Aleon Webinar: Advancing Rare Disease Drug Development: Regulatory Strategy and Clinical Pathway

September 2025

📅 Date: September 9, 2025 ⏰ Time: 3:00–4:15 PM CET / 9:00–10:15 AM EDT 🔗 Register here: https://lnkd.in/e5ZX9y85 You will discover how proven regulatory strategies and optimized clinical pathways can accelerate your rare disease drug development, achieve FDA approvals faster, and get your therapy to patients sooner. In this 75-minute session, we will discuss: ✅ Current challenges and opportunities in rare disease drug development within the regulatory landscape ✅ FDA and EMA Orphan Drug Designation criteria and processes ✅ Effective strategies for engaging FDA throughout the regulatory pathway ✅ Scientific and clinical considerations in designing rare disease clinical trials ✅ Case studies highlighting successful development of small molecules, biologics, gene editing products, cell therapies, and TCEs We look forward to sharing valuable insights with you at the webinar!