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A New Statin Drug: A Brief History of My Career Jaz Alexander, Ph.D. Genome Pharmaceuticals Cambridge, Massachusetts My Educational Background B.S. in Chemistry from Temple University, 1982 Ph.D. in Biochemistry from Bryn Mawr College, 1987 Postdoctoral Research, Cornell University, Ithaca, NY, 1987-1989 My Professional Background Joined Genome Pharmaceuticals, 1989, as Research Scientist Promoted to Research Team Leader, 1994 Promoted to Senior Scientist in 2001 Supervised development of a new statin drug Research and Development Organization at Genome Kristion Godfrey, R&D Vice President Bonnie Ortolano, Senior Scientist James Provost, Team 1A Leader Darrel Broadbent, Team 2A Leader Albert Acuin Stephen Guttmann, Team 3A Leader Statin Drugs Class of cholesterol- lowering drugs Inhibitors of HMGCoA reductase, an enzyme Enzyme catalyzes rate-limiting step in sterol biosynthesis Cholesterol is a sterol Example statins Lovastatin Pravastatin Simvastatin Atorvastatin Fluvastatin Cerivastatin HMG-CoA Reductase Acetyl CoA 2 steps HMG-CoA HMG-CoA Reductase Mevalonate 10 steps Cholesterol Target enzyme of statin drugs Enzyme is key catalyst in synthesizing cholesterol Catalyzes conversion of HMG-Co to mevalonate Statin drugs block enzyme, inhibits production of cholesterol Example Statin: Lipitor Generic name: atorvastatin Our drug is similar, but more effective in diabetics Patent pending Effectiveness of Lipitor 10 0 -10 -20 Placebo Lipitor -30 -40 -50 Tot Chol LDL-C HDL-C Trigly Getting a Drug to Market Scientists design and synthesize drug Test drug in vitro (in test tube) Get pre-approval of FDA for clinical trials Perform placebo-controlled dose-response study on hypercholesterolemia patients Submit results to FDA Get preliminary approval Test on wider group Get final approval from FDA Design delivery system, packaging, etc. Market drug through physicians Reality of Drug Development Initial development and testing 6 years $1.5 million Clinical testing and FDA approval 6 years and $6 million Development and marketing 1 year $2 million My Career Exciting and challenging Meet lots of bright people Financial rewards Satisfaction in developing new pharmaceuticals