Phillip Davis
Chief Executive Officer Ex-FDA
Phillip Davis is a clinical and regulatory leader with a background in nuclear medicine, FDA strategy, clinical development, and medical affairs, supporting the advancement of novel theranostics toward marketing authorization and clinical adoption. He spent a decade as a senior clinical reviewer at the U.S. Food and Drug Administration in the Division of Imaging and Radiation Medicine. After leaving the FDA, he joined Blue Earth Diagnostics, contributing to the development, FDA approval, and U.S. launch of a PSMA-targeted PET tracer. His current work focuses on ADC and radionuclide conjugate theranostics, as well as clinical studies and NDA preparation for rare pediatric and orphan indications.
Seminars
- Clarifying the unique regulatory requirements for radiopharmaceuticals versus conventional therapies like ADCs
- Aligning early-phase trial designs with risk-based, patient-centric approaches to accelerate first-in-human studies
- Facilitating global harmonization by comparing regulatory frameworks in the US, Europe, China, and Australia to reduce development delays