EUCOPE Member Spotlight: Q&A with Muriel O’Byrne Senior Vice President and Head of International Regulatory Affairs and the European Business Office at Regeneron

Every month, EUCOPE spotlights a member company and its great work in advancing the life sciences industry and driving innovation to serve patients better. In April, we spoke with Dr. Muriel O’Byrne, Senior Vice President and Head of International Regulatory Affairs and the European Business Office at Regeneron. 

Tell us about your organisation and its mission and how you drive innovation internally?

Regeneron is a global biotechnology company dedicated to inventing, developing and commercialising life-transforming medicines for people with serious diseases. We have a clear mission: Using the power of science to bring new medicines to life.

Founded and led for over 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved or authorised treatments and product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, hematologic conditions, infectious diseases and rare diseases.

We constantly drive innovation: Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune®, which uses unique genetically humanised mice to produce optimised fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center®, which is conducting one of the largest genetics sequencing efforts in the world.

Over the past two years, Regeneron has been expanding further internationally. Having established our European Business Office in Dublin in 2013, we are now fully operational in key markets including Germany, Italy, France, Spain, UK, Canada and Japan. The catalyst for this expansion was Regeneron deciding to reacquire exclusive worldwide development, commercialisation, and manufacturing rights to one of our cancer medications.

How do your organisation’s activities help patients now and into the future?

Our strategy is simple: we follow the science – we go wherever the most promising research takes us. This approach has fuelled our growth for decades and remains our roadmap for future success. Despite the success to date, we have a saying that “we are just getting started” and I really believe this to be true. In 2024, we invested US$ 5.1 billion in research and development, consistently prioritising investment in our research capabilities, homegrown technologies, and high-performing teams.

We have one of the most productive research engines in the industry and a genuine passion to drive innovation. With our deep expertise in genetics, biology and technology, we continue to evolve our scientific endeavours and pursue multiple therapeutic approaches – from biologics to genetic medicines to cell therapies – to revolutionise medicine. This has resulted in a pipeline of promising clinical programmes that has the potential to truly transform patients’ lives. Regardless of the disease or the size of the patient population – whether it affects millions or just a few individuals worldwide – if our rigorous, evidence-based scientific pursuit demonstrates the potential of a medicine to help patients in need, we will ardently progress its clinical development.

Today, we have more than 40 molecules under investigation and over 100 clinical trials in more than 50 countries around the globe. It is immensely rewarding to see our molecules progress from the lab, into clinical stage research and through regulatory approval and see the lives helped along the way.

What do you see as the biggest challenge facing the life sciences industry today?

We are living through a period of changing global dynamics. The uncertainty on what this will mean for global supply chains and drug pricing remains. Additionally, intellectual property and trade secret protections which are essential for stimulating innovation continue to be eroded. This is happening through proposals such as the EU’s General Pharmaceutical Legislation and European Health Data Space. Recently, within the EU, we are hearing encouraging voices around promotion of innovation and building a competitive life science sector. However, it is important the Commission and other stakeholders are willing to take the perspective of the innovative research industry into account in developing these initiatives.

I encourage policy makers to be open to hearing our lived experience of working with some of the legal instruments that have been developed. For example, we see national ethics committees not consistently adhering to the principles of the Clinical Trials Regulations – this adds to the burden on the industry who must adapt to these variances or risk the delay or even rejection of their clinical study. Patient access and ensuring treatment availability across the EU for patients who need it without stifling innovation at the same time, should remain an ongoing priority for the industry and legislators alike.

What are the major health policy issues and themes that you are most focused on in 2025?

Our policy focus for 2025 is on removing impediments to R&D that slow down patient access to innovative treatments. We believe there is often a disconnect between the intention and practical impact of policies. Examples of where this has manifested are the Clinical Trial Regulation and In Vitro Diagnostic Regulation, which are factors in the reduction of clinical trial activity in Europe. Across all policy topics, we want to contribute to creating an environment that facilitates innovation. That means ensuring alignment between the various EU initiatives such as the Critical Medicines Act and General Pharmaceutical Legislation. When implementing policies such as the European Health Data Space, it must be done in a way that doesn’t further impede innovation.

What attracted you to join EUCOPE and how can we help you achieve your business goals?

EUCOPE is an organisation that enables us to have a greater voice in key policy discussions at an EU level. We have found ourselves to have common interests with the other members and there is a sense of strength in consolidation of views around key topics. It also provides a vehicle to share concerns in an environment that is action-oriented. I have also been reassured by the pragmatism shown by EUCOPE in addressing the challenges facing the industry and the insights provided based on direct access to discussions that impact our sector. Continuing to represent the innovative biopharma sector as critical decisions are made around such topics as regulatory data protection, organisation of the EU agencies, and the EHDS will offer continued benefit to Regeneron and other EUCOPE members.