Chris Wiley is a pharmaceutical CMC leader with more than a decade in biologics formulation, process development, and radiopharmaceutical manufacturing. His career began in radiopharmaceuticals: two years in Dr. Thomas Quinn's nuclear translational medicine lab at the University of Missouri, radiolabeling peptides and bacteriophage for cancer imaging and therapy and following candidates into PET studies in animal models.
He then spent eleven years at Pfizer in biologics drug product development, ultimately as CMC Drug Product Development Lead. He contributed to three FDA-approved biologics, serving as drug product CMC lead for fidanacogene elaparvovec (BEQVEZ), Pfizer's first gene therapy, and authored and reviewed drug product sections across more than twenty approved global regulatory submissions.
He returned to radiopharmaceuticals as Global CMC Lead for the Zircaix BLA at Telix Pharmaceuticals, the first full-length, Zr-89-radiolabeled monoclonal antibody to undergo FDA priority review. That path runs straight into DuraRad: radiopharmaceuticals fail on stability in ways that biologics-grade CMC discipline is built to catch, and the failure happens in the container. DuraRad is the answer built from that vantage point.