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

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

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

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

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

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

Clinical and Regulatory-Dr. Al DeFelice The Long Road to a New Medicine Registration Clinical and Regulatory-Dr. Al DeFelice NDA/MAA Phase II 100-400 Patients Phase III 3-10,000 Patients Extensive Safety Studies Phase I Healthy Volunteers

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