Paula Walker
F
ounder, CEO & Board Member
Paula Walker, a veterinarian and entrepreneur, possesses over two decades of combined experience in regulatory and clinical areas. Her expertise encompasses the design, management, and monitoring of clinical trials, supporting domestic (FDA) and ex-US regulatory reviews in infectious disease, virology, and oncology women’s health, pharmaceutical, and molecular assays.
Walker has made significant contributions to strategic product development plans, business plans, and has served as a clinical subject matter expert for various cross-functional development teams. Notably, she has facilitated 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 for Strep A and Flu. Additionally, she obtained FDA Emergency Use Authorization for two COVID-19 devices and FDA clearance for a sexually transmitted infections device, both for Visby Medical.