1. DRUG DEVELOPMENT The Long Road to a New Medicine
SPEAKERS
Dr. John H. “Wick” Johnson – Pfizer Global R&D
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

2. 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

3. The Long Road to a New Medicine
Discovery
Full Clinical
Development
Registration
Extensive
Safety
Studies

4. The Long Road to a New Medicine
Discovery-Academia - Dr. David Pollock
Target Identification
Synthesis
of Compounds
Screening 4

5. The Long Road to a New Medicine Synthesis of Compounds
Discovery- Industry - Dr. Terry Opgenorth
Efficacy
Target Identification
Synthesis of Compounds
Screening 5

6. The Long Road to a New Medicine
Pharmaceutical Formulation
And Toxicology
Extensive
Safety
Studies

7. Clinical and Regulatory-Dr. Al DeFelice
The Long Road to a New Medicine
Registration
Clinical and Regulatory-Dr. Al DeFelice
NDA/MAA
Phase II Patients
Phase III 3-10,000 Patients
Extensive
Safety
Studies
Phase I Healthy Volunteers

8. Discussion – Dr. Jim Norton
The Long Road to a New Medicine
Discovery
Full Clinical
Development
Registration
Discussion – Dr. Jim Norton
Extensive
Safety
Studies