President, CSSi LifeSciences
Prior to founding CSSi LifeSciences™, Jim has held various positions in academic oncology and cancer research before co-founding ProED, a healthcare services and drug development company. CSSi and ProED have been responsible for over 70 successful FDA NDA/BLA and EMA applications and defenses for various drugs, biologics and diagnostic tests, including over 250 medical devices 510(K) submissions.
Jim has helped clients create a strategic pathway from discovery to commercialization that resulted in a reduction of development time, costs and resources, which was seen in his role played in the commercial success of over 400 drugs and biologics. Jim’s 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 75 scientific and medical publications.
Jim serves as an advisor to numerous private equity and venture backed investment firms. Jim is also a scientific reviewer for the NIH SBIR/STTR Commercial Readiness Program and as a mentor to the NIH/NHLBI and the NIH Larta FeedForward programs. Jim serves as a member of the Global Center for Health Innovation and the NorCoBio Task Forces. In addition, Jim is a frequent speaker focusing on accelerating commercial readiness and value through strategic regulatory and clinical planning.