RESEARCH TRIANGLE PARK, N.C., May 1, 2012 - Novella Clinical, a full service clinical research organization, today announced Kevin B. Johnson, Ph.D., has joined as global head regulatory affairs.
With nearly 20 years of clinical research experience, Dr. Johnson has served both sponsors and CROs in regulatory capacities. He most recently worked as Director of Regulatory Affairs and Quality Systems for the Wake Forest Institute for Regenerative Medicine. Previous experience includes senior regulatory and clinical positions with PPD, Parion Sciences, PharmaKnowledge and Health Decisions.
Dr. Johnson will support Novella’s global oncology, biopharma and medical device clients. He is experienced in regulatory authority interactions and strategic regulatory liaison activities for drugs, biologics, cell and tissue-based products, combination products, and medical devices and has worked in international clinical development teams across a number of therapeutic areas. He has lead a variety of regulatory authority meetings and managed regulatory submissions including INDs, IDEs, NDAs/BLAs, 510(k)s, and PMAs.
Novella Clinical Chief Operating Officer Rob King noted, “Kevin’s depth of regulatory experience, key relationships with agency officials and knowledge across both biopharma and device sponsors will serve Novella and our clients very well.”
Dr. Johnson holds a doctorate in neurobiology from the University of North Carolina School of Medicine. He also earned an M.B.A. from the University of North Carolina’s Kenan-Flagler Business School, and a Bachelor of Science in chemistry from the University of South Florida.