{"id":12335,"date":"2025-03-20T12:15:41","date_gmt":"2025-03-20T12:15:41","guid":{"rendered":"https:\/\/www.healthnews.ie\/?p=12335"},"modified":"2025-03-24T09:13:36","modified_gmt":"2025-03-24T09:13:36","slug":"advancing-science-to-medicine-amid-regulatory-uncertainty","status":"publish","type":"post","link":"https:\/\/www.healthnews.ie\/clinical-trials\/advancing-science-to-medicine-amid-regulatory-uncertainty\/","title":{"rendered":"Advancing science to medicine amid regulatory uncertainty"},"content":{"rendered":"\n<div style=\"background-color:#f2f2f2;color:#32373c\" class=\"wp-block-atomic-blocks-ab-profile-box round ab-has-avatar ab-font-size-14 ab-block-profile ab-profile-columns\"><div class=\"ab-profile-column ab-profile-avatar-wrap\"><div class=\"ab-profile-image-wrap\"><figure class=\"ab-profile-image-square\"><img loading=\"lazy\" decoding=\"async\" width=\"400\" height=\"400\" class=\"ab-profile-avatar wp-image-12336\" src=\"https:\/\/s3.eu-north-1.amazonaws.com\/cdn-site.mediaplanet.com\/app\/uploads\/sites\/94\/2025\/03\/20120746\/vicky-1742472466-08082019_JB1-75.jpg\" alt=\"\" srcset=\"https:\/\/s3.eu-north-1.amazonaws.com\/cdn-site.mediaplanet.com\/app\/uploads\/sites\/94\/2025\/03\/20120746\/vicky-1742472466-08082019_JB1-75.jpg 400w, https:\/\/s3.eu-north-1.amazonaws.com\/cdn-site.mediaplanet.com\/app\/uploads\/sites\/94\/2025\/03\/20120746\/vicky-1742472466-08082019_JB1-75-125x125.jpg 125w\" sizes=\"auto, (max-width: 400px) 100vw, 400px\" \/><\/figure><\/div><\/div><div class=\"ab-profile-column ab-profile-content-wrap\"><h2 class=\"ab-profile-name\" style=\"color:#32373c\">Dr. Muriel O&#8217;Byrne<\/h2><p class=\"ab-profile-title\" style=\"color:#32373c\">SVP International Regulatory Affairs &amp; European Business Office Head, Regeneron Ireland<\/p><div class=\"ab-profile-text\"><\/div><ul class=\"ab-social-links\"><\/ul><\/div><\/div>\n\n\n\n<p><em>Legislation intended to enhance clinical trial applications needs improvements to better serve patients, says biotechnology company committed to conducting trials in Europe.<\/em><\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p>With an approach driven by science, leading <a href=\"https:\/\/www.regeneron.ie\/\" target=\"_blank\" rel=\"noreferrer noopener\">biotechnology company Regeneron<\/a> proudly invents,\u202fdevelops\u202fand commercialises medicines for people with serious diseases. Founded in 1988 and led by physician-scientists, it expanded internationally in 2013 by opening its European Business office in Dublin, acquiring a site in Raheen, Co. Limerick one year later, which has since been transformed into a major bioprocessing campus.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-digital-health-to-transform-clinical-trials-nbsp-nbsp\"><strong>Digital health to transform clinical trials&nbsp;<\/strong>&nbsp;<\/h2>\n\n\n\n<p>Muriel O&#8217;Byrne, SVP of International Regulatory Affairs, discusses how innovative approaches are improving clinical trial outcomes: \u201cClinical trial execution continues to evolve significantly, thanks to the potential of advancements like digital health technologies and AI. We are keenly interested in the implementation of AI-driven predictive modelling to enhance patient recruitment, optimise trial design, and improve data analysis efficiency while advancements in genetic and biomarker-based approaches are forming the backbone of personalised medicine.\u201d<\/p>\n\n\n\n<p>The biotech company\u2019s unique ability to repeatedly translate <a href=\"https:\/\/www.regeneron.ie\/\" target=\"_blank\" rel=\"noreferrer noopener\">science into medicine<\/a> has led to a wide array of approved treatments and products, most of which were homegrown in their laboratories. Conducting clinical research in around 50 countries globally, Regeneron leads clinical trials across a vast range of therapeutic areas, including ophthalmology, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, haematologic conditions, infectious diseases and rare diseases.