Mr. Jonathan Helfgott

With over 20 years of experience, I specialize in translating FDA complexity into innovation pathways. My expertise spans the development of regulatory, clinical, GxP, and market access strategies, enabling successful FDA pre-market submissions, site inspections, and approvals across diverse therapeutic areas, including Neurology, Cardiology, Oncology, Endocrinology, Infectious Diseases, Surgery, Radiology/Imaging, Diagnostics, and Combination Products.

As an industry, academic, and former FDA leader, I have advanced the integration and adoption of cutting-edge solutions such as AI/ML-based technologies, Digital Health, Software as/in a Medical Device (SaMD/SiMD), eClinical tools, and utilization of Real-World Data/Evidence (RWD/RWE).