Speaker: Gary Reedy, PhD, Vice President, World Wide Biopharmaceutical Public Policy, Ortho Biotech Products, Bridge-water, New Jersey.

Biotechnology companies must work with government agencies and with patients to obtain approval of their biological agents. The pharmaceutical industry is experiencing a transformation because of the growth of innovative biotechnology products. These products are moving from research to manufacturing in rapid order.

The time from initial development to approval is lengthening because of the complexity of these large-molecule biological agents, compared with the smaller synthetic molecules; however, there are post-marketing requirements for additional safety and efficacy studies of the new products.

These innovative products provide important benefits for patients with cancer, pain, arthritis, and asthma. They have increased the life expectancy in the U.S. by 1%, which has added $400 billion to the U.S. economy.

In 2004, there will be a greater number of newer large-molecule biotechnology products than the smaller-molecule agents that have dominated the pharmaceutical industry for decades. It is expected that 30% of biotechnology products will be approved when biopharmaceutical companies team up with the large pharmaceutical companies. These collaborations are growing stronger and are expected to provide the base for future therapeutics in the U.S. Companies with dual drug and diagnostics units and devices will probably have a significant advantage in the pharmaceutical industry. The large pharmaceutical companies are looking to biotechnology companies to fill their pipelines of potential drugs. Johnson & Johnson is an example of a large pharmaceutical company with biotechnology alliances.

Patent Medicines: Why Do They Cost So Much?

Speaker: Kate Murashige, PhD, JD, Partner, Morrison & Forester, San Diego, California.

Patent medicines are expensive for consumers. After FDA approval, there is a 20-year patent life for new chemical or biological compounds. The 20-year monopoly is considered a quid pro quo for full disclosure of the invention to the public. The pharmaceutical companies have responded to criticism of their high drug prices by revealing the cost—$500 to $800 million—required to bring a drug to market (including failures). Sales of a successful drug, (AstraZeneca) or fluoxetine (Prozac®, Eli Lilly) are computed in the billions of dollars a year. Those billions would not be forthcoming were it not possible for the patent holder to exclude competition.

The rationale behind protection for genomics-based inventions should be contrasted with what has been used to justify “strong” patents on pharmaceuticals in the traditional sense. Bevacizumab (Avastin™, Genentech), a recently approved anti-angiogenesis drug used for treating colon cancer, costs $80,000 per year to use. Epoietin alfa (EPO) is a genetically engineered version of a natural hormone, erythropoietin, which stimulates the bone marrow to produce red blood cells. In 2004, Epogen® (Amgen) and Procrit® (Ortho Biotech) showed combined sales of $8.1 billion.

Under U.S. law, patent holders are not obligated to permit others to practice the patented technology during the patent term or to grant any license to others; indeed, they are not required to practice this technology either. Although it is difficult to document the case of a valuable research tool that has been simply allowed to lie fallow, this is at least a theoretical possibility. It might be that only the pressure exerted by institutions such as universities and the National Institutes of Health has resulted in at least the potential availability of licenses on almost every research tool that is not being directly exploited for commercial purposes by its developer.

When patents expire, generic drugs can be introduced for marketing by the simple filing of an Abbreviated New Drug Application (ANDA). To earn the FDA’s approval, the generic drug must simply show bioequivalence to the pioneer drug.
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Generic drugs are winning the battle for ANDAs in the courts. They are prevailing 75% of the time; patent holders are not prevailing. Patents are expensive (e.g., $500,000 for both U.S. and international rights), adding to the cost of patented medications.

The New Health Care: Engaging Biotechnology, Technology, and Evidence-Based Medicine with Consumerism

Keynote Speaker: Bill Rowley, MD (Admiral), Institute for Alternative Futures, Alexandria, Virginia.

Health care in the U.S. is becoming unaffordable. The new realities shaping the early 21st century are epidemics of chronic diseases and an aging population, post-genomic prevention strategies transforming medicine, information technology expanding potential reach, a well-informed public that has become eager participants in its own health care, feasible evidence-based outcomes, and the trend of payers demanding safety and value in their health care.
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Approximately 125 million Americans have chronic diseases, and more than 50% have multiple conditions. Ninety-five percent of spending is devoted to treatment, with little going toward reducing unhealthy behaviors (e.g., poor diet and lack of exercise). Patients with five or more chronic conditions visit 13 different doctors a year. In 2010, the baby-boomers will turn 65 years of age. America cannot afford all the diseases that it is generating.

With the use of biotechnology methods, young men and women would be prospectively examined for early detection and early intervention in the case of a chronic condition. Disease might be delayed with individually tailored medications. Thus, the focus of treatment would be shifted from intervention to prospective medicine.

“Biomonitoring” of patients would be possible by means of sensors and information technologies centered in the home for individual therapy that would be tailored to the unique characteristics of the patient’s disease. Electronic medical records would be available to all patients, and they would choose who had access to their records. Evidence-based medicine is the integration of clinical expertise, patient values, and best data into the decision-making process for the care of each patient.

The focus of health care in the future will shift from treating single diseases to customizing treatment to meet the needs of individual patients. Consumer-managed care will empower enrollees by shifting control to patients. This shift can be accomplished by supplying information on health and therapy, providing decision-making tools available on the Internet, offering incentives for patients to improve their health, motivating patients to make better choices and to spend money wisely, and rewarding quality and excellence. tadacip 20

Consumers are more savvy and demanding, and they are ready to take responsibility for their health.