{"id":3448,"date":"2025-11-06T16:56:38","date_gmt":"2025-11-06T15:56:38","guid":{"rendered":"https:\/\/www.technoscience.it\/?page_id=3448"},"modified":"2025-11-17T19:42:05","modified_gmt":"2025-11-17T18:42:05","slug":"pipeline-biofarmaci-trl","status":"publish","type":"page","link":"https:\/\/www.technoscience.it\/en\/servizi\/biotecnologie-e-innovazione\/biopharma-terapie\/pipeline-biofarmaci-trl\/","title":{"rendered":"Biopharmaceutical Pipelines: From Proof of Concept to TRL 7"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"3448\" class=\"elementor elementor-3448\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-3f8e8db elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"3f8e8db\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-extended\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-a07f2dc\" data-id=\"a07f2dc\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-c9662aa elementor-widget elementor-widget-theme-post-featured-image elementor-widget-image\" data-id=\"c9662aa\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-featured-image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"800\" height=\"800\" src=\"https:\/\/www.technoscience.it\/wp-content\/uploads\/2025\/11\/trl7-1024x1024.jpg\" class=\"attachment-large size-large wp-image-3462\" alt=\"Multidisciplinary team reviewing vials, technical documents and KPI\/TRL dashboards for a biopharmaceutical development pipeline\" srcset=\"https:\/\/www.technoscience.it\/wp-content\/uploads\/2025\/11\/trl7-1024x1024.jpg 1024w, https:\/\/www.technoscience.it\/wp-content\/uploads\/2025\/11\/trl7-300x300.jpg 300w, https:\/\/www.technoscience.it\/wp-content\/uploads\/2025\/11\/trl7-150x150.jpg 150w, https:\/\/www.technoscience.it\/wp-content\/uploads\/2025\/11\/trl7-768x768.jpg 768w, https:\/\/www.technoscience.it\/wp-content\/uploads\/2025\/11\/trl7-1536x1536.jpg 1536w, https:\/\/www.technoscience.it\/wp-content\/uploads\/2025\/11\/trl7-12x12.jpg 12w, https:\/\/www.technoscience.it\/wp-content\/uploads\/2025\/11\/trl7.jpg 1920w\" sizes=\"(max-width: 800px) 100vw, 800px\" title=\"Biopharmaceutical Pipeline \u2013 Milestones and KPIs\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-ffd87b2\" data-id=\"ffd87b2\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-5d5f4e1 elementor-widget elementor-widget-heading\" data-id=\"5d5f4e1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Pipeline di biofarmaci: dal proof-of-concept al TRL7<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9ab876a elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"9ab876a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-06b7306 elementor-widget elementor-widget-text-editor\" data-id=\"06b7306\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Un biofarmaco non nasce il giorno in cui lo si formula: comincia a esistere quando l\u2019ipotesi biologica dimostra di saper reggere ai primi urti della realt\u00e0. Il <strong>proof-of-concept<\/strong> \u00e8 quel passaggio in cui un\u2019idea smette di essere una promessa e diventa un risultato misurabile; da l\u00ec parte una traiettoria che, se condotta con metodo, porta al <strong>TRL7<\/strong>, cio\u00e8 alla dimostrazione in ambiente operativo con processi, qualit\u00e0 e sicurezza sotto controllo. In mezzo c\u2019\u00e8 un lavoro paziente: <strong>CMC<\/strong> che non tradisce in scala, disegni di studio che rispondono a domande cliniche vere, controlli statistici che prevengono illusioni, e una relazione adulta con i requisiti <strong>EMA\/FDA<\/strong>. Questa pagina racconta come impostiamo quella traiettoria, quali <strong>milestone<\/strong> non possono mancare e quali <strong>KPI<\/strong> usiamo per non perderci.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-b9d5dbe elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"b9d5dbe\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-extended\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-bf15449\" data-id=\"bf15449\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-7787d0e elementor-position-inline-start elementor-tablet-position-inline-start elementor-view-default elementor-mobile-position-block-start elementor-widget elementor-widget-icon-box\" data-id=\"7787d0e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-box-wrapper\">\n\n\t\t\t\t\t\t<div class=\"elementor-icon-box-icon\">\n\t\t\t\t<span  class=\"elementor-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-fingerprint\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256.12 245.96c-13.25 0-24 10.74-24 24 1.14 72.25-8.14 141.9-27.7 211.55-2.73 9.72 2.15 30.49 23.12 30.49 10.48 0 20.11-6.92 23.09-17.52 13.53-47.91 31.04-125.41 29.48-224.52.01-13.25-10.73-24-23.99-24zm-.86-81.73C194 164.16 151.25 211.3 152.1 265.32c.75 47.94-3.75 95.91-13.37 142.55-2.69 12.98 5.67 25.69 18.64 28.36 13.05 2.67 25.67-5.66 28.36-18.64 10.34-50.09 15.17-101.58 14.37-153.02-.41-25.95 19.92-52.49 54.45-52.34 31.31.47 57.15 25.34 57.62 55.47.77 48.05-2.81 96.33-10.61 143.55-2.17 13.06 6.69 25.42 19.76 27.58 19.97 3.33 26.81-15.1 27.58-19.77 8.28-50.03 12.06-101.21 11.27-152.11-.88-55.8-47.94-101.88-104.91-102.72zm-110.69-19.78c-10.3-8.34-25.37-6.8-33.76 3.48-25.62 31.5-39.39 71.28-38.75 112 .59 37.58-2.47 75.27-9.11 112.05-2.34 13.05 6.31 25.53 19.36 27.89 20.11 3.5 27.07-14.81 27.89-19.36 7.19-39.84 10.5-80.66 9.86-121.33-.47-29.88 9.2-57.88 28-80.97 8.35-10.28 6.79-25.39-3.49-33.76zm109.47-62.33c-15.41-.41-30.87 1.44-45.78 4.97-12.89 3.06-20.87 15.98-17.83 28.89 3.06 12.89 16 20.83 28.89 17.83 11.05-2.61 22.47-3.77 