Vice President, Global Regulatory Affairs
Lisata Therapeutics
Dr. Sietsema is Vice President, Global Regulatory Affairs at Lisata Therapeutics, a clinical-stage pharmaceutical company developing innovative therapies based on clear differentiation and rigorous data applied in areas of high unmet medical need. Prior to Lisata, he was 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 and Adjunct Professor of Pharmaceutical Sciences at the University of Cincinnati, College of Pharmacy, where he taught evening classes in drug development. He has 41 years of experience in the pharmaceutical industry. During his sixteen years with Kendle/INC, he 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. He 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. He is the author of 42 journal articles, 5 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 CTAs and MAAs. He is a member of the Regulatory Affairs Professional Society, and the Association for Regenerative Medicine. He was recognized by R&D Directions as one of the top 20 clinical research scientists in 2007.
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RAPS Store Stage: Meet the Authors - Regulation of Regenerative Medicines: A Global Perspective
Wednesday, October 4, 2023
12:45 PM – 1:15 PM EDT