7 research outputs found
Cross-Sector Review of Drivers and Available 3Rs Approaches for Acute Systemic Toxicity Testing
Acute systemic toxicity studies are carried out in many sectors in which synthetic chemicals are manufactured or used and are among the most criticized of all toxicology tests on both scientific and ethical grounds. A review of the drivers for acute toxicity testing within the pharmaceutical industry led to a paradigm shift whereby in vivo acute toxicity data are no longer routinely required in advance of human clinical trials. Based on this experience, the following review was undertaken to identify (1) regulatory and scientific drivers for acute toxicity testing in other industrial sectors, (2) activities aimed at replacing, reducing, or refining the use of animals, and (3) recommendations for future work in this area
Criteria for feasibility, health and welfare assessment of requirement to use second and subsequent generations of non-human primates or animals from self-sustaining colonies in research CritĂšres dâĂ©valuation de la faisabilitĂ©, de lâincidence sanitaire et des rĂ©percussions sur le bien-ĂȘtre animal, relatifs Ă l'obligation future d'utiliser des primates non humains issus uniquement des animaux de deuxiĂšme gĂ©nĂ©ration et plus ou des animaux provenant de colonies d'Ă©levage auto-entretenues pour la recherche expĂ©rimentale
The European Directive 2010/63/EU on the protection of animals used for scientific purposes requires that a feasibility study must be conducted by the European Commission to determine if all sourcing of non-human primates from parents bred in captivity (F2) or from self-sustaining colonies can be achieved. This study should also include an assessment of animal health and welfare. Prior to the initiation of the European Commissionâs study, it was considered by EFPIA and FELASA that the criteria to be used in the feasibility, health and welfare assessment should be established by experts to help expedite such a study. This paper identifies those criteria which may be useful in making policy decisions on the confirmation or reconsideration of the timetable for implementation of the F2 requirement. A key requirement before a number of criteria can be assessed is the generation of base-line data relating to the supply and future demand of non-human primates and the health and welfare status of current breeding colonies supplying the European market. Three groups of criteria have been indentified, namely feasibility, science and research and welfare. Within each group, a number of parameters are defined and their rationale for inclusion, together with suggested information points, is discussed.<br>La directive europĂ©enne 2010/63/EU sur la protection des animaux utilisĂ©s Ă des fins scientifiques exige qu'une Ă©tude de faisabilitĂ© soit conduite par la Commission europĂ©enne afin de dĂ©terminer si lâapprovisionnement en primates non-humains Ă partir de gĂ©niteurs Ă©levĂ©s en captivitĂ© (F2) ou de colonies d'Ă©levage autosuffisantes, peut ĂȘtre possible. Cette Ă©tude devra Ă©galement inclure une Ă©valuation de la santĂ© des animaux et de leur bien-ĂȘtre. Avant le dĂ©but de cette Ă©tude par la Commission europĂ©enne, l'EFPIA et FELASA ont estimĂ© que les critĂšres Ă utiliser pour les Ă©valuations de la faisabilitĂ©, de la santĂ© des animaux et du bien-ĂȘtre animal devraient ĂȘtre dĂ©finis rigoureusement par des experts pour faciliter et accĂ©lĂ©rer le travail de la Commission europĂ©enne. Cet article identifie les critĂšres qui peuvent ĂȘtre utiles dans la prise de dĂ©cisions politiques sur la confirmation de lâexigence de la directive ou sur le rĂ©examen de l'Ă©chĂ©ancier de mise en Ćuvre de l'exigence d'utiliser dans le futur uniquement des primates non-humains de gĂ©nĂ©rations F2. Un Ă©lĂ©ment clĂ© avant qu'un certain nombre de critĂšres puissent ĂȘtre Ă©valuĂ©s est la dĂ©termination de donnĂ©es de base relatives Ă l'offre et la demande de primates non humains, Ă leur Ă©tat sanitaire et leur Ă©tat de bien-ĂȘtre dans les colonies de reproduction destinĂ©es Ă approvisionner le marchĂ© europĂ©en. Trois grandes catĂ©gories ont Ă©tĂ© identifiĂ©es, Ă savoir la faisabilitĂ© de gĂ©rer ces colonies d'Ă©levage, leur incidence sur la recherche scientifique et la garantie du bien-ĂȘtre animal. Pour chaque catĂ©gorie, un certain nombre de paramĂštres sont dĂ©finis et justifiĂ©s, avec des Ă©lĂ©ments d'information suggĂ©rĂ©s et discutĂ©s
Medicines Adaptive Pathways to Patients (MAPPs): A Story of International Collaboration Leading to Implementation
After nearly a decade of discussion, analysis, and development, the Medicines Adaptive Pathways to Patients (MAPPs) initiative is beginning to see acceptance from regulators, industry, patients, and payers, with the first live pilot project initiated under the guidance of the European Medicines Agency in 2014. Although it is a significant achievement to see the first asset being placed into human trials under an adaptive pathway, there is much to be learned regarding the multinational and multi-stakeholder effort that has driven the growing acceptance of MAPPs as a methodology and concept, as well as the need for continued and increasing international collaboration to foster the wider adoption of MAPPs. Changes in available science and technology, as well as a number of challenges in the current system, outlined in this paper, are transforming approaches to medicines development and approval. It is these challenges that have led directly to the groundbreaking MAPPs collaboration between the Massachusetts Institute of Technology Center for Biomedical Innovationâs New Drug Development Paradigms Initiative, the EMA, patient, payer and health technology assessment groups, the European Federation of Pharmaceutical Industries and Associations, and the Innovative Medicines Initiativeâa European public-private partnership. This article examines the development of MAPPs, from inception of the concept, to the establishment of this trans-Atlantic initiative, and examines challenges for the future.SCOPUS: ar.jinfo:eu-repo/semantics/publishe
One science-driven approach for the regulatory implementation of alternative methods: A multi-sector perspective
EU regulations call for the use of alternative methods to animal testing. During the last decade, an increasing number of alternative approaches have been formally adopted. In parallel, new 3Rs-relevant technologies and mechanistic approaches have increasingly contributed to hazard identification and risk assessment evolution. In this changing landscape, an EPAA meeting reviewed the challenges that different industry sectors face in the implementation of alternative methods following a science-driven approach. Although clear progress was acknowledged in animal testing reduction and refinement thanks to an integration of scientifically robust approaches, the following challenges were identified: i) further characterization of toxicity pathways; ii) development of assays covering current scientific gaps, iii) better characterization of links between in vitro readouts and outcome in the target species; iv) better definition of alternative method applicability domains, and v) appropriate implementation of the available approaches. For areas having regulatory adopted alternative methods (e.g., vaccine batch testing), harmonised acceptance across geographical regions was considered critical for broader application. Overall, the main constraints to the application of non-animal alternatives are the still existing gaps in scientific knowledge and technological limitations. The science-driven identification of most appropriate methods is key for furthering a multi-sectorial decrease in animal testing.JRC.F.3-Chemicals Safety and Alternative Method