Michelle Zaharik, PhD

Lead Diagnostics Development


Novateur Advisor Since



Design and Management of R&D, Clinical and Regulatory Paths for In Vitro Diagnostic Devices, Design of IVDs, Development of IVDs, Global Commercialization of IVDs


Diagnostics, Regulatory, Therapeutics

Dr. Michelle Zaharik, PhD, is an accomplished Research and Development professional with 15+ years of experience in the design and management of R&D, Clinical and Regulatory paths for In Vitro Diagnostic devices. Her areas of expertise include the design, development, and global commercialization of IVDs for various targets including cardiac and infectious disease biomarkers, with experience across multiple platforms ranging from central laboratory tests to Point of Care and Self Tests. Dr. Zaharik is a skilled communicator experienced in interfacing with multiple stakeholders, including KOLs, industry partners, funding agencies, and international regulatory bodies.

Michelle obtained her Ph.D. in Biochemistry and Molecular Biology from the University of British Columbia where she specialized in host-pathogen interactions and completed her post-doctoral training at the UBC CDC in partnership with Sanofi Pasteur on Chlamydial rational vaccine design. 

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