Passage of the 21st Century Cures Act Will Impact Local Research Institutes

Jan 08, 2016 at 05:16 pm by Staff

Research institutes in the Orlando and Tampa area such as Sanford Burnham Prebys (SBP) and H. Lee Moffitt Cancer Center (MCC) are curious to see the outcome in Washington DC of the 21st Century Cures Act. The act is a bipartisan bill to promote medical research and accelerate the process in which medical discoveries reach patients in the form of new medicines and new medical devices by increasing funding for the National Institute of Health (NIH) and making research and healthcare policy changes. The bill was introduced to the house in May and was passed with a 344 to 77 vote in July.

Institutions in Orlando receiving funding from the NIH include the University of Central Florida, SBP, University of Florida Research and Academic Center in Lake Nona, and Florida Hospital. Many of these institutions reside in the Lake Nona Medical City creating Orlando's medical hub. It's no secret that the Medical City has contributed to the major growth and development of that section of Orlando. Institutions in Tampa receiving funding from the NIH include the University of South Florida and MCC. These institutions recruit STEM professionals to the region and create economic development and jobs in the area. The bill will help maintain these institutions and will allow these institutions to contribute to cures faster and more efficiently.

The bill intends to address several issues slowing the progress of medical research. One major issue is decreased funding from the NIH. The director of MCC, Tom Sellers, PhD, MPH described the funding as dismal and said "When you adjust for inflation, funding is at the same amount as we were 10 years ago. If they double the funding for the NIH, this will get us only to where we were in 2008." Sellers also said, "When the pay lines are dismal what ends up funded are the incremental next step obvious sorts of questions that are not going to lead to significant advances." Basically, the NIH can't afford to make risky investments.

Sellers also mentioned "there's a three year trend in this country for decreasing number of post-doctoral fellows." Post-doctoral fellows are scientists at the beginning of their career and are training to become advanced researchers. Lack of post-doctoral fellows means a lack of individuals trained to perform research. "It's a very dangerous trend that will take us a long time to correct unless something like the 21st century cures act gets affected."

We are also entering an age of precision medicine. This comes from the recognition that an individual's disease is as unique as the individual themselves. Stephen Gardell, PhD, Senior Director at SBP, described precision medicine as the "ability to assemble a signature of health, a signature of disease, a signature of one person versus another person, and then act on that signature for a personalized treatment regimen." Yet, clinical trials and research and healthcare policy are not up-to-date with this modern form of healthcare.

The bill addresses many of the issues facing research institutes. First and foremost, the bill proposes to increase funding from the NIH and the funds should go toward high risk high reward research as well as to early stage investigators. Gardell said "Increased funding from NIH puts gas in the tank for us to engage in the activities that we do. It's the discoveries that we make that serve as the beginnings of innovative strategies to combat the large number of unmet medical needs." Sellers said, "We shouldn't fund everything that gets submitted for review because not everything is a good idea." Rather, as Gardell put it "The NIH is making an investment in the work of researchers and looking for a return on that investment. The return of that investment is the discoveries that will provide the foundation for new therapies and new devices that will improve human health and combat disease." The act also proposes to make changes to the clinical trial process that will cater to precision medicine treatment.

Gardell said that SBP has expertise in basic discovery, drug discovery, and biomarker discovery and therefore is equipped to turn medical discoveries into treatments. Gardell described the drug discovery program as "A unique and powerful infrastructure that rivals what has been established in the pharmaceutical companies." Basic research identifies molecular underpinnings of disease. Drug discovery identifies molecules targeting molecular pathways of disease. Biomarker discovery allows identification of patients suffering from specific subtypes of disease and which patients will benefit from specific drugs.

The Act also encourages data sharing to accelerate discoveries. MCC has been a leader on this front and developed a program called ORIEN (Oncology Research Information Exchange Network) that allows several cancer institutes across the country to share patient data. The program allows these institutions to gain consent from patients to collect and profile their tumors, use their medical records for research, to share the data and to re-contact them should researchers learn something from the tumor that may benefit the patient. In fact, John DeMuro, Federal Legislative Affairs Director at MCC, said ORIEN was given as an example of data sharing when congress wrote the bill.

DeMuro and the government relations team at MCC have been active in advocating for increased funding from the NIH. He commented, "The work is not over yet for this bill. We need a passage of a companion bill by the Senate and a signature by the President. We are nearly half-way there."


21st Century Cures Act

Sections: Orlando Regulatory