Recruiting and retaining patients for clinical trials is one of the most intractable problems facing clinical research organizations and biopharma companies. CVS thinks that its thousands of retail locations could be the answer. We also look at Food and Drug Administration-approved video games, tracking patients using radar, drug manufacturing in the United States, and how, 20 years after the completion of the Human Genome Project, we may have finally sequenced the entire human genome.
Each week, we highlight five things you need to know in the life sciences industry. Here’s the latest.
The clinical trial industry faces significant challenges related to trial participation. According to data published in Patient Recruitment and Retention Services Market, 2019-2030, less than 4% of the U.S. population participates in clinical trials. In addition, 80% of trials do not meet their enrollment deadlines and 30% of participants do not complete the study. Building off its momentum assisting pharma companies with the recruitment of COVID-19 trial subjects, CVS will launch its own study business, known as Clinical Trial Services, aimed at addressing these challenges. Leveraging its network of 9,900 retail locations and 1,100 walk-in medical clinics, CVS will provide services related to patient recruitment, decentralized clinical trial delivery, and real-world evidence generation and studies.
Akili Interactive announced last week a $160 million equity and debt financing to support the commercialization of their FDA-approved video game. The game is designed to help children diagnosed with attention-deficit/hyperactivity disorder improve their focus and cognition in conjunction with medication and other ADHD therapies. In studies, approximately two-thirds of parents reported improvements in their child’s ADHD-related impairments after two months of gameplay. The game was FDA-approved last year and is currently the only prescription video game on the market.
Last week, Xandar Kardian’s radar sensor received FDA approval to be used as a monitor to alert clinicians when a patient’s vital signs drop below normal levels. The device, typically mounted above the bed, will help detect a patient’s vital signs without the need for intrusive sensors. The technology will help alleviate staffing burdens and allow clinicians the ability to monitor contagious patients at a safe distance.
Managing cost and capacity have been major factors leading to the majority of U.S. drug production being offshored over the last several decades. The COVID-19 pandemic highlighted vulnerabilities of the global drug supply chain and reignited calls to reshore production. A key step in that process may be continuous manufacturing where raw materials and active pharmaceutical ingredients are fed, blended and processed into tablets in a perpetual and highly automated process. Such processes have seen little success in the past, but companies such as Eli Lilly and Pfizer are making breakthroughs in the technology. According to industry leaders, continuous manufacturing facilities take up less space, have significantly faster production rates, can be deployed several times faster than traditional facilities, and can lead to increased quality and consistency. Given the renewed focus of lawmakers and regulators to support domestic production capabilities, and the significant capital made available through Operation Warp Speed, it is likely that the shift in small molecule production is on the horizon.
Although the human genome project was “completed” in 2000, it was in fact missing about 8% of the total genome. An international team of scientists has submitted a yet to be peer reviewed study of what they claim is the first full sequencing of the human genome. While this may seem like a small victory, the reality is that the reason it took another 20 years to achieve a full sequence is that the research work is very challenging and data-intensive. Recent breakthroughs in computing technology and sequencing techniques have also contributed to the full sequencing achievement. This research will lead to further understanding of the genome, which has become a focal point of next-generation biotechnologies such as cell and gene therapies, immune-oncology and mRNA therapies.