Print 15 September 2014
SAN DIEGO – September 12, 2014 – Epic Sciences announced today the appointment of Glen Paul Freiberg, RAC as vice president of regulatory affairs and quality assurance. Mr. Freiberg has more than 35 years of FDA-related experience and is recognized as a key leader in successful regulatory and compliance strategies for diagnostic products. Epic’s circulating tumor cell (CTC) technology enables the rapid and minimally invasive characterization of protein biomarker and genomic profiles in CTCs allowing for superior therapy, selection and early drug resistance detection to improve the treatment of cancer.
“Glen brings to Epic an invaluable breadth of regulatory experience, starting with his career as an FDA investigator to leading the clinical and regulatory strategies for the approval of innovative and novel molecular diagnostics,” said Murali Prahalad, Ph.D., president and CEO of Epic Sciences. “At Epic, Glen will develop and execute the process to obtain 510(k) clearances and PMA approvals for our circulating tumor cell platform and independent diagnostic tests as well as PMA approvals for our companion diagnostic tests.”
“Throughout my career, I have been excited to advance diagnostic medicine, especially new molecular tests based on detecting DNA and nucleic acid changes to better identify cancer,” said Mr. Freiberg. “When I learned about Epic’s circulating tumor cell technology, I was impressed with how, from a tube of blood, Epic can provide rapid and comprehensive information about the proteomic and genomic changes that occur over time during the treatment of a patient’s cancer. I look forward to helping Epic advance through regulatory approvals for a new type of cancer diagnostic technology that can monitor and personalize therapies at clinical decision points.”
Mr. Freiberg’s career began as an FDA investigator in New England, where he specialized in clinical trials, drug, medical device and diagnostic regulations. He has held positions of increasing responsibility at The Upjohn Company, The Coulter Corporation, Curtin Matheson Scientific, and Boehringer Mannheim. As vice president of clinical and regulatory affairs at Oncor, he most notably completed PMA work on DNA probes for cancer and introduced a successful FDA submission strategy using cytogenetic stains as the predicate device for DNA probes (e.g., trisomy detection). After Oncor, Mr. Freiberg was vice president at Bard Diagnostic Sciences, where he completed a PMA and two 510(k) submissions, including the first home use cancer-monitoring test, which achieved CLIA waiver. Then as vice president of regulatory, quality and government affairs at Gen-Probe, he helped in the completion of the first amplified nucleic acid tests for HIV, hepatitis and West Nile blood screening as well as for other infectious agents. He has also served as vice president of clinical, regulatory and quality at SpectraScience, and vice president of regulatory affairs and quality assurance at Eveia Medical and Alphatec Spine.
About Epic Sciences
Epic Sciences, Inc. is developing novel diagnostics to personalize and advance the treatment and management of cancer. Epic’s mission is to enable the rapid and non-invasive detection of genetic and molecular changes in cancer throughout a patient’s journey. The company was founded on a powerful platform to identify and characterize rare cells, including circulating tumor cells (CTCs). Our technology helps match patients to targeted therapies and monitor for drug resistance, so that the best treatment path can be chosen at every clinical decision point. Today, we partner with leading pharmaceutical companies and major cancer centers around the world. Epic’s goal is to commercialize our technology to increase the success rate of cancer drugs in clinical trials and improve patient outcomes by providing physicians real-time information to guide treatment choices.
Russian pharmaceutical company NovaMedica, a portfolio company of RUSNANO, announces the start of construction of a plant for the production of sterile injectable drugs as part of its long-term strategy to localize innovative medicines and technologies of their development and production in Russia. The plant will be built in the industrial park “Vorsino” in the Kaluga region.
23 March 2018
23 March 2018
22 March 2018