Jae Hoon Kwon
Jae Hoon Kwon is a co-founder and Co-CEO of ACRO. He holds an M.S. in Biostatistics and is a Ph.D. candidate in Regulatory Innovation through Science, and is a specialist in clinical trial operations and real-world evidence (RWE) research, with more than fifteen years across clinical development and evidence generation.
His career spans clinical trial operations and biostatistics at a major pharmaceutical company and a leading domestic CRO, where he led real-world evidence generation programs. He has full-lifecycle experience on Korea's 30th domestically developed new drug — across Phase 1 through Phase 3 and subsequent indication expansion — and has conducted and managed more than 30 pharmacoepidemiology and post-marketing surveillance (PMS) studies. He also served as project manager on a real-world evidence study supporting a new drug approval submission, and as a participating researcher on national R&D programs developing new technologies for clinical trials.
Notably, he has direct experience submitting an external control arm to the regulatory authority (MFDS) in support of an expedited-review designation for an advanced biopharmaceutical — bringing rigorous comparator design and RWE methodology to a frontier regulatory pathway. He connects clinical trial operations and RWE research with regulatory strategy across investigators, sponsors, and hospital partners.