Keiji A is a life sciences entrepreneur and regulatory strategist with eight years of leadership across startups and consulting, focused on bridging U.S.–Japan markets. He co-founded Progenicyte Therapeutics (developing stem-cell–activating small molecules and retinal amyloid diagnostics) and Insanity Labs (AI-driven SaMD for early dementia detection), while running Amenichi Consulting to guide FDA/PMDA pathways and quality systems. Keiji blends hands-on regulatory planning—ISO 13485 lead auditor experience, FDA Q-Subs, clinical trial design for GCP compliance—with business development, investor outreach, and reimbursement strategy to accelerate market entry. A multilingual operator (Japanese, English, Spanish) with a chemical engineering background from Auburn, he pairs deep technical credibility with cross-cultural deal-making and APAC market expertise. Less obvious: he leverages athletic discipline from Division I football and seven marathons to drive resilient, execution-focused teams in high-stakes regulatory and clinical programs. Located in Chicago, he actively forges academic and health-system partnerships to generate the clinical data needed for scalable FDA clearance and commercialization.
8 years of coding experience
15 years of employment as a software developer
Chemical Engineering Technical Services, Chemical Engineering Technical Services at Auburn University
Contributions:1 release, 37 commits, 4 PRs in 10 months
cpusimulationsimulatorcpu-simulatormythical
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