A group of health care company executives are coming together under a single banner to promote personalized medicine in an organization called the Personalized Medicine Coalition (PMC).

The Washington-based organization includes more than 20 pharmaceutical, biotechnology, diagnostics and information-technology companies, along with major academic centers and government agencies. The non-governmental, nonprofit group was formed to bridge the common interests of such different companies and other organizations, said Patrick Terry, the PMC's secretary and one of its co-founders.

"We saw a real need for a forum to organize and pull together the eclectic mix of companies, service delivery and think-tank organizations that revolve around personalized medicine and genomic health delivery," he told BioWorld Today, noting a variety of objectives, such as bringing together opinion leaders to educate member organizations, policymakers and the public, to identify public health and policy needs, address dilemmas that personalized medicine will introduce to health care and articulate positions to help shape future legislation.

Terry, also a co-founder of Genomic Health Inc. in Redwood City, Calif., said the group's members would work within the framework of the PMC to understand one another's needs. Beyond that, the organization is built to engage in dialogue with the FDA, the Centers for Medicare and Medicaid, the National Institutes of Health and National Cancer Institute, and the Institute of Medicine, as well as with other policy arms of the government.

Its inception came about over a three-year process.

"There were some ad hoc meetings and people informally gathering on these topics, and engaging in various public and federal advisory groups and seeing the handwriting on the wall that personalized medicine is not here yet, but it's coming," Terry said. "To be proactive and engage the broad community has a tremendous opportunity to impact clinical outcomes for patients, but there's also a huge challenge of how to engage one another and affect change across a diverse group of stakeholders."

Personalized medicine involves the use of new methods of molecular analysis to better manage a patient's disease or predisposition to a disease. It aims to optimize medical outcomes by helping physicians and patients choose the disease-management approaches likely to work best given a patient's genetic makeup, environment and lifestyle. Such approaches might include molecular-screening programs that more precisely diagnose diseases and their subtypes, and help physicians select the type and dose of medication best suited to certain patients.

"[Personalized medicine] is really a great example of the potential innovation an emerging field of science and medicine holds to solving some of the really difficult health care challenges we're facing right now as we tackle the growing burden of disease and growing strain on health care finances," said Randy Burkholder, a PMC board member representing the Pharmaceutical Research and Manufacturers of America (PhRMA). "It underscores how innovation and some cutting-edge science can help address those problems."

He told BioWorld Today that personalized medicine would affect health care policy through a variety of challenges going forward, and establishing a single advocacy voice would aid in eventually reaching solutions. Burkholder's organization, PhRMA, holds a board seat.

"I think some responsibility lies within the coalition to highlight both the golden age of what this may represent for changing the practice of medicine," said Terry, "as well as highlighting the ethical and situational dilemmas that these technologies present to both policy holders and service delivery organizations and insurers."

The PMC named as its executive director Edward Abrahams, who formerly served in the same capacity for the Pennsylvania Biotechnology Association.

Its board includes executives from Abbot Laboratories, of Abbott Park, Ill.; Vysis Laboratories Inc., of Downer's Grove, Ill.; Affymetrix Inc., of Santa Clara, Calif.; Amgen Inc., of Thousand Oaks, Calif.; AstraZeneca plc, of London; the Biotechnology Industry Organization in Washington; Genentech Inc., of South San Francisco; Genomas LLC, of New Haven, Conn.; F. Hoffmann-La Roche Ltd., of Basel, Switzerland; Pfizer Inc., of New York; and PhRMA in Washington. The National Cancer Institute and the National Human Genome Research Institute, both of the NIH in Bethesda, Md., also are active in the organization as ex officio members.

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