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Digital tools driving innovative clinical trials

The COVID-19 pandemic has catalysed significant changes in the way pharma develops drugs, particularly in the clinical trial
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The COVID-19 pandemic has catalysed significant changes in the way pharma develops drugs, particularly in the clinical trial space. Hybrid or decentralised clinical trials (DCTs) have gained traction as technology, infrastructure and knowledge have evolved to support their use.

Preliminary research suggests that hybrid DCTs can reduce trial timing and resources, improve patient-centricity and  patient engagement, and expand access and recruitment and increase diversity, mitigate bias, and reinforce inclusion in clinical trials. A recent Science 37 survey noted that nearly three-quarters (73%) of respondents from the pharma industry were planning a hybrid or DCT, up from 49% in 2021.

“DCTs have been around for many years, long before the pandemic, but now companies have had the opportunity to utilise DCT approaches,” John Reites, CEO of Thread, told pharmaphorum. “They can solve some immediate challenges with participation in research by conducting eCOA (electronic clinical outcome assessment) remotely or doing virtual visits. We have also seen the regulators actively support the use of these hybrid decentralised research approaches. Importantly, they enable pharma to be more patient-centric and design trials that are more conducive to people’s lifestyles, giving participants choice on how they want to participate in a study. In addition, the modern clinical trial can be more inclusive, because it opens up the geographic boundaries that may otherwise limit participation.”

New sensor technology revolutionising data collection

A variety of digital and sensor technologies have been developed for use in clinical trials to allow the collection of high-quality, reproducible data and provide trialists with real-time insights (Table 1). These tools are already being used by big pharma to monitor congestive heart failure, arrhythmias, hypertension, sleep disorders, diabetes, and respiratory disorders and their use in other therapeutic fields is likely to expand. Significant opportunities exist for pharma to partner with technologists to leverage digital and sensor technologies to drive further time-and cost-efficiencies in clinical trials.

Table 1: Digital and sensor technology available for use in clinical trials

Source:  Izmailova et al, 2017

A new generation of wearable injectors and connected devices emerging that may also have an important role to play in hybrid and DCT trials, these include on-body injectors from Novo Engineering and Tsachi Shaked that ease home administration for the subcutaneous delivery of time-dependent, high-volume, and viscous drugs including biologics and chemotherapeutics.

However, few of the current digital solutions are medical-grade devices and more work is needed to develop tools that are fit for purpose. As Reites points out, “there are two main categories of digital sensors: 510(k) cleared and CE-marked medical devices. These devices and/or the endpoints they generate are with the rigour required to be submitted to regulators. The other type is consumer wearables, voice activated tools and images that can be generated on mobile phones.”

Each device type has an important role to play in hybrid and DCT trials.

“Consumer wearables demonstrate value on exploratory endpoints, whereas medical-grade devices have higher value both as secondary and, in some cases, primary endpoints,” notes Reites.

Novel digital endpoints

Pharma companies have begun to explore a host of novel digital endpoints that could have far-reaching implications for accelerating drug development and adoption. For example, a mobility quality of life metric could be invaluable in demonstrating the efficacy of a drug versus conventional tests in the treatment for musco-skeletal disorders and voice activated devices and wrist-worn activity monitors may be useful in the diagnosis and monitoring of neurodegenerative disorders (Table 2).

“There is no doubt there is an opportunity to develop and validate a variety of digital biomarkers for public health purposes, but the question is what biomarkers are of commercial interest? There are opportunities for biomarkers for public health but from a commercial perspective the jury is still out,” observes Steven LeBoeuf, Founder of Valencell.

However, many of the digital endpoints are still in their infancy and it may take several years before they are fully validated and accepted by regulators and payers.

“Thread is helping customers create and utilise digital endpoints in therapeutic areas like dermatology, respiratory, and CNS applications where the voice data capture is becoming important. It’s super innovative and requires our industry to build an endpoint into a process. There is a lot of investment in this area now, but we won’t start to see any significant volume of results until 2024-2025,” remarks Reites.

