{"id":28044,"date":"2022-10-28T07:17:15","date_gmt":"2022-10-28T05:17:15","guid":{"rendered":"https:\/\/kymos.com\/news\/nouvelles-lignes-directrices-preliminaires-de-la-fda-concernant-les-therapies-oligonucleotidiques\/"},"modified":"2022-10-28T07:17:15","modified_gmt":"2022-10-28T05:17:15","slug":"nouvelles-lignes-directrices-preliminaires-de-la-fda-concernant-les-therapies-oligonucleotidiques","status":"publish","type":"post","link":"https:\/\/kymos.com\/fr\/news\/nouvelles-lignes-directrices-preliminaires-de-la-fda-concernant-les-therapies-oligonucleotidiques\/","title":{"rendered":"Nouvelles lignes directrices pr\u00e9liminaires de la FDA concernant les th\u00e9rapies oligonucl\u00e9otidiques"},"content":{"rendered":"<p><span style=\"font-size: 14pt;\">En juin 2022, la FDA a publi\u00e9 une version pr\u00e9liminaire d&rsquo;une nouvelle directive relative aux <strong>\u00ab<\/strong><strong>&nbsp;Consid\u00e9rations de pharmacologie clinique pour le d\u00e9veloppement de th\u00e9rapies oligonucl\u00e9otidiques&nbsp;\u00bb.<\/strong> Cette directive formule des recommandations pour accompagner l&rsquo;industrie dans le d\u00e9veloppement de ces th\u00e9rapies. Elle soul\u00e8ve de nouveaux d\u00e9fis pour les d\u00e9veloppeurs et les fabricants de th\u00e9rapies oligonucl\u00e9otidiques. <strong>Maria Fauth, responsable du d\u00e9partement Oligonucl\u00e9otides chez Kymos<\/strong> , explique en quoi consiste cette nouvelle directive et comment Kymos peut vous accompagner dans sa mise en \u0153uvre. <\/span><\/p>\n<blockquote><p><span style=\"font-size: 14pt;\">\u00ab Le nouveau projet de directive de la FDA porte sur <strong>les recommandations relatives aux<\/strong> <strong>\u00e9valuations pharmacocin\u00e9tiques, pharmacodynamiques et de s\u00e9curit\u00e9 lors du d\u00e9veloppement de th\u00e9rapies oligonucl\u00e9otidiques<\/strong> . Chez Kymos, nous pouvons accompagner nos clients dans toutes ces activit\u00e9s \u00bb, explique Maria Fauth en guise d&rsquo;introduction. <\/span><\/p><\/blockquote>\n<p><span style=\"font-size: 14pt;\">Le d\u00e9veloppement d&rsquo;un oligonucl\u00e9otide th\u00e9rapeutique s&rsquo;inscrit \u00e0 bien des \u00e9gards dans la continuit\u00e9 du d\u00e9veloppement de m\u00e9dicaments \u00e0 base de petites mol\u00e9cules ou de produits biologiques. Cependant, les oligonucl\u00e9otides th\u00e9rapeutiques pr\u00e9sentent certaines caract\u00e9ristiques uniques, par rapport aux petites mol\u00e9cules ou aux produits biologiques, qui doivent \u00eatre prises en compte. Par exemple, la pharmacocin\u00e9tique plasmatique des oligonucl\u00e9otides th\u00e9rapeutiques peut ne pas refl\u00e9ter leur distribution dans le tissu cible, leur pharmacodynamique, leur innocuit\u00e9 ou leur efficacit\u00e9.  <\/span><\/p>\n<blockquote><p><span style=\"font-size: 14pt;\">Maria Fauth explique comment <strong>Kymos peut vous simplifier la vie<\/strong> \u00e0 ce stade de d\u00e9veloppement&nbsp;: \u00ab&nbsp;Nous <strong>d\u00e9terminons d\u2019abord les concentrations plasmatiques<\/strong> de l\u2019oligo-agent th\u00e9rapeutique par ELISA d\u2019hybridation ou LC-MS\/MS, selon des m\u00e9thodes bioanalytiques conformes aux BPL. Ensuite, nous r\u00e9alisons l\u2019 <g id=\"gid_2\">\u00e9valuation pharmacocin\u00e9tique<\/g> avec notre logiciel valid\u00e9 WinNonLin. Si les donn\u00e9es pharmacocin\u00e9tiques plasmatiques sont insuffisantes, Kymos peut \u00e9galement <strong>quantifier rapidement et facilement les biomarqueurs pharmacodynamiques requis<\/strong> gr\u00e2ce \u00e0 notre syst\u00e8me ECLA de pointe.&nbsp;\u00bb  <\/span><\/p><\/blockquote>\n<p><span style=\"font-size: 14pt;\">En fait, tout le processus a commenc\u00e9 pr\u00e9cis\u00e9ment par la d\u00e9termination de ce biomarqueur.