BlueDil is pleased to announce its membership in EUCOPE, the European Confederation of Pharmaceutical Entrepreneurs. This step reflects BlueDil’s continued commitment to supporting biotech startups and pharmaceutical companies working to bring innovative therapies to patients, particularly in the rare disease space. EUCOPE represents small and mid-sized pharmaceutical and biotechnology companies that play a key role […]

At Bluedil, our mission is to support biotech and pharma companies throughout the entire orphan product lifecycle. A few months ago, we highlighted three key aspects to consider when entering and expanding in the European market. However, just as important as knowing the right moves to make is knowing what to avoid. Here are three […]

Expanding a rare disease therapy across Europe is a great business opportunity but at the same time a unique challenge to handle. Low prevalence, high unmet need, extremely specialized clinical networks and heterogeneity in regulatory and access frameworks among the 27 EU countries mean that success depends on how you build your strategy and not […]

BlueDil International is strengthening its presence in Europe by welcoming on board Marco Grebe as a Regional Country Lead for DACH Region, one of the most strategic and highly regulated European healthcare markets. Marco holds more than 20 years of experience in pharma industries and biotech, and has a deep understanding of rare diseases, ATMPs […]

For biotech companies specializing in rare diseases, expanding in Europe offers an exciting opportunity to generate value, access new markets and deliver therapies to patients with high unmet medical needs. As we previously discussed in our two-part series about the benefits of entering the EU, diversifying the market helps reduce commercial and financial risks while […]

Kamlesh Sheth Co-Founder & Senior Partner and Chair We interviewed our Co-Founder, Senior Partner and Chair, Kamlesh Sheth, about his motivation for working in the world of rare diseases and his involvement in the birth of BlueDil International. Let’s read about what he had to say. 1. What inspired your dedication to the rare disease […]

As we continue our exploration into how Europe represents a strategic opportunity for U.S. biotech startups developing therapies for rare diseases, it’s time to examine two highly impactful growth levers: clinical trial expansion in the EU and Early Access Programs (EAPs). Entering the European landscape can support startups’ development timelines and reduce costs while also […]

Earlier this year, our CEO Leonardo Calzetti attended BioEurope Spring 2025 in Milan, one of the most important events in the biotech startups industry, bringing together innovators, investors and key leaders from around the world. This event served as an invaluable platform for discussing the challenges and opportunities for startups in Europe. Among the key […]

France has positioned itself as a leader in rare disease research, patient care, and data management through the development of the French National Database of Rare Diseases (BNDMR). This comprehensive and secure national health data repository is a fundamental component of France’s national rare disease plans (PNMR), with over 750,000 registered patients across more than […]

At BlueDil International, we are entering a new chapter—one that reflects our commitment to innovation, strategic growth and leadership excellence. We are proud to announce a transition in our executive team as Sylvain Forget, our founder and long-standing leader, passes the baton to Leonardo Calzetti, who will be the new CEO. Since the birth of […]