{"id":11109,"date":"2023-01-19T12:54:27","date_gmt":"2023-01-19T11:54:27","guid":{"rendered":"https:\/\/fei-online.com\/?p=11109"},"modified":"2023-01-19T12:56:59","modified_gmt":"2023-01-19T11:56:59","slug":"the-fda-further-expands-collaboration-with-cn-bio-to-evaluate-the-physiomimix-multi-organ-microphysiological-systemer-expands-collaborati-on-with-cn-bio-to-evaluate-the-physiomimix-multi-organ-mial-sy","status":"publish","type":"post","link":"https:\/\/fei-online.com\/the-fda-further-expands-collaboration-with-cn-bio-to-evaluate-the-physiomimix-multi-organ-microphysiological-systemer-expands-collaborati-on-with-cn-bio-to-evaluate-the-physiomimix-multi-organ-mial-sy\/","title":{"rendered":"The FDA further expands collaboration with CN Bio to evaluate the PhysioMimix Multi-organ microphysiological system"},"content":{"rendered":"<div id='av_section_1'  class='avia-section main_color avia-section-default avia-no-border-styling  avia-bg-style-scroll  avia-builder-el-0  avia-builder-el-no-sibling   container_wrap fullsize' style=' '  ><div class='container' ><main  role=\"main\" itemprop=\"mainContentOfPage\"  class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-11109'><div class='entry-content-wrapper clearfix'>\n<div class=\"flex_column av_one_fifth  flex_column_div av-zero-column-padding first  avia-builder-el-1  el_before_av_three_fifth  avia-builder-el-first  \" style='border-radius:0px; '><section class=\"av_textblock_section \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock  '   itemprop=\"text\" ><p style=\"text-align: center\"><div id=\"ads-slider-28\" class=\"custom-slider ads-slider-1041194062 ads-slider\"><ul><li><!--Begin ClixTrac.com Banner Code -->\r\n<a href=\"https:\/\/clixtrac.com\/goto\/?308404\" target=\"_blank\" rel=\"noopener\"><img decoding=\"async\" src=\"https:\/\/clixtrac.com\/banner\/308404.jpg\" alt=\"Free from food\" title=\"Free from food\" border=\"0\" \/><\/a>\r\n<!--End ClixTrac.com Banner Code --><\/li><li><!--Begin ClixTrac.com Banner Code -->\r\n<a href=\"https:\/\/clixtrac.com\/banner\/click.php?banner=302805\" target=\"_blank\" rel=\"noopener\">\r\n<img decoding=\"async\" src=\"https:\/\/clixtrac.com\/banner\/302805.jpg\" alt=\"LUBRIPLATE\" title=\"LUBRIPLATE\" border=\"0\" width=\"120\" height=\"600\" \/><\/a>\r\n<!--End ClixTrac.com Banner Code --><\/li><li><div style=\"margin-left: auto; margin-right: auto; text-align: center; \" id=\"ads-1527463507\"><!--Begin ClixTrac.com Banner Code -->\r\n<a href=\"https:\/\/clixtrac.com\/banner\/click.php?banner=297426\" target=\"_blank\" rel=\"noopener\">\r\n<img decoding=\"async\" width=\"100%\" height=\"auto\" src=\"https:\/\/clixtrac.com\/banner\/297426.jpg\" alt=\"Click here for more information!\" title=\"Click here for more information!\" border=\"0\" \/><\/a>\r\n<!--End ClixTrac.com Banner Code --><\/div><\/li><\/ul><\/div><script>( window.advanced_ads_ready || jQuery( document ).ready ).call( null, function() {var $adsslider1041194062 = jQuery( \".ads-slider-1041194062\" );$adsslider1041194062.on( \"unslider.ready\", function() { jQuery( \"div.custom-slider ul li\" ).css( \"display\", \"block\" ); });$adsslider1041194062.unslider({ delay:5000, autoplay:true, nav:false, arrows:false, infinite:true });$adsslider1041194062.on(\"mouseover\", function(){$adsslider1041194062.unslider(\"stop\");}).on(\"mouseout\", function() {$adsslider1041194062.unslider(\"start\");});});<\/script><\/p>\n<\/div><\/section><\/div><div class=\"flex_column av_three_fifth  flex_column_div av-zero-column-padding   avia-builder-el-3  el_after_av_one_fifth  el_before_av_one_fifth  \" style='border-radius:0px; '><section class=\"av_textblock_section \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock  '   itemprop=\"text\" ><p style=\"text-align: center\"><\/p>\n<\/div><\/section><br \/>\n<section class=\"av_textblock_section \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock  '   itemprop=\"text\" ><header class=\"entry-content-header\"><h1 class=\"post-title entry-title\" itemprop=\"headline\">The FDA further expands collaboration with CN Bio to evaluate the PhysioMimix Multi-organ microphysiological system<\/h1><span class=\"post-meta-infos\">\/ <span class=\"blog-categories minor-meta\">in <a href=\"https:\/\/fei-online.com\/category\/e-news\/\" rel=\"tag\">E-News<\/a> <\/span><\/span><\/header>\n<\/div><\/section><br \/>\n<section class=\"av_textblock_section \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock  '   itemprop=\"text\" ><h3>CN Bio, a leading Organ-on-a-chip Company (OOC) that designs and manufactures single-and multi-organ microphysiological systems (MPS), today announced that the U.S. Food and Drug Administration (FDA) and CN Bio have expanded their collaboration for the second time, with new research aiming to evaluate multi-organ MPS and their applications using the PhysioMimix\u2122 Multi-organ System. Building on the success of prior studies, the system will initially be investigated for improving the preclinical estimation of human drug bioavailability compared to standard animal models.