Garden State Lawmakers Want to Bring Clinical Drug Trials Home

Lilo H. Stainton | December 6, 2018 | Health Care
Bill calls for working group to help bridge gaps between pharmaceutical companies, research institutions, and healthcare providers

Credit: Via Creative Commons
drug pill
Despite New Jersey’s historic reputation as the “nation’s medicine chest” — a hub for pharmaceutical research and manufacture — clinical trials on drugs developed here have traditionally been done out of state, including at medical centers in nearby New York City and Philadelphia, government and industry representatives note.

Now lawmakers in Trenton are seeking to improve the Garden State’s access to this potentially lucrative and clinically beneficial part of the drug development process. They’re moving ahead with a bill to improve communication and coordination between the pharmaceutical industry, research institutions, and healthcare providers.

On Monday, the Assembly health committee approved legislation to create a working group with public and private members to study what barriers prevent these entities — drug makers, higher education, and clinical providers — from collaborating effectively, recommend ways they can better work together, and identify opportunities for encouraging more clinical trials.

Two-minute vote

Although the measure dates back nearly four years — and has never seen any action in the Assembly before — the vote proceeded quickly and quietly. Neither the bill’s lead sponsor nor the key industry supporters attended the hearing. No one testified in public on the matter. It took the committee just 140 seconds to pass the measure with unanimous support.

Supporters said the situation has improved significantly since the bill debuted in early 2015, largely because of a Rutgers University initiative — the Rutgers Institute for Translational Medicine and Science — that has had some success in connecting the school’s vast network of clinical programs, researchers, and teaching hospitals with drug makers looking to test new products.

Dean J. Paranicas
“When this legislation was first introduced, there was no infrastructure in New Jersey to support clinical trials,” explained Dean J. Paranicas, president and CEO of the HealthCare Institute of New Jersey, the trade group for biopharma research. (The Institute also works with hospitals, medical providers, and insurance companies to tackle various policy issues.)

“Patient recruitment was difficult, the (Institutional Review Board) process to get approval for a trial was time-consuming and cumbersome. All this contributed to our state lagging behind many others, performing in the middle of the pack nationally,” Paranicas said.

Pushing envelope on clinical trials

But while the Rutgers program has been truly beneficial, Paranicas and others said they are eager to work with Assemblyman Gary Schaer, the lead sponsor, to continue to expand clinical trial options here. The New Jersey Hospital Association, that industry’s trade group, and the Fair Share Hospital Collaborative, which represents suburban facilities, also offered support for the measure at Monday’s hearing, but did not testify.

“This state is an excellent venue for clinical trials, given the world-class medical research being conducted here and the diverse patient population, and we have not been fulfilling our potential,” Paranicas added. “In addition to the benefits to patients, clinical trials also have a significant economic impact to the state.”

Debbie Hart, president and CEO of BioNJ, which represents hundreds of biotech companies, said she also welcomed the chance to work with lawmakers to build on existing collaborations.

“BioNJ strongly supports efforts to further advance New Jersey’s status as a global hub for biopharmaceutical research, development, manufacturing, clinical research, and clinical trials. And New Jersey’s reputation in this area continues to be bolstered as the life-sciences sector and their patient and academic partners enhance collaborations to expand efforts in clinical research and trials,” Hart said.

Nationwide, some $2.6 billion in public and private dollars were invested in clinical trials conducted at 179 universities nationwide last year, according to data from the National Science Foundation, representing a fraction of what is spent on pharmaceutical research and development overall. That included more than $15 million in funding for drug testing at Rowan University and Rutgers University.

The economic impact of this work extends far beyond the reach of the research funding itself, experts said. In 2013 — the most recent year available — clinical trials based in New Jersey represented $617 million in estimated total economic impact, including a $245 million direct investment by pharma companies, according to the HINJ.

Struggling to attract startups

The lack of clinical trials is not the only concern for biopharma executives in the Garden State. A white paper published by BioNJ in January found that despite the state’s highly educated workforce, strong network of research institutions, and historic pharmaceutical industry, New Jersey has struggled to attract new companies, especially start-up firms. Additional funding and better coordination are needed to close the gap with other states, the group said.

And in 2016, the largest healthcare network — RWJ Barnabas Health — partnered with Rutgers on a broad-based initiative to improve clinical care and boost the research dollars and prestige of biomedical programs at the state school. In addition to creating a new sports-medicine hub in New Brunswick, the partnership is meant to leverage the capacity of both organizations and attract millions in private and government support.

To boost clinical trials here in New Jersey, state legislation (A-451) sponsored by Schaer (D-Bergen) and Assemblyman Daniel Benson (D-Mercer) seeks to grow this impact even more. It would establish a 15-member “Clinical Trials Working Group” to study the issue and impediments and report back to lawmakers and the governor within six months.

The group will be charged with exploring why New Jersey pharmaceutical companies have had to look beyond the state’s borders to conduct clinical trials and test medications. It would also need to identify obstacles to collaboration among industry, research, and clinical groups and recommend to state officials and other stakeholders how to improve the system.

Choosing the committee

According to the bill, the committee will be named by legislative leaders and would include four members from higher-education organizations and three would represent hospitals, including one from Newark’s University Hospital.

Four more members would come from New Jersey pharmaceutical companies, based on HINJ’s recommendation. Two members would represent biotech companies, as recommended by BioNJ. The state Secretary of Higher Education and the Commissioner of Health would also be part of the group, which would form as soon as possible. All positions are unpaid.

While the full Senate voted in favor of the proposal — sponsored by Sen. President Steve Sweeney (D-Gloucester) and Sen. Steven Oroho (R-Sussex ) — in March 2015, the plan has not been reintroduced in that house in the current session.