Crain’s Cleveland Business discusses the new federal law that aims to speed up drug approval and increase investment in medical research. The article features members of the medical device and healthcare industry in the northeast Ohio area, including Jennifer Palinchik, President of JALEX Medical. In the article, she discusses the benefits the law could have on the medical device industry and how the FDA reviews and approves new products.

Crain’s Cleveland Business Article

Some biomedical companies in Northeast Ohio hope a new federal law that aims to speed up drug approval and to increase investment in medical research will benefit their work.

The 21st Century Cures Act, signed into law in December, is a wide-ranging biomedical innovation act. It commits $6.3 billion over seven years to combating opioid addiction; supporting brain research and precision medicine (tailoring health care and treatments specifically to individual patients); improving mental health care; and investing in cancer research and care.

It also will modernize and streamline clinical trial design, where some area biomedical companies see opportunity in the law.

Dr. Jonathan S. Stamler, president of Harrington Discovery Institute at University Hospitals, said Northeast Ohio could see an influx of dollars behind cancer and neuroscience research investments. Medical centers, health systems and academic medical centers across the country will benefit from the act’s focus on cancer and neuroscience, which Stamler said are both “major unmet needs in medicine.”

“There’s a focus on these areas of unmet needs and cutting-edge science, which we should be competitive for,” Stamler said.

The Cures Act, he said, is a general effort to speed review, support innovative research (particularly in neuroscience and cancer), advance new therapies, accelerate clinical trials and advance precision medicine.

Some have criticized the act for the $3.5 billion cut it makes to the Prevention and Public Health Fund, which was established under the Affordable Care Act and sets aside funds for preventive programs and other activities, including tobacco prevention, immunizations and screenings, research and public health workforce and training.

Patient advocacy groups also fought the bill, saying that it would put patients at risk and would weaken U.S. Food and Drug Administration requirements.

The Cures Act authorizes the FDA to use certain tools to help move along development, said Dr. Gil Van Bokkelen, chairman of Cleveland-based Athersys Inc. He stresses that these tools help reaffirm the FDA’s authority to provide appropriate oversight in a way that ensures that therapies developed are effective and safe.

For instance, he said, the Cures Act is designed to expedite the development of innovative therapies in a way that is “prudent and appropriate.” This is a “really positive step forward,” for companies like Athersys that are actively involved in the regenerative medicine cell therapy space, Van Bokkelen said.

“It makes our development path more efficient and clearer and more transparent, but it’s also good for the patients that we’re committed to helping,” he said. “This basically provides the FDA with additional flexibility to help speed the development of those innovative therapies, but again, doing it in a way that is designed to protect and ensure patient safety and well-being.”

The passage was a “pretty exciting win” for medical device and pharmaceutical companies, among others, said Jennifer Palinchik, president of JALEX Medical, a Westlake company that provides consulting for product development, regulatory and quality needs.

Although it has yet to be seen how exactly it rolls out, Palinchik said she thinks the law will give her clients more access to clinical trial data, and that changes to the review process for FDA approval will be helpful to companies.

“I think it’s definitely a big win for those groups that have that kind of long-term technology and development paths where it’s excessively expensive,” she said. “The clinical trial requirements have been pretty extensive and prohibitive for some of these companies, and especially the smaller companies.”

Palinchik said the act could have the most impact for companies working on breakthrough or innovative projects without anything to compare the device to, but that meet a big need.

“So being able to help a larger population for some of those very rare diseases, this will be a really helpful option as well,” she said.

Abeona Therapeutics is one such company. It’s working to develop therapies for life-threatening rare genetic diseases and has three clinical trials currently underway. Tim Miller, president and CEO of the clinical-stage biopharmaceutical company, said the piece of the Cures Act most relevant to Abeona is the FDA’s ability to consider unique characteristics of therapies — like regenerative medicine — in order to grant accelerated approval.

“This gives the FDA more things in their toolbox for regenerative medicines, for (medical) devices,” Miller said. “It helps with breakthrough status. They’re trying to move forward recognition of standards.”

Athersys’ Van Bokkelen also noted the importance of the added resources and greater flexibility for the FDA to hire people. He said the law is meant to make it easier for the FDA to find and hire experienced individuals so the agency can do what it is charged with doing in a more effective manner.

Palinchik said that implementation will take some time; she expects to see impact closer to and into 2018.

But many hold out hope that the law can help advance discoveries to market. And, looking further ahead, Van Bokkelen hopes that the Cures Act will mean successes that translate to broader positive impacts in the region.

“If companies like us are successful, that’s actually going to have a big impact in terms of creating jobs, attracting investment capital,” he said. “It’s also going to provide meaningful economic benefit for the region as more and more companies like us achieve the success that we believe we can achieve.”