<\/h3>\n<p><!--more--><\/p>\n<p>For orally administered drugs, a critical parameter that needs to be understood by drug developers and regulatory agencies is bioavailability. Bioavailability is defined as the fraction of drug reaching the bloodstream. Accurately predicting the bioavailability of orally administered medicines in humans during preclinical development is crucial as it forms the basis for setting safe and efficacious doses in the clinic. Animal models currently dominate when estimating bioavailability, but evidence has shown these models are poor predictors in part due to inherent physiological and metabolic differences. Paving the way for approaches such as MPS, the recently passed FDA Modernization Act 2.0 has removed the mandatory requirement for animal testing for toxicity where enhanced performance is proven using\u00a0<em>in vitro<\/em>\u00a0alternatives<sup>1<\/sup>.<\/p>\n<\/div><\/section><br \/>\n<div  class='avia-image-container  av-styling-    avia-builder-el-7  el_after_av_textblock  el_before_av_textblock  avia-align-center '  itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\"  ><div class='avia-image-container-inner'><div class='avia-image-overlay-wrap'><img class='avia_image' src='https:\/\/fei-online.com\/wp-content\/uploads\/sites\/4\/2023\/01\/CN-Bio.png' alt='' title='CN Bio' height=\"563\" width=\"1000\"  itemprop=\"thumbnailUrl\"  \/><\/div><\/div><\/div><br \/>\n<section class=\"av_textblock_section \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock  '   itemprop=\"text\" ><p>CN Bio\u2019s PhysioMimix Gut\/Liver model recapitulates\u00a0<em>in vitro<\/em>\u00a0the structure and function of these human tissues and their fluidic interaction, for comparing intravenous and oral compound dosing. This model uniquely recreates the combined effect of intestinal permeability and first-pass metabolism by the liver for the prediction of human oral bioavailability.<\/p>\n<p>During the last five years of collaboration with CN Bio, the FDA has utilized the PhysioMimix Liver model for drug toxicity and metabolism studies resulting in the first co-publication, peer-reviewed article between an MPS provider and a regulator\u00a0<sup>2<\/sup>. Within the same year, the FDA and CN Bio broadened their partnership further to explore the potential of the Company\u2019s Lung model across various inhaled drug applications \u2014 work on this is still ongoing\u00a0<sup>3<\/sup>.<\/p>\n<\/div><\/section><br \/>\n<div   class='hr hr-default   avia-builder-el-9  el_after_av_textblock  el_before_av_textblock '><span class='hr-inner ' ><span class='hr-inner-style'><\/span><\/span><\/div><br \/>\n<section class=\"av_textblock_section \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock  '   itemprop=\"text\" ><p><strong>Dr Emily Richardson, Lead Scientist at CN Bio, said:\u00a0<\/strong>\u201c<em>We are extremely pleased with the FDA\u2019s decision to deepen our research collaboration into the multi-organ space. We are working hard to evidence how our technology can tackle these critical drug development bottlenecks and lead the way towards inclusion of OOC\/MPS data within IND submissions.