Table 2: Selection of digital endpoints under evaluation

Source: Landers et al., 2021

Collaboration is critical

Several tech companies including Apple, Google, and Microsoft, have entered this space and established collaboration with start-ups and pharma to leverage biotechnologies, artificial intelligence (AI) analytics and remote monitoring devices in clinical trials. For instance, Google Cloud released Real-World Insights a real-world data management platform which it co-developed with the FDA in 2019.

Meanwhile, DCT start-ups are pairing up with healthcare and service providers to expand their clinical offerings. For example, Medable and Thread are utilising real-world data generated from remote monitoring devices in conjunction with predictive analytics to speed up clinical trials. In February 2022, CVS Health teamed up with Medable and Thread partnered with Eversana to use their digital technology platform to help tackle diversity in clinical trials. In March 2022, Thread partnered with AWS (Amazon Web Services) to scale up and embed predictive analytics in its real-world data platform.

Reites comments that “our partnership strategy is to align with companies that have an equal view of the market. They want to bring their expertise and capital and have a common goal to bring a comprehensive offering by working together. We‘ve been doing this for seven years and continue to learn and evolve every day. We have innovative studies underway in Asia, Europe, and Latin America and each time we must think holistically about the solution. We’re working with our customers to change how research studies are conducted to make them more patient-centric and globally scalable.”

“Our partnership strategy is to align with companies that have an equal view of the market. They want to bring their expertise and capital and have a common goal to bring a comprehensive offering by working together”

 

Regulatory support and clarity on DCTs guidance is essential

Despite the considerable advances in this field, the adoption of wearable technologies and their integration in clinical trials remains a challenge for the industry. Changes in regulatory guidance and concerns over data handling, data privacy and ownership, plus interconnectivity issues, data analytic capabilities, and device usability, still need to be addressed in order for these technologies to be more widely adopted within the drug development process.

“The regulatory environment is very dynamic and variable and regulatory guidance in this area needs to be clearer and more consistent,” LaBoeuf says. “You can use a wearable device that is not regulated in a clinical study providing it’s not being used for benchmarking purposes but you cannot submit the data to the regulators. It needs to be performed with a benchmark, an FDA-approved device.”

In December 2021, the FDA published draft guidance on how digital technologies can be used to remotely capture data in clinical trials. The guidance also provides advice on the design and selection of technologies that are suitable for use in trials, how they can be verified and validated as fit-for-purpose by the sponsor, and the information required in an application to start a clinical trial or seek marketing approval.

“The regulators have given some guidance on DCTs and organisations like the DTRA (Decentralized Trials Research Alliance) and CTTI (Clinical Trial Transformation Initiative) are coming out with more research and recommendations which is building confidence and helping standardise technologies and DCTs,” Reites said. “We are trying to optimise DCTs from our learnings, and Thread has conducted more than 200 studies in more than 50 countries. More people are getting involved and the regulators are supportive, but we need to be careful to make sure that we don’t take one case study and apply it across the board.”

Greater clarity will help drive further adoption of digital technologies in clinical trials to better improve patient experience and health outcomes.

“Digital technologies will revolutionise medicine and have a substantial impact on clinical trials as more data can be collected to support the use of advanced therapies”

 

Digital technologies will become the new standard for clinical trials

“Digital technologies will revolutionise medicine and have a substantial impact on clinical trials as more data can be collected to support the use of advanced therapies,” forecasts LeBoeuf. The groundwork for digital technologies has already been laid but it will take time to refine these solutions to measure physiological readout with clinical-grade accuracy and to ensure that novel digital biomarkers are validated and utilised in clinical trials.

However, digital technologies will play an increasingly important role in clinical trials as they can “provide real-time tracking and analysis of datasets, so we can inform meaningful actions and deeper insights. That is what’s exciting – as we see DCTs continue to play such a key role that they become the standard for the future of clinical research,” predicts Reites.

 

About the interviewees

John Reites, CEO, Thread, US, is an executive intrapreneur turned digital health entrepreneur. His career includes nearly 20 years leading global drug development, clinical research, and decentralised clinical trials (DCTs) for life science organisations.

