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From Partnering for Cures: The Future of U.S. Research Leadership

November 21, 2014
   
   

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The United States faces a combination of challenges that threaten its status as the world leader in biomedical research. Budget concerns and a weak investment environment have strained the once-strong partnership among the federal government, private industry, universities, and other research institutions. These were the issues that kicked off the opening plenary, “The future of U.S. research leadership,” at the 2014 Partnering for Cures.

Ever-increasing demands on academic research to play new and more significant roles all along the research and development continuum – from translational research and proof-of-concept all the way to regulatory science and outcomes research. Compounding these difficulties is the dearth of faculty positions for young, debt-burdened researchers, who must continually apply for post-doctoral programs instead of beginning their research careers. Confronting strong competition from abroad, what steps can the United States take not only to maintain its leadership role in the biomedical field but also to connect the revolution in medical technology to actionable research?

Moderator Manny Alvarez, senior managing editor of Health News at Fox News and chairman of the Department of Obstetrics and Gynecology at Hackensack University Medical Center, opened the session by asking the two congressional members on the panel about their 21st Century Cures initiative. This bipartisan effort seeks to remake the U.S. medical research system to reflect the new realities along the research spectrum, from patients and doctors to drug and medical device developers.

Rep. Fred Upton (R-Mich.), chairman of the House Energy and Commerce Committee, said the main thrust of the 21st Century Cures initiative is to “expedite the approval of drugs and devices,” which on average takes 10 years. Shortening the cycle, he added, requires “more resources for the NIH [National Institutes of Health].”

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Rep. Diana DeGette (D-Colo.), a member of the House Energy and Commerce Committee, mentioned that part of the problem with today’s current approval system is that the government institutions involved are all at least 100 years old. Because of this, she said, “they don’t operate the way research is conducted now,” and the primary purpose of the 21st Century Cures legislation is to “streamline the processes without causing risk to patients.”

Anna Barker, co-director at Arizona State University’s Complex Adaptive Systems Initiative and a former deputy director for strategic scientific initiatives at the National Cancer Institute, said the research process isn’t only stymied by outdated government agencies. Even as private institutions generate enormous amounts of data, “we can’t move data on a genome from one institution to another.” Private institutions, she said, have stored their data in silos that “aren’t very well connected.” The result has been what Barker called “data tombs” – the data exist, they are powerful, but they can’t be used because they can’t be shared.

“Science is a team sport nowadays,” said panelist Laurie Glimcher, dean of Weill Cornell Medical College. Part of the reason research data are so hard to share, she said, is because too many institutions believe they need to compete, rather than collaborate. “You need a small village to make discovery,” declared Glimcher.

In other words, there’s a continuum from the basic research to the biomedical scientist to the clinician. Rarely are these stakeholders working together, yet their work complements each other. Understanding how a biology researcher’s work can inform the work of a translational researcher is a key concept of the new era of medicine. “We need to collaborate to move our research forward,” she said.

Michael Milken, chairman of the Milken Institute and founder of FasterCures, agreed, pointing out that Partnering for Cures was established precisely because of a greater need for cooperation among researchers. “This conference, Partnering for Cures, says it all,” he added. Indeed, meetings like Partnering for Cures show that the industry is changing from one of competition to one of collaboration.

The panel then moved to the crucial topic of support for researchers. While emphasizing the important role government funding plays in the industry, Glimcher said that “we would not be where we are without private funding.” While government agencies are reluctant to take risks, private investors are much more likely to invest in an unproven concept – a critical component to achieve breakthroughs. Nevertheless, as Milken said, “one-sixth of NIH-funded scientists lost that funding in 2012.”

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Congress can help bridge the funding gap by providing far more certainty to federal agencies in the budget process. DeGette pointed out that last year’s budget sequester, which launched automatic and uniform spending cuts from all federal agencies, hit research institutions like the NIH particularly hard. “We need budget certainty,” echoed Upton.

Of course the problem goes beyond monetary support. The United States has a dearth of young scientists, particularly women, even as nations like China and other Asian nations persuade more of their young people to pursue careers in biomedicine.

And it’s not just a numbers game, said Milken. “Almost all Nobel prizes are awarded for ideas that were formulated within five years of school,” he said, emphasizing the reality that the best scientific breakthroughs in the last hundred years came from researchers in their 20s and 30s. Without a growing base of younger researchers, who knows how many future Nobel winners the United States is losing?

Glimcher agreed, adding that “we don’t celebrate science in the U.S., and that’s partly our fault as scientists.” To better encourage young Americans to pursue a biomedical research career, she said, “It’s so important to make the connection between research and diseases.” Everyone is familiar with diseases, but far fewer are aware how research directly contributes to curing or alleviating those diseases.

But even for those Americans who do choose a research career, the United States hasn’t provided them with adequate support. According to Upton, “the problem is that younger researchers aren’t getting the same bite at the apple that they were 20 or 30 years ago.” By this he means that younger researchers often can’t move directly into a research environment today. Instead, they have to settle for post-doctoral programs as they wait for a faculty position. Compounding the problem is that so many younger researchers carry enormous amounts of loan debt, sometimes as high as $150,000.

Meanwhile, added Milken, nations like China are doing all they can to encourage their citizens educated in the United States to return home. The United States, he said, needs to be doing a better job of keeping the estimated 900,000 foreign post-doctoral students studying in American universities to stay here and build their careers.

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It’s a theme that helped end the panel discussion on a positive tone. However far the United States needs to go in maintaining its leadership edge, “our institutions are the best,” said Milken. “Most of the entrepreneurial people in the world want to come here, but then have a difficult time staying here.”