Audrey Jakubowski

Biography

 Dr. Jakubowski came to Targazyme after a long career in both big and small pharma.  She started her career at Bristol Myers, working with dermatological products and then moving to the Bristol Myers Research Center in Wallingford, CT, where she built and led a regulatory group that focused on building a single, international dossier that could be submitted around the globe.  During that time, Dr. Jakubowski prepared registration plans and documents for drugs in the cancer, cardiovascular, central nervous system, anti-infective and anti-HIV areas for European, Canadian and Japanese submissions.   Dr. Jakubowski went on to DuPont, where she was the head of Global Regulatory Affairs for the pharmaceutical division at DuPont where she had responsibility for investigational drugs as well as marketed products, generic drugs and radiopharmaceuticals.   During her 15th years in big pharma, Dr. Jakubowski was responsible for submitting multiple New Drug Applications, both in the U. S. and abroad.  She also was the regulatory lead for two FDA advisory committee meetings in the U.S.  Dr. Jakubowski was an elected member of the Pharmaceutical Research and Manufacturer’s Association (PhRMA) Regulatory Affairs Committee and was an invited speaker at many professional meetings.  Dr. Jakubowski came to California to join Systemix, a cell therapy company, as their Vice President of Regulatory Affairs and Quality Assurance.  Dr. Jakubowski went on to SuperGen where she also had responsibility for regulatory affairs and quality assurance and submitted two NDAs for cancer drugs.  Dr. Jakubowski went on to support the company’s focus on new molecules that were early on in development, which she continued to do until she retired in 2009.  Dr. Jakubowski left retirement to join Targazyme because she feels that the platform technology that Targazyme has developed has the potential to help so many people who are desperate for help with their serious diseases.  Dr. Jakubowski received her Ph.D in Physical Chemistry from S.U.N.Y. Buffalo.  She also completed a PostDoctoral Fellowship at S.U.N.Y. Buffalo Department of Medicine and another at Rosewell Park Memorial Institute in Buffalo, N.Y.

Research Interest

 Regulatory Affairs and Quality Assurance