{"id":35505,"date":"2025-09-26T09:21:15","date_gmt":"2025-09-26T15:21:15","guid":{"rendered":"https:\/\/brakkeconsulting.com\/?p=35505"},"modified":"2025-09-26T09:24:04","modified_gmt":"2025-09-26T15:24:04","slug":"brakke-viewpoint-september-26-2025","status":"publish","type":"post","link":"https:\/\/brakkeconsulting.com\/pt\/brakke-viewpoint-september-26-2025\/","title":{"rendered":"Mirante de Brakke 26 de setembro de 2025"},"content":{"rendered":"<p>Continuo pensando no n\u00famero de produtos inovadores necess\u00e1rios para atender ao crescimento esperado do mercado de sa\u00fade animal nos pr\u00f3ximos 10 anos, especialmente considerando os parasiticidas gen\u00e9ricos que esperamos ver no mercado para c\u00e3es. Considerando o contexto da discuss\u00e3o em andamento sobre a redu\u00e7\u00e3o da necessidade de testes em animais no processo de aprova\u00e7\u00e3o da FDA, como isso impactar\u00e1 os planos de desenvolvimento futuros?<\/p>\n<p>Alguns dos benef\u00edcios esperados de menos testes em animais incluem:<\/p>\n<ul>\n<li>Redu\u00e7\u00e3o do prazo e do custo de aprova\u00e7\u00e3o, com alguns sugerindo que isso poderia reduzir o tempo e\/ou o custo em 20% ou mais<\/li>\n<li>\u00c9tica e bem-estar animal resultando na necessidade de menos animais para estudos terminais<\/li>\n<li>Utiliza\u00e7\u00e3o de modelos computacionais e sistemas microfisiol\u00f3gicos para facilitar estudos<\/li>\n<li>Aprova\u00e7\u00e3o geral acelerada para apoiar o crescimento do mercado<\/li>\n<li>Facilitar o desenvolvimento e o investimento em medicamentos que podem n\u00e3o atingir o status de sucesso de bilheteria<\/li>\n<\/ul>\n<p>Cada uma delas traz consigo o desafio de como gerir qualquer transi\u00e7\u00e3o:<\/p>\n<ul>\n<li>Investimento inicial em tecnologia<\/li>\n<li>Garantir que os par\u00e2metros regulat\u00f3rios necess\u00e1rios possam ser atingidos por estudos n\u00e3o envolvendo animais<\/li>\n<li>Tendo processos comprovados, confi\u00e1veis e consistentes que s\u00e3o validados<\/li>\n<li>M\u00e9todos alternativos precisos que quantificam corretamente o riscoCaos de viver uma mudan\u00e7a<\/li>\n<\/ul>\n<p>N\u00e3o h\u00e1 diretrizes claras para a ind\u00fastria da sa\u00fade animal, e a maioria suspeita que isso ser\u00e1 tratado primeiro pelo lado humano. \u00c9 imposs\u00edvel eliminar todos os estudos em animais para produtos veterin\u00e1rios. Acredito que podemos concordar que a ado\u00e7\u00e3o de novos m\u00e9todos que possam reduzir os prazos e os custos de aprova\u00e7\u00e3o, garantindo, ao mesmo tempo, a seguran\u00e7a e a efic\u00e1cia cont\u00ednuas dos medicamentos, ser\u00e1 ben\u00e9fica para a inova\u00e7\u00e3o futura.<\/p>\n<p><em>Chuck Johnson\u00a0\u00a0<\/em><\/p>","protected":false},"excerpt":{"rendered":"<p>Continuo pensando no n\u00famero de produtos inovadores necess\u00e1rios para atender ao crescimento esperado do mercado de sa\u00fade animal nos pr\u00f3ximos 10 anos, especialmente considerando os parasiticidas gen\u00e9ricos que esperamos ver no mercado para c\u00e3es. Considerando o contexto da discuss\u00e3o em andamento sobre a redu\u00e7\u00e3o da necessidade de testes em animais no processo de aprova\u00e7\u00e3o da FDA, como isso impactar\u00e1 os planos de desenvolvimento futuros? Alguns dos benef\u00edcios esperados de menos testes em animais incluem: Redu\u00e7\u00e3o do cronograma e do custo de aprova\u00e7\u00e3o, com alguns sugerindo que isso poderia reduzir o tempo e\/ou o custo em 20% ou mais \u00c9tica e bem-estar animal resultando na necessidade de menos animais para estudos terminais Uso de modelos computacionais e sistemas microfisiol\u00f3gicos para facilitar os estudos Aprova\u00e7\u00e3o geral acelerada para apoiar o crescimento do mercado Facilitar o desenvolvimento e o investimento em medicamentos que podem n\u00e3o atingir o status de sucesso Cada um deles traz o desafio de como gerenciar qualquer transi\u00e7\u00e3o: Investimento inicial em tecnologia Garantir que os pontos finais regulat\u00f3rios necess\u00e1rios possam ser atendidos por estudos sem animais Ter processos comprovados, confi\u00e1veis e consistentes que s\u00e3o validados M\u00e9todos alternativos precisos que quantificam corretamente o risco Caos de viver com uma mudan\u00e7a N\u00e3o h\u00e1 uma orienta\u00e7\u00e3o clara para a ind\u00fastria de sa\u00fade animal e a maioria suspeita que isso ser\u00e1 tratado primeiro no lado humano. \u00c9 imposs\u00edvel eliminar todos os estudos em animais para<\/p>\n<div class=\"view-full-post\"><a href=\"https:\/\/brakkeconsulting.com\/pt\/brakke-viewpoint-september-26-2025\/\" class=\"view-full-post-btn\">Ver postagem completa<\/a><\/div>\n<p>;<\/p>","protected":false},"author":19,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":"","_links_to":"","_links_to_target":""},"categories":[43],"tags":[],"class_list":["post-35505","post","type-post","status-publish","format-standard","hentry","category-viewpoints"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>News from Brakke Consulting<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/brakkeconsulting.com\/pt\/brakke-viewpoint-september-26-2025\/\" \/>\n<meta property=\"og:locale\" content=\"pt_PT\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"News from Brakke Consulting\" \/>\n<meta property=\"og:description\" content=\"I continue to think about the number of innovative products necessary to meet the expected growth of the animal health market over the next 10 years, especially given the generic parasiticides we expect to see on the market for dogs. When taken in the context of the ongoing discussion about reducing the necessity for animal testing in the FDA approval process, how will this impact future development plans? Some of the expected benefits of less animal testing include: Reduced timeline and cost of approval, with some suggesting it could reduce time and\/or cost by 20% or more Ethics and animal welfare resulting in fewer animals being needed for terminal studies Use of computational models and microphysiological systems to facilitate studies Overall expedited approval to support market growth Facilitate development and investment in medications that might not reach blockbuster status Each of these comes with the challenge of how to manage any transition: Initial investment in technology Ensuring the necessary regulatory endpoints can be met from non-animal studies Having proven, reliable and consistent processes that are validated Accurate alternative methods that correctly quantify riskChaos of living through a change There is no clear guidance for the animal health industry and most suspect this will be dealt with on the human side first. 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