Transcript GeNetics - MiraCosta College

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
• Postdoctoral Research, Cornell University,
Ithaca, NY, 1987-1989
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
Research and Development
Organization at GeNetics
Statin Drugs
• Class of cholesterollowering 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
• Target enzyme of statin
drugs
2 steps
• Enzyme is key catalyst in
HMG-CoA
synthesizing cholesterol
HMG-CoA Reductase
• Catalyzes conversion of
Mevalonate
HMG-Co to mevalonate
• Statin drugs block enzyme,
10 steps
inhibits production of
cholesterol
Acetyl CoA
Cholesterol
Example Statin: Zocor
• Generic name: atorvastatin
• Our drug is similar, but more effective in
diabetics
• Patent pending
Effectiveness of Zocor
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
Career
•
•
•
•
Exciting and challenging
Meet lots of bright people
Financial rewards
Satisfaction in developing new
pharmaceuticals