New sensing technologies offer benefits for biopharma firms
by Victor Pikov, contributing editor
December 2022 issue, BioElectRx Business Report
Since we started this publication a year ago, we have tried to inform our readers on the potential that new neurostimulation therapies offer to the pharmaceutical and biotechnology industries, with respect to neuromodulation that affects end organs and system physiology. But new technologies that deliver stimulation to the body represent just one way how bioelectronic medicine can impact the drug industry. New sensing technologies stand to benefit bio/pharma just as much.
In the changing healthcare environment, pharma and biotech firms need to find new strategies for survival. They have been laggards in adopting innovations such as mobile healthcare. The pharma and biotech industries have well-established channels for lobbying physicians to promote drug prescriptions and for lobbying private and public payers to establish favorable drug pricing. While these efforts may be helpful in a B2B marketplace, not nearly enough attention is being paid to their ultimate customers, the patients. A focus on collecting patient data would benefit not only the patients but the biopharma industry itself. There are several ways that industry can benefit.
The first potential benefit is in adapting biopharma to novel pricing schemes based on drug efficacy, which are already being tested in the U.K. and may soon be implemented in the U.S. Until this year, drug pricing in the U.S. was largely decoupled from its efficacy and was based primarily on “what the market will bear.” The current drug pricing scheme in the U.S. is not sustainable—branded prescription drugs doubled in price in the eight years from 2008 to 2016. Things are beginning to change, as two months ago, Medicare was finally allowed to negotiate drug prices.
At an NIH-sponsored workshop on patient access to new drugs, experts voiced their support for pricing schemes based on drug efficacy. Patricia Danzon, a professor of Health Care Management at the UPenn Wharton School, described several such pricing schemes including: comparative drug effectiveness, “cost-of-cure,” and a Netflix-like subscription model (a fixed annual fee regardless of a used volume of drugs) that is being tested in the U.K. Once drug pricing becomes dependent on effectiveness, the demand for apps that monitor patient’s activity—particularly neural activity—during drug therapy is likely to skyrocket as a simple way to collect real-world efficacy data.
Tracking neural activity can shed light on key aspects of personal well-being, such as sleep duration and quality, stress incidence and severity, and autonomic balance during the circadian cycle. Neural activity biomarkers are important for monitoring nearly all diseases, not just neurological and psychiatric disorders.
The neurology market, including Alzheimer’s disease, represents a small and further diminishing sector of biopharma R&D. Several large companies, such as GSK, AstraZeneca, Bristol Myers Squibb, Pfizer, and Amgen, have abandoned it altogether. Yet the key driving sectors, such as metabolic, immune, gastroenterological, respiratory, endocrine, cardiovascular, and urological systems, are dependent on the sleep-wake cycle and are under direct autonomic neural control, so neural activity can be used for both tracking the disease progression and advising patients on the timing and dosage of drug use.
The second potential benefit of tracking neural activity is decreasing the cost of clinical trials, as the use of neural activity biomarkers may allow converting confirmatory phase III trials from expensive randomized controlled trial design with many hundreds of patients to a cheaper adaptive study design, which was recently introduced by the FDA. This could soften and potentially even reverse the current trend of diminishing returns in pharma R&D. This trend, known by many as Eroom’s Law (Moore’s Law spelled backwards), highlights that the number of FDA-approved drugs per $1 billion has been reduced by half every nine years from 1950 to 2012 and this trend further accelerated in the last 10 years, despite the use of AI, supercomputers, and automated biotech tools in drug discovery and improved R&D productivity in the overall economy. Neural activity data can also be used as real-world evidence of a drug’s long-term efficacy and safety as a replacement for clinical trials for post-market surveillance, which are required by the FDA.
The third potential benefit of tracking neural activity is for patients with multiple or complex diseases that require personalized prescription of several drugs to manage various symptoms. Daily monitoring of neural activity would allow real-time detection of person-specific interactions among these drugs, thus providing better evaluation of efficacy and safety for drug combinations. With such monitoring, personalized drug combinations could be used for treating diseases with a wider range of co-morbidities and for maintaining drug efficacy for a longer period. As a result, these complex diseases become more “druggable.” Autonomic neural activity might be especially important for personalized treatment of symptoms spanning multiple systems—such as metabolic and immune—where functioning of the patient’s body as a whole is as important as tracking the activity of individual organs or systems.
Lastly, another potential benefit of tracking neural activity may be realized when neural activity data is transferred from the patient’s phone to the cloud. Cloud databases can be sold to tech companies interested in creating better diagnostic and treatment algorithms based on big-data analytics.
In combination, the above-described benefits of tracking neural activity are likely to help in adapting the biopharma industry to rapid changes in access to healthcare in the U.S. In economic terms, with neural activity device costs dropping in keeping with Moore’s law, the biopharma industry may take advantage of these and other diagnostic devices to finally escape the doom of Eroom’s law and rising drug prices.