Ms. Manhard was appointed as our Senior Vice President of Regulatory Affairs and Operations in December 2006. Prior to that Ms. Manhard was President of her own consultancy since 2003 specializing in the development of small molecules intended for the treatment of antiviral oncology central nervous system (CNS) and gastrointestinal indications and was responsible for filing five initial US INDs and multiple clinical trial applications in the European Union and Canada. Prior to starting her consultancy Ms. Manhard was Vice President of Regulatory Affairs for Exelixis Inc. Previously she was Head of Regulatory Affairs for Agouron Global Commercial Operations (a Pfizer company) supporting marketed HIV products. She joined Agouron in 1996 as Director of Regulatory Affairs responsible for anticancer and antiviral products including nelfinavir (Viracept). Prior to Agouron she was with Bristol-Myers Squibb for over five years in Regulatory Affairs and was responsible for investigational oncology compounds including paclitaxel (Taxol) and infectious disease compounds including didanosine (Videx) and stavudine (Zerit). Ms Manhard began her industry career in Clinical Research with Eli Lilly and Company and G.H. Besselaar Associates (Covance). She earned a BS in Zoology and a BA in French from the University of Florida. |