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 […]

The Role of PAGs in European Decision-Making Processes  In several European countries, patient organizations are playing an increasingly crucial role in Health Technology Assessment (HTA) and regulatory decision-making:  – European Union: The new HTA Regulation, set to take effect in 2025, encourages patient associations to participate in Joint Scientific Consultations and Joint Clinical Assessments, fostering […]

Sylvain Forget Co-Founder & Senior Partner, France 1. What inspired your dedication to the rare disease landscape? My dedication to the rare disease landscape stems from a deep conviction that every patient, regardless of the rarity of their condition, deserves access to appropriate care, treatment, and support. After many years working in non-orphan pharma sector, […]