{"id":8895,"date":"2021-05-31T14:41:43","date_gmt":"2021-05-31T12:41:43","guid":{"rendered":"https:\/\/www.marchebiobank.it\/progetto-regione-marche\/?page_id=8895"},"modified":"2021-06-15T09:42:05","modified_gmt":"2021-06-15T07:42:05","slug":"line-2","status":"publish","type":"page","link":"https:\/\/www.marchebiobank.it\/progetto-regione-marche\/en\/business-lines\/line-2\/","title":{"rendered":"Line 2"},"content":{"rendered":"

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LINE 2<\/strong>
\nResearch & development projects<\/h2>\n<\/div><\/div>

3 experimental projects, aimed at setting up innovative, tangible applications within the platform, in the relevant thematic area<\/span><\/p><\/div><\/div><\/div><\/div><\/section><\/div> [\/vc_column][\/vc_row][vc_row zindex=”2″ css=”.vc_custom_1600339082069{margin-top: 0px !important;padding-top: 0px !important;}” el_class=”ts-column-pad-0″][vc_column][vc_tta_tabs style=”outline” shape=”square” spacing=”5″ active_section=”1″ el_class=”tabtitolo”][vc_tta_section title=”RESEARCH PROJECT 1″ tab_id=”1600421967941-4beaa27e-93d6″][vc_column_text css=”.vc_custom_1622464994729{margin-top: 15px !important;}”]<\/p>\n

PROJECT 1
\n\u201cNew diagnostic and therapeutic tools for the targeted and personalized treatment of oncological patients\u201d<\/h3>\n

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Objectives<\/span><\/p>\n

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The general objective of this research project is the development of an integrated approach to the personalized therapy of high-medical-need haematological cancer, with particular reference to acute leukaemias, with the purpose of providing patients and operators with therapeutic instruments more and more targeted to the patients\u2019 features.<\/p>\n

Furthermore, a new diagnostic\/prognostic approach will be developed, in order to identify the expression of selective melanoma markers, that can be used for patient stratification.<\/p>\n

The project involves companies working in the fields of molecular diagnostics and pharmacogenetics and biotherapeutics.<\/p>\n

With the collaboration of the haematology clinic of the Marche Polytechnic University, of regional healthcare facilities and national centres of reference, that will make the biological samples from patients available to the companies and the newly-instituted biobank, Diatech Pharmacogenetics will develop and validate new diagnostic assays for the identification of chromosomal mutations in adult and paediatric patients with leukaemia, while Diatheva will work on the industrial development of new, specific therapeutic antibodies for the targeted treatment of acute leukaemias.<\/p>\n

In particular, the therapeutic antibodies will be tested on biological samples from genetically characterized patients, together with the new assays developed by Diatech Pharmacogenetics, linking the response to the treatment with the genetic profile and therefore developing an example of precision medicine. Thanks to the collaboration of the dermatology clinic of the Marche Polytechnic University, Diatheva will also develop a new diagnostic\/prognostic approach, based on the use of a monoclonal antibody, to identify the expression of selective melanoma markers.<\/p>\n

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Project leader<\/h2>\n<\/div><\/div><\/div><\/div><\/div><\/section><\/div> [vc_separator color=”custom” align=”align_left” el_width=”10″ accent_color=”#ff4511″][vc_column_text css=”.vc_custom_1604584474373{margin-top: 15px !important;}”]<\/p>\n

Diatech Pharmacogenetics Srl<\/h3>\n

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Partners<\/h2>\n<\/div><\/div><\/div><\/div><\/div><\/section><\/div> [vc_separator color=”custom” align=”align_left” el_width=”10″ accent_color=”#ff4511″][vc_column_text css=”.vc_custom_1622465179077{margin-top: 15px !important;}”]<\/p>\n

Diatheva Srl
\nMarche Polytechnic University<\/h3>\n

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PROJECT 2
\n\u201cPlatform for the development of new therapeutic instruments, for the personalized treatment of patients with specific needs and rare conditions\u201d<\/h3>\n

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Objectives<\/span><\/p>\n

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The project aims at the creation of a support platform for the development of new therapeutic approaches for patients with specific needs and rare disease, and it will involve the companies Angelini Pharma, Pharmaprogress, Prosopika and Diatheva and the research institutions Marche Polytechnic University and Urbino University.<\/p>\n

