DRUG DEVELOPMENT The Long Road to a New Medicine

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DRUG DEVELOPMENT The Long Road to a New Medicine

• SPEAKERS
• Dr. John H. Wick Johnson Pfizer Global RD
• Dr. David M. Pollock Medical College of Georgia
• Dr. Terry J. Opgenorth Abbott Laboratories
• Dr. Albert F. DeFelice Food and Drug
  Administration
• Dr. James M. Norton University of New England

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• DRUG DEVELOPMENT The Long Road to a New Medicine
• Objectives
• To acquaint you with the process of drug
  development
• To make you aware of job opportunities in the
  process-some of which may be new to you

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The Long Road to a New Medicine
Extensive Safety Studies
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The Long Road to a New Medicine
Discovery-Academia - Dr. David Pollock
Target Identification
Screening
Synthesis of Compounds
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The Long Road to a New Medicine
Discovery- Industry - Dr. Terry Opgenorth
Efficacy
Target Identification
Synthesis of Compounds
Screening
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The Long Road to a New Medicine
Pharmaceutical Formulation And Toxicology
Extensive Safety Studies
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The Long Road to a New Medicine
Clinical and Regulatory-Dr. Al DeFelice
NDA/MAA
Phase III 3-10,000 Patients
Phase II 100-400 Patients
Extensive Safety Studies
Phase I Healthy Volunteers
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The Long Road to a New Medicine
Discussion Dr. Jim Norton
Extensive Safety Studies