34-3.69 75.43 1.13 137.73 61.5 138.88 134.58.59 37.88-1.28 76.11-5.58 113.63-1.5 13.17 7.95 25.08 21.11 26.58 16.72 1.95 25.51-11.88 26.58-21.11a929.06 929.06 0 0 0 5.89-119.85c-1.56-98.75-85.07-180.33-186.16-181.83zm252.07 121.45c-2.86-12.92-15.51-21.2-28.61-18.27-12.94 2.86-21.12 15.66-18.26 28.61 4.71 21.41 4.91 37.41 4.7 61.6-.11 13.27 10.55 24.09 23.8 24.2h.2c13.17 0 23.89-10.61 24-23.8.18-22.18.4-44.11-5.83-72.34zm-40.12-90.72C417.29 43.46 337.6 1.29 252.81.02 183.02-.82 118.47 24.91 70.46 72.94 24.09 119.37-.9 181.04.14 246.65l-.12 21.47c-.39 13.25 10.03 24.31 23.28 24.69.23.02.48.02.72.02 12.92 0 23.59-10.3 23.97-23.3l.16-23.64c-.83-52.5 19.16-101.86 56.28-139 38.76-38.8 91.34-59.67 147.68-58.86 69.45 1.03 134.73 35.56 174.62 92.39 7.61 10.86 22.56 13.45 33.42 5.86 10.84-7.62 13.46-22.59 5.84-33.43z\"><\/path><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t<div class=\"elementor-icon-box-content\">\n\n\t\t\t\t\t\t\t\t\t<h3 class=\"elementor-icon-box-title\">\n\t\t\t\t\t\t<span  >\n\t\t\t\t\t\t\tDal banco al primo \u201cs\u00ec\u201d: il proof-of-concept che vale\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a418f6d elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"a418f6d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-edabc6c elementor-widget elementor-widget-text-editor\" data-id=\"edabc6c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Un <strong>PoC<\/strong> credibile chiarisce tre cose. Primo: <strong>meccanismo d\u2019azione<\/strong> e razionale biologico non sono un racconto, ma una catena di evidenze coerenti (in vitro, ex vivo, modelli preclinici appropriati). Secondo: esiste un <strong>endpoint<\/strong> misurabile che si muove nella direzione attesa quando l\u2019intervento \u00e8 presente. Terzo: il <strong>profilo di sicurezza<\/strong> iniziale \u00e8 compatibile con il prosieguo. Questo \u201cs\u00ec\u201d non \u00e8 definitivo, ma basta a trasformare un progetto in <strong>programma<\/strong>: definisce ipotesi, risorse, tempi e rischi in un linguaggio che investitori, clinici e qualit\u00e0 possono condividere.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8dc073d elementor-position-inline-start elementor-tablet-position-inline-start elementor-view-default elementor-mobile-position-block-start elementor-widget elementor-widget-icon-box\" data-id=\"8dc073d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-box-wrapper\">\n\n\t\t\t\t\t\t<div class=\"elementor-icon-box-icon\">\n\t\t\t\t<span  class=\"elementor-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-filter\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M487.976 0H24.028C2.71 0-8.047 25.866 7.058 40.971L192 225.941V432c0 7.831 3.821 15.17 10.237 19.662l80 55.98C298.02 518.69 320 507.493 320 487.98V225.941l184.947-184.97C520.021 25.896 509.338 0 487.976 0z\"><\/path><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t<div class=\"elementor-icon-box-content\">\n\n\t\t\t\t\t\t\t\t\t<h3 class=\"elementor-icon-box-title\">\n\t\t\t\t\t\t<span  >\n\t\t\t\t\t\t\tCMC: qualit\u00e0 che non si sbriciola quando cresci\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3a3d6fb elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"3a3d6fb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bffc321 elementor-widget elementor-widget-text-editor\" data-id=\"bffc321\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>La <strong>Chemistry, Manufacturing and Controls<\/strong> \u00e8 il cuore silenzioso del biotech. Un processo che funziona a banco pu\u00f2 fallire al primo salto di scala se purezza, resa e stabilit\u00e0 non sono state progettate per crescere. Qui si decide la <strong>tracciabilit\u00e0<\/strong> dei lotti, la coerenza tra <strong>processo<\/strong> e <strong>prodotto<\/strong>, la strategia di <strong>analytical comparability<\/strong> quando cambiano impianti o materie prime. La domanda \u00e8 semplice e spietata: quello che prometti oggi lo potrai <strong>rifare uguale<\/strong> domani, tra sei mesi, in un altro sito? Se la risposta vacilla, la pipeline si inceppa pi\u00f9 avanti, quando costa dieci volte tanto.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-99f9daa\" data-id=\"99f9daa\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-a7fcec9 elementor-widget elementor-widget-wp-widget-tag_cloud\" data-id=\"a7fcec9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"wp-widget-tag_cloud.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h5>Esplora i temi<\/h5><nav aria-label=\"Esplora i temi\"><div class=\"tagcloud\"><a href=\"https:\/\/www.technoscience.it\/en\/news\/tag\/cardiologia\/\" class=\"tag-cloud-link tag-link-191 tag-link-position-1\" style=\"font-size: 15.225806451613pt;\" aria-label=\"Cardiologia (5 items)\">Cardiologia<\/a>\n<a href=\"https:\/\/www.technoscience.it\/en\/news\/tag\/dieta-mediterranea\/\" class=\"tag-cloud-link tag-link-137 tag-link-position-2\" style=\"font-size: 10.709677419355pt;\" aria-label=\"dieta mediterranea (2 items)\">dieta mediterranea<\/a>\n<a href=\"https:\/\/www.technoscience.it\/en\/news\/tag\/digital-health\/\" class=\"tag-cloud-link tag-link-188 tag-link-position-3\" style=\"font-size: 16.279569892473pt;\" aria-label=\"Digital Health (6 items)\">Digital Health<\/a>\n<a href=\"https:\/\/www.technoscience.it\/en\/news\/tag\/ecosistema-dellinnovazione\/\" class=\"tag-cloud-link tag-link-185 tag-link-position-4\" style=\"font-size: 21.548387096774pt;\" aria-label=\"Ecosistema dell\u2019innovazione (15 items)\">Ecosistema dell\u2019innovazione<\/a>\n<a