Specifically, Angelini Pharma will develop innovative formulations of selected active principles, which will make the therapies for patients with specific needs safer and more targeted, thanks to their body mass-based scalability, their suitability for dysphagic patients and their ease of management for caregivers.<\/p>\n

Innovative formulations will also be developed using emerging technologies, including 3D printing, significantly increasing the related know-how available at the local level.<\/p>\n

Next to the formulation activities, stress tests will be carried out on prototypes by Pharmaprogress.<\/p>\n

Furthermore, formulation studies on skin conditions will be carried out by Prosopika, in collaboration with Angelini Pharma. The Urbino University, in collaboration with Diatheva, will carry out a preclinical study on enzyme replacement therapy in a phenylketonuria (the most common among rare metabolic diseases) animal model, with the aim of developing a new biotherapeutic drug to prevent neurological damage and improve the patients\u2019 quality of life.<\/p>\n

After identifying new molecular targets for treating scleroderma, a rare condition that mainly affects young-to-middle-aged women, causing extended damage, disabilities and high mortality, the Marche Polytechnic University will develop, together with Diatheva, new biotherapeutic drugs to be associated to a new companion diagnostic, which will be useful to identify molecular markers for patient stratification and therapy monitoring.<\/p>\n

The samples from patients and the cell lines used in the studies will be deposited in the new biobank.<\/p>\n

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Project leader<\/h2>\n<\/div><\/div><\/div><\/div><\/div><\/section><\/div> [vc_separator color=”custom” align=”align_left” el_width=”10″ accent_color=”#ff4511″][vc_column_text css=”.vc_custom_1604584754844{margin-top: 15px !important;}”]<\/p>\n

Angelini Pharma Spa<\/h3>\n

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Partners<\/h2>\n<\/div><\/div><\/div><\/div><\/div><\/section><\/div> [vc_separator color=”custom” align=”align_left” el_width=”10″ accent_color=”#ff4511″][vc_column_text css=”.vc_custom_1622465559369{margin-top: 15px !important;}”]<\/p>\n

Diatheva Srl
\nPharmaprogress Srl
\nProsopika Srl
\nUrbino University
\nMarche Polytechnic University<\/h3>\n

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PROJECT 3
\n\u201cDevelopment of new pharmaceutical and nutraceutical approaches for the treatment\/management of chronic pathologies\u201d<\/h3>\n

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Objectives<\/span><\/p>\n

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The project has two objectives: developing targeted nutraceutical approaches for the prevention and management of two chronic diseases, that are affecting a growing number of individuals, i.e. type II diabetes mellitus and osteopenia, by integrating preventive therapies with the development of predictive diagnostic tools, that can identify subjects who are at risk for the same pathologies and\/or who are drug-resistant; and tackling crippling chronic diseases that are difficult to prevent, such as nervous system chronic diseases for specific populations, age groups or sub-groups and the auto-immune pathology called atopic dermatitis.<\/p>\n

In particular, Mivell will develop two new nutraceutical products which, thanks to the collaboration of the Marche Polytechnic University, will be tested in vitro and then in vivo in two clinical studies on subjects at risk of developing type II diabetes mellitus and osteoporosis.<\/p>\n

In parallel, Diatech Pharmacogenetics will develop and test assays for the identification of polymorphisms that predispose for both the above-mentioned pathologies or are involved in the response to pharmacological treatments, identifying the at-risk subjects who may benefit more from preventive treatments. In those same clinical studies, the patients treated with the new nutraceutical products will be genotyped with specifically developed kits. The patients\u2019 samples used for the studies will be then deposited in the new biobank.<\/p>\n

While developing the two new nutraceutical products, Pharmaprogress will collaborate in the development of new analytical methods for the determination\/characterization of active principles, it will carry out stability studies on formulated products and it will develop tests to precisely define the dissolution profile and release of active principles in the two formulated products, while Angelini Pharma will participate in the study of formulations that may improve the bioavailability of active principles, exploring the use of the spray-drying technology.<\/p>\n

Gluos will develop a new medical device to be tested at the dermatology clinic of the Marche Polytechnic University for the treatment of atopic dermatitis, for which Italy has the highest incidence among adults in the world (8.1%). During the study, biological samples will be collected and deposited in the new biobank.<\/p>\n