 

Dr Steven LeBoeuf, founder, Valencell, US, a market leader in the innovative science of wearable biometric devices that deliver enhanced health results.

 

About the author

Dr Cheryl Barton is a freelance life sciences and health writer and previously worked as a senior research scientist at Merck, Sharp & Dohme, UK, and a pharmaceutical business analyst at ABN Amro before setting up her own consultancy research company, Pharmavision.co.uk.

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Bolsonaro Indicted By Brazilian Police For Falsifying Covid-19 Vaccine Records

Bolsonaro Indicted By Brazilian Police For Falsifying Covid-19 Vaccine Records

Federal police in Brazil have indicted former President Jair…

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March 19, 2024

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Bolsonaro Indicted By Brazilian Police For Falsifying Covid-19 Vaccine Records

Federal police in Brazil have indicted former President Jair Bolsonaro for falsifying his Covid-19 vaccine card in order to travel to the United States and elsewhere during the pandemic.

Federal prosecutors will review the indictment and decide whether to pursue the case - which would be the first time the former president has faced criminal charges.

According to the indictment, Bolsonaro ordered a top deputy to obtain falsified Covid-19 vaccine records of himself and his 13-year-old daughter in late 2022, right before he flew to Florida for a three-month stay following his election loss.

Brazilian police are also waiting to hear back from the US DOJ on whether Bolsonaro used said cards to enter the United States, which would open him up to further criminal charges, the NY Times reports.

Bolsonaro has repeatedly claimed not to have received the Covid-19 vaccine, but denies any involvement in a plan to falsify his vaccination records. A previous investigation by Brazil's comptroller general concluded that Bolsonaro's vaccination records were false.

The records show that Bolsonaro, a COVID-19 skeptic who publicly opposed the vaccine, received a dose of the immunizer in a public healthcare center in Sao Paulo in July 2021. [ZH: hilarious, Reuters calling the vaccine an 'immunizer.']

The investigation concluded, however, that the former president had left the city the previous day and didn't leave Brasilia until three days later, according to a statement.

The nurse listed in the records as having applied the vaccine on Bolsonaro denied doing so and was no longer working at the center. The listed vaccine lot was also not available on that date, the comptroller general's office said. -Reuters

"It's a selective investigation. I'm calm, I don't owe anything," Bolsonaro told Reuters. "The world knows that I didn't take the vaccine."

During the pandemic, Bolsonaro panned the vaccine - and instead insisted on alternative treatments such as Ivermectin, which has antiviral properties against Covid-19. For this, he was investigated by Brazil's congress, which recommended that the former president be charged with "crimes against humanity," among other things, for his actions during the pandemic.

In May, Brazilian police raided Bolsonaro's home, confiscating his cell phone and arresting one of his closest aides and two of his security cards in connection to the vaccine record investigation.

Brazil's electoral court ruled that Bolsonaro can't run for public office until 2030 after he suggested that the country's voting system was rigged. For that, he has to sit out the 2026 election.

Tyler Durden Tue, 03/19/2024 - 11:00

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This gambling tech stock is future-proofing the world’s casinos

Supported by the universal thrill of a quick payout and the need for leisure, gambling stocks make a compelling case for long-term returns.
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Supported by the universal human thrill of a quick payout, and the need for leisure and entertainment to bring enjoyment to adult life, casinos will remain essential spaces for people to dream and play for the foreseeable future, making gambling stocks a prospective space to look for long-term returns.

According to Research and Markets, the global casino industry was valued at US$157.5 billion in 2022, and it will grow to US$224.1 billion by 2030 at a compound annual growth rate of 4.5 per cent. This trend includes:

Approximately 100 million gamblers in the United States, who generated US$66.5 billion in revenue in 2023, a 10 per cent gain from 2022, which itself was a record year A little fewer than 20 million gamblers in Canada, who generated about C$15 billion in revenue in 2023 A global addressable market of thousands of casinos, and more than 4.2 billion people who gamble at least once every year, according to a 2016 study by Casino.org

The main challenge with attracting these billions through casino doors is they sway heavily toward middle age. The mean age of U.S. casino visitors has hovered around 50 for the past decade, with a similar trend across the world, forcing casinos to attract younger, tech-savvy customers, many with less gambling experience, to continue growing profits for their stakeholders over the long term.

