Leon Stross
Executive Director & Head of Market Development & New Product Planning Cabaletta Bio
Seminars
Tuesday 24th February 2026
Planning Early for European Market Entry: Navigating Regulatory & Access Differences Between the US & EU
12:00 pm
- Highlight the importance of early strategic planning for US biotechs expanding into Europe to avoid rushed launches and regulatory setbacks
- Compare FDA prerequisites and EMA expectations to identify critical divergences that can impact timelines and trial readiness
- Discuss market access procedures and lessons learned from companies like Cabaletta on how to successfully prepare for European entry
Thursday 26th February 2026
Panel Discussion: Navigating Patient Selection & Eligibility in Europe to Ensure Timely Access to Cell Therapies
8:30 am
- Examine the complexities of trial design across oncology and autoimmune indications, including comorbidities, inpatient requirements, and overlapping recruitment efforts
- Discuss the readiness of Europe’s academic and healthcare ecosystems, from educating rheumatologists and haematologists to training medical staff in managing CAR-T related toxicities
- Highlight strategies to streamline patient identification and enrolment, including earlier eligibility assessments and addressing barriers such as hospital capacity and fragile patient timelines
