Dr. Maria Chan, has joined the PGDx as Vice President of Regulatory Strategy. Dr. Chan will play a major role in shaping regulatory strategy at PGDx and will oversee all regulatory activities. Previously, Dr. Chan was the FDA Division Director, Division of Immunology & Hematology Devices at the Center for Devices & Radiological Health, Office of In Vitro Diagnostics & Radiological Health, where she headed four branches including Immunology, Hematology, Pathology and Genetics. Earlier in her career at the FDA, Dr. Chan was promoted from Scientific to Team Leader and then Associate Division Director for the Immunology Branch. Prior to the FDA, Dr, Chan was Director of Immunology and Director of Technical Services in the Department of Laboratory Medicine at the Children’s National Health System. During this period she was also Associate Professor, Departments of Pediatrics and Pathology at the George Washington University Medical Center. Early in her career, Dr. Chan was Associate Director of the Immunogenetics Laboratory and an Assistant Professor in the Division of Medical Genetics at the Johns Hopkins University School of Medicine. Dr. Chan received a BA degree from the University of Oregon and a PhD in Immunology from the State University of New York at Buffalo. She completed post-doctoral training in Immunogenetics at Johns Hopkins.
Dr. Jennifer Dickey has joined PGDx as Director of Regulatory and Quality. Dr. Dickey comes with an impressive background having most recently been with the FDA as Senior Scientific Reviewer in the Molecular Genetics branch of the Office of In Vitro Diagnostics and Radiological Health. Dr. Dickey has more than 7 years of regulatory review experience and was Regulatory Affairs Certified (RAC) through the Regulatory Affairs Professional Society (RAPS) in 2012. Dr. Dickey has played a leadership role in several regulatory initiatives including serving as Chair of the Next Generation Sequencing-based Oncology Panels Public Workshop (February 25, 2016) and as lead reviewer for the first NGS-based assay (Illumina assay for cystic fibrosis). Dr. Dickey has spoken at several association conferences on subjects such as Regulatory Review of NGS Assays; Potential Roles for NGS in Companion Diagnostics; FDA Review of NGS Technologies; Multi-Analyte NGS Assays; and Enabling NGS in Global Clinical Trials, additionally Dr. Dickey has co-authored numerous peer-reviewed articles.
Mr. James Lewis joined Personal Genome Diagnostics as Senior Vice President, Corporate Development in November 2016 from Esperance Pharmaceuticals, where he served as Vice President, Business Development and a member of the management team. Jim is a life science industry executive with more than 25 years of growth-oriented corporate leadership experience across a spectrum of strategic planning, general management, business development, fundraising and commercial roles at companies including AstraZeneca, plc., Biosyn, Inc., ViroPharma, Inc. and TAP Pharmaceuticals. Jim has also recently served as a business advisor and consultant for emerging stage life science companies including Jenrin Discovery, Zelos Therapeutics, Amorcyte, Inc. and Azur Pharma.