IRVINE, Calif., July 12, 2018 /PRNewswire/ — Laboratory for Advanced Medicine (LAM), a clinical-stage medical technology company focused on developing innovative technologies for the early diagnosis and intervention of cancers, today announced that the Company has recently appointed Dr. Jinjie Hu as its Chief Regulatory Officer. Dr. Hu has over a decade of experience working directly with the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER).
“Following LAM’s recent commercialization of the Company’s IvyGene test for the early diagnosis and detection of cancer, having Dr. Hu on board as we continue our ongoing discussions with the FDA is an enormous asset to our team moving forward,” said Dr. Shu Li, LAM’s Chairman. “Additionally, given Dr. Hu’s deep experience in reviewing analytical and clinical study data – as well as her hands-on experience in meeting regulatory requirements for companion diagnostic products, combination products and other biological product applications – she will serve as an invaluable member of LAM’s senior leadership from both a broad regulatory scientific and strategic business perspective.”
As President and Principal Consultant at Axteria BioMed Consulting, Inc., and as a Senior Consultant for Biologics Consulting Group, Dr. Hu has a successful track record in helping sponsors with FDA applications. She has also served as a World Health Organization adviser for its diagnostic pre-qualification program, as well as the International Network Committee Chair of the FDA Alumni Association.
“As LAM is at a pivotal moment in the Company’s history, having just launched IvyGene – the first laboratory-developed test that uses a methylation-based approach to test for multiple types of cancer – the opportunity to join LAM and assist in its regulatory efforts made perfect sense as the next step in my career,” added Dr. Hu. “What’s more, LAM has a tremendous advantage in the liquid biopsy space, as the assays in development are supported with the Company’s unmatched patient sample biobank, and there is nothing more exciting to be a part of across the life sciences industry today. I look forward to working closely with management to make cancer a more manageable disease due to successful early diagnostics for people all over the world in hopes of saving countless lives in the process.”
Dr. Hu received her Ph.D. in comparative pathology from the University of California, Davis, and completed her post-doctoral fellowship at the National Institute of Health’s National Institute of Allergy and Infectious Diseases.
About Laboratory for Advanced Medicine
LAM is a clinical-stage medical technology company focused on developing innovative, non-invasive, nontoxic technologies for the early diagnosis and intervention of cancers, possibly years before current technology can detect. LAM is dedicated to building and growing world-class technologies from the laboratory to the clinic. LAM operates scientifically, ethically and efficiently to bring these technologies into the mainstream.
LAM is headquartered in the United States with offices in California, Texas and Indiana. LAM is a multi-national business with collaborations in both the U.S. and China, including leading scientists, physicians, research institutions and business leaders. LAM strives to combine the experiences of these innovators and achievers to provide the most effective and safest diagnostic technologies to everyone.
LAM has CLIA-registered and CAP-accredited laboratories, third-party laboratories and cGMP facilities all working toward the endeavor of bringing these first-class technologies into the medical community.
SOURCE Laboratory for Advanced Medicine