Andrew Henry has been named vice president of clinical operations, responsible for global implementation of the company's clinical program. Mr. Henry has 23 years of experience managing clinical trials in life science companies with roles at Schering-Plough Oncology, Novartis Oncology and MedImmune, the biologics division of Astra Zeneca. Most recently, he served as senior director of global clinical operational strategy, and as senior director of clinical trial management at MedImmune.
Andrea Loewen has been appointed vice president of regulatory affairs and quality, responsible for building out the company's quality and regulatory systems to ensure compliance and continued development of late-stage regulatory strategies. Ms. Loewen has 24 years of experience in regulatory and quality management roles, including positions at Baxter Healthcare, Biogen Idec, and Shire Pharmaceuticals. Most recently, she served as the head of regulatory affairs for the Shire Regenerative Medicine business, where she was responsible for global regulatory oversight of licensed and development stage combination biologic and medical device products.
Richard Murawski was appointed vice president of manufacturing, responsible for manufacturing of the cellular therapy and device components of the company’s extracorporeal liver assist device, ELAD. He has four decades of experience in pharmaceutical manufacturing, including significant experience in cellular therapy manufacturing and engineering at Dendreon. His prior manufacturing roles were at Cytogen, Baxter Healthcare and Favrille, where he has developed and overseen international manufacturing organizations and directed the design, construction, validation, regulatory approval, and start up of multiple international biotech manufacturing facilities.
Terry Winters, Ph.D., the company's chief executive officer and co-chairman, said, "Each of our new members holds a wealth of experience in their respective fields. We are fortunate to have a team of this exceptional caliber to oversee our recently-initiated Phase III program, anticipated regulatory filings and transition to commercialization."