Biomedical Product Development.ppt

Product Transfer Lecture 1 Biomedical Product Development Start with the end in mind Focus on areas of strength US Package Insert Sections Description Clinical Pharmacology Indications and Usage Contraindications Warnings Precautions Adverse Reactions Drug Abuse and Dependence Overdosage Dosage and Administration How Supplied Clinical Studies References Paul Ehrlich 1854 - 1915 Immunologist Tissue staining 1908 Nobel Prize for Medicine “Magic Bullet” Salvarsan Essentials Paul Ehrlich: All who are about to embark on developing a new drug must bring to the task four essentials: brains persistence capital luck Development Time Line Research and Development The term includes basic and applied research as well as development activities carried on or supported in the pharmaceutical, biological, chemical, medical, and related sciences, including psychology and psychiatry, if the purpose of such activities is concerned ultimately with the utilization of scientific principles in understanding diseases or in improving health. Discovery The term “Discovery” is used to describe the early phases of the overall biomedical discovery process, that is, the synthesis of or the search for compounds and the screening processes developed to identify “lead” compounds. Idea sources Where do ideas for new products originate? The Process of Discovery  Prevalence and Cost of Uncured Disease in the US National Institutes of Health National Cancer Institute National Heart, Lung and Blood Institute National Institute on Aging National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Diabetes and Digestive and Kidney Diseases  Private Organizations American Cancer Society American Heart Association Howard Hughes Medical Institute Salk Institute for Biological Studies Share of U.S. Ethical Pharmaceutical Market by Product Class, 1995 The Process of Discovery  Strategic Plan Select area of therapeutic or diagnostic inter