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Replacing Animal Testing in Research—A Scientific and Regulatory Perspective of...
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Replacing Animal Testing in Research—A Scientific and Regulatory Perspective of Current Efforts Towards the 1R

A special issue of Animals (ISSN 2076-2615). This special issue belongs to the section "Animal Welfare".

Deadline for manuscript submissions: closed (30 June 2022) | Viewed by 28904

Special Issue Editors

Dr. Dania Movia

E-Mail Website
Guest Editor
LBCAM, Trinity Translational Medicine Institute and Department of Clinical Medicine, Trinity College Dublin, The University of Dublin, Dublin 2, Ireland
Interests: animal-free research; cancer models; tissue-mimetic in vitro models
Dr. Adriele Prina-Mello

E-Mail Website
Guest Editor
LBCAM, Trinity Translational Medicine Institute and Department of Clinical Medicine, Trinity College Dublin, The University of Dublin, Dublin 2, Ireland
Interests: nanomedicine; translational research; medical devices; diagnostics

Special Issue Information

Dear Colleagues,

According to the most recent regulations on animal research across the globe, alternative methods in basic and applied research should replace animals when available. The problem is, alternative methods are meaningless without validation and suitable regulatory applications. This Special Issue aims at initiating a conversation on the role of contemporary replacement research and on how barriers to its implementation can be overcome in practice. It focuses on highlighting current state-of-the-art and cutting-edge developments that have the potential to replace animal tests in any research and educational field. This includes, for example, alternative methods developed for biomedical research in the toxicology, product safety and drug discovery/development fields, techniques implemented in alternatives methods (e.g., 3D bioprinting, micro- and milli-fluidics), as well as alternative methods for teaching, towards the aim of creating humane education. Other associated topics that are also of interest for this Special Issue are:

  • The validation process and regulatory acceptance of alternative methods, where the field should be heading, and how to speed the process.
  • Perspectives on potential concerns towards the 1R from the regulatory, scientific and industrial point-of-view.
  • Identification of priorities to reduce animal use in biomedical research (including addressing concerns related to the need of more research for aiming towards the 1R).
  • Description of tools (e.g., systematic reviews, databases, etc.) supporting the use of alternative methods/models as biotechnological resources.
  • Examples of how alternative models can be developed and promoted as key enabling biotechnology to stimulate innovation and growth in a variety of sectors.
  • The mission and achievements of existing 3Rs Centers across the world, with specific emphasis on education, training and research initiatives supported by these centers.
  • Quality and ethical aspects of animal replacement.

Commentaries, reviews and original manuscripts that address one or more of the topics listed above are invited for this Special Issue.

Dr. Dania Movia
Dr. Adriele Prina-Mello
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Animals is an international peer-reviewed open access semimonthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2400 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • animal replacement
  • biomedical research
  • education and training
  • new approach methodologies

Published Papers (8 papers)

