Paul D. Mozley, M.D.
(Paul) David Mozley, M.D., is a board-certified physician in nuclear medicine. He currently serves as Professor and Chief of the Division of Nuclear Medicine at Weill Cornell Medical College and the NewYork-Presbyterian Hospital/Weill Cornell Campus in Manhattan. He is also the Medical Director of the Medical College’s Citigroup Biomedical Imaging Center (CBIC), a member of the NYPH-Weill Cornell Radiation Safety Committee, and a co-chair of the Institutional Review Board. He has over 25 years of experience using radioactive materials to diagnose and treat disease, and currently manages a clinical service which performs over 8,000 nuclear medicine procedures each year.
Dr. Mozley is the recipient of numerous research grants from the National Institutes of Health, private foundations, and the biopharmaceutical industry. He specializes in developing novel radiopharmaceuticals for cell surface targets and proteins that mediate intracellular signal transduction. He is currently focused on the immunomodulation of inflammation, neuroproteinopathies, and immune therapies of cancer. He has written or co-authored over 100 original research reports, is a member of the editorial board of Clinical Imaging, and serves as an active reviewer for a wide range of journals.
Dr. Mozley held multiple positions with progressively increasing responsibility in big pharma from July 2001 until he transitioned back into academia in July of 2012. At Merck & Co Inc, he served as Senior Imaging Lead across therapeutic areas for mega-multi-center trials that used imaging as a major endpoint. He contributed to the design of the image acquisition protocols, authored the related documents, selected the image analysis partners, negotiated the contracts, managed the imaging subteams, and helped execute the trials from launch to final study report. He was the Business Owner for the Merck image management system. He initiated the idea, built the business case for in-boarding all medical images into a searchable archive, led a “voice of the customer” exercise involving more than 150 internal stakeholders to create the design specifications, co-led the due diligence team that selected the vendor, and then spent more than 2 years actively helping an internal and external IT team understand the requirements for constructing a system that cost more than $4 MM in cash burn just to “go live” for the first time. He sponsored two related Six Sigma projects, one of which won “Best in IT” as well as “Best Overall in Merck”. As the clinical PET neuroreceptor lead, he contributed to the design and execution of translational imaging studies, with a special emphasis on deploying novel radiopharmaceuticals for selecting doses of therapeutic candidates for proof-of-concept studies. He transferred his education as the Physician/Sponsor of 5 investigational new radioactive drugs and the PI of 11 Phase Ia radiotracer studies while on the faculty at the University of Pennsylvania to pharma, where his paradigms and vocabulary for describing adaptive designs with just-in-time, data driven decision making algorithms were used in over 30 early phase studies of novel imaging biomarkers at Merck, as well as 7 at Eli Lilly & Co. His more ordinary designs contributed to over 60 business essential, early phase, proof-of-concept trials with imaging biomarkers.
Dr. Mozley served as an oncology paradigm shift leader for transforming reliance on RECIST (Response Evaluation Criteria for Imaging of Solid Tumors) to volumetric image analysis of CT and MRI scans in oncology. He created “smart” systems for analyzing only the medical images that matter based on as needed, just-in-time, data driven decisions triggered by thresholds specified in advance. He convinced several imaging CRO partners to create these capabilities, and initiated master service agreements with them that were drug independent. He drove these processes to the RSNA Quantitative Imaging Biomarker Alliance (QIBA), harmonized Merck processes with QIBA processes as indicated, and ran a similar harmonization process with UPICT Work Group and the PhRMA Imaging Group.
While in pharma, his external efforts included 4 years as the Chair of the Extended PhRMA Imaging Group, a consortium of imaging professionals from the FDA, the imaging CRO industry, the pharmaceutical industry, and others focused on using imaging in clinical trials. During his term from 2006-to-2010, the group delivered the first universally endorsed standardized format for imaging charters, other imaging manuals, and a set of quality metrics for quantifying performance in clinical trials. Dr. Mozley was an advisor to the National Institute of Standards & Technology’s quantitative imaging initiative from 2006-to-2007, which led to his involvement with the RSNA's Quantitative Imaging Biomarker Alliance (QIBA). He served as a co-chair for its Technical CT Committee. Contributions included primary authorship of the "Process Map" for qualifying quantitative imaging biomarkers as endpoints in clinical trials.
“Moze” was raised as the son of a US Naval officer, living in Riverside, California; San Diego, California, Yokuska, Japan; Yokohama, Japan; Memphis, Tennessee; Washington, D.C.; Naples, Italy; Philadelphia; and Tidewater, Virginia before leaving home for college. He received his B.S at the College of William & Mary, Williamsburg, VA, in 1980, and his M.D. from the Brody School of Medicine at East Carolina University in 1984. He trained at the University of Pennsylvania, where he became Assistant Professor of Nuclear Medicine in Radiology in 1991, and Associate Professor in 1997. He joined Weill Cornell Medical College on July 1, 2012, and now resides in Manhattan.