href=\"https:\/\/www.technoscience.it\/en\/news\/tag\/flebologia\/\" class=\"tag-cloud-link tag-link-181 tag-link-position-5\" style=\"font-size: 12.516129032258pt;\" aria-label=\"Flebologia (3 items)\">Flebologia<\/a>\n<a href=\"https:\/\/www.technoscience.it\/en\/news\/tag\/formazione-avanzata\/\" class=\"tag-cloud-link tag-link-182 tag-link-position-6\" style=\"font-size: 17.784946236559pt;\" aria-label=\"Formazione avanzata (8 items)\">Formazione avanzata<\/a>\n<a href=\"https:\/\/www.technoscience.it\/en\/news\/tag\/iba\/\" class=\"tag-cloud-link tag-link-198 tag-link-position-7\" style=\"font-size: 8pt;\" aria-label=\"IBA (1 item)\">IBA<\/a>\n<a href=\"https:\/\/www.technoscience.it\/en\/news\/tag\/industria-4-0\/\" class=\"tag-cloud-link tag-link-193 tag-link-position-8\" style=\"font-size: 10.709677419355pt;\" aria-label=\"Industria 4.0 (2 items)\">Industria 4.0<\/a>\n<a href=\"https:\/\/www.technoscience.it\/en\/news\/tag\/innovazione\/\" class=\"tag-cloud-link tag-link-64 tag-link-position-9\" style=\"font-size: 20.795698924731pt;\" aria-label=\"innovazione (13 items)\">innovazione<\/a>\n<a href=\"https:\/\/www.technoscience.it\/en\/news\/tag\/intelligenza-artificiale\/\" class=\"tag-cloud-link tag-link-39 tag-link-position-10\" style=\"font-size: 14.021505376344pt;\" aria-label=\"intelligenza artificiale (4 items)\">intelligenza artificiale<\/a>\n<a href=\"https:\/\/www.technoscience.it\/en\/news\/tag\/international-biotech-academy\/\" class=\"tag-cloud-link tag-link-199 tag-link-position-11\" style=\"font-size: 8pt;\" aria-label=\"International Biotech Academy (1 item)\">International Biotech Academy<\/a>\n<a href=\"https:\/\/www.technoscience.it\/en\/news\/tag\/invitalia\/\" class=\"tag-cloud-link tag-link-155 tag-link-position-12\" style=\"font-size: 8pt;\" aria-label=\"Invitalia (1 item)\">Invitalia<\/a>\n<a href=\"https:\/\/www.technoscience.it\/en\/news\/tag\/life-sciences\/\" class=\"tag-cloud-link tag-link-183 tag-link-position-13\" style=\"font-size: 22pt;\" aria-label=\"Life Sciences (16 items)\">Life Sciences<\/a>\n<a href=\"https:\/\/www.technoscience.it\/en\/news\/tag\/medicina-rigenerativa\/\" class=\"tag-cloud-link tag-link-129 tag-link-position-14\" style=\"font-size: 14.021505376344pt;\" aria-label=\"medicina rigenerativa (4 items)\">medicina rigenerativa<\/a>\n<a href=\"https:\/\/www.technoscience.it\/en\/news\/tag\/medicina-traslazionale\/\" class=\"tag-cloud-link tag-link-192 tag-link-position-15\" style=\"font-size: 15.225806451613pt;\" aria-label=\"Medicina traslazionale (5 items)\">Medicina traslazionale<\/a>\n<a href=\"https:\/\/www.technoscience.it\/en\/news\/tag\/networking-scientifico\/\" class=\"tag-cloud-link tag-link-195 tag-link-position-16\" style=\"font-size: 10.709677419355pt;\" aria-label=\"Networking scientifico (2 items)\">Networking scientifico<\/a>\n<a href=\"https:\/\/www.technoscience.it\/en\/news\/tag\/nutraceutica\/\" class=\"tag-cloud-link tag-link-186 tag-link-position-17\" style=\"font-size: 10.709677419355pt;\" aria-label=\"Nutraceutica (2 items)\">Nutraceutica<\/a>\n<a href=\"https:\/\/www.technoscience.it\/en\/news\/tag\/nutrizione-e-prevenzione\/\" class=\"tag-cloud-link tag-link-196 tag-link-position-18\" style=\"font-size: 10.709677419355pt;\" aria-label=\"Nutrizione e prevenzione (2 items)\">Nutrizione e prevenzione<\/a>\n<a href=\"https:\/\/www.technoscience.it\/en\/news\/tag\/pnrr\/\" class=\"tag-cloud-link tag-link-122 tag-link-position-19\" style=\"font-size: 14.021505376344pt;\" aria-label=\"PNRR (4 items)\">PNRR<\/a>\n<a href=\"https:\/\/www.technoscience.it\/en\/news\/tag\/ricerca-applicata\/\" class=\"tag-cloud-link tag-link-121 tag-link-position-20\" style=\"font-size: 20.795698924731pt;\" aria-label=\"Ricerca applicata (13 items)\">Ricerca applicata<\/a>\n<a href=\"https:\/\/www.technoscience.it\/en\/news\/tag\/rome-future-week\/\" class=\"tag-cloud-link tag-link-190 tag-link-position-21\" style=\"font-size: 10.709677419355pt;\" aria-label=\"Rome Future Week (2 items)\">Rome Future Week<\/a>\n<a href=\"https:\/\/www.technoscience.it\/en\/news\/tag\/rome-technopole\/\" class=\"tag-cloud-link tag-link-117 tag-link-position-22\" style=\"font-size: 10.709677419355pt;\" aria-label=\"Rome Technopole (2 items)\">Rome Technopole<\/a>\n<a href=\"https:\/\/www.technoscience.it\/en\/news\/tag\/sistema-invitalia\/\" class=\"tag-cloud-link tag-link-156 tag-link-position-23\" style=\"font-size: 8pt;\" aria-label=\"Sistema Invitalia (1 item)\">Sistema Invitalia<\/a>\n<a href=\"https:\/\/www.technoscience.it\/en\/news\/tag\/sostenibilita\/\" class=\"tag-cloud-link tag-link-184 tag-link-position-24\" style=\"font-size: 16.279569892473pt;\" aria-label=\"Sostenibilit\u00e0 (6 items)\">Sostenibilit\u00e0<\/a>\n<a href=\"https:\/\/www.technoscience.it\/en\/news\/tag\/startup-e-pmi\/\" class=\"tag-cloud-link tag-link-197 tag-link-position-25\" style=\"font-size: 12.516129032258pt;\" aria-label=\"Startup e PMI (3 items)\">Startup e PMI<\/a>\n<a href=\"https:\/\/www.technoscience.it\/en\/news\/tag\/tecnologie-indossabili\/\" class=\"tag-cloud-link tag-link-194 tag-link-position-26\" style=\"font-size: 12.516129032258pt;\" aria-label=\"Tecnologie indossabili (3 items)\">Tecnologie indossabili<\/a>\n<a href=\"https:\/\/www.technoscience.it\/en\/news\/tag\/telemedicina\/\" class=\"tag-cloud-link tag-link-187 tag-link-position-27\" style=\"font-size: 14.021505376344pt;\" aria-label=\"Telemedicina (4 items)\">Telemedicina<\/a>\n<a href=\"https:\/\/www.technoscience.it\/en\/news\/tag\/trasferimento-tecnologico\/\" class=\"tag-cloud-link