Donna Kato is strategic advisor to Premier Consulting and has spent her career in the pharmaceutical industry, specializing in regulatory affairs for the past 30 years. She started her career at Syntex in discovery research and later joined its worldwide regulatory affairs department. After Syntex, she led regulatory affairs at Acologix and Celtrix before founding Regulatory Professionals, Inc., in 1995, which she grew to a full-service regulatory affairs consultancy assisting hundreds of clients with product development worldwide. As part of her support for the regulatory affairs community, Ms. Kato has been an instructor in the Extension Certificate Program in Regulatory Affairs at the University of California, Berkeley. She holds a bachelor’s degree in biochemistry from the University of California, Davis, and an MBA from Santa Clara University.