CONTACT
Gwen Gordon
Phone: (202) 589-1770
ggordon@PersonalizedMedicineCoalition.org

Washington, D.C. (June 10, 2011) – John J. Castellani, President and CEO of the Pharmaceutical Research and Manufacturers of America (PhRMA), spoke Thursday to an audience of nearly 200 representatives from industry, government, and academe at the Personalized Medicine Coalition’s (PMC) Seventh Annual State of Personalized Medicine Luncheon at the National Press Club.  In his keynote address, Mr. Castellani discussed how personalized medicine has the potential to improve health outcomes and bend the cost curve by making our health system more efficient.  He also discussed policy changes needed to accelerate the development and adoption of personalized approaches to care.

In his first speech focused on personalized medicine since taking the helm at PhRMA, Mr. Castellani’s remarks emphasized the biopharmaceutical sector’s commitment to personalized medicine amid the complexities of applying insights from recent discoveries in genetics and molecular biology to research and development.

“The era of one-size-fits-all medicine is over,” said Edward Abrahams, President of the PMC, hosts of the annual “State of Personalized Medicine Luncheon.”  “The news coming out of the American Society of Clinical Oncology (ASCO) Annual Meeting this week on the successful clinical trials of targeted therapies including crizotinib and vemurafenib demonstrates that the biopharmaceutical industry has embraced the principle of pinpointing disease at the molecular level to ensure that the right patients receive the right treatments.”

With scientific advances driving the biopharmaceutical industry’s increased focus on personalized medicine, Mr. Castellani discussed the need for changes to FDA regulation and reimbursement models to further accelerate innovation.

“Last year, a study from the Tufts Center for Drug Development affirmed the commitment of America’s biopharmaceutical research companies to personalized medicine, with 94 percent of respondents reporting having invested in personalized medicine research,” said Mr. Castellani.  “But in order for this investment to turn into a reality for America’s patients, we need public policies that reflect the shifting realities of drug development.  Now is the time to look seriously at misaligned regulatory, reimbursement, and educational systems that have not kept pace with advances in science and the needs of patients.” 

In introducing Mr. Castellani, Werner Verbiest, head of Johnson & Johnson’s Companion Diagnostics Center of Excellence, highlighted the importance of partnerships to overcome the many scientific, regulatory, and policy barriers to adoption and implementation of personalized medicine -- a theme echoed throughout Mr. Castellani’s keynote.

“To bring personalized medicine forward, scientists, regulators, policymakers, physicians, the patient community, payers, and pharmaceutical and diagnostics companies must work in concert,” said Mr. Verbiest.  “We must find ways to more successfully work together, adopt a new mindset, and pursue a more open, “networked” approach to innovation.” 

The Personalized Medicine Coalition’s annual “State of Personalized Medicine Luncheon” serves as a forum for PMC members from across the health care spectrum to engage with leaders in health care policy and to discuss key issues facing personalized medicine.

Previous keynote speakers at the luncheon have included Dr. Margaret Hamburg, Commissioner of the U.S. Food and Drug Administration; Dr. Denis Cortese, President and CEO of the Mayo Clinic; Dr. Harvey Fineberg, President of the Institute of Medicine; The Honorable Michael O. Leavitt, Secretary of the U.S. Department of Health and Human Services (2005-2009); Dr. Andrew von Eschenbach, Commissioner of the U.S. Food and Drug Administration (2006-2009); and Dr. Francis Collins, Director of the National Human Genome Research Institute (1993-2008).

About the Personalized Medicine Coalition
The Personalized Medicine Coalition (PMC), representing scientists, patients, providers and payers, promotes the understanding and adoption of personalized medicine concepts, services and products to benefit patients and the health system.  For more information on the Personalized Medicine Coalition, please visit www.PersonalizedMedicineCoalition.org.