Mehdi-Alexandre MANGA

Mehdi-Alexandre Manga is Co-founder and Chief Innovation Officer of ODDIFACT, where he architected the AI system that transforms off-label clinical evidence into FDA-designated orphan drug programs structuring 16 complete programs across 4 monoclonal antibodies, with 13 FDA Orphan Drug Designations granted in under 20 months. At the core of his work is the belief that regulatory intelligence, when built on real FDA submissions and compounded through inference at scale, becomes a structural and defensible asset. This principle drives both the architecture of ODDIFACT's system and its capacity to orchestrate multidisciplinary teams to run multiple orphan programs in parallel, faster and at a fraction of traditional cost. Trained in entrepreneurship at emlyon business school and certified in data science and AI by IBM, he brings a unique combination of strategic vision and operational execution, to every stage of company building from early product structuring to Series A financing. A returning BIO International speaker previously featured at BIO Boston 2025 Mehdi-Alexandre engages with pharma partners and investors on the scalable intersection of agentic AI and rare disease space.