{"id":39157,"date":"2024-07-12T11:13:57","date_gmt":"2024-07-12T11:13:57","guid":{"rendered":"https:\/\/ibima.eu\/?p=39157"},"modified":"2024-07-12T11:14:02","modified_gmt":"2024-07-12T11:14:02","slug":"transbioline","status":"publish","type":"post","link":"https:\/\/ibima.eu\/es\/transbioline\/","title":{"rendered":"TransBioLine"},"content":{"rendered":"\n[et_pb_section fb_built=\u00bb1″ _builder_version=\u00bb4.25.0″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_row _builder_version=\u00bb4.25.1″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_column type=\u00bb4_4″ _builder_version=\u00bb4.25.1″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_heading title=\u00bbTranslational Safety Biomarker Pipeline (TransBioLine): Enabling development and implementation of novel safety biomarkers in clinical trials and diagnosis of disease\u00bb _builder_version=\u00bb4.25.1″ _module_preset=\u00bbdefault\u00bb title_font=\u00bb||||||||\u00bb title_text_align=\u00bbcenter\u00bb title_text_color=\u00bb#0C71C3″ module_alignment=\u00bbcenter\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][\/et_pb_heading][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=\u00bb2_3,1_3″ _builder_version=\u00bb4.25.1″ _module_preset=\u00bbdefault\u00bb custom_padding=\u00bb30px||||false|false\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_column type=\u00bb2_3″ _builder_version=\u00bb4.25.0″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_text _builder_version=\u00bb4.25.1″ _module_preset=\u00bbdefault\u00bb hover_enabled=\u00bb0″ global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb sticky_enabled=\u00bb0″]
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Financed by<\/strong>: European Union<\/span><\/p>\n

Programme<\/strong>: H2020-EU.3.1.7. \u2013 Innovative Medicines Initiative 2 (IMI2): H2020-JTI-IMI2-2017-13-two-stage<\/span><\/p>\n

Rol in the project:\u00a0<\/strong>Partner<\/span><\/p>\n

Grant Agreement ID:\u00a0\u00a0<\/b><\/span>821283-2<\/u><\/b><\/a><\/span><\/p>\n

Duration:\u00a0<\/b>February 2019 to January 2025<\/span><\/p>\n

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Contact:\u00a0Andrade Bellido, Ra\u00fal J.<\/span><\/p>\n

Implementation centre:<\/span>\u00a0Hospital Universitario Virgen de la Victoria<\/a><\/span><\/p>\n

Research group of IBIMA involved:<\/span>\u00a0Hepatogastroenterology, Pharmacology, and Translational Clinical Therapeutics<\/a><\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/section>[\/et_pb_text][\/et_pb_column][et_pb_column type=\u00bb1_3″ _builder_version=\u00bb4.25.0″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_post_title title=\u00bboff\u00bb meta=\u00bboff\u00bb image_height=\u00bb154px\u00bb image_max_height=\u00bb110px\u00bb admin_label=\u00bbT\u00edtulo de publicaci\u00f3n\u00bb _builder_version=\u00bb4.25.1″ _module_preset=\u00bbdefault\u00bb title_font=\u00bbArial||||||||\u00bb title_text_align=\u00bbcenter\u00bb title_text_color=\u00bb#2ea3f2″ title_font_size=\u00bb35px\u00bb background_enable_image=\u00bboff\u00bb text_orientation=\u00bbcenter\u00bb width=\u00bb100%\u00bb max_width=\u00bb100%\u00bb module_alignment=\u00bbright\u00bb min_height=\u00bb100px\u00bb height=\u00bb100px\u00bb max_height=\u00bb100px\u00bb custom_margin=\u00bb21%||1%||false|false\u00bb hover_enabled=\u00bb0″ title_font_size_last_edited=\u00bboff|desktop\u00bb locked=\u00bboff\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb sticky_enabled=\u00bb0″ background_enable_color=\u00bboff\u00bb meta_text_align=\u00bbcenter\u00bb][\/et_pb_post_title][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=\u00bb4.25.1″ _module_preset=\u00bbdefault\u00bb custom_margin=\u00bb||-48px||false|false\u00bb custom_padding=\u00bb50px||50px||true|false\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_column type=\u00bb4_4″ _builder_version=\u00bb4.25.0″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_heading title=\u00bbABSTRACT\u00bb _builder_version=\u00bb4.25.1″ _module_preset=\u00bbdefault\u00bb title_font=\u00bb||||||||\u00bb title_text_color=\u00bb#0C71C3″ global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][\/et_pb_heading][et_pb_text _builder_version=\u00bb4.25.1″ _module_preset=\u00bbdefault\u00bb custom_margin=\u00bb0px||19px||false|false\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb]

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Qualified biomarkers help to optimize drug development and patient safety, yet for the regulatory acceptance of safety biomarkers substantial sample sizes are needed to ensure adequate case and control numbers, and robust evidence sufficient for qualification. To address this challenge, a consortium of leading European research institutions and SMEs has been established. The consortium will generate exploratory and confirmatory data enabling regulatory qualification of new safety biomarkers for application in drug development; establish robust datasets on the DILI, DIKI, DIPI, DIVI and DINI biomarkers to enhance diagnosis of disease; develop and validate assays for new safety biomarkers; implement profiles of circulating miRNAs as tissue and mechanism specific diagnostic tool; have key safety biomarkers accepted as qualified drug development tools by EMA, FDA, and PMDA.<\/span><\/p>\n

Given the significant expertise available across the consortium, the group will be able to tackle the key challenges related to successful biomarker qualification. A key driving principle of the consortium is cross-linking via existing networks of top profile research institutions, as well as capitalizing on existing data and resources. The Consortium is embedded into a network of international research collaborations such as the Pro-Euro-DILI-registry, TransQST, eTRANSAFE, the i2b2 tranSMART Foundation, the CIOMS DILI working group, EPoS, LITMUS, and BBMRI. To optimize regulatory interaction, we intend to continue our successful collaboration with non-European consortia such as PSTC, the FNIH Biomarkers Consortium, and US DILIN. A key expected result of the consortium will be a \u201cSafety Biomarker Factory\u201d, regularly qualifying new markers, with an associated \u201cSafety Biomarker Warehouse\u201d, providing to the scientific community, industry, and patients detailed data and information, and knowledge across a large spectrum of advanced safety biomarkers.<\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/section>[\/et_pb_text][et_pb_text _builder_version=\u00bb4.25.1″ _module_preset=\u00bbdefault\u00bb hover_enabled=\u00bb0″ global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb sticky_enabled=\u00bb0″]

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Website of the Project<\/a><\/span><\/h2>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/section>[\/et_pb_text][et_pb_heading title=\u00bbPartners\u00bb _builder_version=\u00bb4.25.1″ _module_preset=\u00bbdefault\u00bb title_font=\u00bb||||||||\u00bb title_text_color=\u00bb#0C71C3″ custom_margin=\u00bb30px||||false|false\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][\/et_pb_heading][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=\u00bb1_2,1_2″ _builder_version=\u00bb4.25.1″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_column type=\u00bb1_2″ _builder_version=\u00bb4.25.1″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_text _builder_version=\u00bb4.25.1″ _module_preset=\u00bbdefault\u00bb hover_enabled=\u00bb0″ global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb sticky_enabled=\u00bb0″]