Health CareKey Drivers Shaping the Health Care Industry Today

Keynote Speaker: David B. Nash, MD, MBA, Associate Dean and Chair, Department of Health Policy, Thomas Jefferson Medical College, Philadelphia, Pennsylvania.

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.
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“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.

Using Human Genetics to Improve the Safety and Efficacy of Therapeutics

Speaker: Michael Pellini, MD, MBA, President, Chief Executive Officer, Genomics Collaborative, Inc., Cambridge, Massachusetts.

As of 2004, pharmaceutical/biotechnology productivity has been decreasing because of the struggle for access to high-quality “biospecimens” and because of the problems in validating targets for biotechnology agents. The current expenditure for biotechnology drugs in the U.S. is $30 billion, with $16.4 billion directed toward research and development (R&D). Income from these drugs in fewer than 10 companies is approximately $100 billion, with a growth rate of more than 14%. There are 1.1 million employees in the biotechnology industry, and the workforce is growing at a rate of 12%.

The realities of R&D involve high risks; inflation has grown in dramatic fashion (at a rate of 12%), although R&D budgets are growing more slowly. Expectations of the new biological products by regulatory agencies and by patients may be unrealistic and might not be achievable. It appears that innovative biotechnology drugs will take longer to develop than previously anticipated.

The impact of genomics came into its own in the latter part of the 1990s; in 2001, however, only one genomic-based product was studied in humans. Only four genomic-based Investigational New Drug (IND) applications were filed in 2002, and eight were filed in 2003. Although the genomic revolution has increased the production of new potential targets because of genomic-based technologies, many false-positive and false-negative results have created a bottleneck that could slow the pace of further study. viagra soft

In reality, the pharmaceutical/biotechnology industry is still considered immature, and the early expectations of rapid growth are now considered unrealistic. Research conducted in isolated “silos” has created diversified groups; that is, the targets for therapies have increased (e.g., colon and breast cancers), whereas less emphasis has been placed on the value of the targets.

In 2004, genomic research appears to be advancing with the integration of once distinct silos and with more resources directed toward genomic-based improved information technology. Genomics is no longer focused only on the early stages of R&D but, rather, throughout the entire R&D process and on the smarter and more efficient validation of targets. In addition, several positive changes in the industry have taken place:

  • More than 19 genomic drugs are being tested in clinical trials.
  • From 22 to 30 drugs will be entering clinical trials to treat systemic lupus erythematosus, rheumatoid arthritis, muco-sitis, cancers, pulmonary arterial disease, and so on.
  • Drugs are becoming more specialized.
  • Diagnostics are being used along with drug development.
  • Drugs are being directed toward a patient’s genotype for individualized treatment plans.
  • Cancers are being subtyped for better targeting of therapy.
  • The use of pharmacogenetic technology has helped to customize the efficacy of biotechnology products in cerain patients.
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Target validation is a central problem in genomic-based biological research. A glut of targets has been identified on the basis of single cell lines or tissue samples found in 0.01% of the population. There is also a heavy reliance on in vitro studies and less emphasis on work with human data that can eventually be costly and dangerous. It is imperative that large DNA sample sets from humans be analyzed in the early stages of R&D (starting in the beginning of the drug-discovery process). DNA samples must be selected, and a detailed genetics assessment of populations must be conducted; a clear correlation between genotypes and phenotypes indicates a target site for a clinical condition.