Challenges for Urologic Research: Moving Biomarkers into Practice


Regulatory Processes for Biomarkers

Sunday, May 20
8:15 AM - 8:35 AM
Location: MCC SOUTH, 208

Maria M. Chan

Maria M Chan, Ph.D., DABMLI is a Vice President of Regulatory Strategy at Personal Genome Diagnostics Inc (PGDx), Baltimore, Maryland. She is a diplomat of the American Board of Medical Laboratory Immunology. Dr. Chan was a former Division Director in the Office of In Vitro Diagnostics and Radiological Health (OIR), Center for Devices and Radiological Health (CDRH) at FDA. At OIR, her division regulates cancer diagnostics (including companion diagnostics), molecular genetics, pathology, immunology and hematology in vitro diagnostic devices. Before joining the FDA, Dr. Chan was Associate Professor in the Department of Pediatrics and Pathology at the George Washington University Medical Center and Director of Immunology in the Department of Laboratory Medicine at the Children’s National Health System. After completion of her postdoctoral training in immunogenetics at Johns Hopkins School of Medicine in the Division of Medical Genetics, she became an instructor at Johns Hopkins and subsequently an Assistant Professor. During her tenure at Johns Hopkins, she also served as the Associate Director of the Immunogenetics Laboratory. Dr. Chan acquired her Ph.D. in immunology with a minor in microbiology from the University of New York, Buffalo, NY.


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Regulatory Processes for Biomarkers

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