Has 25 years of life sciences experience and has been involved in the formation and management of numerous biotechnology companies. He is currently Executive Chairman and Chief Executive Officer of Precision Immune, Inc., and was the President, CEO, and Director of Labrys Biologics, Inc. from December 2012 until it was acquired by Teva Pharmaceuticals in July 2014. Prior to joining Labrys, Steve was President, CEO and Director of KAI Pharmaceuticals, Inc. from October 2004 until the company was acquired by Amgen in July 2012. His previous positions have included Senior Vice President of Commercial Operations at Exelixis; Chief Business Officer at Sunesis Pharmaceuticals and VP of Business Development at Isis Pharmaceuticals (now Ionis). He began his career in new product planning at Eli Lilly. He holds a Masters in Management from the Kellogg School of Northwestern University and an undergraduate degree from Brown University. Steve is Chairman of Antiva Biosciences, and a director of Ocera Therapeutics, Chrono Therapeutics, and Cascadian Therapeutics (formerly, Oncothyrean, Inc).
Vinita has 25 years of industry experience in pharmaceutical development at both start-up and large companies. Her experience encompasses working from early phase development to full-scale commercial production both in an in-house and out-sourced environment. She has worked with several contract service organizations and contract laboratories where she has ensured compliance with FDA and EMA standards. Prior to joining Versartis, Vinita most recently served as Vice President of Quality at Relypsa where she built and led the quality organization from early development phase through FDA approval and commercial phase. Her career began as a pre-formulation Scientist at Syntex, followed by 23 years working at Roche, Oread, Telik, Ilypsa (Amgen) and Relypsa. Vinita has provided leadership to the quality organization primarily in small molecule and polymeric drugs. She has hosted several Regulatory Authority Inspections and has been successful in obtaining positive outcomes. She has been involved in marketed drugs such as Naprosyn®, Cellcept®, Toradol® and Veltassa®. Vinita is responsible for the overall quality operations and quality control, including quality management of all GxP Compliance, Validation, QC GMP, QC Clinical and QC Research. She holds two MS degrees: one in Physical Organic Chemistry from Southern Illinois University and another in Organic Chemistry from Patna University.
On June 25, 2010, Bayer sued Teva for falsely claiming that Gianvi, Teva's Generic of Yaz, was "stabilized by betadex as a clathrate ."  The lawsuit stems from Bayer's US patent, 5798338, on the binding and preservative agents that were not in fact present in Gianvi. "In the preparation of such low-dosed dosage forms, strong fluctuations of the active ingredient concentrations in the dosage units occur almost unavoidably (inadequate content uniformity), which manifest themselves more strongly, the smaller the amount of the active ingredient. It has now been found that the drawbacks that are observed especially in the preparation and storage of dosage forms which contain low-dosed steroidal sex hormones can be avoided, at least to a large extent, if dosage forms are prepared that contain powdery cyclodextrin clathrates of these active ingredients."  The settlement of the lawsuit resulted in Teva changing its product marketing to remove the claim that it used the same ingredients as Yaz.  [ dead link ] Bayer's patent is on a method specifically designed to prevent oxidative degradation of the estrogen.