Strategic Innovation in Health Care Delivery: Capturing the Full Potential of Biotechnology in Health Care

Dr. Nash welcomed the attendees and program participants. He noted that the speakers were prepared to demonstrate that genomics research represents the solution for the diminished drug pipeline in the pharmaceutical industry. Breakthroughs in new drug development will be occurring at the intersection of human genetics, functional genomics, and proteomics. Scheduled were sessions covering the principles and clinical utility of molecular diagnostic testing with a review of cost and current procedural terminology (CPT) coding. “Specialty pharmacies,” which assist in dispensing biotechnology agents, enable physicians to optimize the cost and quality of care for patients receiving new and potent biological agents (“biologicals”). These pharmacies are particularly suited to launches of biotechnology products and are essential in the overall success of these agents. A panel of experts assembled to discuss the business and economics of biotechnology in terms of the importance of discovery research by smaller “biopharma” companies and the need for adequate reimbursement to justify the risks in financing new therapies. To maximize financial gain, marketing experts and proponents of drug development must agree on a biotechnology product to be introduced. Changes in the manner in which biotechnology agents are manufactured are necessary to reduce costs. Transgenic biological agents are under investigation for making “humanized” and fully human antibodies. Many hurdles remain before these products will be acceptable for use in humans. Part of the biotechnology equation is the regulatory body, the U.S. Food and Drug Administration (FDA), and its perception of the biotechnology industry. Granting and obtaining approvals for the new biological agents are posing serious challenges for the FDA and for pharmaceutical manufacturers.