tag-link-88 tag-link-position-28\" style=\"font-size: 17.784946236559pt;\" aria-label=\"Trasferimento tecnologico (8 items)\">Trasferimento tecnologico<\/a>\n<a href=\"https:\/\/www.technoscience.it\/en\/news\/tag\/trasformazione-digitale\/\" class=\"tag-cloud-link tag-link-189 tag-link-position-29\" style=\"font-size: 10.709677419355pt;\" aria-label=\"Trasformazione digitale (2 items)\">Trasformazione digitale<\/a><\/div>\n<\/nav>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-f5f07ea elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"f5f07ea\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-extended\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-688beaa\" data-id=\"688beaa\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-21171d4 elementor-position-inline-start elementor-tablet-position-inline-start elementor-view-default elementor-mobile-position-block-start elementor-widget elementor-widget-icon-box\" data-id=\"21171d4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-box-wrapper\">\n\n\t\t\t\t\t\t<div class=\"elementor-icon-box-icon\">\n\t\t\t\t<span  class=\"elementor-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-hand-holding-medical\" viewBox=\"0 0 576 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M159.88,175.82h64v64a16,16,0,0,0,16,16h64a16,16,0,0,0,16-16v-64h64a16,16,0,0,0,16-16v-64a16,16,0,0,0-16-16h-64v-64a16,16,0,0,0-16-16h-64a16,16,0,0,0-16,16v64h-64a16,16,0,0,0-16,16v64A16,16,0,0,0,159.88,175.82ZM568.07,336.13a39.91,39.91,0,0,0-55.93-8.47L392.47,415.84H271.86a16,16,0,0,1,0-32H350.1c16,0,30.75-10.87,33.37-26.61a32.06,32.06,0,0,0-31.62-37.38h-160a117.7,117.7,0,0,0-74.12,26.25l-46.5,37.74H15.87a16.11,16.11,0,0,0-16,16v96a16.11,16.11,0,0,0,16,16h347a104.8,104.8,0,0,0,61.7-20.27L559.6,392A40,40,0,0,0,568.07,336.13Z\"><\/path><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t<div class=\"elementor-icon-box-content\">\n\n\t\t\t\t\t\t\t\t\t<h3 class=\"elementor-icon-box-title\">\n\t\t\t\t\t\t<span  >\n\t\t\t\t\t\t\tIl disegno di studio che risponde, non quello che compiace\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7a6d86b elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"7a6d86b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-054bfd3 elementor-widget elementor-widget-text-editor\" data-id=\"054bfd3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Un buon <strong>design<\/strong> nasce dalla domanda giusta. Qual \u00e8 l\u2019effetto clinico plausibile? In quale popolazione si manifesta con pi\u00f9 chiarezza? Qual \u00e8 l\u2019<strong>endpoint<\/strong> che cattura quell\u2019effetto senza prestarsi a interpretazioni arbitrarie? In fase precoce privilegi <strong>endpoints<\/strong> di <strong>biologia<\/strong> (marcatori di target engagement, surrogati robusti), in fase successiva misuri <strong>esiti clinici<\/strong> che contano per pazienti e regolatori. Ogni scelta statistica\u2014randomizzazione, stratificazione, potenza\u2014va dichiarata <strong>a priori<\/strong>; i cambi di rotta sono possibili, ma solo se giustificati e tracciati. La differenza tra un segnale e un miraggio, spesso, sta qui.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3fc2d84 elementor-position-inline-start elementor-tablet-position-inline-start elementor-view-default elementor-mobile-position-block-start elementor-widget elementor-widget-icon-box\" data-id=\"3fc2d84\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-box-wrapper\">\n\n\t\t\t\t\t\t<div class=\"elementor-icon-box-icon\">\n\t\t\t\t<span  class=\"elementor-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-flushed\" viewBox=\"0 0 496 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M344 200c-13.3 0-24 10.7-24 24s10.7 24 24 24 24-10.7 24-24-10.7-24-24-24zm-192 0c-13.3 0-24 10.7-24 24s10.7 24 24 24 24-10.7 24-24-10.7-24-24-24zM248 8C111 8 0 119 0 256s111 248 248 248 248-111 248-248S385 8 248 8zM80 224c0-39.8 32.2-72 72-72s72 32.2 72 72-32.2 72-72 72-72-32.2-72-72zm232 176H184c-21.2 0-21.2-32 0-32h128c21.2 0 21.2 32 0 32zm32-104c-39.8 0-72-32.2-72-72s32.2-72 72-72 72 32.2 72 72-32.2 72-72 72z\"><\/path><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t<div class=\"elementor-icon-box-content\">\n\n\t\t\t\t\t\t\t\t\t<h3 class=\"elementor-icon-box-title\">\n\t\t\t\t\t\t<span  >\n\t\t\t\t\t\t\tLe milestone che non puoi saltare\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f69b189 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"f69b189\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-97d1dee elementor-widget elementor-widget-text-editor\" data-id=\"97d1dee\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Dopo PoC e <strong>preclinica regolatoria<\/strong> arrivano i passaggi umani. <strong>Fase 1<\/strong>: sicurezza, farmacocinetica, prima caratterizzazione del profilo dose-risposta. <strong>Fase 2<\/strong>: conferma di segnale su popolazioni pi\u00f9 definite, scelta della dose e del regime. <strong>Fase 3<\/strong>: verifica definitiva su <strong>endpoint clinici<\/strong> concordati con i regolatori. Tra una fase e l\u2019altra non c\u2019\u00e8 un vuoto: ci sono <strong>Go\/No-Go<\/strong> legati a KPI specifici (sicurezza, coerenza degli esiti, fattibilit\u00e0 operativa, integrit\u00e0 dei dati). La pipeline sana non \u201ctira dritto\u201d: <strong>decide<\/strong>.