Chaired by Dr. Jerrold Levy, the Kepley BioSystems Scientific and Business Advisory Board includes leading physicians, researchers and business developers. Emerging companies depend on objective, outside experts for strategic and tactical guidance, and as such the Kepley BioSystems advisory team is a vital resource to the company when submitting grants, designing clinical studies, or publishing its findings and progress toward disruptive innovations. Our advisors are also proactively engaged in the executive development of young operating managers with their insightful advice.
Jerrold Levy is currently Professor of Anesthesiology and Surgery (Cardiothoracic), and CoDirector of the Cardiothoracic Surgical Intensive Care Unit at Duke University Medical Center in Durham, NC. He obtained his medical degree from the University of Miami, FL, where he was an intern in internal medicine, and undertook his residency in the Department of Anesthesiology of the Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA, where he was also Chief Resident, and completed fellowships in both Respiratory ICU and Cardiac Anesthesiology. He previously was Professor, Deputy Chair for Research, and Chief of Cardiothoracic Anesthesiology at Emory University. His clinical and research interests include therapeutic strategies to prevent and treat bleeding, anticoagulation and its reversal, clinical applications of recombinant and purified protein concentrates, pharmacologic strategies to treat shock/ventricular dysfunction, and anaphylaxis. His clinical practice involves managing critically ill patients in the perioperative setting and intensive care unit. Some of his current appointments include Executive Editor of Anesthesiology, Co-chair of the Subcommittee on Perioperative and Critical Care Thrombosis and Hemostasis for the International Society of Thrombosis and Hemostasis, and consultant to the FDA‘s Blood Products Advisory Committee. He has authored over 400 publications, including original research articles, reviews, books, and book chapters.
James Bowey joined 3Macs (Raymond James) in 2007 after a distinguished academic career at the Williams School of Business, Bishop's University and The Lancaster University Management School in Lancaster, England. Today, he works as part of a Portfolio Management team, blending a wide skillset with a commitment to exceptional client service. For more than twenty years, Dr. Bowey successfully combined an active strategic consulting practice with his academic responsibilities. He was an award-winning Business Strategy, Industry Analysis and Competitiveness educator. Prior to joining the Bishop's faculty, he owned and operated several successful Canadian footwear businesses. He has been actively involved in private portfolio management for more than a decade, and he continues to serve as a director on both public and private boards. Dr. Bowey received his Ph.D. from Lancaster University in England.
Frank LaDuca is an independent consultant and adviser to the medical industry with extensive experience as a corporate officer in the medical diagnostics field. Dr. LaDuca received his doctoral degree from SUNY at Buffalo, NY, and completed a fellowship in Hematology at Johns Hopkins School of Medicine. His expertise encompasses a unique blend of regulatory, compliance, quality, clinical and technical disciplines, allowing him to master the operational issues facing companies of all sizes and to effectively address regulatory and compliance needs. He has successfully completed remediation projects, relocated medical businesses and executed product and facility registration while ensuring business continuity. He has built organizations focused on product innovation while positioning companies for optimal fiscal performance, and his teams have been recognized as “Best in Class” in their sectors. As a corporate officer, Dr. LaDuca has also managed strategic business transformation with positioning and finalization of the business for sale. At Siemens Diagnostics, he was a member of a select team of senior staff responsible for the due diligence and integration of Bayer, Diagnostic Product Corporation and Dade to Siemens Diagnostics. As the CSO member of the Accriva Diagnostics Executive Leadership Team, he provided technical and compliance guidance in its sale to Instrumentation Laboratories/Werfen. Thereafter, he established an independent regulatory, compliance and scientific consultancy to the medical industry. Dr. LaDuca has served as Chair for both the Critical and Point of Care division of the AACC and of the Clinical & Laboratory Standards Institute (CLSI) Point of Care Consensus Committee. He has authored numerous technical publications and routinely presents at national and international scientific meetings, most recently at the FDA Workshop for Standardization Guidelines for POCT Coagulation Testing (2016) - and has subsequently co-chaired the CLSI committee drafting the resulting CLSI Harmonized Standard.
Andrew Saxon serves as Chief Emeritus, Clinical Immunology/Allergy in the Department of Medicine, David Geffen School of Medicine at UCLA. He received his Medical degree from Harvard Medical School and is board certified in Internal Medicine, Allergy and Clinical Immunology and Diagnostic/Laboratory Immunology. Dr. Saxon is a world-renowned expert in human cellular and molecular immunology and serves as the Editor-in-Chief of Clinical Immunology, the official journal of the Clinical Immunology Society. Dr. Saxon is also a Professor of David Geffen School of Medicine at UCLA, where he and his colleagues were the first to recognize HIV/AIDS in 1980. They brought this new disease to the attention of the CDC in 1981 and published their seminal research describing it in the New England Journal of Medicine that same year. Dr. Saxon and his collaborators have made breakthrough immunology discoveries, particularly with respect to allergic antibodies (IgE), and conducted pioneering research into the role of environmental factors in the modulation of the human immune response. Dr. Saxon also has developed extensive experience with KLH (Keyhole limpet hemocyanin) in its various molecular forms in his work. He serves as the Chair of the Scientific Advisory Board at Stellar Biotechnologies, Inc. and has authored over 180 peer-reviewed research publications primarily dealing with the control and assessment of the human immune response.
With nearly 25 years of developing medical products for Fortune 500 companies, as well as industrial, military and consumer products, Barry has logged over 50,000 hours on SolidWorks, Onshape and MasterCam, 3D Design CAD Software. This experience is complemented by unmatched, hands-on knowledge and proficiency of jurisdictions prototyping and manufacturing processes for product development.
In fact, Barry has played a key role in the successful development of over 100 products in the marketplace today, with a primary focus on medical devices. He is the inventor/co-inventor on numerous patents spanning: mechanical design, assembly and manufacturing for military, industrial, commercial, consumer, and medical product development. Additionally, Barry is expert in Quality Systems Management (13485-2016 and FDA Regulations for design controls CFR 820.30). He specializes in human factors, 3D printing technologies, injection molding, tooling, sheet metal forming, stamping, double-shot molding, molded plastics, polymers, co-polymers, extrusions, rubber, and die casting.
Barry’s connection to Kepley has a somewhat storied past, as Terry E. Brady, now chief inventor at Kepley, engaged John E. Studer, Jr. while Brady was the co-founder of W.T. Associates. Studer is a prolific design maven, who gained industry notoriety for designing the Ortho-McNeil Pharmaceuticals oral contraceptives DialPak®. Studer also developed the initial, streamlined and ergonomic drawings for two of Brady’s products: Surgicutt® - Bleeding Time Device, and Tenderfoot® - Heel Incision Device, both of which have enjoyed over thirty years of market dominance without reengineering. Thereafter, Barry worked alongside Studer for many years, including refining further innovations with Brady when the latter was president of Array Medical.
Surgicutt® and Tenderfoot® are now registered trademarks of Accriva Diagnostics, Inc. | 6260 Sequence Drive | San Diego, CA 92121 USA.