Investors seeking exposure to a leadership position in building the bridge between casinos and the next generation of gamblers should evaluate Jackpot Digital (TSXV:JJ). The Vancouver-based company is a manufacturer of dealerless electronic table games that deliver immersive experiences tailored to the digital age, while earning casinos attractive returns on investment.

The gambling technology stock benefits from no direct competition in the dealerless poker space, with orders spanning North America, Europe, Asia, Africa and the Caribbean, a long-established presence with major cruise ship brands, such as Carnival, Princess Cruises and Holland America, and a growing land-based presence with orders or ongoing installations across 12 U.S. states. Its highlight partnership to date is a master services agreement with Penn Entertainment, the country’s largest regional gaming operator with 43 properties across 20 states.

Jackpot Digital’s differentiated technology and well-rounded management team are at the heart of its success in landing several blue-chip casino gaming companies as customers.

Jackpot Blitz

The gambling technology stock’s flagship product, Jackpot Blitz, is a dealerless poker table featuring three of the world’s most popular variations – Texas Hold’ em, Omaha, and Five-Card-Omaha – brought to life through slick 4k graphics on a 75-inch touchscreen, and offered in three formats – pot-limit, no-limit and fixed-limit – designed to attract a diversity of revenue from casual to experienced players.

Spokesperson and NFL championship-winning coach Jimmy Johnson explains the benefits of the Jackpot Blitz. Source: Jackpot Digital.

The table also comes equipped with house-banked mini-games, including blackjack, baccarat and video poker, as well as side bets on the main poker game, such as Bet the Flop, all of which keep players engaged and entertained between, and even during, poker hands. The stunning Jackpot Blitz machine also offers multi-venue “Bad Beat” jackpot functionality, allowing casinos to offer a “Poker Powerball” with massive Jackpots, further enhancing the attractiveness of Jackpot Blitz to new players.

It’s by striking a balance between the needs of the modern gambler, and efficiency and profitability that in-person operators couldn’t hope to match – unless they ordered the machine for themselves – that Jackpot Digital has earned itself the top spot in dealerless poker.

Player benefits

When a veteran or novice gambler takes a seat at the Jackpot Blitz, his or her experience begins with an easy-to-use interface, laid out in a modern and stylish design, programmed to respond to hand gestures that bring real casino play into the digital age, including card bending and chip jingling.

Source: Jackpot Digital.

The table’s intuitive controls, combined with instant payouts and its dealerless nature, translate into faster game play, which maximizes playing time and player excitement, while minimizing human error and the intimidation new gamblers might feel about approaching an analog poker table. The gambling technology stock’s in-house development team is also constantly working on new games to keep content fresh, with a special focus on bringing international games and regional versions of poker to casino audiences in Asia, South America and the Indian subcontinent.

As hands are laid down and pots pile up, players can also track game stats in real time, which inform future strategy and enhance the thrill of the moment with an added element of competition.

Operator benefits

From an operator’s perspective, a floor of automated gaming tables can meaningfully and instantly reduce casino staff expenditures and management pain points, while avoiding wage inflation, labour shortages and supply costs.

The Blitz is no slouch on revenue either, dealing more hands per hour, resulting in higher revenue and higher profitability, which is further enhanced by onboard side bets and mini-games that can be played while players are engaged in a poker hand.

The Jackpot Blitz’s economics are attractive to operators thanks to its ability to accommodate non-stop play, while monetizing downtime through side games and bets. While a human dealer must spend time shuffling, interacting with players, and consulting with colleagues, the Jackpot Blitz can accept wagers 100 per cent of the time, making sure gamblers get the action they came for and operators see a return on their investment.

Source: Jackpot Digital.

Beyond gaming revenue, casinos are further incentivized to onboard the Jackpot Blitz because of its fully customizable advertising functions, including logos, card backs, chips and felt colors, all of which bolster casino culture and enable the pursuit of revenue from third-party advertising partners.