<\/p>\n\n\n<div id=\"healt-481222655\"><div class=\"healt-adlabel\">Advertisements<\/div><div id=\"healt-606277324\" style=\"margin-top: 30px;margin-bottom: 30px;\"><a data-no-instant=\"1\" href=\"https:\/\/www.regeneron.ie\/\" rel=\"noopener\" class=\"a2t-link\" target=\"_blank\" aria-label=\"vicky-1742473837-Regeneron desk\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/s3.eu-north-1.amazonaws.com\/cdn-site.mediaplanet.com\/app\/uploads\/sites\/94\/2025\/03\/20123038\/vicky-1742473837-Regeneron-desk.jpg\" alt=\"\"  width=\"750\" height=\"250\"   \/><\/a><\/div><\/div>\n\n\n<h2 class=\"wp-block-heading\" id=\"h-challenges-posed-by-new-eu-clinical-trial-legislation-nbsp\"><strong>Challenges posed by new EU clinical trial legislation<\/strong>&nbsp;<\/h2>\n\n\n\n<p>Thriving within the biotechnology sector in Europe is currently no easy feat, with the implementation of new clinical trial regulations creating serious hurdles and delays. \u201cOne example is the EU Clinical Trials Regulation, passed in 2014 became fully operational this year, which was initially designed to streamline trial applications, and position the EU as an attractive location for continued placement of clinical studies. Unfortunately, in its implementation, it has fallen short of its primary objectives,\u201d says O\u2019Byrne.<\/p>\n\n\n\n<p>Although the application process has been streamlined, it is now resource-intensive from a sponsor\u2019s point of view, with complex requirements, prolonged setup times and increased administrative burden. These ongoing regulatory hurdles are proving challenging. \u201cAuthorities who have a seat at the table need to respond to remediate these issues which are reducing the opportunities for patients to access the latest innovations\u201d she adds.<\/p>\n\n\n\n<p>As a result of these regulatory changes, many sponsors are reconsidering their trial strategies, with some shifting their focus to non-EU regions with less bureaucratic regulatory landscapes. \u201cReports indicate that Europe is losing its share of large-scale clinical studies to Asia and the US, due to these heavy administrative processes and extended startup times. This is a concerning trend for the industry, but it is particularly concerning for patients across the EU who need access to innovative therapies,\u201d she explains.<a id=\"_msocom_1\"><\/a><\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>Reports indicate that Europe is losing <br>its share of large-scale clinical <br>studies to Southeast Asia and the US.<\/p>\n<\/blockquote>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-a-continued-dedication-to-patients-nbsp\"><strong>A continued dedication to patients<\/strong>&nbsp;<\/h2>\n\n\n\n<p>Despite the ongoing regulatory hurdles, Regeneron remains committed to investing in clinical trials in Ireland and Europe, actively engaging in strategies to address regulatory challenges and maintain its competitive edge.<\/p>\n\n\n\n<p>\u201cIt is important that we stay nimble. We have excellent clinical research sites here in Ireland, with committed doctors and good patient access,\u201d says O\u2019Byrne. \u201cWe have strong partnerships with major clinical research organisations and institutions and proactively engage to facilitate an attractive EU clinical research ecosystem.\u201d<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-ireland-s-position-as-a-biopharma-innovation-hub-nbsp\"><strong>Ireland\u2019s position as a biopharma innovation hub<\/strong>&nbsp;<\/h2>\n\n\n\n<p>Ireland maintains a strong presence in the global <a href=\"https:\/\/www.regeneron.ie\/\" target=\"_blank\" rel=\"noreferrer noopener\">biopharmaceutical sector<\/a>, with a well-established research infrastructure and an extremely skilled workforce supporting ongoing clinical innovation, strengthening its position as a hub for research excellence despite regulatory challenges.