Leading Policymakers, Scientists, Industry Executives Discuss Implementation of Evidence-Based, Personalized Medicine

— Keynotes include HHS Secretary Leavitt, Dr. McClellan of The Brookings Institution,
Dr. FitzGerald of Georgetown University Medical Center, and
The Hon. Billy Tauzin of PhRMA —

— HHS Issues First Report on Personalized Health Care —

Washington, D.C., September 19, 2007 — As the U.S. confronts significant issues in improving healthcare quality and controlling costs, the combined benefits of personalized healthcare and evidence-based medicine are emerging as complementary approaches to address these challenges. Recognizing the critical importance of evidence-based medicine and personalized medicine to healthcare, leading figures in government, industry and academia are gathering on September 18-19, 2007 at the Georgetown University Law Center to discuss the policies that will be needed to ensure that healthcare of the future is both evidence-based and patient-centered. 21st Century Medicine: Personalized and Evidence-Based is an evening and one day conference, hosted by the Personalized Medicine Coalition (PMC) and the Georgetown University School of Nursing and Health Studies, to frame the debate about improving the healthcare system.

Key topics at the conference include:

• The potential of personalized, evidence-based medicine to address the biggest challenges of the healthcare system
• The role of pharmacogenomics in improvement of clinical outcomes
• Partnering opportunities between the public and private sectors
• The development of common goals and a new policy framework

The event features keynote speaker Michael O. Leavitt, Secretary of Health and Human Services (HHS). At the conference HHS will release its first report on personalized medicine, entitled "Personalized Health Care: Opportunities, Pathways, Resources." The report outlines a common vision of opportunities and benefits from combining personalized medicine, health information technology and evidence-based care. It also catalogs the multiple personalized healthcare initiatives throughout HHS currently underway.

Additional highlighted speakers include:

• Mark McClellan, M.D., Ph.D., Senior Fellow and Director of the Engelberg Center for Health Care Reform of The Brookings Institution and former head of the US Food and Drug Administration and the Centers for Medicare and Medicaid Services;
• The Honorable W.J. Billy Tauzin, President and Chief Executive Officer of the Pharmaceutical Research and Manufacturers of America (PhRMA);
• Carolyn Clancy, M.D., Director of the Agency for Healthcare Research and Quality;
• Janet Woodcock, M.D., Deputy Commissioner and Chief Medical Officer of the US Food and Drug Administration;
• George Poste, D.V.M., Ph.D., D.Sc., F.R.S., Director, Del E. Webb Distinguished Professor of Biology, and Regents' Professor, The Biodesign Institute at Arizona State University;
• Kevin FitzGerald, S.J., Ph.D., the Dr. David Lauler Chair in Catholic Health Care Ethics, Georgetown University Medical Center, and Chairman, Pharmacogenomics Task Force, Secretary's Advisory Committee on Genetics, Health, and Society;
• Michael McGinnis, M.D., M.P.P., Senior Scholar, Institute of Medicine;
• Dan Roden, M.D., Professor - Medicine and Pharmacology, Assistant Vice-chancellor for Personalized Medicine, Vanderbilt University School of Medicine;
• Lewis Sandy, M.D., Senior Vice President - Clinical Advancement, United Health Group.

"By gathering leading thinkers in both evidence-based medicine and personalized medicine at a critical moment, the conference will elucidate new ideas on improving the healthcare system," said Edward Abrahams, PMC Executive Director.

"Personalized medicine and evidence-based healthcare offer important solutions for better health and better healthcare," noted The Hon. W. J. Billy Tauzin, President and Chief Executive Officer, Pharmaceutical Research and Manufacturers of America (PhRMA). "America's biopharmaceutical companies are at the forefront of the scientific research advancing these solutions, and we are committed to working with partners from across the spectrum of healthcare on personalized, evidence-based solutions that put the patient first," he added.

"The forces of healthcare reform are gathering steam, and there is a growing recognition of the importance of advancing personalized healthcare and evidence-based medicine in ways that are mutually reinforcing," added Wayne Rosenkrans, President and Chair of the PMC Board. "To realize this potential, it will be critically important to establish policies that support both evidence-based and personalized medicine," he concluded.

"We are closer to a vision of personalized healthcare than ever before," said Carolyn Clancy, M.D., Director of the Agency for Healthcare Research and Quality. "It is therefore important that we continue to collaborate on setting clear priorities that meet the needs of all stakeholders."

Personalized healthcare applies knowledge of an individual's genetic and molecular profile to determine predisposition to certain diseases, guide disease prevention strategies and facilitate the smarter use of therapies-that is, select treatments that are more likely to be effective and less likely to cause harmful side effects for the individual patient. Often called "personalized medicine," linking therapy to molecular diagnostics has the potential to enhance preventative medicine and reduce the use of "one-size-fits-all" and "trial-and-error" approaches to patient management.

Evidence-based medicine is an approach to clinical decision making that combines a physician's expertise with knowledge derived from the systematic comparison and analysis of available interventions and their clinical outcomes. Proponents of evidence-based medicine stress the importance of ensuring that clinical decision-making is grounded in best available evidence.

"The effort to evolve our healthcare system will require a close collaboration of policymakers and practitioners," said Bette Keltner, Ph.D., Dean and Professor at Georgetown University School of Nursing & Health Studies. "We must train our healthcare professional workforce for the new realities of personalized medicine. We also need to focus attention on product regulation, insurance reimbursement, information technology infrastructure, medical privacy legislation, and ethical considerations. This conference launches an important collaboration to improve the health and well being of all people."

21st Century Medicine: Personalized and Evidence-Based is sponsored by AstraZeneca and PhRMA, along with co-sponsors Novartis, Wyeth, Abbott Laboratories, Affymetrix, Clinical Data Corp., Genzyme Corporation, IBM, Millennium Pharmaceuticals and Pfizer. Event partners include The Health Industry Forum and Avalere Health LLC.

For more information about 21st Century Medicine: Personalized and Evidence-Based including agenda and registration, visit: /programs/ebm_seminar_2007/overview.php.

About the Personalized Medicine Coalition

The Personalized Medicine Coalition (PMC), representing a broad spectrum of academic, industrial, patient, provider, and payer communities, seeks to advance the understanding and adoption of personalized medicine concepts and products for the benefit of patients. For more information on the Personalized Medicine Coalition, please visit www.PersonalizedMedicineCoalition.org.

About Georgetown University School of Nursing & Health Studies

Georgetown University School of Nursing & Health Studies (NHS) translates science into outcomes that benefit the public's health. NHS lives its mission "to improve the health and well being of all people" through innovative educational and research programs. The school houses a multimillion-dollar research portfolio and includes the Departments of Health Systems Administration, Human Science, International Health, and Nursing, as well as the Center on Health and Education and-in partnership with Georgetown University Law Center-the Linda and Timothy O'Neill Institute for National and Global Health Law. For more information, visit: http://nhs.georgetown.edu/.

Contact:
Christine Mackenzie
Feinstein Kean Healthcare
617-577-8110
cmackenzie@fkhealth.com