Angelini Pharma will develop new liquid and solid paediatric formulations of active principles or active principle combinations, which are used in clinical practice for the treatment of nervous system pathologies or for pain management. During the study, relevant analytical methods will be developed and preclinical studies will be carried out to verify that they are suitable for the objective. The subsequent stability tests will be carried out in collaboration with Pharmaprogress.<\/p>\n

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Project leader<\/h2>\n<\/div><\/div><\/div><\/div><\/div><\/section><\/div> [vc_separator color=”custom” align=”align_left” el_width=”10″ accent_color=”#ff4511″][vc_column_text css=”.vc_custom_1604584954057{margin-top: 15px !important;}”]<\/p>\n

Mivell Srls<\/h3>\n

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Partner<\/h2>\n<\/div><\/div><\/div><\/div><\/div><\/section><\/div> [vc_separator color=”custom” align=”align_left” el_width=”10″ accent_color=”#ff4511″][vc_column_text css=”.vc_custom_1622465799973{margin-top: 15px !important;}”]<\/p>\n

Angelini Pharma Spa
\nDiatech Pharmacogenetics Srl
\nGluos Srl
\nPharmaprogress Srl
\nMarche Polytechnic University<\/h3>\n

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PROGETTO DI RICERCA 1<\/h3>\n

Obiettivi<\/span><\/p>\n

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PROGETTO 1
\n\u201cNuovi strumenti diagnostici e terapeutici per il trattamento mirato e personalizzato di pazienti oncologici\u201d<\/h3>\n

 <\/p>\n

L\u2019obiettivo generale di questo progetto di ricerca \u00e8 quello di sviluppare un approccio integrato per la terapia personalizzata dei tumori ematologici ad elevato medical need con particolare riferimento alle leucemie acute al fine di offrire ai pazienti e agli operatori strumenti terapeutici sempre pi\u00f9 aderenti alle caratteristiche dei pazienti.<\/p>\n

Inoltre, verr\u00e0 sviluppato anche un nuovo approccio diagnostico\/prognostico per identificare l\u2019espressione di marcatori selettivi di tumori della pelle utili per la stratificazione dei pazienti.<\/p>\n

Il progetto coinvolger\u00e0 aziende operanti nel settore della diagnostica molecolare e della farmacogenetica e nel settore dei bioterapeutici.<\/p>\n

Con la collaborazione della clinica ematologica di Universit\u00e0 Politecnica delle Marche e delle strutture sanitarie della regione e di centri di riferimento nazionali, che metteranno a disposizione delle aziende e della biobanca appena costituita i campioni biologici derivanti dai pazienti, Diatech Pharmacogenetics svilupper\u00e0 e valider\u00e0 nuovi saggi diagnostici per l\u2019identificazione di mutazioni cromosomiche in pazienti adulti e pediatrici affetti da leucemia mentre Diatheva porter\u00e0 avanti lo sviluppo industriale di nuovi anticorpi terapeutici specifici per il trattamento mirato delle leucemie acute.<\/p>\n

In particolare, gli anticorpi terapeutici verranno testati sui campioni biologici dei pazienti caratterizzati geneticamente anche con i nuovi saggi sviluppati da Diatech Pharmacogenetics correlando la risposta al trattamento con il profilo genetico e sviluppando cos\u00ec un esempio di medicina di precisione. Diatheva inoltre, grazie alla collaborazione della clinica dermatologica di Universit\u00e0 Politecnica delle Marche, svilupper\u00e0 un nuovo approccio diagnostico\/prognostico che prevede l\u2019utilizzo di un anticorpo monoclonale per identificare l\u2019espressione di marcatori selettivi di tumori della pelle.<\/p>\n

