NEW YORK (GenomeWeb) – At a cocktail reception in Boston last week ahead of an annual meeting on personalized medicine, attendees milled around not talking about the latest advances in genomics or the challenges of companion diagnostics development. They were too preoccupied with the impact of the Presidential elections the week before.
Will the new administration value genomics research and personalized medicine projects going on around the country that depend on government funding? How will a change in administration and priorities impact projects such as the Precision Medicine Initiative (PMI) and the Cancer Moonshot? Who will head up the US Department of Health and Human Services, the National Institutes of Health, and the US Food and Drug Administration? And will these new government officials continue efforts of the last administration to advance data sharing, privacy protections, and integrated systems critical for the implementation of personalized medicine?
Ed Abrahams, president of the advocacy organization Personalized Medicine Coalition, which hosted the 12th Annual Personalized Medicine Conference last week, tried to reassure stakeholders. At the cocktail reception, he articulated what was already on the minds of many attendees: the recent Presidential elections would bring change. But he also said that "the promise of personalized medicine has not changed," and reminded the crowd that "the commitment to it, going back to President [George W.] Bush, is bipartisan."
Abrahams didn't shy away, however, from admitting that persuading policymakers to increase investment in and spur greater adoption of personalized medicine is challenging and would remain so. Two days later, leaders in the House of Representatives and Senate announced they wouldn't approve the 2017 appropriations bill, and chose instead to advance another continuing resolution that would fund the federal government until March 31, 2017.
This in turn, raises questions about whether the new Congress controlled by Republicans will bolster NIH funding by $2 billion, as legislators had previously intended. Under a Senate proposal advanced over the summer, the planned $34 billion NIH budget included $300 million for the PMI, which seeks to enroll 1 million Americans, collect genomic and a variety of other data, and use that information to accelerate the development of personalized care. In 2016, the PMI received around $200 million in funding.
The Senate budget proposal also sought a $100 million increase for the BRAIN Initiative, which seeks to advance technologies for imaging, mapping, and studying the brain; and a $216.3 million increase for the National Cancer Institute. Last year, the BRAIN Initiative received $150 million and the NCI got $5.21 billion.
Though it's not unusual to put appropriations on hold in an election year, Daryl Pritchard, PMC's VP of science policy, told GenomeWeb he's not sure where funding for PMI will end up in 2017 after the continuing resolution runs out in March. He expects Congress might not pass full appropriations for 2017 after March since the fiscal year will be half over.
Meanwhile, Eric Dishman, who is heading efforts to enroll the 1 million participants in the PMI (newly named the All of Us Research Program), has been working feverishly since July to set up the recruitment process. However, at the Personalized Medicine Conference last week, he said that enrollment wouldn't start this fall as originally projected, but would likely begin in the first quarter of 2017.
The NIH gave the All of Us program $55 million for fiscal year 2016, likely enough to begin bringing in participants and collecting certain kinds of information from them. However, according to Dishman, discussions are just starting on how to approach genomic testing, data collection, reporting, and counseling. He suggested that the price point for genomic sequencing will need to drop further to enable testing a million participants. Additional funds will certainly be necessary to reach the PMI's enrollment goal over four years, keep participants engaged and participating long term, and collect the different kinds of data the project has planned.
While there might be "an attempt to do major surgery" on the 2017 budget, Russ Altman, a professor of bioengineering, genetics, and medicine at Stanford University, is also optimistic that PMI has bipartisan support. Altman, a member of the committee that advises the NIH director on the initiative, met with Senator Lamar Alexander at a PMI event in February at the White House and said the Republican congressman from Tennessee was totally supportive of President Obama on this front.
"However, the new administration is not necessarily in sync with either party on this, so we will need to see," Altman said over e-mail. "However, there is reason to be optimistic since the Republicans have a history of supporting basic science research and understand how it can be an economic driver."
But Altman cautioned that stakeholders involved with PMI shouldn't take bipartisan support as a given, and that the initiative could be at risk of being scrapped if Republicans consider it just another Obama legacy project. It might be effective, he proposed, to present PMI as a basic research project that can bolster the US leadership in science internationally, given that other countries, such as the UK, have launched similar large-scale genomics and personalized medicine projects.
"I think that the NIH has to make sure that they get in front of the new administration and present the benefits and promise of the PMI in very clear terms — the scientific and economic long-term benefits, the benefits to healthcare long term and the competitiveness of the US in the next generation of health," he said. "If they can do this, it should be safe."
Meanwhile, the funding for the Cancer Moonshot — which aims to achieve 10 years of progress in cancer research in five — doesn't have any appropriations. So, there's even more uncertainty around Vice President Joe Biden's pet project, for which the Obama administration had requested $750 million in 2017, the majority of which would go to NIH with $75 million earmarked for the FDA.
At the Personalized Medicine Conference last week, Greg Simon, executive director of the Cancer Moonshot task force, said he hadn't met with the Trump transition team yet. "The bad news is I have no idea what's going to happen. The good news is we're supposed to know by January 20th," said Simon, who was an aide to former VP Al Gore from 1991 to 1997, and headed up FasterCures, a think tank focused on accelerating medical research.
But he was optimistic that the Cancer Moonshot has widespread support across academia, industry, and government. "I've worked on a lot of stuff that I felt was important," he said, reflecting on his 30 years in Washington. "Nothing has the bipartisan support like this has bipartisan support."
Speculation on the future of the Cancer Moonshot has increased over the last few days, after Trump's Greatagain.gov website issued a statement that the president-elect and vice president-elect had dinner with billionaire biotech entrepreneur Patrick Soon-Shiong. He is CEO of NantHealth, which offers a service called GPS Cancer that integrates whole-genome sequencing, whole-transcriptome sequencing, and quantitative proteomics to provide oncologists with a molecular profile of a cancer patient. Soon-Shiong last year also launched his own Cancer Moonshot 2020 — an effort to join pharma and government around immunotherapy clinical trials — around the time Biden's Cancer Moonshot was announced.
Regardless of where the government lands on the Cancer Moonshot, the private sector has committed to sharing data and launching precision oncology programs in support of the national project, and those efforts will continue to advance — and Biden will remain a champion.
"There are all the reasons in the world too keep it going at the government level," Simon reflected at the meeting. "But apart from that, Vice President Biden has said publicly many times he will continue to do this work from wherever he is, in terms of convening people around problems … and helping the international community work together better."