes through EU projects), USA (National Institute of Occupational Safety and Health, University of Rochester, Duke University, Arizona University) and Japan. I have been an expert advisory panel member for CEINT (Center for the Environmental Implications of Nanotechnology, Duke University, USA) and NANOTEST (EC FP7 funded project). I have published over 180 research papers with high citations as recognised by my Clarivate Analytics Highly Cited Researcher award.