Advanced Science Elective in New Drug Development

Offered to medical students.

Developing New Drugs

Preceptors:    Drs. Stephen Oliver and Bruce Cronstein

Enrollment:    Limited to 15 students

Schedule:      Daily 10 AM – 12 Noon

Description:   The rapid pace of pharmaceutical research and development in recent years has resulted in a diverse range of therapeutic agents available to today’s physicians.  Understanding how drugs are developed and evaluated for clinical application will assist physicians in interpreting the literature on newly licensed drugs.  This course consists of 1 hour lectures presented by different individuals from both the academic and private sector on topics that will provide the student with a background in how a drug is developed and brought from the laboratory bench to the patient’s bedside.  Early in the course, each participant will choose a drug recently approved by the FDA to learn more about through a literature search.  During the final meetings of the selective, each participant will provide a short 10-15 minute presentation to the group on the background of their chosen drug, highlighting the drug’s indication rationale and development through animal studies and clinical studies.

A list of lecture topics includes:” “Ethical Issues in Testing New Drugs,” “Health Care Policy and Prescription Drugs,” “Regulatory Issues in Drug Development,” “Critical Analysis of Clinical Trial Design,” “Post-Marketing Surveillance,” “Orphan Drug Development,” “Generic Drugs and Their Equivalents,” and “Pharmacogenomics and Pharmacogenetics,” “Intellectual Property,” “Developing Inexpensive Drugs for the Third World,” “Drug Discovery: From Bench to Bedside” and “The Peer Review Process and New Drug Studies.”