replacement

/Tag:replacement

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.
You need to register (for free) to download this article. Please log in/register here.

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.
You need to register (for free) to download this article. Please log in/register here.

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).

This article is currently only available in full to paid subscribers. Click here to subscribe, or you will need to log in/register to buy and download this article

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.
You need to register (for free) to download this article. Please log in/register here.

2014 Lush Science Prize – background paper

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. 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. This Background Paper includes information on recent work by the relevant scientific institutions and projects in this area, including AXLR8, OECD, CAAT, 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, with a view to presenting the two papers receiving the highest score to the judges for consideration.
You need to register (for free) to download this article. Please log in/register here.

Humane Education in Brazil: Organisation, Challenges and Opportunities

Róber Bachinski, Thales Tréz, Gutemberg G. Alves, Rita de C.M. Garcia, Simone T. Oliveira, Luciano da S. Alonso, Júlio X. Heck, Claudia M.C. Dias, João M. Costa Neto, Alexandro A. Rocha, Valeska R.R. Ruiz and Rita L. Paixão

Humane education and the debate on alternatives to harmful animal use for training is a relatively recent issue in Brazil. While animal use in secondary education has been illegal since the late 1970s, animal use in higher science education is widespread. However, alternatives to animal experiments in research and testing have recently received attention from the Government, especially after the first legislation on animal experiments was passed, in 2008. This article proposes that higher science education should be based on a critical and humane approach. It outlines the recent establishment of the Brazilian Network for Humane Education (RedEH), as a result of the project, Mapping Animal Use for Undergraduate Education in Brazil, which was recognised by the 2014 Lush Prize. The network aims to create a platform to promote change in science education in Brazil, starting by quantitatively and qualitatively understanding animal use, developing new approaches adapted to the current needs in Brazil and Latin America, and communicating these initiatives nationally. This paper explores the trajectory of alternatives and replacement methods to harmful animal use in training and education, as well as the status of humane education in Brazil, from the point of view of educators and researchers engaged with the network.
You need to register (for free) to download this article. Please log in/register here.

Comparative Costs of the Mouse Inoculation Test (MIT) and Virus Isolation in Cell Culture (VICC) for Use in Rabies Diagnosis in Brazil

Vanessa C. Bones, Augusto H. Gameiro, Juliana G. Castilho and Carla F.M. Molento

The decision to use laboratory animals rather than in vitro methods is frequently based on the financial costs involved, so the objective of our study was to compare the costs of performing the Mouse Inoculation Test (MIT) and Virus Isolation in Cell Culture (VICC) for use in rabies diagnosis in Brazil. Based on observations of laboratory routines at the Pasteur Institute, São Paulo, we listed the fixed cost (FC) and variable cost (VC) items necessary to perform both tests. Considering that 200 MITs are equivalent to 350 VICC assays, in terms of facilities and staff-hours needed per month, we calculated, for both tests, the average total cost per sample, the costs of the implementation of the laboratory structure, and the costs of routine use. With regard to absolute values, the total cost was mainly influenced by FC items, as they represented 60% of the cost for the MIT and 86% of the cost for VICC. A sample analysed by the MIT costs around 205% more than one analysed by using VICC. The MIT costs 74% and 406% more than VICC, when implementation costs and routine use per month, respectively, are taken into account. Our results can assist in the resolution of costing disputes that could hinder the replacement of animals for rabies diagnosis in Brazil. The method demonstrated here might also be useful for cost comparisons in other situations where animal use still continues when validated alternatives exist.
You need to register (for free) to download this article. Please log in/register here.

2013 Lush Science Prize Background Paper

Rob Harrison

The annual Lush Science Prize is designed to reward outstanding contributions to 21st Century Toxicology Research. A Background Paper is prepared each year prior to the judging process, in order to provide the judging 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 some key institutional developments in the area — such as the OECD’s Adverse Outcome Pathway Project, the Hamner Institute’s work, and the Human Toxome Project, and on the phenomenon of collaborative computer systems relevant to the field. From the literature review that was also performed as part of the background research, the two papers receiving the highest score were recommended for consideration by the judges for the 2013 Science Prize.
You need to register (for free) to download this article. Please log in/register here.