James S. Sergi

James Sergi is a highly accomplished regulatory and commercialization strategist, life sciences veteran, and investor with over three decades of experience in advancing therapeutics and medical devices to global approval. He is the Founder and President of QNova LifeSciences (formerly CSSi LifeSciences), a global contract drug and medical technology design and development company with experience handling over 500 drugs and 300 medical device technologies.

His teams have been responsible for over 85 successful NDA, ANDA, and BLA approvals and over 200 successful 510(k) and PMA approvals. He served as Advisor to numerous life sciences venture funds and portfolio companies, including Defta Partners and North Coast Angel Venture, and is a General Partner at QNova Capital, LLC.

He co-founded an international pharmaceutical development company, Pro ED Communications, INC., which was recognized by the FDA as “best in class” and acquired by Omnicom. He served as Director of the Department of Experimental Therapeutics at the Cleveland Clinic Cancer Center and maintains an Adjunct Faculty appointment at Georgetown University’s Biotechnology Graduate Program.