SAN DIEGO, April 2, 2014 /PRNewswire/ -- Polaris Group announced today that Shaw T. Chen, M.D., Ph.D. has joined Polaris Pharmaceuticals, Inc. (a subsidiary of Polaris Group) as Executive Vice-President of Regulatory Affairs. Dr. Chen had previously been with the United States (US) Food & Drug Administration (FDA) for over 26 years in new drug development as a primary/supervisory medical staff. His achievements at the FDA included management of new drug review divisions, drafting and implementing FDA guidance for new class drug products and establishing modern drug review agency, as well as educating and training regulatory scientists in the Asian Pacific region. He most recently was Deputy Director, Office of Drug Evaluation, Center for Drug Evaluation and Research at the FDA.
Dr. Chen received his M.D. degree from the University of Miami, and his Ph.D. from Johns Hopkins University. He undertook post-graduate training at Johns Hopkins, Yale University, the University of Minnesota and the US National Institutes of Health where he was a medical staff fellow in clinical genetics in the Human Genetics Branch. He is the author of numerous basic science and clinical papers, as well as drug regulatory guidance publications.
“We are pleased to have Dr. Chen join us,” said Bor-Wen Wu, Ph.D., M.B.A., Chief Executive Officer of Polaris Pharmaceuticals, Inc. “His strong regulatory background at the FDA coupled with his clinical and basic science expertise provides a unique skill set. We look forward to his leadership in moving our primary compound ADI-PEG 20 forward in clinical trials, as well as to helping guide our development of other agents in our pipeline.”
About ADI-PEG 20
ADI-PEG 20 (pegylated arginine deiminase) is a biologic being developed by Polaris Group to treat cancers, especially those carrying a major metabolic defect that renders such cancer cells, unlike normal cells, unable to internally synthesize arginine. Because arginine is one of the 20 amino acids that are essential for protein synthesis and survival of cells, it is believed these cancer cells become dependent upon the external supply of arginine to survive and grow. ADI-PEG 20 is designed to systemically deplete the external supply of arginine, which causes arginine-dependent cancer cells to die while leaving the normal cells unharmed. Multiple cancers have been reported to have a high degree of arginine-dependency.
About Polaris Group
Polaris Group is a privately held biopharmaceutical company that specializes in the research and development of protein drugs to treat cancer and other debilitating diseases. The company’s lead therapeutic, ADI-PEG 20, is currently being evaluated in a pivotal Phase 3 trial for hepatocellular carcinoma. Polaris Group is also investigating ADI-PEG 20 as a treatment for other cancers. In addition to the ADI-PEG 20 program, Polaris Group is researching and developing other biotherapeutic agents and is advancing a small molecule drug program that utilizes a rational structure-based approach to design novel compounds that inhibit the biological function of cancer-related protein targets.
For additional information please visit www.polarispharma.com
SOURCE Polaris Group
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