Neil Ichiro Laruan is the Director of Science & Regulatory Affairs at the Biotechnology Innovation Organization (BIO), where he leads key regulatory and policy initiatives shaping biotechnology innovation. He oversees BIO’s Manufacturing, Quality, and Distribution Regulatory Committee, working with member companies to advance policies that strengthen manufacturing resilience and global supply chain reliability. He also directs BioSafe, BIO’s preclinical safety initiative, which brings together biotechnology experts to address scientific, regulatory, and policy issues related to nonclinical development and toxicology. In addition to his U.S. regulatory portfolio, Neil plays a key role in BIO’s international regulatory engagement, particularly through the International Council for Harmonisation (ICH). He represents BIO’s delegation and, working closely with member experts, helped advance BIO’s first ICH topic proposal to explore harmonization in the rapidly evolving cell and gene therapy space. He also supports BIO’s work on patient-focused drug development (PFDD), ensuring patient perspectives inform regulatory decision-making. With a strong project management background, Neil is passionate about regulatory modernization, streamlining frameworks to reduce complexity, foster innovation, and accelerate patient access to transformative medicines. He holds an M.S. in Biotechnology from Georgetown University and remains actively engaged as an industry mentor, supporting the next generation of biotechnology leaders.