Dr. Jennifer Dickey, PhD, RAC has joined PGDx as Vice President 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.
Dr. Mary Padilla has joined PGDx as Vice President of Customer Service and Support. Dr. Padilla will play a major role in building a team and infrastructure for supporting PGDx reagent and software products that are on the market and in the PGDx CLIA lab. Previously, Mary most recently served as General Manager for Spring Bioscience and Discovery for Instruments at Roche Tissue Diagnostics. Dr. Padilla has extensive experience supporting both Research & Development as well as diagnostic commercialization. Dr. Padilla received a BA degree in Biochemistry and Anthropology as well as earning MD, and completing residency training in Pathology at the University of Arizona. Dr. Padilla spent her fellowship years at the University of Chicago. Dr. Padilla also spent 2 years in Barcelona, Spain, with her family, where she traveled globally to support CDx products and was appointed Medical Director of Companion Diagnostics.
Dr. John Simmons joined Personal Genome Diagnostics in 2016 and serves as the Vice President of Translational Medicine. In this role, John focuses broadly on scientific strategy and diagnostics partnerships with pharma/biotech. Previously, John was at the National Cancer Institute where his research focused on identifying novel therapeutic strategies for multiple myeloma through chemical genomic approaches with a particular focus on drug combinations. He received his undergraduate degree in Biology with honors from American University and Ph.D. in Tumor Biology from Georgetown University as part of the NIH Graduate Partnership Program. As a post-doctoral fellow, he received the Multiple Myeloma Research Foundation (MMRF) Research Fellow award to support his work in developing systems-level approaches for drug combination identification and prioritization.