Paula walker
founder, CEO & Board Member
Paula Walker Veterinarian and Entrepreneur. Dr. Walker has over 15 years of combined experience in regulatory and clinical areas, including the design, management, and monitoring of clinical trials to support domestic (FDA) and ex-US regulatory reviews of infectious disease, virology, and oncology women’s health, pharmaceutical, and molecular assays. She has contributed to strategic product development plans, business plans, and has served as clinical subject matter expert for several cross-functional development teams. She has enabled several FDA clearances ranging from moderately-complex molecular infectious diseases and CLIA waiver applications including LIAT (Roche’s first CLIA waived point-of-care molecular in-vitro diagnostic device) and Cepheid assays (Strep A and Flu). She obtained FDA Emergency Use Authorization for two COVID-19 devices and FDA clearance for a sexually transmitted infections device, both for Visby Medical.