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A New Statin Drug: A Brief History of My Career

A New Statin Drug: A Brief History of My Career. Bonny Ornatowski, Ph.D. GeNetics Pharmaceuticals Cambridge, Massachusetts. Educational Background. B.S. in Chemistry from Temple University, 1982 Ph.D. in Biochemistry from Bryn Mawr College, 1987

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A New Statin Drug: A Brief History of My Career

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  1. A New Statin Drug: A Brief History of My Career Bonny Ornatowski, Ph.D. GeNetics Pharmaceuticals Cambridge, Massachusetts

  2. 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

  3. Professional Background • Joined GeNetics Pharmaceuticals, 1989, as Research Scientist • Promoted to Research Team Leader, 1994 • Promoted to Senior Scientist in 2001 • Supervised development of a new cholesterol-lowering drug

  4. Research and Development Organization at GeNetics

  5. Class of cholesterol-lowering drugs Inhibitors of HMG-CoA reductase, an enzyme Enzyme catalyzes rate-limiting step in sterol biosynthesis Cholesterol is a sterol Example statins Lovastatin Pravastatin Simvastatin Atorvastatin Fluvastatin Cerivastatin Statin Drugs

  6. HMG-CoA Reductase • 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 Acetyl CoA HMG-CoA Mevalonate Cholesterol 2 steps HMG-CoA Reductase 10 steps

  7. Example Statin: Zocor • Generic name: atorvastatin • Our drug is similar, but more effective in diabetics • Patent pending

  8. Effectiveness of Zocor

  9. 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

  10. 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

  11. Career • Exciting and challenging • Meet lots of bright people • Financial rewards • Satisfaction in developing new pharmaceuticals

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