Neil Inhaber, MD, FRCPC Head, Neuroscience and Marketed Products Medical Global Medical, Takeda Neil leads marketed products medical affairs at Takeda with a focus on the planning of product and service support and launches in the US and internationally. He brings 20+ years of academic and private practice experience as a board certified pulmonary, critical care, and sleep physician in the Unites States and Canada in addition to 15+ years of worldwide pharmaceutical, medical device, and biotechnology industry experience. Prior to joining Takeda, Neil served as Chief Medical Officer of Sequana Medical AG based in Zurich. Earlier in his career, he held positions in medical affairs and clinical development at Jazz Pharmaceuticals, Novartis, Baxter, and Boston Scientific. Neil received his BSc in Biomedical Engineering from Rensselaer Polytechnic Institute in Troy, NY, and an MD from McGill University in Montreal. Session abstract: Diagnostics – Unique Considerations for the Diagnosis of Rare Disease In this session, the complexities and challenges of diagnosing rare diseases are highlighted, with over 7,000 identified, affecting more than 3% of the global population. Less than 10% have FDA-approved treatments, and the average time to diagnosis is over six years, often leading to misdiagnosis and increased economic burden. Early diagnosis is crucial, especially as 70% of rare diseases manifest in childhood. A multidisciplinary approach involving patient organizations, healthcare providers, regulators, and industry is needed to improve health outcomes and equitable care access for individuals with rare diseases, particularly in marginalized communities. The role of novel diagnostics, biomarkers, and AI in advancing rare disease management is discussed, along with an opportunity for rethinking orphan disease definitions and united the various communities is challenged.