Kevin B. Johnson, Ph.D., has been named global head regulatory affairs at Novella Clinical. 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.
Dr. Johnson has nearly 20 years of clinical research experience, serving 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.
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.”