{"id":3394,"date":"2015-09-28T14:00:26","date_gmt":"2015-09-28T12:00:26","guid":{"rendered":"https:\/\/int-ecole-org.flywheelsites.com\/?p=3394"},"modified":"2021-06-30T17:03:39","modified_gmt":"2021-06-30T15:03:39","slug":"reflexion-sur-la-creation-dune-filiere-industrielle-en-therapie-cellulaire","status":"publish","type":"post","link":"https:\/\/www.supbiotech.fr\/recherche-innovation-biotechnologie\/2015\/09\/28\/reflexion-sur-la-creation-dune-filiere-industrielle-en-therapie-cellulaire\/","title":{"rendered":"R\u00e9flexion sur la Cr\u00e9ation d&rsquo;une Fili\u00e8re Industrielle en Th\u00e9rapie Cellulaire"},"content":{"rendered":"\n<p>R\u00e9flexion sur la Cr\u00e9ation d&rsquo;une Fili\u00e8re Industrielle en\nTh\u00e9rapie Cellulaire<\/p>\n\n\n\n<p><strong>Un nouveau papier dans le journal Th\u00e9rapies, issu de\nla participation de Frank Yates aux excellentes Rencontres nationales de\nPharmacologie et Recherche clinique, pour l\u2019Innovation et l\u2019\u00c9valuation des\nTechnologies de Sant\u00e9 Tables rondes GIENS, organis\u00e9es le 5 au 6 octobre 2014<\/strong><\/p>\n\n\n\n<p><strong>Cr\u00e9er les conditions du succ\u00e8s de la fili\u00e8re\nindustrielle fran\u00e7aise des th\u00e9rapies innovantes<\/strong><\/p>\n\n\n\n<p><em>Pierre Noel Lirsac1, Olivier Blin2,\nJ\u00e9r\u00e9my Magalon3,4, les participants \u00e0 la table ronde N\u00b0 5 de Giens XXX :,\nPierre Angot5, Estelle de Barbeyrac6, Pascal Bilbault7, Elisabeth Bourg8, Odile\nDamour9, Patrick Faure10, Nicolas Ferry11, B\u00e9n\u00e9dicte Garbil5, J\u00e9r\u00f4me\nLarghero12, Marina Nguon12, Fran\u00e7ois Pattou13, St\u00e9phane Thumelin14 et Frank\nYates15<\/em><\/p>\n\n\n\n<ol><li>CELLforCURE, Groupe LFB, Les Ulis,\nFrance<\/li><li>Assistance Publique-H\u00f4pitaux de\nMarseille, Pharmacologie Clinique, CHU Timone, Marseille, France<\/li><li>Laboratoire de Culture et Th\u00e9rapie\nCellulaire, Assistance Publique des H\u00f4pitaux de Marseille, Marseille, France<\/li><li>Vascular Research Center Marseille,\nInserm UMRS 1076, Facult\u00e9 de Pharmacie, Marseille, France<\/li><li>Minist\u00e8re de l\u2019Economie, de\nl\u2019Industrie et du Num\u00e9rique, Paris, France<\/li><li>Genethon, Evry, France<\/li><li>Laboratoire Boehringer Ingelheim,\nReims, France<\/li><li>Laboratoire Novartis, Rueil\nMalmaison, France<\/li><li>Hospices Civils de Lyon, Lyon, France<\/li><li>SATT Sud Est, Marseille, France<\/li><li>ANSM, Saint Denis la Plaine, France<\/li><li>Assistance Publique-H\u00f4pitaux de\nParis, Paris, France<\/li><li>Centre Hospitalier R\u00e9gional\nUniversitaire, Lille, France<\/li><li>Inserm Transfert, Paris, France <\/li><li>Sup\u2019Biotech\/CEA, France <\/li><\/ol>\n\n\n\n<p><strong>R\u00e9sum\u00e9<\/strong><\/p>\n\n\n\n<p>Alors que l\u2019Union Europ\u00e9enne n\u2019avait\nfait que suivre les initiatives des Etats-Unis et du Japon en introduisant des\nr\u00e9gimes particuliers pour les m\u00e9dicaments orphelins, elle a instaur\u00e9 un statut\nparticulier \u00e0 une nouvelle cat\u00e9gorie de m\u00e9dicaments biologiques, les\nm\u00e9dicaments de th\u00e9rapie innovante (MTI) et y associe des r\u00e8gles sp\u00e9cifiques. Le\nr\u00e8glement europ\u00e9en (qui constitue l\u2019instrument juridique le plus \u00e9lev\u00e9 dans la\nhi\u00e9rarchie des textes du droit europ\u00e9en) CE n\u00b0 1394\/2007, publi\u00e9 en 2007\nd\u00e9finit sous ce terme les m\u00e9dicaments de th\u00e9rapie cellulaire somatique, les\nm\u00e9dicaments issus de l\u2019ing\u00e9nierie tissulaire, et les m\u00e9dicaments de th\u00e9rapie\ng\u00e9nique, \u00e9ventuellement coupl\u00e9s \u00e0 des dispositifs m\u00e9dicaux. L\u2019objectif affich\u00e9\n\u00e9tait double : \u00e0 la fois promouvoir leur industrialisation et leur acc\u00e8s au\nmarch\u00e9 tout en garantissant un niveau \u00e9lev\u00e9 de protection sanitaire aux\npatients. Depuis la publication du r\u00e8glement, les autorisations de mise sur le\nmarch\u00e9 d\u00e9livr\u00e9es en Europe sont peu nombreuses et ne sont pas accompagn\u00e9es par\nun succ\u00e8s commercial. Cependant, certaines \u00e9tudes r\u00e9centes