William K. Sietsema, PhD

Vice President, Global Regulatory Affairs

Dr. Sietsema joined Lisata in 2014 and is currently Vice President of Global Regulatory Affairs. Prior to Lisata, he was a Global Regulatory Lead at Amgen where he provided strategic guidance to a portfolio of early stage projects in oncology and inflammation. He was also Vice President, Global Regulatory Consulting and Submissions at Kendle International/INC Research (now Syneos) and Adjunct Professor of Pharmaceutical Sciences at the University of Cincinnati, College of Pharmacy, where he taught evening classes in drug development. He has 42 years of experience in the pharmaceutical industry.

During his sixteen years with Kendle/INC Research, Dr. Sietsema brought leadership to several initiatives in the fields of inflammation, skeletal disease, analgesia, gastrointestinal disease, ophthalmology, and women’s health. He played a pivotal role in the rapid development of Pharmacia’s Celebrex, which transited from beginning of Phase 2 to NDA approval in less than three years.

Dr. Sietsema received his BA, magna cum laude, in chemistry from the University of Colorado, Boulder in 1977 and his PhD in biochemistry from the University of Wisconsin, Madison in 1982.

Dr. Sietsema is the author of 43 journal articles, 6 book chapters, 80 presentations and posters and is an inventor on 6 patents. He has published 10 books on regulatory topics ranging from strategic planning to practical aspects of preparing clinical trial applications and marketing authorization applications. He is a member of the Regulatory Affairs Professional Society, and the Association for Regenerative Medicine. Dr. Sietsema was recognized by R&D Directions as one of the top 20 clinical research scientists in 2007.