Dr. Muriel O’Byrne
SVP International Regulatory Affairs & European Business Office Head, Regeneron Ireland
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, develops and 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.
Digital health to transform clinical trials
Muriel O’Byrne, SVP of International Regulatory Affairs, discusses how innovative approaches are improving clinical trial outcomes: “Clinical 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.”
The biotech company’s unique ability to repeatedly translate science into medicine 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.
Challenges posed by new EU clinical trial legislation
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. “One 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,” says O’Byrne.
Although the application process has been streamlined, it is now resource-intensive from a sponsor’s point of view, with complex requirements, prolonged setup times and increased administrative burden. These ongoing regulatory hurdles are proving challenging. “Authorities 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” she adds.
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. “Reports 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,” she explains.
Reports indicate that Europe is losing
its share of large-scale clinical
studies to Southeast Asia and the US.
A continued dedication to patients
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.
“It is important that we stay nimble. We have excellent clinical research sites here in Ireland, with committed doctors and good patient access,” says O’Byrne. “We have strong partnerships with major clinical research organisations and institutions and proactively engage to facilitate an attractive EU clinical research ecosystem.”
Ireland’s position as a biopharma innovation hub
Ireland maintains a strong presence in the global biopharmaceutical sector, 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.
Regeneron’s Limerick facility is one of the largest-scale biopharmaceutical production sites in Ireland, and it has been pivotal in the company’s production capacity for various therapies. The site has seen continuous investment and expansion, reflecting the company’s commitment to Ireland as a strategic location for its operations. Driven by the pursuit of scientific breakthroughs, it continues to ‘follow the science,’ seeking innovative solutions for people living with serious illnesses.
From science to medicine: regeneron.ie
Date of Preparation: March 2025