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Diagnosi: Sede e Istotipo (codifica AJCC e ICD9CM), Grado istotipo, Classificazioni (TNM, UICC, FIGO, DUKES, MAC, AIEOP), Criterio di stadiazione (Ann Arbor, INSS, Murphy LnH, ecc…), Score diagnostici, Marcatori biomolecolari, Metastasi, Dati Interventi Chirurgico, Terapie adiuvanti o neoadiuvanti <\/div>\t\t\t\t\t<\/div>\n\t<\/div>\n\t\n<\/div>\n\n\n\n\n\n
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Programma terapeutico: Radioterapia, Chemioterapia, immunoterapia, ecc.<\/div>\t\t\t\t\t<\/div>\n\t<\/div>\n\t\n<\/div>\n\n\n\n\n\n
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Valutazione tossicit\u00e0 farmacologica (NCI- CTC)<\/div>\t\t\t\t\t<\/div>\n\t<\/div>\n\t\n<\/div>\n\n\n\n\n\n
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Rivalutazione andamento percorso cura e follow up: risposta del paziente durante il programma terapeutico (risposta completa, parziale, stazionaria, progressione, ecc.), secondo le classificazioni internazionali (WHO, RECIST), valutando gli esami eseguiti<\/div>\t\t\t\t\t<\/div>\n\t<\/div>\n\t\n<\/div>\n\n\n\n\n\n
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Referti di esami strumentali. <\/div>\t\t\t\t\t<\/div>\n\t<\/div>\n\t\n<\/div>\n\n\n\n[\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row zindex=”2″ disable_element=”yes” css=”.vc_custom_1600424728810{margin-top: 0px !important;padding-top: 0px !important;padding-bottom: 0px !important;}” el_class=”ts-column-pad-0″][vc_column][vc_column_text]<\/p>\n

La biobanca rappresenter\u00e0 un\u2019unit\u00e0 di servizio senza scopo di lucro, finalizzata a raccolta, processazione, conservazione e distribuzione di campioni biologici umani e di dati a essi collegati, per ricerca e diagnosi. Sar\u00e0 ufficialmente riconosciuta dalle autorit\u00e0 sanitarie competenti, applicher\u00e0 un sistema qualit\u00e0 e garantir\u00e0 i diritti dei soggetti coinvolti.<\/p>\n

La biobanca si porr\u00e0 come punto di riferimento regionale interponendosi tra gli enti di ricerca universitari, l\u2019azienda sanitaria regionale e le associazioni di volontariato che specificatamente si occupano di malattie genetiche rare ed onco-ematologiche.<\/p>\n

Conferire dei campioni a una biobanca significa investire sul futuro e partecipare allo sviluppo della \u201cprecision medicine\u201d, di una medicina che si prefigge di diagnosticare e curare in modo personalizzato., con un beneficio per l\u2019intera comunit\u00e0. Avere un campione depositato permette al soggetto donatore di migliorare la diagnosi e pu\u00f2 anche consentirgli di partecipare a studi clinici pionieristici su nuovi trattamenti. Fondamentalmente, attraverso il biobancaggio si pu\u00f2 contribuire alla costruzione dinamica di una grande base dati, con requisiti di qualit\u00e0, da utilizzare nella ricerca medica per indagare la causa delle malattie, per prevenirle e per individuare le migliori opzioni di trattamento e cura.<\/p>\n

MARCHEBIOBANK<\/strong> sar\u00e0 inserita in uno spazio opportunamente offerto ed integrato nell\u2019Azienda Ospedaliera degli Ospedali Riuniti di Ancona Torrette allo scopo di favorire lo sviluppo della medicina di precisione nel sistema sanitario regionale.
\nSecondo le linee delineate nel Programma Nazionale della Ricerca 2015-2020, una buona assistenza sanitaria dovrebbe includere la ricerca costante di modelli sempre pi\u00f9 raffinati di trattamento e diagnosi, soprattutto per quelle malattie che mettono a rischio la vita. Attraverso la ricerca, effettuata su campioni biologici umani, si potr\u00e0 infatti: meglio comprendere l’origine della malattia e\/o la sua predisposizione ereditaria, dando gli strumenti per evitarne o ritardarne l’insorgenza; identificare le caratteristiche di risposta ai trattamenti nei pazienti e di migliorare la diagnosi dal primo momento; identificare le caratteristiche di risposta dei pazienti ai trattamenti ed individuare il miglior trattamento tra gli esistenti sulla base delle caratteristiche proprie del singolo; comprendere gli aspetti molecolari della progressione di una malattia e conseguentemente identificare nuovi bersagli farmacologici e strumenti di diagnosi precoce.<\/p>\n

MARCHEBIOBANK<\/strong> sar\u00e0 inserita in una rete nazionale di biobanche (BBMRI-Biobanking and Biomolecular Resources Research) a cui partecipano le maggiori biobanche nazionali, a loro volta collegate a network di biobanche europei attraverso il Consorzio Europeo per le Infrastrutture di Ricerca BBMRI-ERICB<\/strong> (Biobanking And Biomolecular Resources Research and European Research Infrastructure Consortium) che rappresenta uno strumento legale per facilitare la creazione e il funzionamento delle Infrastrutture di Ricerca europee.<\/p>\n

