Developing New Drugs Please click here to view the class list >> 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 one hour lectures presented by different individuals from both the academic and private sectors 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 tentative list of lecture topics includes: Ethical Issues in Testing New Drugs, The Rising Cost of Prescription Drugs, Regulatory Issues in Drug Development, Critical Analysis of Clinical Trial Design, Post-Marketing Surveillance, Orphan Drug Development, Generic Drugs, Pharmacogenomics and Pharmacogenetics, Intellectual Property, The Story of TNF Inhibitors: From Bench to Bedside, Biostatistics and Study Design, Starting up a Biotechnology Company, Financial Conflicts of Interest, Clinical Studies and Drug Development, The Review of Process and Drug Studies.