Innovations Enhancing The Patient Experience

Paving the way for new therapeutics to meet unmet medical needs

Innovative scientists are paving the way for new therapeutics to meet unmet medical needs. Equally important are advances being made that enhance the patient experience, particularly when it comes to the delivery methods of those molecules as well as more effective diagnostics testing.

A new diagnostics frontier

Historically, blood samples were outsourced because complete blood counts (CPCs), tests that measure the quantity of different types of cells that comprise blood as well as provide information about their physical properties, were done in central labs. When CPCs were first performed, somebody had to manually count cells under a microscope. Then in the late 1960s, a German scientist developed a novel method to count and characterize cells that used lasers, not human eyes. When this method known as flow cytometry eventually took hold, it revolutionized the speed and efficiency with which blood tests could be performed.

In 2022, the diagnostics space is undergoing another revolution. Sight Diagnostics has developed its Sight OLO, a high-performance CPC analyzer that the company claims can provide lab grade results in minutes utilizing just two drops of blood. According to Yossi Pollak, the company’s CEO: “This technology is essentially replacing the human eye behind the microscope.”

The technology driving Sight OLO leverages machine vision and AI to collect and analyze over 1,000 images per blood sample. As the company continued to amass data, it realized it could do something with all the information it was gathering. According to Pollak: “We soon recognized that the ability to digitize blood samples and collect large amounts of blood morphology data could have a far greater impact than just CBCs, so we started to collaborate with pharma companies to develop companion diagnostics capabilities, providing them with tailored tools to streamline the clinical trial process for the development of new drugs.”

Sight Diagnostics has partnered with hospitals and major pharma companies like Pfizer and is currently expanding into the companion diagnostics space. To its end, Karius, a California-based company also working to reshape the diagnostics landscape, has seen its Karius Test implemented in hundreds of hospitals. The test can help rapidly diagnose infections in patients and is particularly beneficial to people undergoing cancer treatment, as they are likely to experience some degree of immunosuppression.

Like Sight Diagnostics, Karius uses technology to mitigate the invasive nature of diagnostics testing. “The unique advantage of our liquid biopsy test is that it does not require an invasive sample collection of infected tissue or fluid,” explained Alec Ford, the company’s CEO. “Instead, it detects small fragments of DNA from the pathogen causing the infection within the bloodstream. In this way we can find over 1,000 different pathogens from the site of the infection, irrespective of where the infection is in the body.”

“When we think about how people consume healthcare, there are essentially two kinds of populations – those who show up at physical locations for care, and those who do not. There is a growing number of people who are looking for care in non-traditional locations like urgent care centers, at-home, in-dorms, or in other remote locations, which is where binx health can step in.”

Jeff Luber, CEO, binx health, inc.

“We wanted to provide a fast, simple, and accurate diagnostics tool in a compact platform that could be used in a wide range of clinical settings. To do this, we created technology that digitizes blood sampling, essentially replacing the human eye behind the microscope.”

Yossi Pollak, Co-Founder & CEO, Sight Diagnostics

According to internal analysis conducted by Karius, approximately 60% of invasive diagnostics procedures could have been avoided if the Karius Test were used.

In addition to non-invasive alternatives to testing, patients are increasingly demanding privacy and convenience for tests, especially when it comes to the detection of sexually transmitted infections. binx health has developed a molecular platform that provides lab-quality test results in 30 minutes for chlamydia and gonorrhea, allowing for patients to receive diagnosis and treatment within a single visit. According to CEO Jeff Luber, this “test and treat” capability presents a solution to a demand exacerbated by the pandemic: people now more than ever want convenient solutions to care. With binx’s tests patients have the option to collect samples from within the privacy of their own home. “When we think about how people consume healthcare, there are essentially two kinds of populations – those who show up at physical locations for care, and those who do not,” explained Luber. “There is a growing number of people who are looking for care in non-traditional locations like urgent care centers, at-home, in-dorms, or in other remote locations, which is where binx health can step in.”

The diagnostics arena has proven how powerful the combination of clinical data and powerful new technologies can be.

