Accomplished regulatory leader to advance Epic's circulating tumor cell (CTC) technology for 510(K) and PMA approvals.
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
At Epic Sciences, we develop clinically proven predictive tests to detect and monitor cancer at the individual cell level. With a proprietary rare-cell detection engine, we provide insights to clinical, biotech, pharmaceutical and academic teams on how cancer emerges, mutates and remits so they can make pivotal decisions at every point in patient treatment with greater certainty. Recognizing the unique nature of each person’s cancer, we offer truly personalized diagnostic tests, while being non-invasive for the patient.
We have developed the first clinically proven predictive test for metastatic castration-resistant prostrate cancer (mCRPC), the Epic AR-V7 test. Using the same rare-cell detection platform and Epic’s biobank of over 30,000 blood samples, each profiled with predictive biomarkers, we partner with leading pharmaceutical and biotechnology companies, major cancer centers, the National Cancer Institute (NCI), and the National Institutes of Health (NIH) to pursue additional predictive tests for breast, ovarian, colon and other cancers and diseases. Our mission is to revolutionize cancer care and therapies to make them as precise, safe and life-sustaining as humanly possible.
For more information, visit epicsciences.com.
Epic Sciences Media Contact: Jessica Yingling, Ph.D., Little Dog Communications Inc., firstname.lastname@example.org,+1.858.344.8091