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2ecb792 elementor-position-inline-start elementor-tablet-position-inline-start elementor-view-default elementor-mobile-position-block-start elementor-widget elementor-widget-icon-box\" data-id=\"2ecb792\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-box-wrapper\">\n\n\t\t\t\t\t\t<div class=\"elementor-icon-box-icon\">\n\t\t\t\t<span  class=\"elementor-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-file-medical\" viewBox=\"0 0 384 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M377 105L279.1 7c-4.5-4.5-10.6-7-17-7H256v128h128v-6.1c0-6.3-2.5-12.4-7-16.9zm-153 31V0H24C10.7 0 0 10.7 0 24v464c0 13.3 10.7 24 24 24h336c13.3 0 24-10.7 24-24V160H248c-13.2 0-24-10.8-24-24zm64 160v48c0 4.4-3.6 8-8 8h-56v56c0 4.4-3.6 8-8 8h-48c-4.4 0-8-3.6-8-8v-56h-56c-4.4 0-8-3.6-8-8v-48c0-4.4 3.6-8 8-8h56v-56c0-4.4 3.6-8 8-8h48c4.4 0 8 3.6 8 8v56h56c4.4 0 8 3.6 8 8z\"><\/path><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t<div class=\"elementor-icon-box-content\">\n\n\t\t\t\t\t\t\t\t\t<h3 class=\"elementor-icon-box-title\">\n\t\t\t\t\t\t<span  >\n\t\t\t\t\t\t\tKPI per non auto-ingannarci\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cb08623 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"cb08623\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4ae3f29 elementor-widget elementor-widget-text-editor\" data-id=\"4ae3f29\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Usiamo indicatori che raccontano la <strong>sostanza<\/strong>, non solo l\u2019avanzamento di Gantt. In CMC: resa, purezza, <strong>stabilit\u00e0<\/strong> reale, tasso di <strong>deviation<\/strong> e tempi di rilascio lotto. Nello sviluppo clinico: <strong>arruolamento<\/strong> e <strong>retention<\/strong> vs piano, aderenza al protocollo, qualit\u00e0 del dato (query, missingness), consistenza dell\u2019effetto tra sottogruppi pre-specificati, <strong>safety signals<\/strong> e confronto con lo <strong>standard of care<\/strong>. Nel percorso regolatorio: puntualit\u00e0 delle <strong>interazioni<\/strong> con EMA\/FDA, chiarezza delle <strong>scientific advice<\/strong>, stato dei <strong>CMC packages<\/strong> e del <strong>dossier<\/strong>.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-37106fb elementor-position-inline-start elementor-tablet-position-inline-start elementor-view-default elementor-mobile-position-block-start elementor-widget elementor-widget-icon-box\" data-id=\"37106fb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-box-wrapper\">\n\n\t\t\t\t\t\t<div class=\"elementor-icon-box-icon\">\n\t\t\t\t<span  class=\"elementor-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-flask\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M437.2 403.5L320 215V64h8c13.3 0 24-10.7 24-24V24c0-13.3-10.7-24-24-24H120c-13.3 0-24 10.7-24 24v16c0 13.3 10.7 24 24 24h8v151L10.8 403.5C-18.5 450.6 15.3 512 70.9 512h306.2c55.7 0 89.4-61.5 60.1-108.5zM137.9 320l48.2-77.6c3.7-5.2 5.8-11.6 5.8-18.4V64h64v160c0 6.9 2.2 13.2 5.8 18.4l48.2 77.6h-172z\"><\/path><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t<div class=\"elementor-icon-box-content\">\n\n\t\t\t\t\t\t\t\t\t<h3 class=\"elementor-icon-box-title\">\n\t\t\t\t\t\t<span  >\n\t\t\t\t\t\t\tVerso il TRL7: la dimostrazione che si pu\u00f2 davvero fare\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cf91280 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"cf91280\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5de8d27 elementor-widget elementor-widget-text-editor\" data-id=\"5de8d27\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Arrivare a <strong>TRL7<\/strong> significa aver dimostrato che il prodotto non vive solo nel recinto dello studio. La produzione \u00e8 <strong>ripetibile<\/strong> su scala pilota\/industriale, la <strong>catena di fornitura<\/strong> \u00e8 affidabile, la <strong>qualit\u00e0<\/strong> regge, la <strong>sicurezza<\/strong> \u00e8 presidiata e il <strong>valore clinico<\/strong> \u00e8 documentato con evidenza sufficiente a parlare con <strong>payer<\/strong> e <strong>HTA<\/strong>. \u00c8 il punto in cui il biofarmaco pu\u00f2 essere valutato in <strong>ambienti operativi<\/strong> realistici, con le complicazioni della vita vera: logistica, tempistiche di somministrazione, interazioni con altre terapie, aderenza.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-d487a8e elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"d487a8e\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-extended\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-9c728c4\" data-id=\"9c728c4\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-d539d93 elementor-position-inline-start elementor-tablet-position-inline-start elementor-view-default elementor-mobile-position-block-start elementor-widget elementor-widget-icon-box\" data-id=\"d539d93\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-box-wrapper\">\n\n\t\t\t\t\t\t<div class=\"elementor-icon-box-icon\">\n\t\t\t\t<span  class=\"elementor-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-file-signature\" viewBox=\"0 0 576 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M218.17 424.14c-2.95-5.92-8.09-6.52-10.17-6.52s-7.22.59-10.02 6.19l-7.67 15.34c-6.37 12.78-25.03 11.37-29.48-2.09L144 386.59l-10.61 31.88c-5.89 17.66-22.38 29.53-41 29.53H80c-8.84 0-16-7.16-16-16s7.16-16 16-16h12.39c4.83 0 9.11-3.08 10.64-7.66l18.19-54.64c3.3-9.81 12.44-16.41 22.78-16.41s19.48 6.59 22.77 16.41l13.88 41.64c19.75-16.19 54.06-9.7 66 14.16 1.89 3.78 5.49 5.95 9.36 6.26v-82.12l128-127.09V160H248c-13.2 0-24-10.8-24-24V0H24C10.7 0 0 10.7 0 24v464c0 13.3 10.7 24 24 24h336c13.3 0 24-10.7 24-24v-40l-128-.11c-16.12-.31-30.58-9.28-37.83-23.75zM384 121.9c0-6.3-2.5-12.4-7-16.9L279.1 