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Government Researchers Target Fiscal Year 2016 for Precision Medicine Initiative Kickoff

BOSTON – The NIH is hoping to launch the Precision Medicine Initiative during Fiscal Year 2016, which begins in October, according to Eric Green, director of the National Human Genome Research Institute.

Speaking at the Festival of Genomics ongoing this week, Green reminded the audience that this fall will also mark the 25th anniversary of the start of the Human Genome Project. "What has happened in genomics in the last quarter century is nothing short of spectacular," he said, noting that the launch of the Precision Medicine Initiative mirrors the mood in the federal government when researchers set out to sequence the human genome in 1990.

If people had asked Green back then what the precise plan was for sequencing the human genome, he said he wouldn't have been able to articulate much more than a general idea of how to begin. "I would contend that the Precision Medicine is identical 25 years later," he said. "We don't know exactly all the details, [but] we have a general framework. We will work this out."

President Obama in January announced the Precision Medicine Initiative, within which the NIH will put together a cohort of 1 million consented subjects and gather a myriad of data points, including information on genomics and environmental exposures. Within this effort, the National Cancer Institute will expand efforts to improve understanding of the genomic underpinnings of cancer; the US Food and Drug Administration will develop curated databases for the speedier evaluation of next-generation sequencing technologies; and the Office of the National Coordinator for Health Information will be responsible for developing standards for electronic data sharing and address privacy concerns.

Currently, the Working Group of the Advisory Committee to the NIH Director is ironing out the precise framework for the Precision Medicine Initiative in terms of study design, as well as short- and long-term goals. The near-term advances within the initiative will happen in cancer genomics, the realm in which genomic information has already made a difference in patient care through new drugs and tests. The NCI, for which the White House has requested $70 million under the initiative, will push forward several programs, some of which have already launched, Green said.

During the American Society of Clinical Oncology's annual meeting, NCI officially launched its Molecular Analysis for Therapy Choice (MATCH) study, a Phase II trial in which researchers will investigate targeted treatments against tumor alternations in different malignancies. The project will  start off by studying treatments in 10 arms and will expand to 20 arms by the fall.

Some other genomics-focused NCI programs include ALCHEMIST, a phase III randomized trial for non-squamous, non-small cell lung cancer; LungMAP, a Phase II and III randomized trial for second-line squamous lung cancer treatments; M-PACT, a pilot trial for refractory solid tumors; and an Exceptional Responders Initiative to study the less-than-10-percent of patients who fare especially well on otherwise failed drug trials.

Green acknowledged that in spite of the insights gleaned from the Human Genome Project, the field has been criticized for hyping the potential of genomic information to impact human health. He emphasized the need to better manage the public's expectations and educate them about genomics so that they can better understand the limits and possibilities when advances occur.

He further pointed out that an effort similar to the Precision Medicine Initiative was proposed a decade ago but didn't go anywhere. In Green's view, there are reasons to be optimistic that the latest program will make headway. "The field of genomics is just radically different than it was a decade ago" in terms of cost and technologies, and the field's understanding of the science, he noted.

For example, a decade ago, around 20 percent of healthcare delivery systems had information in electronic medical records. Today that number, is around 95 percent. "All that data is there to be analyzed," Green said. Around 160 million Americans use smartphones today, and mobile sensors will make it easier to collect the lifestyle and environmental data that are so important to making sense of genetic information, he added.

There are also important social changes driving the Precision Medicine Initiative, as members of the public want to take charge of their own genomic information. "They don't want to be considered subjects. They don't want to be considered patients. They want to be partners," he said, noting that the project's organizers will engage the public via social media and crowdsourcing techniques.

"They will be in control of their data and they will know who is analyzing the data and they will know what we're learning from the data," he said.

Craig Venter disagreed with Green that the Precision Medicine Initiative today is reminiscent of where the Human Genome Project was in the 1990s. Venter, whose commercial shop Celera Genomics launched the race to sequence the human genome with the US government, observed that with the Precision Medicine Initiative, there is no race. Collaborations will be key to advancing the Precision Medicine Initiative, Venter said during a separate presentation at the Festival of Genomics. The Human Genome Project was completed when the government and Celera decided to work together.

Government agencies appear to be moving ahead in planning for the Precision Medicine Initiative, but funding for the effort as part of the President's Fiscal Year 2016 budget isn't secured. During President Obama's State of the Union address, Republicans and Democrats alike applauded the idea of the initiative, but it remains to be seen whether the bipartisan enthusiasm in January will translate into support this fall for the $215 million the White House is requesting.