Kelvin Chan

Director, Commercial Strategy & Business Development
Kudo Biotechnology, Inc.
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Kelvin Chan, PhD, is the Director of Commercial & Business Development at Kudo Biotechnology, a global CDMO providing a complete suite of GMP solutions for manufacturing pDNA, mRNA, and LNP, all under one roof. Kelvin is a globally experienced healthcare investor-operator and was formerly Director of Business Development at ABio-X, a CBC Group biotech incubator, as well as Director of Business Development at RVAC Medicines, a mRNA product company. Previously, Kelvin was an operator of several portfolio companies at Tavistock Group. He was formerly a cross-border venture capital investor with EDBI, the strategic investment arm of the Singapore Economic Development Board, investing broadly across healthcare and life sciences. Kelvin holds a PhD in Organic Chemistry from Scripps Research, and conducted his postdoc at the Singapore Bioimaging Consortium. He received his BA (Hons) in Chemistry with First Class Honors at the University of Cambridge, UK. Kelvin is a recipient of the prestigious National Science Scholarship from A*STAR Singapore.
 

Speech title & Synopsis

CMC Strategy for mRNA-LNP Vaccines and Therapeutics

In this presentation, we discuss how a thoughtful Chemistry, Manufacturing and Controls (CMC) strategy can improve success in drug development, in the emerging and transformative modality of messenger RNA-lipid nanoparticles (mRNA-LNP). CMC risks exist in the various stages of the process of manufacturing, from sequence to drug substance and to fill-finished drug product. Because of the complexity and deep specialism needed in this new modality, there is an ever-increasing list of key considerations from supply chain, cost, quality, IP, slot availability and beyond. With the advent of personalized vaccines, chain of interest (CoI) and chain of custody (CoC) becomes critical in a successful CMC strategy. Finally, beyond risk mitigation, we also discuss new opportunities in CMC, such as innovative manufacturing, analytical and automation technologies in the manufacturing of mRNA-LNP vaccines and therapeutics.