Download Genome Drug Research.ppt

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
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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
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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
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6 years
$1.5 million
 Clinical testing and FDA
approval
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6 years and
$6 million
 Development and
marketing
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1 year
$2 million
My Career
 Exciting and challenging
 Meet lots of bright people
 Financial rewards
 Satisfaction in developing new
pharmaceuticals