December 2015, Vol. 4, No. 6

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The Annual Report of the Personalized Medicine Coalition

Edward Abrahams, PhD; William S. Dalton, PhD, MD

The Last Word

abrahams-Stroke (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 policymakers in government, industry, and academia about the benefits of personalized medicine; and serves as a forum for identifying and informing others of policies that could advance or impede the development of personalized medicine. Just entering their second decade, and having just released their annual report, it is our pleasure to present WilliamDalton98pxthe introduction to their annual report by their President and PMO contributor, Dr Edward Abrahams, and the Chair of the PMC Board of Directors, Dr William S. Dalton. The full report can be viewed at

We congratulate PMC on a decade of service and wish them continued success in their endeavors.

When, in his State of the Union Address, President Obama called for a “Precision Medicine Initiative” that would, he said at a White House ceremony 10 days later, unleash “one of the greatest opportunities for new medical breakthroughs that we have ever seen,” he underscored PMC’s ongoing contention that a new era in medicine is within our reach. If we invest wisely in research and put in place new and carefully calibrated systems to ensure that government keeps pace with emerging science and technology, we can, he noted, improve both patient care and the efficiency of the healthcare system.

But the President also recognized a second reality, which is that this paradigm shift will not happen just because the science and new technologies suggest it should. This is the reality on which the Coalition has built its port­folio of activities.

The President’s program has four parts, which include: increased funds for the National Cancer Institute to study the genetic factors that cause cancer; the creation of a “voluntary national research cohort” of one million Americans who would share genomic data, lifestyle information, electronic health records, and biological information in order to answer questions about wellness and disease; additional funds for the Food and Drug Administration to update its ability to regulate personalized medicine technologies; and, not least, more financial support for the Office of the National Coordinator to develop interoperability standards to secure the exchange of health data across systems.

In brief, the President has recognized, as PMC has contended since it was publicly launched in 2004, that a move from one-size-fits-all/trial-and-error medicine to health care based on an understanding of individual variation necessitates systems-level change. In addition to further understanding the biological basis of patient heterogeneity, it requires a willingness to reconsider and reform the intervening variables impacting the delivery of new treatments to patients, which include regulation, reimbursement, and education. Through these efforts, we can provide better health care solutions, including enhanced abilities to predict and prevent disease, personalize treatments, and develop a more value-oriented health system.

PMC had tremendous success promoting this agenda in 2015. Having organized all of the stakeholders around the world with an interest in advancing personalized medicine, the Coalition’s voice is sought out and respected—by government as well as health care manufacturers and providers, which, like government, are required to alter their systems to keep up with changing science and technology.

Like PMC itself, this report is focused on three themes: education, advocacy, and impact.

We invite you to read it and share with us your thoughts as we move into the second decade of promoting personalized medicine so that both patients and our health system benefit from improved clinical care and increased overall value.

We believe that this is the future of medicine and are committed to getting us there.

The Annual Report of the Personalized Medicine Coalition

FDA Approvals, News & Updates - December 28, 2015

FDA Approves Portrazza to Treat Advanced Squamous Non–Small Cell Lung Cancer

On November 24, 2015, the FDA approved Portrazza (necitumumab) in combination with 2 forms of chemotherapy to treat patients with advanced (metastatic) squamous non–small cell lung cancer (NSCLC) who have not previously received medication specifically for treating their advanced lung cancer. Lung cancer is the leading cause of cancer death [ Read More ]

European Cancer Congress - December 28, 2015

Encouraging New Options for Neuroendocrine Tumors

Patients with advanced neuroendocrine tumors (NETs) have 2 promising new treatment options, according to separate phase 3 studies presented as late-breakers at the 2015 European Cancer Congress. The NETTER-1 trial evaluated the radiopharmaceutical agent 177Lu-DOTATATE in NETs confined to the midgut, while RADIANT-4 evaluated the mTOR inhibitor everolimus in patients [ Read More ]