L\u2019inserimento nel circuito BBMRI.it permetter\u00e0 di promuovere l\u2019efficienza e la visibilit\u00e0 di MARCHEBIOBANK nella rete di biobanche italiane ed europee.<\/p>\n

Inoltre, l\u2019inserimento nella directory BBMRI-ERIC favorir\u00e0 un migliore accesso per gli utenti del settore pubblico e privato ai servizi erogati alla biobanca. Per raggiungere questi obiettivi, BBMRI.it promuove attivit\u00e0 volte ad armonizzare le procedure operative standard delle biobanche, implementare il sistema di gestione della qualit\u00e0, migliorare l\u2019interoperabilit\u00e0 dei database di ricerca, incoraggiare le collaborazioni pubblico\/privato, promuovere, facilitare ed accompagnare le biobanche in un percorso di sostenibilit\u00e0 economica.<\/p>\n

Infine, la partecipazione alle attivit\u00e0 dei gruppi BBMRI permetter\u00e0 di creare una road map per l\u2019implementazione della rete e promuovere il coinvolgimento della comunit\u00e0 dei malati rari con il fine di organizzare insieme attivit\u00e0 e\/o eventi per aumentare la consapevolezza sul biobanking nella comunit\u00e0 dei pazienti, ma anche nella comunit\u00e0 medico-scientifica.<\/p>\n

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[vc_row zindex=”2″ el_class=”ts-column-pad-0″ css=”.vc_custom_1600249691069{padding-bottom: 20px !important;}”][vc_column css=”.vc_custom_1600248032136{padding-right: 15% !important;}”][\/vc_column][\/vc_row][vc_row zindex=”2″ css=”.vc_custom_1600339082069{margin-top: 0px !important;padding-top: 0px !important;}” el_class=”ts-column-pad-0″][vc_column][vc_tta_tabs style=”outline” shape=”square” spacing=”5″ active_section=”1″ el_class=”tabtitolo”][vc_tta_section title=”RESEARCH PROJECT 1″ tab_id=”1600421967941-4beaa27e-93d6″][vc_column_text css=”.vc_custom_1622464994729{margin-top: 15px !important;}”] PROJECT 1 \u201cNew diagnostic and therapeutic tools for the targeted and personalized treatment of oncological patients\u201d [\/vc_column_text][vc_column_text css=”.vc_custom_1622465009725{margin-bottom: 15px !important;}”] Objectives [\/vc_column_text][vc_separator color=”custom” align=”align_left” el_width=”10″ accent_color=”#ff4511″][vc_column_text css=”.vc_custom_1622465131828{margin-top: … Continue reading Line 2<\/span><\/a><\/p>\n","protected":false},"author":5,"featured_media":0,"parent":8870,"menu_order":6,"comment_status":"closed","ping_status":"closed","template":"","meta":[],"_links":{"self":[{"href":"https:\/\/www.marchebiobank.it\/progetto-regione-marche\/wp-json\/wp\/v2\/pages\/8895"}],"collection":[{"href":"https:\/\/www.marchebiobank.it\/progetto-regione-marche\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.marchebiobank.it\/progetto-regione-marche\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.marchebiobank.it\/progetto-regione-marche\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/www.marchebiobank.it\/progetto-regione-marche\/wp-json\/wp\/v2\/comments?post=8895"}],"version-history":[{"count":5,"href":"https:\/\/www.marchebiobank.it\/progetto-regione-marche\/wp-json\/wp\/v2\/pages\/8895\/revisions"}],"predecessor-version":[{"id":8900,"href":"https:\/\/www.marchebiobank.it\/progetto-regione-marche\/wp-json\/wp\/v2\/pages\/8895\/revisions\/8900"}],"up":[{"embeddable":true,"href":"https:\/\/www.marchebiobank.it\/progetto-regione-marche\/wp-json\/wp\/v2\/pages\/8870"}],"wp:attachment":[{"href":"https:\/\/www.marchebiobank.it\/progetto-regione-marche\/wp-json\/wp\/v2\/media?parent=8895"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}