RESEARCH-AND-DEVELOPMENT OF DRUGS AND BIOLOGIC ENTITIES

Uses of and problems associated with the products of biotechnology are described, and implications of the new technology for pharmacy practice and education are outlined. Biotechnology is the application of biological processes to the generation of new therapeutic and diagnostic drug products and vaccines. More than 100 biotechnology products are under development in the United States. Sixteen products, including 13 therapeutic agents and three vaccines, have been marketed. The largest category of biotechnology products now in development is monoclonal antibodies; nearly half of these are targeted for cancer therapy. The second largest group of agents undergoing clinical trials is vaccines. Showing particular promise are products such as colony-stimulating factors and growth factors, which may offer therapy for conditions that are currently untreatable. Problems intrinsic to the products of biotechnology include their short half-lives, difficulties associated with delivering the product in a timely fashion to a specific site, and, in the case of vaccines, the ability of the target organisms to change their structure. Ethical and economic considerations complicate decisions facing those concerned with the rational use of these products. Preparing pharmacy students and practitioners to take a lead role in the use of the products of biotechnology will require substantial modifications in pharmacy education and training at all levels. While some schools of pharmacy have instituted major curriculum revisions to accommodate such needs, others have yet to respond to the challenge of biotechnology. Biotechnology offers increasing opportunities for pharmacists to take an active role in therapeutic decision making, drug delivery, and the education of their health-care colleagues and of patients.