Practice Areas: Healthcare, Bioscience
Kevin has been associated with the biomedical industry for nearly twenty years, including receipt of competitive grant awards at the undergraduate, graduate, and post-graduate levels as well as a research fellowship at Yale University.
Prior to enjoining with the CMEI family of corporations as Chief Medical Officer and Strategic and Innovation Officer, Kevin served as Chief Medical Officer of an in vitro diagnostic medical device company as well as VP of Medical Affairs for an exchange-listed global pharmaceutical corporation, where he engaged with over eighty clinical trial sites worldwide for Phase II and III clinical studies for treating glioblastoma multiforme and other aggressive solid tumors. He also developed new clinical protocols and forged collaborations with universities and larger multinational pharma concerns. In addition, Dr. Lye is a co-founder of Telomax Biotech, Inc., a corporation dedicated to developing products designed to inhibit and reverse intracellular aging; he also co-founded EDWO, LLC, a partnership focusing on dental improvement technologies.
Prior to the above, Kevin was VP and Chief Medical Officer of another technology-holding company, and led its pharmaceutical subsidiary through an evaluation of its intellectual property covering two pipeline molecules. Working concomitantly with another subsidiary, Dr. Lye designed algorithms to identify high-risk patients from aggregated patient claims data provided by healthcare insurers. Kevin also spent over five years in the world of biomedical device development as the director of clinical research for a cellular technology company, helping bring a stem cell isolation robot to defined markets and authoring first-in-man clinical trial protocols in orthopædic surgery, vascular surgery, cardiac surgery, plastic surgery, and other venues. Preceding this was ten years of experience in post-graduate training.
Dr. Lye brings expertise to clients from experiences with these and other biomedical and healthcare groups, ranging in size from startup to multinational; he has authored or co-authored over 25 publications on topics including novel therapies, wound closure devices, stem cells, and gene transfer.
Interacting with FDA and USPTO, managing intellectual property registrations, coordinating contract research organizations, and securing business development transactions are examples of how he has increased the value of groups with whom he has served.
Kevin is privileged to have worked in the laboratories of and been mentored by luminaries such as James D. Otvos, Ph.D., founder of LipoMed, Inc.; Louis Argenta, MD, inventor of negative-pressure wound therapy devices used worldwide to heal complex wounds; and Irvin M. Modlin, MD, Ph.D., a widely renowned innovator and director of the Gastric Pathobiology Research Group at Yale. Dr. Lye has been an invited speaker to multiple international conferences, and over 60 presentations relating to his research projects and corporate properties have been made around the world in various venues. Kevin earned his MD degree from the Wake Forest University School of Medicine and his MBA from Hawaii Pacific University with highest distinction. In addition to serving as an assistant professor at the John A. Burns School of Medicine of the University of Hawaii, Dr. Lye serves on the board of directors of the Association of Owners of Kukui Plaza, the largest condominium project in the state of Hawaii, with a property valuation exceeding $275 million. He also serves as an emeritus member of the board of Adult Friends for Youth, a Honolulu-based organization renowned for interrupting the gang-life cycle that can befall at-risk children on the island of O‘ahu and elsewhere; he is a past co-treasurer of the Hawaii chapter of SAG-AFTRA. Dr. Lye is an elected official serving on the Downtown–Chinatown Neighborhood Board of the City and County of Honolulu.
- Medicine and healthcare
- Non-dilutive funding source identification
- Military/DOD asset acquisition
- Quality Management system implementation
- Medical affairs
- Clinical and preclinical research
- Statistical analyses
- Medical device development
- FDA and EMA regulatory processes
- Creative problem solving
- Business plan development
- Document editing