<\/p>\n\n\n\n<p>Regeneron&#8217;s Limerick facility is one of the largest-scale biopharmaceutical production sites in Ireland, and it has been pivotal in the company&#8217;s production capacity for various therapies. The site has seen continuous investment and expansion, reflecting the company\u2019s commitment to Ireland as a strategic location for its operations. Driven by the pursuit of scientific breakthroughs, it continues to \u2018follow the science,\u2019 seeking innovative solutions for people living with serious illnesses.<\/p>\n\n\n\n<div style=\"color:#32373c;background-color:#d61a5e\" class=\"wp-block-atomic-blocks-ab-notice ab-font-size-18 ab-block-notice\" data-id=\"5e5432\"><div class=\"ab-notice-text\" style=\"border-color:#d61a5e\"><p>From science to medicine: <a href=\"https:\/\/www.regeneron.ie\/\" target=\"_blank\" rel=\"noreferrer noopener\">regeneron.ie<\/a>\u00a0<\/p><\/div><\/div>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p>Date of Preparation: March 2025<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Legislation intended to enhance clinical trial applications needs improvements to better serve patients, says biotechnology company committed to conducting trials in Europe. With an approach driven by science, leading biotechnology company Regeneron proudly invents,\u202fdevelops\u202fand commercialises medicines for people with serious diseases. Founded in 1988 and led by physician-scientists, it expanded internationally in 2013 by opening &hellip; <a href=\"https:\/\/www.healthnews.ie\/clinical-trials\/advancing-science-to-medicine-amid-regulatory-uncertainty\/\">Continued<\/a><\/p>\n","protected":false},"author":91,"featured_media":12337,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[5829],"tags":[5960],"class_list":["post-12335","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-clinical-trials","tag-clinical-trials-2025"],"acf":[],"featured_image_src":"https:\/\/s3.eu-north-1.amazonaws.com\/cdn-site.mediaplanet.com\/app\/uploads\/sites\/94\/2025\/03\/20121317\/vicky-1742472796-GettyImages-1387090964-600x400.jpg","featured_image_src_square":"https:\/\/s3.eu-north-1.amazonaws.com\/cdn-site.mediaplanet.com\/app\/uploads\/sites\/94\/2025\/03\/20121317\/vicky-1742472796-GettyImages-1387090964-600x600.jpg","author_info":{"display_name":"henryphillips","author_link":"https:\/\/www.healthnews.ie\/author\/henryphillips\/"},"vicky_category_order":[{"category_id":5829,"order":"2"}],"vicky_index_order":"","_links":{"self":[{"href":"https:\/\/www.healthnews.ie\/wp-json\/wp\/v2\/posts\/12335","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.healthnews.ie\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.healthnews.ie\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.healthnews.ie\/wp-json\/wp\/v2\/users\/91"}],"replies":[{"embeddable":true,"href":"https:\/\/www.healthnews.ie\/wp-json\/wp\/v2\/comments?post=12335"}],"version-history":[{"count":4,"href":"https:\/\/www.healthnews.ie\/wp-json\/wp\/v2\/posts\/12335\/revisions"}],"predecessor-version":[{"id":12436,"href":"https:\/\/www.healthnews.ie\/wp-json\/wp\/v2\/posts\/12335\/revisions\/12436"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.healthnews.ie\/wp-json\/wp\/v2\/media\/12337"}],"wp:attachment":[{"href":"https:\/\/www.healthnews.ie\/wp-json\/wp\/v2\/media?parent=12335"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.healthnews.ie\/wp-json\/wp\/v2\/categories?post=12335"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.healthnews.ie\/wp-json\/wp\/v2\/tags?post=12335"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}