Hirokuni Mizoguchi

Hirokuni Mizoguchi has extensive experience in regulatory strategy and affairs, particularly in the biopharma and ophthalmology sectors, with a focus on gene therapies and oligonucleotide therapeutics. At Astellas Pharma, from August 2011 to March 2025, Mizoguchi held the position of Associate Director, leading global and regional regulatory efforts through various phases, including NDA and MAA submissions. Additional roles included leading the Asia Partnership Conference of Regenerative Medicine Working Group on gene therapy regulation, and overseeing regulatory affairs for biologics and small compounds. Prior experience includes roles as a Clinical Research Associate at Novartis and SSP, focusing on clinical development in the ophthalmology field. Mizoguchi holds a Ph.D. in Science from The University of Tokyo and is currently pursuing an Executive MBA from Quantic School of Business and Technology.