replacement

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A Review of the Contributions of Cross-discipline Collaborative European IMI/EFPIA Research Projects to the Development of Replacement, Reductionand Refinement Strategies

Sarah Wolfensohn

The objective of this review is to report on whether, and if so, how, scientific research projects organised and managed within collaborative consortia across academia and industry are contributing to the Three Rs (i.e. reduction, replacement and refinement of the use of animals in research). A number of major technological developments have recently opened up possibilities for more direct, human-based approaches leading to a reassessment of the role and use of experimental animals in pharmacological research and biomedicine. This report reviews how projects funded by one of the research funding streams, the Innovative Medicines Initiative (IMI), are contributing to a better understanding of the challenges faced in using animal models. It also looks how the results from these various projects are impacting on the continued use of laboratory animals in research and development. From the progress identified, it is apparent that the approach of private–public partnership has demonstrated the value of multicentre studies, and how the spirit of collaboration and sharing of information can help address human health challenges. In so doing, this approach can reduce the dependence on animal use in areas where it has normally been viewed as necessary. The use of a collaborative platform enables the Three Rs to be addressed on multiple different levels, such that the selection of models to be tested, the protocols to be followed, and the interpretation of results generated, can all be optimised. This will, in turn, lead to an overall reduction in the use of laboratory animals.

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The Replacement of Animal Tests

Robert D. Combes

Progress toward the acceptance and application of validated alternative test methods as replacements for animal tests, is being frustrated by the unsatisfactory procedures involved in approving new test guidelines and deleting existing ones

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2018-05-31T11:58:08+00:00 Tags: , |

2016 Lush Science Prize

Jenny McCann and Terry McCann

The Lush Prize supports animal-free testing by awarding monetary prizes totalling £250,000 to the most effective projects and individuals who have been working toward the goal of replacing animals in product or ingredient safety testing. Prizes are awarded for developments in five strategic areas: Science; Lobbying; Training; Public Awareness; and Young Researchers. In the event of a major breakthrough leading to the replacement of animal tests in the area of 21st Century Toxicology, a Black Box Prize (equivalent to the entire annual fund of £250,000) is awarded. The Science Prize is awarded to the researchers whose work the judging panel believe has made the most significant contribution to the replacement of animal testing in the preceding year. This Background Paper outlines the research projects that were shortlisted and presented to the judging panel as potential candidates for the 2016 Lush Science Prize. This process involved reviewing recent work of the relevant scientific institutions and projects in this area, such as the OECD, CAAT, The Hamner Institutes, ECVAM, UK NC3Rs, and the US Tox21 Programme. Recent developments in toxicity testing research were also identified by searching for relevant published papers in the literature, and analysing abstracts from conferences focusing on animal replacement in toxicity testing that had been held in the preceding 12 months — for example the EUSAAT-Linz, Society of Toxicology, and SEURAT-1 conferences.
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New Animal-free Concepts and Test Methods for Developmental Toxicity and Peripheral Neurotoxicity

Marcel Leist

The complex toxicological fields of repeat dose organ toxicity (RDT) and developmental and reproductive toxicity (DART) still require new concepts and approaches to achieve a fully animal-free safety assessment of chemicals. One novel approach is the generation of relevant human cell types from pluripotent stem cells, and the use of such cells for the establishment of phenotypic test methods. Due to their broad endpoints, such tests capture multiple types of toxicants, i.e. they are a readout for the activation of many adverse outcome pathways (AOPs). The 2016 Lush Science Prize was awarded for the development of one such assay, the PeriTox test, which uses human peripheral neurons generated from stem cells. The assay endpoints measure various cell functions, and these give information on the potential neurotoxicity and developmental neurotoxicity hazard of test compounds. The PeriTox test method has a high predictivity and sensitivity for peripheral neurotoxicants, and thus addresses the inherent challenges in pesticide testing and drug development. Data from the test can be obtained quickly and at a relatively high-throughput, and thus, the assay has the potential to replace animal-based safety assessment during early product development or for screening potential environmental toxicants.
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Training and Good Science are the Foundation Stones for Animal Replacement

Kelly S. Davidge and J. Malcolm Wilkinson

Good science, the training of energetic and enthusiastic young researchers, and the experience of industry veterans, will all be needed to drive the implementation and regulatory approval of animal replacement methods in industry
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2017-11-08T13:52:19+00:00 Tags: , , |

On the Journey Toward Humane Education in Brazil: First Request for a Total Ban of Harmful Animal Use in Professional and Higher Education

Róber Bachinski, Gutemberg Alves, Mariângela Freitas de Almeida Souza, Vanessa Carli Bones, Rita de Cassia Maria Garcia, Rosangela Gebara, Valeska Regina Reque Ruiz, Luciano da Silva Alonso, Thales Tréz, Simone Tostes Oliveira, Alexandro Aluisio Rocha, Rita Leal Paixão, Roseli Pizzigatti Klein, Débora Gasparetto, Nick Jukes and Júlia Maria Matera