<\/span><\/p>\n<blockquote><p><span style=\"font-size: 14pt;\">\u00ab Nous avons identifi\u00e9 le besoin de m\u00e9thodes bioanalytiques reproductibles il y a plusieurs ann\u00e9es et nous avons agi en cons\u00e9quence \u00bb, explique Maria Fauth. \u00ab D\u00e8s 2017, nous avons commenc\u00e9 \u00e0 d\u00e9velopper et \u00e0 valider des m\u00e9thodes bioanalytiques conformes aux BPL pour les microARN biomarqueurs par qPCR dans diff\u00e9rents tissus et biofluides. Depuis, nous avons \u00e9largi notre champ d&rsquo;action \u00e0 d&rsquo;autres acides nucl\u00e9iques et domaines d&rsquo;application. Aujourd&rsquo;hui, nous sommes confort\u00e9s dans notre choix, puisque la <strong>FDA souligne explicitement la n\u00e9cessit\u00e9 de m\u00e9thodes bioanalytiques valid\u00e9es<\/strong> dans cette nouvelle directive. \u00bb   <\/span><\/p><\/blockquote>\n<p><span style=\"font-size: 14pt;\">Cependant, la FDA va plus loin. Dans le nouveau projet de directive, elle souligne que les nouvelles modifications chimiques et autres <g id=\"gid_0\">oligonucl\u00e9otides th\u00e9rapeutiques peuvent provoquer des r\u00e9actions immunitaires ind\u00e9sirables<\/g> . Par cons\u00e9quent, les immunoessais des oligonucl\u00e9otides, mais surtout de leurs composants vecteurs et des conjugu\u00e9s oligonucl\u00e9otidiques \u00e0 des ligands de ciblage prot\u00e9ique, sont essentiels.  <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">En r\u00e9ponse \u00e0 la recommandation de la FDA, Maria Fauth pr\u00e9sente un bref aper\u00e7u de la vaste exp\u00e9rience de Kymos en mati\u00e8re d&rsquo;immunog\u00e9nicit\u00e9.<\/span><\/p>\n<blockquote><p><span style=\"font-size: 14pt;\">\u00ab Nous <strong>disposons de deux sites, l&rsquo;un \u00e0 Barcelone et l&rsquo;autre \u00e0 Francfort, d\u00e9di\u00e9s \u00e0 la d\u00e9termination de l&rsquo;immunog\u00e9nicit\u00e9.<\/strong> Mes coll\u00e8gues, tr\u00e8s exp\u00e9riment\u00e9s, sont pr\u00eats \u00e0 vous aider \u00e0 r\u00e9soudre tout probl\u00e8me d&rsquo;immunog\u00e9nicit\u00e9 qui pourrait survenir au cours de votre d\u00e9veloppement. \u00bb<\/span><\/p><\/blockquote>\n<p><span style=\"font-size: 14pt;\">En conclusion, toute l&rsquo;\u00e9quipe de Kymos se tient \u00e0 votre disposition pour vous conseiller sur la mise en \u0153uvre de cette directive et vous accompagner dans le d\u00e9veloppement de vos th\u00e9rapies oligonucl\u00e9otidiques. Pour plus d&rsquo;informations, veuillez nous contacter \u00e0 l&rsquo;adresse <a href=\"mailto:commercial@kymos.com\" data-wpel-link=\"internal\">commercial@kymos.com<\/a> . <strong>Vous pourrez \u00e9galement rencontrer Maria Fauth en personne lors du salon TIDES, qui se tiendra du 16 au 18 novembre \u00e0 Vienne, en Autriche.<\/strong> <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Pour votre commodit\u00e9, vous trouverez le guide complet <a href=\"https:\/\/www.fda.gov\/media\/159414\/download\" data-wpel-link=\"external\">ici<\/a> .<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>En juin 2022, la FDA a publi\u00e9 une version pr\u00e9liminaire  [&#8230;]<\/p>\n","protected":false},"author":7,"featured_media":28047,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[257,267],"tags":[],"class_list":["post-28044","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-bioanalyse","category-cmc"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Th\u00e9rapie par oligonucl\u00e9otides | Nouvelle directive de la FDA<\/title>\n<meta name=\"description\" content=\"Apprenez-en davantage sur le nouveau projet de lignes directrices de la FDA concernant les th\u00e9rapies oligonucl\u00e9otidiques, publi\u00e9 en juin 2022. 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