LUNALI
CMC SOLUTIONS

Johann Chan, Ph.D., is the founder and principal consultant of LUNALI CMC Solutions, where he helps biotechnology companies translate promising science into executable CMC strategies and advance complex development programs toward the clinic and commercialization.

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Johann brings more than 20 years of pharmaceutical development experience spanning drug substance, drug product, analytical development, manufacturing, quality, and CMC regulatory strategy. He has served as a hands-on technical leader, Head of CMC, and strategic advisor across organizations ranging from venture-backed startups to established global biopharmaceutical companies.

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At Gilead Sciences, Johann led process chemistry development for voxilaprevir, the NS3 inhibitor in Vosevi®. He coordinated more than 65 internal and external scientists across multiple sites and CDMOs, guided the development and technology transfer of a synthesis requiring more than 45 chemical steps, and enabled manufacturing at scales of up to 200 kilograms. The program progressed from IND to NDA filing in less than three years and ultimately received approval in the United States and multiple international markets.

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Through LUNALI, Johann provides emerging companies with experienced, flexible CMC leadership tailored to their stage and resources. He helps clients identify critical development risks, establish fit-for-purpose technical and regulatory strategies, select and manage external partners, and make disciplined decisions about where to invest time and capital. When broader expertise is needed, he draws upon a trusted network of specialists in process chemistry, analytical development, formulation, and quality.

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Johann earned his Ph.D. in Chemistry from the Massachusetts Institute of Technology and his B.S. in Chemistry from the University of Toronto. He is an author or inventor on more than 35 scientific publications, presentations, and patents.