\u201d<\/em><\/p>\n<\/div><\/section><br \/>\n<div  class='av-social-sharing-box  avia-builder-el-11  el_after_av_textblock  avia-builder-el-last  av-social-sharing-box-minimal '><div class='av-share-box'><h5 class='av-share-link-description av-no-toc '>Share this<\/h5><ul class='av-share-box-list noLightbox'><li class='av-share-link av-social-link-facebook' ><a target=\"_blank\" aria-label=\"Share on Facebook\" href='https:\/\/www.facebook.com\/sharer.php?u=https:\/\/fei-online.com\/the-fda-further-expands-collaboration-with-cn-bio-to-evaluate-the-physiomimix-multi-organ-microphysiological-systemer-expands-collaborati-on-with-cn-bio-to-evaluate-the-physiomimix-multi-organ-mial-sy\/&#038;t=The%20FDA%20further%20expands%20collaboration%20with%20CN%20Bio%20to%20evaluate%20the%20PhysioMimix%20Multi-organ%20microphysiological%20system' aria-hidden='false' data-av_icon='\ue8f3' data-av_iconfont='entypo-fontello' title='' data-avia-related-tooltip='Share on Facebook' rel=\"noopener\"><span class='avia_hidden_link_text'>Share on Facebook<\/span><\/a><\/li><li class='av-share-link av-social-link-twitter' ><a target=\"_blank\" aria-label=\"Share on Twitter\" href='https:\/\/twitter.com\/share?text=The%20FDA%20further%20expands%20collaboration%20with%20CN%20Bio%20to%20evaluate%20the%20PhysioMimix%20Multi-organ%20microphysiological%20system&#038;url=https:\/\/fei-online.com\/?p=11109' aria-hidden='false' data-av_icon='\ue8f1' data-av_iconfont='entypo-fontello' title='' data-avia-related-tooltip='Share on Twitter' rel=\"noopener\"><span class='avia_hidden_link_text'>Share on Twitter<\/span><\/a><\/li><li class='av-share-link av-social-link-whatsapp' ><a target=\"_blank\" aria-label=\"Share on WhatsApp\" href='https:\/\/api.whatsapp.com\/send?text=https:\/\/fei-online.com\/the-fda-further-expands-collaboration-with-cn-bio-to-evaluate-the-physiomimix-multi-organ-microphysiological-systemer-expands-collaborati-on-with-cn-bio-to-evaluate-the-physiomimix-multi-organ-mial-sy\/' aria-hidden='false' data-av_icon='\uf232' data-av_iconfont='entypo-fontello' title='' data-avia-related-tooltip='Share on WhatsApp' rel=\"noopener\"><span class='avia_hidden_link_text'>Share on WhatsApp<\/span><\/a><\/li><li class='av-share-link av-social-link-linkedin' ><a target=\"_blank\" aria-label=\"Share on LinkedIn\" href='https:\/\/linkedin.com\/shareArticle?mini=true&#038;title=The%20FDA%20further%20expands%20collaboration%20with%20CN%20Bio%20to%20evaluate%20the%20PhysioMimix%20Multi-organ%20microphysiological%20system&#038;url=https:\/\/fei-online.com\/the-fda-further-expands-collaboration-with-cn-bio-to-evaluate-the-physiomimix-multi-organ-microphysiological-systemer-expands-collaborati-on-with-cn-bio-to-evaluate-the-physiomimix-multi-organ-mial-sy\/' aria-hidden='false' data-av_icon='\ue8fc' data-av_iconfont='entypo-fontello' title='' data-avia-related-tooltip='Share on LinkedIn' rel=\"noopener\"><span class='avia_hidden_link_text'>Share on LinkedIn<\/span><\/a><\/li><li class='av-share-link av-social-link-mail' ><a  aria-label=\"Share by Mail\" href='mailto:?subject=The%20FDA%20further%20expands%20collaboration%20with%20CN%20Bio%20to%20evaluate%20the%20PhysioMimix%20Multi-organ%20microphysiological%20system&#038;body=https:\/\/fei-online.com\/the-fda-further-expands-collaboration-with-cn-bio-to-evaluate-the-physiomimix-multi-organ-microphysiological-systemer-expands-collaborati-on-with-cn-bio-to-evaluate-the-physiomimix-multi-organ-mial-sy\/' aria-hidden='false' data-av_icon='\ue805' data-av_iconfont='entypo-fontello' title='' data-avia-related-tooltip='Share by Mail'><span class='avia_hidden_link_text'>Share by Mail<\/span><\/a><\/li><\/ul><\/div><\/div><\/p><\/div><div class=\"flex_column av_one_fifth  flex_column_div av-zero-column-padding   avia-builder-el-12  el_after_av_three_fifth  avia-builder-el-last  \" style='border-radius:0px; 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Building on [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":11110,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[3],"tags":[],"_links":{"self":[{"href":"https:\/\/fei-online.com\/wp-json\/wp\/v2\/posts\/11109"}],"collection":[{"href":"https:\/\/fei-online.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/fei-online.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/fei-online.com\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/fei-online.com\/wp-json\/wp\/v2\/comments?post=11109"}],"version-history":[{"count":3,"href":"https:\/\/fei-online.com\/wp-json\/wp\/v2\/posts\/11109\/revisions"}],"predecessor-version":[{"id":11113,"href":"https:\/\/fei-online.com\/wp-json\/wp\/v2\/posts\/11109\/revisions\/11113"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/fei-online.com\/wp-json\/wp\/v2\/media\/11110"}],"wp:attachment":[{"href":"https:\/\/fei-online.com\/wp-json\/wp\/v2\/media?parent=11109"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/fei-online.com\/wp-json\/wp\/v2\/categories?post=11109"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/fei-online.com\/wp-json\/wp\/v2\/tags?post=11109"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}