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14 pages, 1261 KiB  
Communication
The Promises of Speeding Up: Changes in Requirements for Animal Studies and Alternatives during COVID-19 Vaccine Approval–A Case Study
by Merel Ritskes-Hoitinga, Yari Barella and Tineke Kleinhout-Vliek
Animals 2022, 12(13), 1735; https://doi.org/10.3390/ani12131735 - 05 Jul 2022
Cited by 8 | Viewed by 4029
Abstract
On 21 December 2020, the European Commission granted conditional marketing authorisation for the BNT162b2 COVID-19 vaccine ‘Comirnaty’, produced by Pfizer/BioNTech. This happened only twelve months after scientists first identified SARS-CoV-2. This stands in stark contrast with the usual ten years needed for vaccine [...] Read more.
On 21 December 2020, the European Commission granted conditional marketing authorisation for the BNT162b2 COVID-19 vaccine ‘Comirnaty’, produced by Pfizer/BioNTech. This happened only twelve months after scientists first identified SARS-CoV-2. This stands in stark contrast with the usual ten years needed for vaccine development and approval. Many have suggested that the changes in required animal tests have sped up the development of Comirnaty and other vaccine candidates. However, few have provided an overview of the changes made and interviewed stakeholders on the potential of the pandemic’s pressure to achieve a lasting impact. Our research question is: how have stakeholders, including regulatory agencies and pharmaceutical companies, dealt with requirements concerning in vivo animal models in the expedited approval of vaccine candidates such as ‘Comirnaty’? We interviewed key stakeholders at the Dutch national and European levels (n = 11 individuals representing five stakeholder groups in eight interviews and two written statements) and analysed relevant publications, policy documents and other grey literature (n = 171 documents). Interviewees observed significant changes in regulatory procedures and requirements for the ‘Comirnaty’ vaccine compared to vaccine approval in non-pandemic circumstances. Specifically, the European Medicines Agency (EMA) actively promoted changes by using an accelerated assessment and rolling review procedure for fast conditional marketing authorisation, requiring a reduced number of animal studies and accepting more alternatives, allowing pre-clinical in vivo animal experiments to run in parallel with clinical trials and allowing re-use of historical data from earlier vaccine research. Pharmaceutical companies, in turn, actively anticipated these changes and contributed data from non-animal alternative sources for the development phase. After approval, they could also use in vitro methods only for all batch releases due to the thorough characterisation of the mRNA vaccine. Pharmaceutical companies were optimistic about future change because of societal concerns surrounding the use of animals, adding that, in their view, non-animal alternatives generally obtain faster, better, and cheaper results. Regulators we interviewed were more hesitant to permanently implement these changes as they feared backlash regarding safety issues and uncertainty surrounding adverse effects. Our analysis shows how the EMA shortened its approval timeline in times of crisis by reducing the number of requested animal studies and promoting alternative methods. It also highlights the readiness of pharmaceutical companies to contribute to these changes. More research is warranted to investigate these promising possibilities toward further replacement in science and regulations, contributing to faster vaccine development. Full article
(This article belongs to the Special Issue Replacing Animal Testing in Research—A Scientific and Regulatory Perspective of Current Efforts Towards the 1R)
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15 pages, 10042 KiB  
Article
New In Vitro Methodology for Kinetics Distribution Prediction in the Brain. An Additional Step towards an Animal-Free Approach
by Bárbara Sánchez-Dengra, Isabel González-Álvarez, Marta González-Álvarez and Marival Bermejo
Animals 2021, 11(12), 3521; https://doi.org/10.3390/ani11123521 - 10 Dec 2021
Cited by 4 | Viewed by 2141
Abstract
The development of new drugs or formulations for central nervous system (CNS) diseases is a complex pharmacologic and pharmacokinetic process; it is important to evaluate their access to the CNS through the blood–brain barrier (BBB) and their distribution once they have acceded to [...] Read more.
The development of new drugs or formulations for central nervous system (CNS) diseases is a complex pharmacologic and pharmacokinetic process; it is important to evaluate their access to the CNS through the blood–brain barrier (BBB) and their distribution once they have acceded to the brain. The gold standard tool for obtaining this information is the animal microdialysis technique; however, according to 3Rs principles, it would be better to have an “animal-free” alternative technique. Because of that, the purpose of this work was to develop a new formulation to substitute the brain homogenate in the in vitro tests used for the prediction of a drug’s distribution in the brain. Fresh eggs have been used to prepare an emulsion with the same proportion in proteins and lipids as a human brain; this emulsion has proved to be able to predict both the unbound fraction of drug in the brain (fu,brain) and the apparent volume of distribution in the brain (Vu,brain) when tested in in vitro permeability tests. The new formulation could be used as a screening tool; only the drugs with a proper in vitro distribution would pass to microdialysis studies, contributing to the refinement, reduction and replacement of animals in research. Full article
(This article belongs to the Special Issue Replacing Animal Testing in Research—A Scientific and Regulatory Perspective of Current Efforts Towards the 1R)
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Other