The next generation of drug delivery

As pharma and biopharma companies advance their pipelines to meet a range of unmet medical needs, certain new molecules require novel methods of delivery. Crucial to their success is the work of companies specializing in alternative drug delivery methods that work with innovators who have invested hundreds of millions of dollars on the API side to get over the finish line in safely and effectively reaching patients.

Dyve Biosciences is working on a new approach to transdermal drug delivery that dramatically increases the breadth of molecules that can be delivered through the skin to help bridge the gap between drug innovation and implementation. “Innovation within biotech is exciting, but many new APIs and targets being validated will ultimately run into either a delivery challenge that prevents their promotion from preclinical studies into the clinic, or an opportunity to be more effective if delivered in a different way. As drug development addresses more complex biological challenges, increased delivery challenges arise,” explained Ryan Beal, the company’s CEO.

“For one group, 76% of 103 participants surveyed indicated they would prefer to take a pill every day than have an injection every six months. And across all groups surveyed in the 611-patient study, participants would prefer a daily pill over their existing injectable treatment regimen. People in general have a clear aversion for needles.”

Talat Imran, CEO, Rani Therapeutics

“Innovation within biotech is exciting, but many new APIs and targets being validated will ultimately run into either a delivery challenge that prevents their promotion from preclinical studies into the clinic or an opportunity to be more effective if delivered in a different way.”

Ryan Beal, Co-Founder & CEO, Dyve Biosciences

Beal is most excited about the potential his company’s technology has to transform cancer treatment. Its transdermal approach can influence the acidity of the tumor microenvironment in a manner that is impossible with orally dosed drugs and is currently difficult to inject.

Taking an alternative approach, Rani Therapeutics is a clinical-stage biotech company that has come up with a way to turn injectable biologics into pills. The perennial challenge of biologics is overcoming the problem of the gut breaking down these biological materials before they are absorbed effectively. As the biologics industry has exploded in recent years, more patients have had to endure chronic injectable therapies. Rani Therapeutics saw the need for an alternative and developed its RaniPill, a pill that serves as a swallowable auto-injector, bypassing these historic challenges.

According to Talat Imran, the company’s CEO, there has been considerable commercial interest in the RaniPill. His company commissioned market research that surveyed US-based patients who take injectable drugs to quantify the interest. “For one group, 76% of 103 participants surveyed indicated they would prefer to take a pill every day than have an injection every six months. And across all groups surveyed in the 611-patient study, participants would prefer a daily pill over their existing injectable treatment regimen,” said Imran. “People in general have a clear aversion for needles, so any chronically dosed biologic presents an opportunity for Rani.”

In addition to overcoming challenges of how molecules can effectively reach patients, advancements within the drug delivery space have the potential to overcome a significant challenge across therapeutic treatments: medication non-adherence. “Even easy-to-use medicines have measured real-world adherence rates no greater than 50-60% across most chronic diseases,” said Adam Mendelsohn, CEO and chairman of Nano Precision Medical (NPM). “Adherence rates in clinical trials are artificially high, and despite how effective available medicines are, the primary reason people do not experience better health outcomes is because they do not take them.”

NPM is developing highly miniaturized implants that can maintain constant rate delivery, relieving patients of the burden of daily oral and weekly injectable medicines. The company is particularly focused on metabolic diseases. According to Mendelsohn, within the US alone it has been measured that there are avoidable expenses of approximately US$5,500 per non-adherent patient per year when it comes to type 2 diabetes. Across all diseases, estimates of avoidable expenses that result from medication non-adherence reach US$100-290 billion per year. From boosting efficacy to ensuring adherence, innovative drug delivery companies provide the crucial link needed to ensure molecules are reaching their full therapeutic potential.

“Medication non-adherence is a significant problem – even easy-to-use medicines have measured real-world adherence rates no greater than 50-60% across most chronic diseases. Adherence rates in clinical trials are artificially high, and despite how effective available medicines are, the primary reason people do not experience better health outcomes is because they do not take them.”

Adam Mendelsohn, CEO, Co-Founder & Chairman, Nano Precision Medical

Image courtesy of Arcturus Therapeutics