Timely Access for Patients with Unmet Needs - Real-World Patient-Centered Evidence

Since 1998, we are an independent consultancy focussed on:

  • Accelerated marketing authorisation and early market access for innovative orphan medicinal products, cell and gene therapies which address high unmet medical needs. We support our clients in the attainment of “fast to market" objectives by integrating next-generation rare disease development, regulatory and market access strategies, that leverage the use of real-world evidence (RWE).
  • Real-World Patient-Centered Evidence is crucial in rare conditions, where the collection of data via traditional randomised clinical trials is difficult. We propose planning real-world research as an integral component of an early access evidence generation strategy in a life-cycle full-spectrum approach.


ORPHA Strategy's principal, David Schwicker (Biography), has biopharmaceutical expertise spanning more than 25 years, and proposes that strategic “fast to market" thinking can crucially benefit a client’s assets and prospectively accelerate marketing authorisation and market access, pricing and reimbursement.


We were awarded  start-up company of the year in Switzerland in the year 2000 for innovation in services.



Transformative orphan and advanced therapy medicinal products often defy traditional routes of authorisation and access. This offers innovative opportunities for early market access strategies.