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15 pages, 316 KiB  
Commentary
Identifying Key Factors for Accelerating the Transition to Animal-Testing-Free Medical Science through Co-Creative, Interdisciplinary Learning between Students and Teachers
by Fatima Zohra Abarkan, Anna M. A. Wijen, Rebecca M. G. van Eijden, Fréderique Struijs, Phoebe Dennis, Merel Ritskes-Hoitinga and Ingrid Visseren-Hamakers
Animals 2022, 12(20), 2757; https://doi.org/10.3390/ani12202757 - 13 Oct 2022
Cited by 2 | Viewed by 3395
Abstract
Even with the introduction of the replacement, reduction, refinement (the three Rs) approach and promising technological developments in animal-testing-free alternatives over the past two decades, a significant number of animal tests are still performed in medical science today. This article analyses which factors [...] Read more.
Even with the introduction of the replacement, reduction, refinement (the three Rs) approach and promising technological developments in animal-testing-free alternatives over the past two decades, a significant number of animal tests are still performed in medical science today. This article analyses which factors could accelerate the transition to animal-free medical science, applying the multi-level perspective (MLP) framework. The analysis was based on qualitative research, including a desk study (literature review and document analysis), lectures from experts, and nine online focus group sessions with experts on 26 July 2021. These were undertaken as part of an honours project between May and September 2021 to identify barriers, levers, and opportunities for accelerating this transition. The MLP framework identifies required changes at three levels: innovations and new practices (niche level), the current (bio)medical research system (regime level), and larger societal forces (landscape level). All three levels interact in a non-linear fashion. The model enabled us to identify many relevant factors influencing the transition to animal-testing-free medical science and enabled priority setting. Our findings supported the formulation of six “focus areas” to which stakeholders could devote efforts in order to accelerate the transition to animal-testing-free medical science: (1) thorough and translatable new approach methods (NAMs) for human-relevant medical research; (2) open science and sharing data; (3) targeted funding for NAMs; (4) implementing and modernising legislation for NAMs; (5) interdisciplinary education on animal-testing-free medical science; and (6) facilitating a shift in societal views, as this would be of benefit to both animals and humans. It is proposed that these focus areas should be implemented in parallel. Full article
(This article belongs to the Special Issue Replacing Animal Testing in Research—A Scientific and Regulatory Perspective of Current Efforts Towards the 1R)
6 pages, 192 KiB  
Opinion
EURL ECVAM Literature Review Series on Advanced Non-Animal Models for Respiratory Diseases, Breast Cancer and Neurodegenerative Disorders
by Laura Gribaldo and Adelaide Dura
Animals 2022, 12(17), 2180; https://doi.org/10.3390/ani12172180 - 25 Aug 2022
Cited by 2 | Viewed by 2818
Abstract
In vivo models are used in biomedical research to reproduce human disease and develop new drugs. However, they do not mimic the disease as it occurs in humans, and their use has failed to identify novel therapies effective for many highly prevalent non-communicable [...] Read more.
In vivo models are used in biomedical research to reproduce human disease and develop new drugs. However, they do not mimic the disease as it occurs in humans, and their use has failed to identify novel therapies effective for many highly prevalent non-communicable diseases, such as Alzheimer’s disease. Indeed, the clinical failure rate in drug development remains very high, with an overall likelihood of approval from Phase I of about 9.6%. On the other hand, human-based models, advanced imaging techniques and human epidemiological studies may increase our understanding of disease aetiology and pathogenesis and enable the advance of safe and effective therapies. Particularly when human tissues are used, they may produce faster, cheaper results, more predictive for humans, whilst yielding greater comprehensions of human biochemical processes. A first effort to collect existing knowledge about non-animal models of highly prevalent human diseases was made by the Joint Research Centre of the European Commission. The final aim was to identify and share information on the capabilities and limits of human-based models at different levels: scientific communities, universities and secondary schools, national committees for animal welfare and the public at large. Full article
(This article belongs to the Special Issue Replacing Animal Testing in Research—A Scientific and Regulatory Perspective of Current Efforts Towards the 1R)
12 pages, 259 KiB  
Commentary
Modernizing Medical Research to Benefit People and Animals
by Isobel Hutchinson, Carla Owen and Jarrod Bailey
Animals 2022, 12(9), 1173; https://doi.org/10.3390/ani12091173 - 03 May 2022
Cited by 3 | Viewed by 5374
Abstract
In the context of widespread public and political concern around the use of animals in research, we sought to examine the scientific, ethical and economic arguments around the replacement of animals with New Approach Methodologies (NAMs) and to situate this within a regulatory [...] Read more.
In the context of widespread public and political concern around the use of animals in research, we sought to examine the scientific, ethical and economic arguments around the replacement of animals with New Approach Methodologies (NAMs) and to situate this within a regulatory context. We also analyzed the extent to which animal replacement aligns with British public and policymakers’ priorities and explored global progress towards this outcome. The global context is especially relevant given the international nature of regulatory guidance on the safety testing of new medicines. We used a range of evidence to analyze this area, including scientific papers; expert economic analysis; public opinion polls and the Hansard of the UK Parliament. We found evidence indicating that replacing animals with NAMs would benefit animal welfare, public health and the economy. The majority of the British public is in favor of efforts to replace animals and focusing on this area would help to support the British Government’s current policy priorities. We believe that this evidence underlines the need for strong action from policymakers to accelerate the transition from animal experiments to NAMs. The specific measure we suggest is to introduce a new ministerial position to coordinate and accelerate the replacement of animals with NAMs. Full article
