The FDA accepted its failure
ARNA becomes relevant on the backdrop of the FDA business model collapse
On the background of ever-increasing health care costs in the United States, often speaks about the national system of clinical trials, which doesn’t have the best condition.
This system is currently “broken” and needs to change in order to define the diagnosis more precisely and to facilitate patients recovery.
“I personally believe, like many other people, that the clinical trial system we have right now is broken. Our inability to generate the needed evidence efficiently and in a cost-effective manner will continue to be a barrier to innovation and to the quality of care around the world”, director of the Center for Drug Evaluation and Research at the Food and Drug Administration Janet Woodcock said.
Past FDA commissioner who now holds data science positions at Duke University and Verily Life Sciences LLC, part of Google‘s parent company Alphabet Inc Robert M. Califf who mentioned that the shortcomings in the current system are wasting hundreds of millions of dollars have the similar opinion.
They both are convinced that more real-world evidence in the FDA’s regulatory decisions isn’t just a legal mandate but also its natural and direct responsibility.
During a two-day workshop organized by the National Academies and sponsored by the FDA on examining the impact of real-world evidence on medical product development also were discussed other issues. While the cost and time of developing a new drug get more than $2.5 billion and 12 years of duration, according to an analysis from the Biotechnology Innovation Organization, candidate has about a 10 percent chance of getting through the clinical trial process, with a 42 percent chance of failing within III clinical stage, the large and expensive phase of trial.
Health officials see the way out of this issue in bringing the clinical trial universe and the health-care universe as close together as possible to influence the actual medical care system. But this will require new testing platforms and new investments of course. And while they only declare intentions, medical researchers draw on the experiences of successful startups and use the machine from the branch of IT, to offer a product that is already able to make a real difference.
ARNA Genomics developed the platform of liquid biopsy based on several breakthroughs, including the unique method of DNA amplification to defining the set of cancer DNAs. It’s truly fundamental and allows to provide screening for many types of cancer. The company intends to produce these tests in industrial scale but now focused on the first one — ARNA BC, the breast cancer test.
ARNA BC development was completed last year and first patients were submitted for laboratory tests. In 2017 get started clinical research of ARNA BC which provided in I.M. Sechenov First Moscow State Medical University.
But its only beginning, given recent economic trends, the ICO and the impact of crypto currency, the company launched its own ARNA token. Customers will pay for their tests, researchers will be able to spend it on the development of the company and to accept as payment for services at other medical institutions. Most importantly, ARNA token will become the crypto currency exchange item and will generate income for their shares.
