EUCOPE Member Spotlight: Q&A with Corinne Schmitz – Chairman, Founder & CEO at Azurbio Pharma

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 April, we spoke with Corinne Schmitz Chairman, Founder & CEO at Azurbio Pharma.

Corinne Schmitz is an accomplished entrepreneur with over 30 years of experience in global pharmaceutical and biotech companies. She has successfully built and led regulatory and pharmaceutical consultancies focused on developing customer-centric services to help bring therapies to market across Europe. She currently leads AzurBio Pharma, a company she founded, committed to empowering biopharmaceutical companies with a first life-changing medicine to expand across Europe. AzurBio Pharma’s mission is to build strategic partnerships with these companies, offering turnkey, customized, and innovative solutions to navigate EU complexities and successfully deliver their therapies to European patients.

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

AzurBio Pharma was created in response to a disruptive observation: too many innovative therapies, especially for rare diseases, never make it to patients in Europe. Nearly 50% of FDA-approved orphan drugs from US companies are not approved by the EMA, highlighting a stark access gap between the US and EU.

This disparity highlights a major challenge: navigating the complexities of the European regulatory and market landscape remains a significant barrier for many biotech innovators, especially those introducing their first life-changing treatment.

AzurBio Pharma exists to address that. We partner with biopharma companies to deliver tailored, end-to-end solutions that accelerate access, simplify EU expansion. We are mainly focused on treatments for rare or serious diseases, where the unmet need is high and timely access is critical.

Innovation is embedded in our operating model. We bring together a cross-functional team of industry experts with deep regulatory, market access, and commercialisation expertise. By fostering close collaboration, agility, and a solution-oriented mindset, we challenge conventional pathways and develop tailored strategies that reduce complexity and time-to-market for our partners.

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

Our core business—partnering with biopharmaceutical innovators to bring therapies across Europe—has a direct and meaningful impact on patients. By addressing operational and regulatory hurdles with creative, tailored solutions and our expert network, we help ensure that innovative treatments reach those in need more quickly and effectively.

In the long term, our work contributes to a healthier, more dynamic ecosystem where innovation is rewarded, and patients, particularly those affected by rare or serious diseases, benefit from faster and more consistent access to life-changing therapies across Europe.

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

One of the most pressing challenges is navigating the fragmented and complex regulatory and reimbursement landscape across Europe. Biopharmaceutical companies often face a maze of country-specific requirements that can significantly delay patient access, especially for orphan and advanced therapies, where time is critical and populations are small.

In some cases, a therapy may be approved and reimbursed in one country within a year, yet take up to five years to reach patients in another. This inconsistency is not only inefficient—it is unfair. Patients across Europe deserve equitable and timely access to life-changing treatments, regardless of where they live.

In parallel, financial barriers remain a major hurdle. Bringing a therapy to market is a costly endeavor, and while investment is improving in certain regions, many companies, particularly smaller innovators, still struggle to secure adequate funding. The future of healthcare innovation depends on sustainable models that link investment to meaningful patient outcomes.

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

In 2025, we are particularly focused on policies that impact access to orphan drugs and advanced therapies. We’re closely following reforms aimed at improving early access mechanisms, clarifying pricing and reimbursement pathways, and recognizing the unique value these therapies bring.

We also support initiatives that foster innovation in regulatory science, including the expansion of collaborative tools like joint clinical assessments and enhanced HTA alignment. Our policy priorities are shaped by the belief that the system must evolve to match the pace of scientific progress.

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

EUCOPE‘s commitment to supporting small and mid-sized innovative companies strongly aligns with our own mission. The opportunity to collaborate with like-minded peers, contribute to forward-thinking policy discussions, and gain early insight into legislative developments made joining EUCOPE a natural choice.

EUCOPE helps us amplify our voice, access critical knowledge, and build strategic relationships with key stakeholders across Europe. Through this partnership, we hope to continue shaping a regulatory and policy environment that accelerates innovation and ensures better outcomes for patients.