montrent qu\u2019il\ns\u2019agit d\u2019un secteur en croissance et que la France reste la premi\u00e8re nation\neurop\u00e9enne en termes de nombre d\u2019essais cliniques. Cette table ronde a r\u00e9uni un\npanel de repr\u00e9sentants d\u2019acteurs publics et priv\u00e9s fran\u00e7ais du secteur des\nth\u00e9rapies innovantes. Les discussions ont \u00e9t\u00e9 focalis\u00e9es sur les conditions du\nsucc\u00e8s de la recherche translationnelle et de mani\u00e8re plus globale, de la\nfili\u00e8re fran\u00e7aise des th\u00e9rapies innovantes. Elles ont conduit \u00e0 identifier un\ncertain nombre de verrous dont la lev\u00e9e, formul\u00e9e sous forme de\nrecommandations, permettrait de faciliter le d\u00e9veloppement et le succ\u00e8s de\ncette fili\u00e8re.<\/p>\n\n\n\n<p>Mots cl\u00e9s : m\u00e9dicaments de th\u00e9rapies\ninnovantes \/ m\u00e9dicaments de th\u00e9rapies innovantes pour un patient \/ organisme\ng\u00e9n\u00e9tiquement modifi\u00e9 \/ acc\u00e8s au march\u00e9<\/p>\n\n\n\n<p>Journal Th\u00e9rapie, 70 1 (2015) 69-81<\/p>\n\n\n\n<p>Publi\u00e9 en ligne: 9 f\u00e9vrier 2015<\/p>\n\n\n\n<p>DOI: <a href=\"http:\/\/dx.doi.org\/10.2515\/therapie\/2014225\">http:\/\/dx.doi.org\/10.2515\/therapie\/2014225<\/a><\/p>\n\n\n\n<div class=\"wp-block-image\"><figure class=\"aligncenter is-resized\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.supbiotech.fr\/recherche-innovation-biotechnologie\/wp-content\/uploads\/2021\/06\/Image44-724x1024.png\" alt=\"\" class=\"wp-image-3395\" width=\"573\" height=\"810\" srcset=\"https:\/\/www.supbiotech.fr\/recherche-innovation-biotechnologie\/wp-content\/uploads\/2021\/06\/Image44-724x1024.png 724w, https:\/\/www.supbiotech.fr\/recherche-innovation-biotechnologie\/wp-content\/uploads\/2021\/06\/Image44-212x300.png 212w, https:\/\/www.supbiotech.fr\/recherche-innovation-biotechnologie\/wp-content\/uploads\/2021\/06\/Image44-768x1086.png 768w, https:\/\/www.supbiotech.fr\/recherche-innovation-biotechnologie\/wp-content\/uploads\/2021\/06\/Image44.png 850w\" sizes=\"auto, (max-width: 573px) 100vw, 573px\" \/><\/figure><\/div>\n\n\n\n<p style=\"text-align:center\"><a href=\"https:\/\/www.researchgate.net\/publication\/273326114_Creating_Conditions_for_the_Success_of_The_French_Industrial_Advanced_Therapy_Sector\">https:\/\/www.researchgate.net\/publication\/273326114_Creating_Conditions_for_the_Success_of_The_French_Industrial_Advanced_Therapy_Sector<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>R\u00e9flexion sur la Cr\u00e9ation d&rsquo;une Fili\u00e8re Industrielle en Th\u00e9rapie Cellulaire Un nouveau papier dans le journal Th\u00e9rapies, issu de la participation de Frank Yates aux excellentes Rencontres nationales de Pharmacologie et Recherche clinique, pour l\u2019Innovation et l\u2019\u00c9valuation des Technologies de Sant\u00e9 Tables rondes GIENS, organis\u00e9es le 5 au 6 octobre 2014 Cr\u00e9er les conditions du [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[237],"tags":[],"class_list":["post-3394","post","type-post","status-publish","format-standard","hentry","category-celltechs-fr"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.2 (Yoast SEO v27.2) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>R\u00e9flexion sur la Cr\u00e9ation d&#039;une Fili\u00e8re Industrielle en Th\u00e9rapie Cellulaire - La recherche \u00e0 SupBiotech<\/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:\/\/www.supbiotech.fr\/recherche-innovation-biotechnologie\/2015\/09\/28\/reflexion-sur-la-creation-dune-filiere-industrielle-en-therapie-cellulaire\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"R\u00e9flexion sur la Cr\u00e9ation d&#039;une Fili\u00e8re Industrielle en Th\u00e9rapie Cellulaire\" \/>\n<meta property=\"og:description\" content=\"R\u00e9flexion sur la Cr\u00e9ation d&rsquo;une Fili\u00e8re Industrielle en Th\u00e9rapie Cellulaire Un nouveau papier dans le journal Th\u00e9rapies, issu de la participation de Frank Yates aux excellentes Rencontres nationales de Pharmacologie et Recherche clinique, pour l\u2019Innovation et 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