NIH Director Francis Collins, MD, PhD, outlined plans for a new, multi-agency Precision Medicine Initiative that could lead to more effective treatments for cancer and other diseases. Of the $215 million proposed by President Barack Obama for the first year of funding, $70 million is earmarked for NCI to support the initiative's early focus on linking genomic changes to cancer.

Presenting his agency's proposed budget of $31.31 billion for fiscal year 2016 to a congressional subcommittee in March, NIH Director Francis Collins, MD, PhD, outlined plans for a new, multi-agency Precision Medicine Initiative (PMI) that could lead to more effective treatments for cancer and other diseases. Suggested by President Barack Obama in his State of the Union Address, the initiative, if funded by Congress, would cost $215 million in its first year.

Historically, Collins told the committee, physicians have made recommendations for disease prevention and treatment based on what worked for an average patient, a one-size-fits-all approach. “Technology developments, along with the plummeting costs of DNA sequencing, now make it possible to develop an innovative approach to treatment that accounts for individual differences in patients' genes, environments, and lifestyles,” he said.

For many years, cancer research has led the way in precision medicine, Collins noted. Now, the new initiative earmarks $70 million for the NCI to support the near-term goal of linking more individual genome changes to cancer.

“Precision medicine is really about re-engineering the diagnostic categories for cancer to be consistent with its genomic underpinnings, so we can make better choices about therapy,” says Harold Varmus, MD, director of the NCI at the time of the presentation.

Last year, the NCI announced four of its own precision medicine initiatives, three of which are under way: Lung-MAP, a multi-arm clinical trial that matches patients who have squamous cell carcinoma of the lung with an experimental therapy based on genetic biomarkers; ALCHEMIST, a trial involving patients with lung adenocarcinoma whose tumors harbor ALK or EGFR mutations; and the Exceptional Responders Initiative, a study of tumors that have shown remarkable responses to drug therapies. Its MATCH trial, which will enroll up to 1,000 patients with various late-stage cancers in phase II drug studies based on mutations in their cancers, launches later this year.

The PMI “allows us to say to the public: Here's an important thing that's happening in cancer control, primarily in therapy, but with prospects for also improving our ability to make prognoses and design new therapies,” says Varmus. “The PMI also intends to provide additional resources to do more clinical trials, do more genomics, and build better informatics platforms.”

Also under the plan, the NIH would receive $130 million to launch a long-term study of 1 million volunteers who agree to share their medical information with researchers. The remaining $15 million would help the FDA and the Department of Health and Human Services to develop supporting regulatory infrastructure and data security protocols.

“It's big and long-term science. It's going to take time to realize the benefits,” says Eric Green, MD, PhD, director of the National Human Genome Research Institute, an organizer of the million-person cohort study.

However, “one thing is clear,” says Roy Herbst, MD, PhD, chief of medical oncology at Yale Comprehensive Cancer Center in New Haven, CT. “If we don't collaborate, develop larger data sets, and share that data, we'll never make the progress we want.”

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