The Brazilian Network for Humane Education (RedEH) is an independent and self-managed group comprised of academics from ten different Brazilian states and a number of international collaborators. In 2016, in a concerted effort to change the educational field in Brazil and propagate humane education, RedEH sent a request to the Brazilian National Council for the Control of Animal Experimentation (CONCEA), asking that harmful animal use in education in professional and undergraduate courses be banned. This was the first formal request for a total replacement of harmful animal use in education in Brazil, and represented a major historic landmark in the advancement of Brazilian science education. This paper presents the full text of the request, as well as outlining its national and international repercussions. The request was supported by InterNICHE and representatives of 18 other international organisations. A major national impact of the request was its recognition by the Federal Council of Veterinary Medicine. With this action, academics and researchers took a potentially revolutionary step in the Brazilian education arena, with regard to advancing and supporting a higher quality, ethical and democratic educational system.
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It Takes a Village: Stakeholder Participation is Essential to Transforming Science

Kristie Sullivan

Efforts toward replacing the use of animals in toxicology testing have begun to make significant headway in the last several years, due to co-operative and pragmatic efforts on the part of many stakeholders, and the public pressure that non-governmental advocacy organisations represent. Science-focused advocacy organisations have a unique role to play in these efforts, as they often have flexibility to adapt quickly to keep a project going and forge connections among different kinds of stakeholders to help encourage buy-in. This year, meaningful progress has been made, especially in regulatory laws and policies, which will lead to the replacement of animals in toxicology testing. In order to keep this momentum, we need to measure progress — but this requires improved transparency and regular reporting of animal use. In addition, we should consider how strategies that have successfully reduced and replaced animal use in toxicology can be applied to basic biomedical research practices.
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2015 Lush Science Prize

Jenny McCann and Terry McCann

The Lush Prize supports animal-free testing by rewarding the most effective projects and individuals who have been working toward the goal of replacing animals in product or ingredient safety testing. Prizes are awarded for developments in five strategic areas: Science; Lobbying; Training; Public Awareness; and Young Researchers. Should there be a major breakthrough in 21st century toxicology, a Black Box Prize equivalent to the entire annual fund of £250,000 is awarded. A Background Paper is prepared each year, prior to the judging process, to provide the panel with a brief overview of current developments in the field of Replacement alternatives, particularly those relevant to the concept of toxicity pathways. The Background Paper includes information on recent work by the relevant scientific institutions and projects in this area, including AXLR8, the OECD, The Hamner Institutes, the Human Toxome Project, EURL ECVAM, ICCVAM, the US Tox21 Programme, the ToxCast programme, and the Human Toxicology Project Consortium. Recent developments in toxicity pathway research are also assessed by reviewing the relevant literature (including conference proceedings), and the abstracts and papers receiving the highest score are presented to the judges for consideration.
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Evaluation of Non-animal Methods for Assessing Skin Sensitisation Hazard: A Bayesian Value-of-Information Analysis

Leontaridou_suppl_info_FINAL

Maria Leontaridou, Silke Gabbert, Ekko C. Van Ierland, Andrew P. Worth and Robert Landsiedel

This paper offers a Bayesian Value-of-Information (VOI) analysis for guiding the development of non-animal testing strategies, balancing information gains from testing with the expected social gains and costs from the adoption of regulatory decisions. Testing is assumed to have value, if, and only if, the information revealed from testing triggers a welfare-improving decision on the use (or non-use) of a substance. As an illustration, our VOI model is applied to a set of five individual non-animal prediction methods used for skin sensitisation hazard assessment, seven battery combinations of these methods, and 236 sequential 2-test and 3-test strategies. Their expected values are quantified and compared to the expected value of the local lymph node assay (LLNA) as the animal method. We find that battery and sequential combinations of non-animal prediction methods reveal a significantly higher expected value than the LLNA. This holds for the entire range of prior beliefs. Furthermore, our results illustrate that the testing strategy with the highest expected value does not necessarily have to follow the order of key events in the sensitisation adverse outcome pathway (AOP).

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Barriers to the Uptake of Human-based Test Methods, and How to Overcome Them

Kathy Archibald, Tamara Drake and Robert Coleman

Although there is growing concern as to the questionable value of animal-based methods for determining the safety and efficacy of new medicines, which has in turn led to many groups developing innovative human-based methods, there are many barriers to their adoption for regulatory submissions.
The reasons for this are various, and include a lack of confidence that the available human-based methods, be they in vivo, in silico or in vitro, can be sufficiently predictive of clinical outcomes. However, this is not the only problem: the issue of validation presents a serious impediment to progress, a particularly frustrating situation, in view of the fact that the existing animal-based methods have never themselves been formally validated. Superimposed upon this is the issue of regulatory requirements, where, although regulators may be willing to accept non-animal approaches in place of particular animal tests, nowhere is this explicitly stated in their guidelines. Such problems are far from trivial, and represent major hurdles to be overcome. In addition, there are a range of other barriers, real or self-imposed, that are hindering a more-predictive approach to establishing a new drug’s clinical safety and efficacy profiles. Some of these barriers are identified, and ways forward are suggested.
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