Jim Sergi is President of CSSi LifeSciences, a global drug discovery and technology development company providing fully integrated, specialized regulatory and clinical services for pharmaceutical and medical device companies. Prior to this role, Jim held various positions in academic oncology and cancer research before co-founding ProED, a healthcare services and drug development company. Jim has been responsible for over 100 successful NDA/BLA submissions and over 250 medical device approvals. His academic and medical experience includes Director for the Department of Experimental Therapeutics at the Cleveland Clinic Cancer Center, Associate Professor of Medical-Surgical Nursing at the Case Western Reserve University and Lecturer for Oncology at Cleveland State University. He has authored over 50 peer reviewed publications and has numerous issued patents. Jim serves a scientific reviewer for the NIH SBIR/STTR Commercial Readiness Program, as well as a mentor to the NIH/NHLBI and the NIH Larta FeedForward programs. He also serves as a member of the Global Center for Health Innovation and the NorCoBio Task Forces, and as a scientific advisor to numerous private equity and venture backed investment firms, including Defta Partners.