As the director of Rutgers Cancer Institute of New Jersey, Dr. Robert S. DiPaola has keenly followed the progress of a federal bill intended to spark new medical research.
One of the goals of the bill is to foster “personalized medicine,” in which treatments are tailored to meet the individual genetic profile of a patient — an area of research in which the Rutgers institute is already a leader. After a U.S. House of Representatives committee released the bill yesterday, DiPaola summed up his response in one word.
The legislation has earned rave reviews across New Jersey’s research community, as well as its biotechnology and pharmaceutical industries. They see its goals of increasing medical research funding and speeding the approval of new drugs and medical devices as essential to promoting therapies that will serve patients and promote the state’s biotech and pharma companies
The importance of these industries to the state helps explain why two of the bipartisan bill’s leading House advocates are from New Jersey: U.S. Rep. Frank Pallone Jr. (D-6th), one of its four cosponsors, and U.S. Rep. Leonard Lance (R-7th).
Lance sponsored a section of the bill that would ease limits on the amount of money that the Food and Drug Administration can spend to test drugs. That would increase the speed at which the FDA can approve drugs.
Finding additional federal funding for medical research has grown in urgency since 2013, when a provision of federal budget law known as “sequestration” went into effect, effectively limiting the amount of money many federal programs, including the National Institutes of Health, can spend
The NIH is the central source of federal funding for medical and biological research. The 21st Century Cures Act, which the House Energy & Commerce Committee passed unanimously, provides $10 billion to the NIH over the next five years and is a way around the sequestration limits.
DiPaola said the innovative therapies that the Rutgers institute is researching depend on federal funding.. The more federal money that is available, the more quickly the New Brunswick-located institute can advance the research that it’s doing in conjunction with biotech and drug companies, he said.
“Research funding for New Jersey is incredibly important,” said DiPaola, whose institute is the only designated National Cancer Institute center in New Jersey. Since the National Cancer Institute is part of NIH, the Rutgers institute will be eligible for the funding under the bill.
There have been rapid advances in personalized medicine research in the past several years, including work at the Rutgers institute since it launched a precision medicine initiative in 2013. The institute has formed a team that includes experts who study genes at a molecular level, as well as biologists who use computers to model complex systems, and doctors who conduct clinical trials.
“The funds that the bill would help with are federal dollars that would fuel that type or research,” DiPaola said. “It’s been much more difficult with more limitations on federal research dollars (under sequestration) – precision medicine really relies on that. In tough times we’re also relying on other sources,” including philanthropies.
Debbie Hart, president and CEO of biotech trade group BioNJ, said Pallone’s and Lance’s leadership demonstrates the importance of the bill to the state, as well as to the companies that produce biologics — therapies that are developed from living cells rather than synthesized in laboratories like most traditional drugs.
“It is very encouraging, actually, the speed with which (the bill) went through and that it was unanimous,” she said. “It gives us high hopes that the industry will be supported in new and innovative ways and hopefully that new therapies and cures will get to patients who need them faster.”
Pallone said that along with cancer research, he anticipates the funding will also help work to prevent infectious disease epidemics.
“NIH’s budget has been consistently eroding over the last decade, but with 21st Century Cures, New Jersey and our health and research organizations would receive a critical boost,” Pallone said in a statement.
The bill also includes $5 million in grants to research institutions to study ways to increase the quality and efficiency of prescription drug manufacturing.
Pallone pointed to the bill as one of many that Congress has been quietly advancing in the past six months, after several years of partisan gridlock. They include measures that remove federal limits on Medicaid reimbursements and extend funding for the Children’s Health Insurance Program and community health centers.
“It’s certainly the opposite of what you hear,” Pallone said last week to a gathering of the New Leaders Council, a group of self-described progressives inside and outside of government.
Lance sponsored a piece of the bill known as the FDA Safety over Sequestration Act. Currently, companies pay fees that fund the FDA personnel who process applications for new drugs and medical devices. However, the sequestration spending limits apply to the FDA spending this money, which slows down the speed with which it can process applications. The provision proposed by Lance would remove the sequestration limits on the spending these industry-generated fees, allowing applications to be processed faster.
Lance said in a statement that the overall bill “will help usher in a new era of collaboration among researchers, patients and physicians and those who hold the key to a new generation of healthcare innovation.”
And Dean Paranicas, president and CEO of pharmaceutical trade group the HealthCare Institute of New Jersey, said the bill is “vitally important to New Jersey’s life sciences community, but more importantly, to patients around the world.”
He thanked both New Jersey congressmen for their work.
The bill “would accelerate the pace of discovering cures for some of the world’s most dreaded diseases. Much of that work would involve and take place right here in New Jersey, by New Jersey companies.”
Paranicas singled out the provisions sponsored by Lance. “This means that new, lifesaving breakthroughs can be reviewed, approved, and delivered to patients as quickly, efficiently and safely as possible.”