7c-4.5-4.5-10.6-7-17-7H256v128h128v-6.1zm-96 225.06V416h68.99l161.68-162.78-67.88-67.88L288 346.96zm280.54-179.63l-31.87-31.87c-9.94-9.94-26.07-9.94-36.01 0l-27.25 27.25 67.88 67.88 27.25-27.25c9.95-9.94 9.95-26.07 0-36.01z\"><\/path><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t<div class=\"elementor-icon-box-content\">\n\n\t\t\t\t\t\t\t\t\t<h3 class=\"elementor-icon-box-title\">\n\t\t\t\t\t\t<span  >\n\t\t\t\t\t\t\tCome lavoriamo insieme \t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7fd0026 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"7fd0026\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0151eb5 elementor-widget elementor-widget-text-editor\" data-id=\"0151eb5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Quando ci viene proposto un progetto in area <strong>BioPharma<\/strong>, chiediamo una <strong>briefing note<\/strong> essenziale: ipotesi biologica, stato CMC, disegno e stato degli studi, rischio principale, dati disponibili. In pochi giorni restituiamo un <strong>fit check<\/strong> con mappa dei <strong>gap<\/strong>, milestone e un percorso <strong>TRL<\/strong> credibile. Se c\u2019\u00e8 sostanza, coordiniamo gli interlocutori giusti (clinici, qualit\u00e0, regolatorio, finanza) e definiamo con precisione cosa misurare e quando. Se non ci sono le condizioni, lo diciamo subito: meglio un no onesto che un s\u00ec che spreca risorse.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-c6a7408 elementor-section-content-middle elementor-reverse-mobile elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"c6a7408\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-extended\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-ebc0b4e\" data-id=\"ebc0b4e\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div 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74.7-74.7 74.7 33.5 74.7 74.7-33.6 74.7-74.7 74.7zm146.4-194.3c0 14.9-12 26.8-26.8 26.8-14.9 0-26.8-12-26.8-26.8s12-26.8 26.8-26.8 26.8 12 26.8 26.8zm76.1 27.2c-1.7-35.9-9.9-67.7-36.2-93.9-26.2-26.2-58-34.4-93.9-36.2-37-2.1-147.9-2.1-184.9 0-35.8 1.7-67.6 9.9-93.9 36.1s-34.4 58-36.2 93.9c-2.1 37-2.1 147.9 0 184.9 1.7 35.9 9.9 67.7 36.2 93.9s58 34.4 93.9 36.2c37 2.1 147.9 2.1 184.9 0 35.9-1.7 67.7-9.9 93.9-36.2 26.2-26.2 34.4-58 36.2-93.9 2.1-37 2.1-147.8 0-184.8zM398.8 388c-7.8 19.6-22.9 34.7-42.6 42.6-29.5 11.7-99.5 9-132.1 9s-102.7 2.6-132.1-9c-19.6-7.8-34.7-22.9-42.6-42.6-11.7-29.5-9-99.5-9-132.1s-2.6-102.7 9-132.1c7.8-19.6 22.9-34.7 42.6-42.6 29.5-11.7 99.5-9 132.1-9s102.7-2.6 132.1 9c19.6 7.8 34.7 22.9 42.6 42.6 11.7 29.5 9 99.5 9 132.1s2.7 102.7-9 132.1z\"><\/path><\/svg>\t\t\t\t\t<\/a>\n\t\t\t\t<\/span>\n\t\t\t\t\t\t\t<span class=\"elementor-grid-item\" role=\"listitem\">\n\t\t\t\t\t<a class=\"elementor-icon elementor-social-icon elementor-social-icon-youtube elementor-repeater-item-664baeb\" href=\"https:\/\/www.youtube.com\/@technoscience3169\">\n\t\t\t\t\t\t<span class=\"elementor-screen-only\">Youtube<\/span>\n\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fab-youtube\" viewBox=\"0 0 576 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M549.655 124.083c-6.281-23.65-24.787-42.276-48.284-48.597C458.781 64 288 64 288 64S117.22 64 74.629 75.486c-23.497 6.322-42.003 24.947-48.284 48.597-11.412 42.867-11.412 132.305-11.412 132.305s0 89.438 11.412 132.305c6.281 23.65 24.787 41.5 48.284 47.821C117.22 448 288 448 288 448s170.78 0 213.371-11.486c23.497-6.321 42.003-24.171 48.284-47.821 11.412-42.867 11.412-132.305 11.412-132.305s0-89.438-11.412-132.305zm-317.51 213.508V175.185l142.739 81.205-142.739 81.201z\"><\/path><\/svg>\t\t\t\t\t<\/a>\n\t\t\t\t<\/span>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-47061e0\" data-id=\"47061e0\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-7bc1e52 elementor-widget elementor-widget-heading\" data-id=\"7bc1e52\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Scegli Technoscience!<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a854892 elementor-widget elementor-widget-divider\" data-id=\"a854892\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-50d59b0 elementor-widget elementor-widget-heading\" data-id=\"50d59b0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Se stai progettando uno studio che richiede campioni e dati di qualit\u00e0 verificata, chiedi un fit check: in una call breve allineiamo domanda clinica o industriale, disponibilit\u00e0 di campioni, requisiti etici e standard di qualit\u00e0; se il perimetro \u00e8 solido, pianifichiamo un percorso che porti dall\u2019accesso responsabile alla validazione, senza perdere tempo..\n<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5e2e314 elementor-button-align-start elementor-mobile-button-align-stretch elementor-widget elementor-widget-form\" data-id=\"5e2e314\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;step_next_label&quot;:&quot;Next&quot;,&quot;step_previous_label&quot;:&quot;Previous&quot;,&quot;button_width&quot;:&quot;40&quot;,&quot;button_width_tablet&quot;:&quot;50&quot;,&quot;button_width_mobile&quot;:&quot;100&quot;,&quot;step_type&quot;:&quot;number_text&quot;,&quot;step_icon_shape&quot;:&quot;circle&quot;}\" data-widget_type=\"form.