The Last Word

Where We Agree When It Comes to Regulating Laboratory-Developed Diagnostics

Federal agencies have a long history of finalizing regulatory documents at the end of an administration. If that history repeats itself in 2016, it may mean a new regulatory environment for an industry that includes more than 60,000 genetic testing products and services. The FDA published a detailed proposal for [ Read More ]

PMC’s Progress Report

In its strategic plan for 2016, the Personalized Medicine Coalition (PMC) defined 3 overarching goals for the personalized medicine community: 1) highlight the issues facing personalized medicine; 2) identify the best strategies to integrate personalized medicine into healthcare; and 3) promote public policies that encourage investment in personalized medicine, including [ Read More ]

The President and Personalized Medicine

“As science and technology have advanced,” President Obama wrote in an op-ed he titled ‘Medicine’s Next Step’ in the Boston Globe for July 7, “it’s become possible to make it personalized as well, giving us the tools to better understand, prevent, and treat everyone’s individual health needs.”No one has laid [ Read More ]

Biden’s “Moonshot”

Vice President Joe Biden closed the 2016 American Association for Cancer Research annual meeting in New Orleans by telling the audience what he had learned since his son, Beau, had been diagnosed with glioblastoma some 5 years ago. To cure cancer, he said, or in his words, “to make a [ Read More ]

Personalized Medicine’s Skeptics

The premise of personalized medicine is actually rather simple. If the diagnosis is correct at the molecular level, the prescribed treatment has a greater potential to be more accurate, efficacious, and safe. And if treatments are more accurate, patients will benefit from improved outcomes, and the health system will expend [ Read More ]

Regulation and Reimbursement Policies Will Determine the PMI’s Legacy

On February 25, the Obama administration laid out the next steps for the Precision Medicine Initiative (PMI) before an eager crowd of stakeholders at the White House. The initiative is promising.Zeroing in on President Obama’s vision of building a research cohort that includes 1 million Americans, the National Institutes of [ Read More ]

Personalized Medicine at FDA: 2015 Progress Report

One year after the initial observation by the Personalized Medicine Coalition (PMC) of an increased rate of personalized medicine approvals at the FDA Center for Drug Evaluation and Research (CDER), the most recent data show that the trend has continued, with oncology leading the way for the field.A new analysis [ Read More ]

The Annual Report of the Personalized Medicine Coalition

(PMO) is a proud partner of the Personalized Medicine Coalition (PMC). PMO and PMC share the common goal of promoting the understanding and adoption of personalized medicine concepts to ultimately benefit patients and the health system. PMC provides opinion leadership on policy issues that affect personalized medicine; helps to educate [ Read More ]

Alternative Payment Models and the Future of Personalized Medicine

Alarmed by the escalating price of cancer drugs, the American Society of Clinical Oncology (ASCO) last month published for review a new “value framework” to consider the cost of those drugs to both patients and society. In a radical departure for American medicine, which has, until now, focused predominantly on [ Read More ]

President Obama’s Bet on Personalized Medicine

"I want the country that eliminated polio and mapped the human genome to lead a new era of medicine, one that delivers the right treatment at the right time." So said the president of the United States in his State of the Union Address on January 20, 2015. By calling [ Read More ]

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