{"id":186742,"date":"2025-04-15T21:13:32","date_gmt":"2025-04-15T21:13:32","guid":{"rendered":"https:\/\/peraltafinancing.com\/animal\/fda-roadmap-launched-a-cause-for-hope\/"},"modified":"2025-04-15T21:13:32","modified_gmt":"2025-04-15T21:13:32","slug":"fda-roadmap-launched-a-cause-for-hope","status":"publish","type":"post","link":"https:\/\/fivemor.com\/?p=186742","title":{"rendered":"FDA roadmap launched \u2013 a cause for hope?"},"content":{"rendered":"<p> <br \/>\n<\/p>\n<div>\n<p style=\"font-weight: 400;\">The roadmap cites overwhelming public support too, similar to that we\u2019ve found in the UK:<\/p>\n<p style=\"font-weight: 400;\"><em>\u2018Public sentiment is also supportive of this transition with a recent survey finding that &gt;85% of both <\/em><em>Democratic and Republican-identifying adults felt that animal experiments should be phased out in favor of more modern methods.\u2019<\/em><\/p>\n<p style=\"font-weight: 400;\">The roadmap admits that it is beginning with one class of medication monoclonal antibodies \u2013 mAb \u2013 and will then expand to similar ones and \u2018eventually\u2019 others. They do, however, outline the many issues with using animals in laboratories:<\/p>\n<p style=\"font-weight: 400;\"><em>\u2018In addition to inherent biological differences, stress of laboratory life and use in research can impact immune function, inflammatory responses, metabolism, and disease susceptibility and progression. Moreover, some safety risks may go undetected in animals \u2013 a notable example is the mAb TGN1412, which caused a life-threatening cytokine release syndrome in human volunteers despite appearing safe in preclinical monkey studies. That tragedy highlighted the limitations of animal models for certain immune-activating mAbs and spurred efforts to develop in vitro assays to better predict human-specific responses\u2019<\/em><\/p>\n<p style=\"font-weight: 400;\">Animal Aid reported on the TGN1412 tragedy over a decade ago.<\/p>\n<p style=\"font-weight: 400;\">The FDA roadmap describes several different \u2018New approach methodologies\u2019 which can be used, highlighting their benefits and the \u2018innovative approaches\u2019 which, when used in tandem, <em>\u2018might together cover the same ground as a traditional whole-animal study, but with greater accuracy and ethical acceptability\u2019<\/em><\/p>\n<p style=\"font-weight: 400;\">Animal Aid\u2019s roadmap has not tied itself to specific timelines, \u2013 we want an immediate end to all animal experiments, whilst the FDA aim to implement <em>\u2018reduced toxicity testing in animals at the FDA in the next 3 years\u2019. <\/em>They explain their ultimate goal is:<\/p>\n<p style=\"font-weight: 400;\"><em>\u2018that no conventional animal testing will be required for mAb safety, and eventually all drugs\/therapeutics \u2013 instead, a comprehensive integrated NAM toolbox (human cell models + computational models) will be the new standard.\u2019 <\/em><\/p>\n<p style=\"font-weight: 400;\">They outline specific steps, some of which appear in Animal Aid\u2019s roadmap, such as targeting the development of <em>\u2018NAM technologies\u2019<\/em> and also the importance of <em>\u2018Training, Communication, and Culture Change\u2019<\/em>. They also suggest proposing changes to international guidelines so that global regulations are aligned, that they will collaborate with other bodies to <em>\u2018accelerate progress by pooling expertise, data, and resources across government\u2019<\/em>. They also mention a <em>\u2018central database for validated NAMs\u2019<\/em>, a version of which should be available by the middle of this year.<\/p>\n<p style=\"font-weight: 400;\">We\u2019re encouraged by their talk of <em>\u2018workshops and outreach\u2019, \u2018cross-agency training and expertise exchange\u2019<\/em> and also of the FDA\u2019s wish to engage with others besides government agencies, such as <em>\u2018industry, academic, and NGO stakeholders\u2019<\/em>. This is something which the UK government has pledged and we look forward to working with them to shape the UK roadmap, so it can be as ambitious and progressive as possible.<\/p>\n<p style=\"font-weight: 400;\">The FDA roadmap is not written exactly as we would like, (they are a government department and we are an animal rights group), but their headline recommendations and policy considerations, are encouraging as is their concluding sentiment:<\/p>\n<p style=\"font-weight: 400;\"><em>\u2018By combining cutting-edge in vitro systems, advanced in silico modeling, and robust validation efforts \u2013 and by working collaboratively across government and industry \u2013 the FDA can ensure that drug development becomes more ethical, more efficient, and more predictive of human outcomes. Patients will benefit from safer and faster-to-market therapies, animals will be spared from testing, and the science of drug development will enter a new era aligned with 21st-century technology.\u2019<\/em><\/p>\n<p style=\"font-weight: 400;\">As Animal Aid wait to see the UK governments own roadmap, we hope that they will be even more progressive than the FDA, in order to end animal suffering, facilitate better, more humane science in the UK and to position us as the global leader in non-animal NAMs and science which is fit for the 21<sup>st<\/sup> Century!<\/p>\n<\/p><\/div>\n\n","protected":false},"excerpt":{"rendered":"<p>The roadmap cites overwhelming public support too, similar to that we\u2019ve found in the UK: \u2018Public sentiment is also supportive of this transition with a recent survey finding that &gt;85% of both Democratic and Republican-identifying adults felt that animal experiments should be phased out in favor of more modern methods.\u2019 The roadmap admits that it [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":186743,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[11766],"tags":[19889,5202,16701,19449],"dealstore":[],"offerexpiration":[],"class_list":["post-186742","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-animal","tag-fda","tag-hope","tag-launched","tag-roadmap"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FDA roadmap launched \u2013 a cause for hope? 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