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<form class=\"elementor-form\" method=\"post\" name=\"New Form\" aria-label=\"New Form\">\n\t\t\t<input type=\"hidden\" name=\"post_id\" value=\"3448\"\/>\n\t\t\t<input type=\"hidden\" name=\"form_id\" value=\"5e2e314\"\/>\n\t\t\t<input type=\"hidden\" name=\"referer_title\" value=\"Pipeline di biofarmaci: dal proof-of-concept al | Technoscience\" \/>\n\n\t\t\t\t\t\t\t<input type=\"hidden\" name=\"queried_id\" value=\"3448\"\/>\n\t\t\t\n\t\t\t<div class=\"elementor-form-fields-wrapper elementor-labels-\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-text elementor-field-group elementor-column elementor-field-group-name elementor-col-50 elementor-field-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-name\" class=\"elementor-field-label elementor-screen-only\">\n\t\t\t\t\t\t\t\tNome\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"text\" name=\"form_fields[name]\" id=\"form-field-name\" class=\"elementor-field elementor-size-md  elementor-field-textual\" placeholder=\"Nome\" required=\"required\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-text elementor-field-group elementor-column elementor-field-group-field_24422e2 elementor-col-50 elementor-field-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-field_24422e2\" class=\"elementor-field-label elementor-screen-only\">\n\t\t\t\t\t\t\t\tCognome\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"text\" name=\"form_fields[field_24422e2]\" id=\"form-field-field_24422e2\" class=\"elementor-field elementor-size-md  elementor-field-textual\" placeholder=\"Cognome\" required=\"required\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-email elementor-field-group elementor-column elementor-field-group-email elementor-col-50 elementor-field-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-email\" class=\"elementor-field-label elementor-screen-only\">\n\t\t\t\t\t\t\t\tEmail\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"email\" name=\"form_fields[email]\" id=\"form-field-email\" class=\"elementor-field elementor-size-md  elementor-field-textual\" placeholder=\"Email\" required=\"required\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-tel elementor-field-group elementor-column elementor-field-group-field_189ff95 elementor-col-50\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-field_189ff95\" class=\"elementor-field-label elementor-screen-only\">\n\t\t\t\t\t\t\t\tTelefono\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t<input size=\"1\" type=\"tel\" name=\"form_fields[field_189ff95]\" id=\"form-field-field_189ff95\" class=\"elementor-field elementor-size-md  elementor-field-textual\" placeholder=\"Telefono\" pattern=\"[0-9()#&amp;+*-=.]+\" title=\"Only numbers and phone characters (#, -, *, etc) are accepted.\">\n\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-textarea elementor-field-group elementor-column elementor-field-group-message elementor-col-100 elementor-field-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-message\" class=\"elementor-field-label elementor-screen-only\">\n\t\t\t\t\t\t\t\tMessaggio\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t<textarea class=\"elementor-field-textual elementor-field  elementor-size-md\" name=\"form_fields[message]\" id=\"form-field-message\" rows=\"4\" placeholder=\"Messaggio\" required=\"required\"><\/textarea>\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-acceptance elementor-field-group elementor-column elementor-field-group-field_5f71bcb elementor-col-100 elementor-field-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-field_5f71bcb\" class=\"elementor-field-label elementor-screen-only\">\n\t\t\t\t\t\t\t\tAcceptance\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-subgroup\">\n\t\t\t<span class=\"elementor-field-option\">\n\t\t\t\t<input type=\"checkbox\" name=\"form_fields[field_5f71bcb]\" id=\"form-field-field_5f71bcb\" class=\"elementor-field elementor-size-md  elementor-acceptance-field\" required=\"required\">\n\t\t\t\t<label for=\"form-field-field_5f71bcb\">Acconsento a Technoscience di raccogliere i miei dati tramite questo modulo. Dichiaro di aver letto e di accettare l'informativa sulla protezione dei dati disponibile al seguente link \n<a href=\"https:\/\/www.technoscience.it\/politicaprivacy\/\" target=\"_blank\">https:\/\/www.technoscience.it\/politicaprivacy\/<\/a><\/label>\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-group elementor-column elementor-field-type-submit elementor-col-40 e-form__buttons elementor-md-50 elementor-sm-100\">\n\t\t\t\t\t<button class=\"elementor-button elementor-size-md\" type=\"submit\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">invia<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/button>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/form>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-547022b\" data-id=\"547022b\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-5a8e72a elementor-widget elementor-widget-image\" data-id=\"5a8e72a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img title=\"Biotech Contacts \u2013 Collaboration and Network\" decoding=\"async\" width=\"1920\" height=\"1920\" src=\"https:\/\/www.technoscience.it\/wp-content\/uploads\/2025\/11\/scegli-tech.jpg\" class=\"attachment-full size-full wp-image-3264\" alt=\"Biotech contacts: professionals ready to collaborate and innovate\" srcset=\"https:\/\/www.technoscience.it\/wp-content\/uploads\/2025\/11\/scegli-tech.jpg 1920w, https:\/\/www.technoscience.it\/wp-content\/uploads\/2025\/11\/scegli-tech-300x300.jpg 300w, https:\/\/www.technoscience.it\/wp-content\/uploads\/2025\/11\/scegli-tech-1024x1024.jpg 1024w, https:\/\/www.technoscience.it\/wp-content\/uploads\/2025\/11\/scegli-tech-150x150.jpg 150w, https:\/\/www.technoscience.it\/wp-content\/uploads\/2025\/11\/scegli-tech-768x768.jpg 768w, https:\/\/www.technoscience.it\/wp-content\/uploads\/2025\/11\/scegli-tech-1536x1536.jpg 