Wendy Valenius

Wendy Valenius shapes global strategies for integrating companion diagnostics (CDx) into oncology drug development and commercialization at Pfizer. With expertise across IVD, SaMD, and CDx regulatory pathways, she leads regulatory submissions, clinical trial governance, and Health Authority engagement to enable efficient, end-to-end development. She is recognized for driving IVDR readiness initiatives and advancing regulatory approaches that balance compliance with innovation through collaboration with industry and trade associations.
Wendy has a strong focus on rethinking how stakeholders collaborate to solve shared challenges. She designs and advances engagement models that convene multiple sectors, like regulators, industry, academia, and healthcare systems, within structured forums that enable joint problem-solving, transparent dialogue, and collective action beyond traditional bilateral partnerships. Through these efforts, she helps build more connected, resilient ecosystems that accelerate patient-centered innovation.