Howard Holden, Ph.D. Vice President, Regulatory Affairs & Quality Assurance
Howard Holden has served as Vice President of Regulatory Affairs and Quality Assurance since April 2012. Over the past 25 years, Dr. Holden has built and led regulatory and compliance functions for programs from Investigational New Drug (IND) applications to New Drug Applications (NDA), Biologics License Applications (BLA), and Marketing Authorization Applications (MAA); developed and implemented regulatory drug development and compliance strategies; and obtained approval for several products in the U.S., Europe and Canada. From 2005 until 2012, Dr. Holden was Senior Vice President of Regulatory Affairs and Compliance at Nereus Pharmaceuticals. Prior to joining Nereus, Dr. Holden was Vice President of Regulatory Affairs and Compliance at Stressgen Biotechnologies and Ligand Pharmaceuticals, Senior Director at Parke-Davis/Warner-Lambert, Director at Centocor and Senior Investigator at the National Cancer Institute. Dr. Holden received his bachelor's degree from Drew University and his Ph.D. in microbiology from the University of Miami, School of Medicine.