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By Tony Strattner

August 15, 2003 | Two featured keynote speakers -- Kathy Ordoñez of Celera Genomics and Steven Galson of the FDA -- forcefully presented the opportunities and challenges of adopting new technology for evidence-based medicine at Bio-IT World’s inaugural Best Practices Awards ceremony, held during the BIO 2003 conference in Washington, D.C.

Addressing an audience of nearly 150 industry executives at the National Press Club, Kathy Ordoñez, president of Celera Genomics, recalled how far clinical diagnostic techniques have advanced during the past decade, with genotyping tests, for example, now enabling doctors to monitor and select optimal therapies for HIV and the hepatitis C virus. Ordoñez noted that while the technical and social barriers to adopting these now-familiar diagnostic methods were formidable, they were eventually overcome.

Likewise, the challenges facing the gene-based stratification of patients into subpopulations representing those most likely to respond to a given therapy, or those for whom the therapy represents a safety risk, will be surmounted, she said. Rather than shrink the market or eliminate the potential for blockbuster drugs, she argued, new genomic and proteomic tools for stratifying patients will have just the opposite effect.

“Better, targeted medicines that link diagnostics to select and de-select target populations for therapy, supported by additional diagnostics to monitor a drug’s safety and effectiveness, will indeed result in better medicine,” Ordoñez said. “More efficient clinical trials incorporating pharmacogenomic studies could lead to faster drug approvals. Better patient compliance and earlier intervention through the new diagnostics will also help sustain the market for these new targeted therapies.”

Steven Galson, deputy director of the Center for Drug Evaluation and Research (CDER) at the FDA, extended the theme of technology adoption to the concept of a “national health information network.” Such a network, he said, would “help doctors monitor their patients’ progress and deliver healthcare and really get the answers right, get the medications right, and mitigate the risks.”

A uniform health information infrastructure, Galson added, could also enable sophisticated remote monitoring of seriously ill patients who’ve undergone complex medical procedures and treatments. But the biggest benefit, he stressed, would come from the ability of ordinary patients and their doctors to quickly access comprehensive records of personalized treatments and therapies.

“For all the innovations of drugs and medical devices,” he said, “they’re dwarfed by what well-informed patients can do for themselves through better medical decision making.”

Galson acknowledged that creating an integrated, nationwide health-IT network was a tall order. “Our present system lacks even rudimentary IT capabilities,” he noted. “More than 90 percent of the estimated 30 billion health-related transactions each year are conducted by phone, fax, or mail.”

While he called on the biotechnology and pharmaceutical leaders in the audience for help, Galson admitted that the FDA itself would need to “build systems internally that can receive and manage data automatically transmitted, for example, on adverse events.” He said the agency’s ability to marry its own software and systems with those of medical providers will be “essential to ensure that we can partner with those providers across the healthcare spectrum.”

The FDA is arranging this marriage by partnering with private-sector groups to develop effective standards for clinical-data transfer and integration. And to spur greater IT adoption, the agency has leveraged a powerful tool: bar coding.

“According to the hospital community,” Galson said, “our new bar-coding rule will facilitate the adoption of bar codes on most of the products regulated by the FDA.” This will be a crucial step, he noted, to expediting the informed prescribing, dispensing, and administration of products that the agency regulates, preventing errors and associated costs. “It will also be an important incentive for doctors in hospitals to begin adopting powerful IT tools.”

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