Robert Simon to lead regulatory affairs at Threshold

Robert Simon has joined Threshold Pharmaceuticals as its senior VP of regulatory affairs and will oversee regulatory activities for investigational cancer treatment TH-302, which the company is developing in partnership with Merck KGaA.

Threshold wants to tap into Simon's 28 years of experience in drug development and regulatory affairs as it attempts to launch the drug in several areas of oncology, including soft tissue sarcoma and pancreatic cancer.

“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 Dr Tillman Pearce, chief medical officer of Threshold.

Prior to joining Threshold, Simon spent almost a decade at OSI Pharmaceuticals, in roles that included VP of global regulatory affairs and chemistry manufacturing controls (CMC) for oncology, as well as executive VP.

He has also spent time at Gilead as VP of global regulatory affairs following a 13-year spell at Bristol-Myers Squibb in several regulatory affairs positions.

"I am looking forward to working with the Threshold team in developing the first hypoxia-targeted cancer drug, TH-302," said Simon.