1536w, https:\/\/www.technoscience.it\/wp-content\/uploads\/2025\/11\/scegli-tech-12x12.jpg 12w\" sizes=\"(max-width: 1920px) 100vw, 1920px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-38ce07d elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"38ce07d\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-extended\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-8c99e09\" data-id=\"8c99e09\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-eec6deb elementor-widget elementor-widget-heading\" data-id=\"eec6deb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">FAQ<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cf24555 elementor-widget elementor-widget-heading\" data-id=\"cf24555\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Le cose che ci chiedete pi\u00f9 spesso<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-847c234 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"847c234\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-wide\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-292b52c\" data-id=\"292b52c\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-49653fc elementor-widget elementor-widget-toggle\" data-id=\"49653fc\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"toggle.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-toggle\">\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-7691\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-7691\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Qual \u00e8 la differenza tra Fase 1, 2 e 3?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-7691\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-7691\"><p>La <strong>Fase 1<\/strong> valuta sicurezza e profilo dose-risposta (spesso su volontari sani o piccoli gruppi di pazienti). La <strong>Fase 2<\/strong> cerca conferma di <strong>efficacia<\/strong> su popolazioni selezionate, definisce dose e regime e prepara gli endpoint per la fase successiva. La <strong>Fase 3<\/strong> verifica in modo definitivo <strong>efficacia e sicurezza<\/strong> su campioni pi\u00f9 ampi e con <strong>endpoint clinici<\/strong> condivisi con i regolatori.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-7692\" class=\"elementor-tab-title\" data-tab=\"2\" role=\"button\" aria-controls=\"elementor-tab-content-7692\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Cos\u2019\u00e8 il compassionate use?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-7692\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"2\" role=\"region\" aria-labelledby=\"elementor-tab-title-7692\"><p>\u00c8 l\u2019<strong>uso compassionevole<\/strong> di un medicinale sperimentale fuori dagli studi clinici, in pazienti senza valide alternative terapeutiche. \u00c8 regolato da norme precise e non sostituisce i trial: risponde a situazioni eccezionali, con <strong>valutazione rischio-beneficio<\/strong> e tracciabilit\u00e0 completa.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-e1b06d0\" data-id=\"e1b06d0\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-748645b elementor-widget elementor-widget-toggle\" data-id=\"748645b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"toggle.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-toggle\">\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1221\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-1221\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Che cosa significa Orphan Drug e perch\u00e9 \u00e8 rilevante?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-1221\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-1221\"><p>Lo <strong>status di Orphan Drug<\/strong> si applica a terapie per <strong>malattie rare<\/strong> con bisogno clinico non soddisfatto. Pu\u00f2 includere <strong>incentivi<\/strong> come esclusivit\u00e0 di mercato, fee ridotte e supporto regolatorio dedicato: accorcia i tempi e rende sostenibile lo sviluppo dove i numeri sarebbero scoraggianti.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<div class=\"elementor-element elementor-element-f4b816c elementor-align-center elementor-button-info elementor-mobile-align-justify elementor-widget elementor-widget-button\" data-id=\"f4b816c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-md\" href=\"https:\/\/www.technoscience.it\/servizi\/biotecnologie-e-innovazione\/faq\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Vedi tutte le domande<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Un biofarmaco non nasce il giorno in cui lo si formula: comincia a esistere quando l\u2019ipotesi biologica dimostra di saper reggere ai primi urti della realt\u00e0. Il proof-of-concept \u00e8 quel [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":3462,"parent":3685,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_price":"","_stock":"","_tribe_ticket_header":"","_tribe_default_ticket_provider":"","_tribe_ticket_capacity":"0","_ticket_start_date":"","_ticket_end_date":"","_tribe_ticket_show_description":"","_tribe_ticket_show_not_going":false,"_tribe_ticket_use_global_stock":"","_tribe_ticket_global_stock_level":"","_global_stock_mode":"","_global_stock_cap":"","_tribe_rsvp_for_event":"","_tribe_ticket_going_count":"","_tribe_ticket_not_going_count":"","_tribe_tickets_list":"[]","_tribe_ticket_has_attendee_info_fields":false,"footnotes":"","_tec_slr_enabled":"","_tec_slr_layout":""},"class_list":["post-3448","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.5 - 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