Threshold Pharmaceuticals Appoints Senior Vice President of Regulatory Affairs
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Six clinical trials of TH-302 are currently enrolling, including a Phase 3 trial in soft tissue sarcoma, and others are either pending or under consideration with partner, Merck KGaA across numerous oncology indications. Mr. Simon brings more than 28 years of drug development and regulatory affairs experience, particularly as a liaison with the US Food and Drug Administration (FDA) and international health authorities on new drug registrations, the initiation of clinical trials, and in the area of chemistry, manufacturing and controls (CMC).
"Bob has played key roles in the successful registration of more than a dozen new drug applications worldwide, including the established oncology drugs, Tarceva and Taxol," said Tillman Pearce, MD, Chief Medical Officer of Threshold. "His wealth of experience in the regulatory affairs arena will be especially valuable to us as we and Merck determine next steps following our successful Phase 2 trial in pancreatic cancer, look ahead to the completion of our Phase 3 pivotal trial in soft tissue sarcoma, and continue to move other studies forward in various oncology indications."
Before joining Threshold, Mr. Simon spent nearly 10 years at OSI Pharmaceuticals, initially as Vice President of Global Regulatory Affairs and CMC for oncology but more recently as an Executive Vice President in roles relating to pharmaceutical development, manufacturing and technical operations. Prior to OSI, he was Vice President of Global Regulatory Affairs for Gilead, covering oncology and anti-viral products, and before that, served at Bristol-Myers Squibb for more than 13 years in global regulatory affairs positions. With a degree in chemistry, Mr. Simon held chemistry and regulatory-related positions at Syntex and SRI International (formerly Stanford Research Institute) early in his career.
"I am looking forward to working with the Threshold team in developing the first hypoxia-targeted cancer drug, TH-302," said Bob Simon. "Cancer is an unforgiving disease that often recurs with a vengeance. TH-302 provides, for the first time, the promise of a drug that targets the hypoxic cells that are believed to underlie metastasis and treatment failure and which are little affected by available therapies. Because of TH-302's unique mode of action, it may well be someday the drug of choice to combine with other cancer therapy in a one-two knockout punch approach to managing this dreadful disease."