Michael Smith
Director, Emerging Technologies Moderna
Michael “Mike” Smith currently serves as Director of the Emerging Technologies group at Moderna. In his role, Mike leads a cross-disciplinary science and engineering team developing lipid nanoparticle (LNP) formulation platforms for messenger RNA (mRNA). Mike is a self-proclaimed “nanoparticle geek” and has a deep curiosity for the physical chemistry of nanoparticle self-assembly. Leveraging the science of nanoparticle synthesis, the team has built robust scale-up capabilities that service Moderna’s ambitious development portfolio, which includes over 40 drug candidates in active development. Mike and team were major contributors towards the development of Moderna vaccine against SARS-COVID-2 (mRNA-1273). His efforts, together with the Moderna team, were featured in a CNN Hero’s segment and further showcased in NY Magazine (see links below).
Mike has led numerous scientific and engineering projects over eleven years at Moderna. In years prior, Mike contributed to nanoparticle formulation efforts at Merck that include siRNA LNP and liposomal formulations. Prior to his time in industry, Mike received his PhD from Georgia Tech with a dissertation on the topic of stimuli-responsive hydrogel nanoparticles for therapeutic delivery.
Seminars
- What are the greatest technical challenges in translating LNP formulations from preclinic to human studies?
- Given the complexity of LNP manufacturing, scale-up, and analytical characterization, what are the critical process and regulatory bottlenecks that currently slow clinical entry?
- How can developers prioritize indications, optimize clinical trial design, and build CMC readiness to ensure more programs successfully reach patients?