Jim Sergi

Jim is the founder of CSSi LifeSciences, which is headquartered in Baltimore, MD with offices in San Francisco, CA; London, UK; and Hyderabad, India. The company provides fully integrated preclinical, CMC, regulatory, and clinical services to global and virtual biopharmaceutical companies, medical device and diagnostic companies, universities, and venture capital and private equity companies. CSSi LifeSciences has helped clients create a strategic pathway from discovery to commercialization that resulted in a reduction of development time, costs and resources, as well as the commercial success of over 400 drugs and biologics. More recently, the company has helped clients navigate the FDA for the medical use of CBDs and ENDS products.

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. ProED was responsible for over 80 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’s team was responsible for the FDA approval of Marinol (Dronabinol).

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 75 scientific and medical publications and holds numerous patents.

Jim serves as an advisor to numerous private equity and venture backed investment firms and 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. In addition, Jim is a frequent speaker focusing on new drug development and accelerating commercial readiness and value through strategic regulatory and clinical planning. Contact: jsergi@cssilifesciences.com.