Member Spotlight - January 31, 2025

EUCOPE Member Spotlight: Q&A with Antoine Bernasconi, Executive VP, Chief Commercial Officer Europe & International at SERB Pharmaceuticals

Every month, EUCOPE spotlights a member company and the great work they’re doing to advance the life sciences industry and drive innovation to serve patients better. In January, we spoke with Antoine Bernasconi, Executive VP, Chief Commercial Officer Europe & International at SERB Phamaceuticals.

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

SERB Pharmaceuticals equips healthcare providers worldwide with life-saving medicines for rare conditions and emergencies. Founded in France in 1951, we have consistently supplied emergency medicines and medical countermeasures, including the broadest antidote portfolio in the world and addressing all areas of CBRN (Chemical, Biological, Radiological, and Nuclear) threats. In this time, we have built trusted partnerships, integrated infrastructure and quality processes to get our medicines to patients with urgency.

Today healthcare providers in over 100 countries rely on us for a broad range of essential medicines delivered via healthcare systems, first responders, emergency preparedness agencies, and non-profit organisations.   Our vision is to improve access and improve the standard of care for patients worldwide through our proven ability to acquire, develop, manufacture, launch, and commercialize specialist medicines.

Although operating internationally, SERB’s European footprint remains strong, with a significant presence in Europe, particularly in France. We reach healthcare providers in the rest of the world through a network of trusted distribution partners who share our expertise.

SERB also has expertise in the research and development of biological medicines. We are one of the few global players with an in-house polyclonal antibody platform, capable of producing biological medicines on a commercial scale while adhering to current pharmaceutical quality standards.

Aware and concerned about the issues of health sovereignty and the sensitive nature of many of our products, we are particularly vigilant about the supply of active ingredients and the location of production. Whenever we can manufacture or source in Europe, we do. Almost all of our current CBRN medical countermeasures, and their active ingredients, are manufactured in Europe, with the remainder manufactured in the US.

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

At SERB, we are fortunate to have a portfolio of medicines made up primarily of life-saving therapies. We are of course very proud of this, but it also comes with a tremendous responsibility, as these are often niche medicines with few or no alternatives. So the impact of our work is very direct and tangible, as it involves supplying these medicines with urgency and reliability. Many of our medicines, for instance, are listed as critical or essential medicines, highlighting the value of our products for patients who need them.

Our commitment is to ensure that patients worldwide who need these treatments can access them. Even though we currently hold over 500 marketing authorizations for our various medications, there is still much work to be done to expand access to these drugs to new geographies across the globe.

This ambition to serve patients is also reflected in SERB’s rapid growth: the company had 10 employees in 2001, 50 in 2018 and today, we are over 500!

Looking ahead, SERB will continue to expand our reach through selective acquisitions, accessing new patient groups, and entering new markets. Building on our strength in delivering quality medicines with urgency, we aim to address additional needs in rare conditions and emergencies and to enhance the security of both civilians and the military in Europe and globally in the realm of CBRN (Chemical, Biological, Radiological, and Nuclear) threats.

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

One of the greatest challenges facing the life sciences industry today is undoubtedly the need to harmonize, both from a regulatory and economic perspective, an ecosystem that is ultimately extremely diverse without pitting the actors against each other. There is, of course, the necessity for breakthrough therapies, but there it is above all a priority to maintain mature, proven medicines on the market.

Furthermore, at a time when sovereignty issues have been brought back to the forefront, particularly following the COVID-19 pandemic, a courageous political approach is required, not only to encourage actors to produce in Europe but also to value those who have always made this choice. In this regard, a fundamental question arises: do we truly want to ensure a sustainable life sciences industry in Europe? This would require strong political commitments to enhance our competitiveness against other geographic regions and to develop a genuine strategy that involves all stakeholders: pharmaceutical companies, regulators, healthcare providers, and policymakers.

Balancing innovation with the maintenance of essential, established treatments, while fostering a self-reliant and competitive European life sciences market, is critical to addressing the industry’s contemporary challenges. This strategic alignment is vital for creating a resilient and sustainable life sciences sector that can continually meet the evolving needs of patients in Europe and globally.

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

I think that like all pharmaceutical companies, one of the key issues we must focus on is the revision of European pharmaceutical legislation. This is crucial because it directly impacts orphan drugs, which are essential for treating rare diseases with limited therapeutic options. The proposed reform aims to improve incentives for the development of these medications and streamline regulatory processes, ensuring quicker access for patients. Revising the legislation can significantly enhance the availability and affordability of orphan drugs, ultimately improving patient outcomes and advancing public health by addressing unmet medical needs across Europe and beyond. It is also vital that the Orphan Drug Designation (ODD) remains a robust element of protection to ensure continued support and development of these critical therapies.

More specifically, considering SERB’s profile, the topics of critical medicines and preparedness are also at the forefront of what interests us and I’m pleased that these two topics are clearly outlined in the new European Commission’s roadmap.

The issue of critical medicines ties into the broader topic of managing shortages, which has become a major political concern. I believe that Europe is the appropriate scale to address this. SERB is part of the Critical Medicines Alliance, a coalition of a wide range of stakeholders that works collaboratively to formulate proposals and advocate for policies that address these critical issues. A Critical Medicine Act has been announced for the first quarter, and it is crucial to strike the right balance between new constraints and incentives, avoiding a one-size-fits-all approach considering the diversity of the life sciences sector.

Preparedness is also a key focus for us, and the continuity of HERA and its missions is crucial. The sustainability of HERA is important as it ensures the coordination and complementarity needed to effectively address major health risks. More specifically, the stockpiling approach is a critical component of Europe’s preparedness strategy, especially in the current global context marked by more frequent health crises and geopolitical tensions. Ensuring that we have adequate reserves of essential medical countermeasures is vital for a rapid and effective response to emergencies. Moreover, building and maintaining strategic stockpiles of medicines requires a long-term approach, backed up by a clear vision and appropriate funding since annual budgeting is not the right way for ensuring proper stock management. This approach not only safeguards public health but also reinforces our health systems’ resilience against potential threats. In this framework, SERB’s contributions to programs like rescEU are pivotal in strengthening Europe’s health security.

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

For a company like SERB, being a member of EUCOPE makes perfect sense as EUCOPE represents small to mid-sized companies in the life sciences sector. The saying “alone we go faster, but together we go further” captures the value of EUCOPE membership: collective action leads to sustainable and far-reaching impact. By joining forces with EUCOPE, SERB can benefit from shared knowledge, resources, and advocacy efforts vital for navigating regulatory landscapes, influencing health policies, and driving innovation.

EUCOPE’s focus on European pharmaceutical legislation, particularly regarding orphan drugs and critical medicines, aligns with SERB’s priorities. The network and alliance fostered by EUCOPE amplify SERB’s voice in critical discussions, enabling it to contribute to and benefit from sector-wide advancements.

On the other hand, SERB brings to EUCOPE the unique vision of a one-of-a-kind pharmaceutical player at the crossroads of health, defense, security and sovereignty. Our expertise and the challenges we face often illustrate or give a different perspective to the issues addressed by EUCOPE, supporting collective actions.

EUCOPE membership not only supports SERB’s growth and strategic objectives but also reinforces the collective strength of the life sciences community, driving progress in healthcare across Europe.