Since 1998, we are an independent consultancy based in Basle, Switzerland, and are focussed on two specialties: Accelerated marketing authorisation and early market access for orphan, specialty and advanced medicines. We support our clients in the development and enhancement of “fast to market" early access strategies, including patient engagement, differentiated value-based offerings, the benefits of orphan designation, compassionate use programs, and early value demonstration with fewer data. This includes innovative, adaptive development pathways that emphasise the use of real-world evidence. Real-World Patient-Centered Evidence is increasingly crucial for rare diseases, where the collection of data via traditional routes is difficult. We propose pre-planning real-world research as an integral component of an early access strategy in a life-cycle and full-spectrum approach. We support our clients in the strategic evidence generation planning and design of real-world research with a focus on meaningful patient-relevant outcomes from very early in development to post-authorisation. ORPHA Strategy's principal, David Schwicker, has biopharmaceutical expertise spanning more than 25 years, and proposes that strategic thinking on “fast to market" early access can crucially benefit a client’s transformative medicine to prospectively accelerate marketing authorisation and market access, pricing and reimbursement in the dynamic and challenging European environment.