Frank M. LaDuca

Regulatory Advisor at Kepley BioSystems

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.

Links

Timeline

  • Regulatory Advisor

    Current role