As technology outpaces the regulatory process and spending caps cut into federal investments in biomedical R&D, several lawmakers are asking the experts to put on their thinking caps to envision new ways to sponsor research and speed the development of promising new treatments and cures.

Reps. Fred Upton (R-Mich.) and Diana Degette (D-Colo.) kicked off their 21st Century Cures Initiative late Tuesday with a roundtable brainstorming session that brought together current and former government officials, as well as thought leaders from the academic, investment and nonprofit worlds.

"We've got to get better at making it faster to get to cures," Rep. Eric Cantor (R-Va.) said as the ideas began to flow around the table in the first-of-its-kind hearing before a House subcommittee. Taking 10 years and $1 billion to bring a drug to market is unacceptable, he said.

While the Cures initiative will look at everything from discovery to development to delivery, much of the discussion at the roundtable focused on research. The best path for encouraging research is a "steady, predictable trajectory of support," NIH Director Francis Collins said. That's something his agency hasn't seen in years. The NIH wasn't broken 10 years ago, but a decade of declining funding is breaking it, he added.

Because of sequestration and spending caps on discretionary spending, the agency has a smaller budget today than it did in fiscal 2012. Collins' concern is how that shortfall is discouraging the next generation of researchers. The unpredictability of the funding and the resulting futility of writing nonproductive grants in what has become a hypercompetitive science environment is sending young researchers to other fields or countries. It also is wasting time that could be used to develop new science. (See BioWorld Today, Nov. 21, 2013.)

The potential discoveries and knowledge that disappear with those researchers are opportunities that could be lost for years to come. The transformative cures coming to market today are the result of decades of research, Jonathan Leff, chairman of the Deerfield Institute, pointed out.

Shifting from the problems to possible solutions, Collins asked, "Why is medical research discretionary?" The question quickly grew legs as several people supported moving NIH into the mandatory pot of federal spending. If it's mandatory instead of discretionary, NIH funding would no longer be subject to sequestration and other cuts.

REGULATORY HOUSECLEANING NEEDED

The solutions aren't just about more money. Noting bureaucratic barriers to scientists doing their jobs, Collins said, "A bit of housecleaning here would be most welcome" in creating more efficiency and allowing for better utilization of limited resources.

One barrier Collins cited is the "onerous oversight" of conference travel for government researchers. Scientific conferences and the exchange of ideas they provide are necessary to research, he said. But the process of getting approval to attend a conference is so lengthy that federal employees miss out on early bird discounts and end up having to pay a lot more to attend a conference.

The growing regulatory burden also is affecting faculty and staff at medical schools, said James Woolliscroft, dean of the University of Michigan Medical School. Duplicative or contradictory regulations, such as those governing various conflicts of interest, are unfunded mandates that add no value to the research enterprise, he added.

Another victim of the regulatory burden is translational science. Because of gaps in the ecosystem, universities must partner with industry and government agencies, Woolliscroft said, but regulations often make that partnering difficult.

At the other end of the process is reimbursement. Currently, the reimbursement question is "if you build it, will they pay?" Responding to the difficulty some companies have had in getting Medicare reimbursement for new technologies, the FDA's Jeffrey Shuren said a streamlined approval path is needed, along with greater payment predictability.

Margaret Anderson, executive director of Fastercures, agreed that questions about reimbursement must be addressed to encourage the development of new cures. "If we can prevent disease, then please, let's do that," she said, adding that a way to value new drugs and devices must be developed.

Rep. Henry Waxman (D-Calif.) said new cures must be affordable. "We don't do anybody a favor if we develop a drug that cannot be bought," he noted.

But "if we're not prepared as a society to pay" for new therapies that offer real value, the investors won't back the research and development, Leff said. Without private investment, many new drugs wouldn't get to market. The private sector pumps about $80 billion a year into biomedical R&D, compared with the $30 billion the federal government spends through the NIH.

Speeding the pace of biomedical R&D is basically an economic issue, Leff said, adding that economic problems must be treated with economic solutions. Providing economic incentives and fundamentally reforming tax policies would make a difference.

Several ideas were offered to reduce the cost of development so drugs could be more affordable. They included:

• greater use of clinical trial networks, which can reduce the time involved in planning, initiating and conducting a clinical trial;

• replacement of outdated and cumbersome drug manufacturing processes with innovative systems;

• increased biomarker research;

• effective use of electronic health records and the massive amounts of data now available;

• more efficient ways to gather that data.

The roundtable was one of several Upton and Degette are planning as they look for realistic ways to move the drug and device development and approval process into the 21st century and maintain the U.S.'s position as the innovation capital of the world.

One of the greatest barriers to moving forward is getting beyond the culture of "this is how we've always done it," the FDA's Janet Woodcock warned.