(This article belongs to the Special Issue Replacing Animal Testing in Research—A Scientific and Regulatory Perspective of Current Efforts Towards the 1R)
10 pages, 258 KiB  
Commentary
The Case for Modernizing Biomedical Research in Ireland through the Creation of an Irish 3Rs Centre
by Viola Galligioni, Dania Movia, Daniel Ruiz-Pérez, José Manuel Sánchez-Morgado and Adriele Prina-Mello
Animals 2022, 12(9), 1078; https://doi.org/10.3390/ani12091078 - 21 Apr 2022
Cited by 1 | Viewed by 1743
Abstract
Since its publication, the 3Rs principle has provided a cornerstone for more ethical and humane biomedical and regulatory research. In Europe, the 3Rs principle has been incorporated into the European Directive 63/2010/EU, with the ultimate aim of fully replacing the procedures on live [...] Read more.
Since its publication, the 3Rs principle has provided a cornerstone for more ethical and humane biomedical and regulatory research. In Europe, the 3Rs principle has been incorporated into the European Directive 63/2010/EU, with the ultimate aim of fully replacing the procedures on live animals for scientific and educational purposes as soon as it is scientifically possible to do so. Thus, a critical shift in the discussion on animal use in biomedical and regulatory research is undergoing in Europe, a discussion where satisfying the “replacement” principle is becoming more and more defined as a scientific rather than ethical need. 3Rs Centres have been established in recent years across Europe. To date, Ireland has no 3Rs Centre, and the uptake of the 3Rs principle, and in particular of the “replacement” aspect, has been slow. In this Commentary, we present the Irish context of the use of animal models in biomedical and regulatory research, and urge for what, in the authors’ opinion, are the most critical actions that Ireland must undertake to align its biomedical (basic, applied and translational) research with the European 3Rs strategy. Full article
(This article belongs to the Special Issue Replacing Animal Testing in Research—A Scientific and Regulatory Perspective of Current Efforts Towards the 1R)
18 pages, 1231 KiB  
Commentary
Phase-In to Phase-Out—Targeted, Inclusive Strategies Are Needed to Enable Full Replacement of Animal Use in the European Union
by Lindsay J. Marshall, Helder Constantino and Troy Seidle
Animals 2022, 12(7), 863; https://doi.org/10.3390/ani12070863 - 29 Mar 2022
Cited by 9 | Viewed by 3234
Abstract
In September 2021, the European Parliament voted overwhelmingly in favour of a resolution to phase out animal use for research, testing, and education, through the adoption of an action plan. Here we explore the opportunity that the action plan could offer in developing [...] Read more.
In September 2021, the European Parliament voted overwhelmingly in favour of a resolution to phase out animal use for research, testing, and education, through the adoption of an action plan. Here we explore the opportunity that the action plan could offer in developing a more holistic outlook for fundamental and biomedical research, which accounts for around 70% of all animal use for scientific purposes in the EU. We specifically focus on biomedical research to consider how mapping scientific advances to patient needs, taking into account the ambitious health policies of the EU, would facilitate the development of non-animal strategies to deliver safe and effective medicines, for example. We consider what is needed to help accelerate the move away from animal use, taking account of all stakeholders and setting ambitious but realistic targets for the total replacement of animals. Importantly, we envisage this as a ‘phase-in’ approach, encouraging the use of human-relevant NAMs, enabling their development and application across research (with applications for toxicology testing). We make recommendations for three pillars of activity, inspired by similar efforts for making the shift to renewable energy and reducing carbon emissions, and point out where investment—both financial and personnel—may be needed. Full article
(This article belongs to the Special Issue Replacing Animal Testing in Research—A Scientific and Regulatory Perspective of Current Efforts Towards the 1R)
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14 pages, 272 KiB  
Commentary
Protecting Canada’s Lab Animals: The Need for Legislation
by Vaughan Black, Andrew Fenton and Elisabeth H. Ormandy
Animals 2022, 12(6), 770; https://doi.org/10.3390/ani12060770 - 18 Mar 2022
Cited by 2 | Viewed by 3618
Abstract
Canada’s current non-legislated oversight system for animal-based science not only fails to adequately incentivize the replacement of sentient animals as best scientific practice in any meaningful way, but also fails to adequately protect those animals bred, harmed, and killed in the name of [...] Read more.
Canada’s current non-legislated oversight system for animal-based science not only fails to adequately incentivize the replacement of sentient animals as best scientific practice in any meaningful way, but also fails to adequately protect those animals bred, harmed, and killed in the name of science. In this paper, we outline the various shortcomings of the Canadian Council on Animal Care, and we highlight the need for Canada to move towards national legislation akin to that seen in other jurisdictions like the U.K. We conclude that while legislation alone cannot ensure the replacement of sentient animals in science, it appears to be a precondition for significant progress in animal protection and for the development and adoption of non-animal methods. Full article
(This article belongs to the Special Issue Replacing Animal Testing in Research—A Scientific and Regulatory Perspective of Current Efforts Towards the 1R)
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