Ralf-Dieter Hilgers is professor at the Sigmund Freud Private University (SFU) and coordinator of the Innovative Health Initiative (IHI) RealiseD project initiated together with AstraZeneca and nearly 40 partners. The initiative aims to fundamentally improve clinical trials for rare and ultra-rare diseases and accelerate the development of therapies for over 30 million people across Europe. With a budget of 17 million euros, the project will develop new methodological tools over the next five years to address challenges such as small patient populations and fragmented regulatory frameworks. Technologies like Real World Evidence (RWE) and digital tools will play a key role in optimizing trial designs and fostering patient-centered innovations. Key partners, including the European Medicines Agency (EMA) and several European Reference Networks (ERNs), support the project, which also aims to advance cutting-edge therapies like Advanced Therapy Medicinal Products (ATMPs). RealiseD strengthens the European research landscape and demonstrates the value of public-private partnerships in improving care for patients with rare diseases. With this project, SFU reaffirms its leadership in innovative medical research.