Has 2020 influenced the transition to animal-free testing alternatives?

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The year 2020 will not be forgotten in a hurry. It’s been tough for businesses in all sectors since the beginning of the global pandemic, which has transformed the way we interact socially and professionally. If that wasn’t enough to be dealing with, Brexit is edging ever closer, which impacts the regulatory frameworks for all areas of business. What a year we picked to establish ImmuONE Ltd, bringing our innovative in vitro inhaled safety assessment products and services to market.

How will the major events of 2020 shape the future of animal-free chemical and product safety testing in the UK? 

1. COVID-19

Lessons learnt from the animal-free safety assessment of cosmetics over the past decade have supported other industries in the move away from animal assessments in other industries. The rapid progression of COVID-19 vaccine trials in humans has in part been attributed to the availability of alternative in vitro and in silico tools, reducing the need for lengthy animal studies. There is every reason to adopt this approach wider within the pharmaceutical and chemical sectors. After all, 95 out of every 100 drugs that test safe and effective in animals go on to fail in human clinical trials. With the increasing demand for bringing safe products to market in a more timely and cost-effective way, the necessity for more human-relevant studies has never been greater. Perhaps this will spur the wider uptake of human in vitro cell culture methods and expand innovation in this field.

2. EU’s Chemicals Strategy

As part of the European Green Deal, the new European Chemicals Strategy for Sustainability is intended as a first step towards a toxin-free environment. The strategy highlights the need to develop multidisciplinary research and innovations for in vitro methodologies and data analysis capabilities to support the move away from animal testing. However, it has been argued that the strategy lacks clear goals for phasing out animal testing and promotion of alternative methods. The unveiling of the strategy in October generated mixed reactions as to whether it would support the reduction of animal studies or increase the reliance on animal testing in chemicals safety assessment.

3. Brexit

The good news is that the UK government has confirmed the key principles of the EU regulation for the Registration, Evaluation, Authorisation, or Restriction of Chemicals (REACH) will be brought into UK law, which will be known as ‘UK REACH’, from 1st January 2021. This runs the risk of substantial repetition of both in vivo and in vitro studies for application under the UK REACH framework. However, there is no commitment to align with the EU REACH regulation in the future.

The UK remains a global leader in the movement to replace animal testing. The reduction and replacement of animals in safety testing is lobbied for by a diverse range of institutions in the UK including charities (FRAME, Animal Free Research-UK, Lord Downing Trust), the commercial sector (Unilever, Lush, The Body Shop), scientific-commercial alliances (Human Relevant Science) and scientific organisations (NC3Rs). With this growing national support, perhaps Brexit could provide the catalyst for the UK to extend an animal-free approach to safety assessment beyond the cosmetics industry.

Outlook for 2021

As we bid farewell to the personal, societal and economic challenges of 2020, there may be some consolation that achieving animal-free safety assessment in all industries may be closer than we thought.

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To sum up, relevant strong micro-physiological models will improve R&D efficiency and reduce drug attrition. Micro-physiological systems show great promise once fully developed. Like most medical devices, the models are challenged and present many obstacles.

As the system is small and intricate, it takes longer for the models to be optimised. Initially the availability of MPS models for drug assessment will improve human safety whilst keeping controversies at bay.

By establishing sustainable MPS banks, relevant quantitative data can be reproduced and applied to various studies. The life sciences community need to collaborate and communicate with each other to generate quality systems efficiently.

 

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