The Blitz ties its value proposition together by generating automatic reports – including demographics and consumer behaviour through a rewards card system – and plugging directly into most back-end management systems, saving casinos the hassle of manual tracking, while also minimizing tampering, money-laundering and theft through the use of isolated servers.

Whether it’s streamlining the player experience or putting automation at the service of operators’ bottom lines, Jackpot Digital’s flagship product is positioned to create value, and plenty of it.

Jackpot Digital’s path to profitability

After existing as an exclusively cruise-ship-based operation since 2015, Jackpot Digital suffered a steep decline in revenue during the COVID pandemic, falling from C$2.18 million in 2019 to C$0.42 million in 2021.

Management quickly pivoted in the face of uncertainty, redesigning the Blitz to execute on a land-based expansion strategy – backed by Gaming Labs International certification in fall 2023 – which is bringing about a successful turnaround after the re-emergence of the casino business. Revenue more than tripled to C$1.43 million in 2022, and reached C$1.57 million through three quarters of 2023, with the company expecting to ramp up significant recurring revenue after it installs several dozen machines currently in its backlog.

The Jackpot Blitz electronic gaming table in action. Source: Jackpot Digital.

The first installation of land-ready Jackpot Blitz machines is now completed at the Jackson Rancheria Casino in California, as the company announced today. The three-machine installation marks a new era of growth for the company, having announced 25 Blitz deals since November 2021 (slide 12), with many more across Canada and the United States in the works, in addition to a strong pipeline in Asia and Europe.

“Jackpot Digital could be a profitable company right now if it only focused on care and maintenance of the revenues it currently generates. But that’s not why we’re here,” Mathieu McDonald, Vice President of Corporate Development at Jackpot Digital, said in a recent interview with Stockhouse. “We intend to scale up to many multiples of the tables we have out right now, with the potential for up to 2,000 tables over the next three to five years.”

According to McDonald, the company is fielding three to five inquiries per week about the Blitz from casinos around the world that recognize the machines’ first-mover advantage in dealerless poker and potential expansion into other games in need of automation.

Jackpot Digital’s ambitious plan of action is supported by a management team of proven gambling, finance, advertising and legal professionals, many of which have been serving Jackpot stakeholders for more than two decades.

A long-tenured management team

The management team behind Jackpot Digital is led by Jake Kalpakian, who has served as president and chief executive officer since 1999, including under the gambling technology stock’s former incarnation as Las Vegas From Home.com Entertainment Inc. Kalpakian brings more than 30 years of experience managing small-cap publicly listed companies, granting him a steady hand when it comes to maneuvering through the volatility of the economic cycle.

Kalpakian’s efforts are supported by three directors whose well-rounded expertise positions Jackpot Digital for long-term sustainable growth:

Gregory T. McFarlane, a director at Jackpot Digital since 1999, previously ran an independent advertising firm and holds a degree in mathematics from the University of Toronto. McFarlane is also a co-founder of the popular Control Your Cash personal finance website. Chief financial officer Neil Spellman, a director at the company since 2002, boasts an almost two-decade track record as vice president at Wall Street firm Smith Barney, where he developed a multi-industry understanding of the journey to profitability. Finally, Alan Artunian, a director since 2017, currently serves as CEO of Nice Guy Holdings, a corporate and legal consulting company advising clients across a diversity of sectors.

Guided by a strategic management team, and benefiting from a macro-trend toward casino automation, Jackpot Digital is on course to ride a wave of millions of gamblers looking for an elegant, tech-informed alternative to traditional in-person play.

A multi-bagger opportunity

The Jackpot Digital opportunity sets up savvy investors who recognize the soundness of the company’s value proposition. The tremendous risk/reward value of Jackpot Digital gives investors the opportunity to ride the macro-trend toward casino automation, as deals for the Blitz keep pouring in, the company adds games to its portfolio, and the global casino industry adds hundreds of billions in revenue through this decade.

Join the discussion: Find out what everybody’s saying about this gambling technology stock on the Jackpot Digital Bullboard.

This is sponsored content issued on behalf of Jackpot Digital, please see full disclaimer here.

The post This gambling tech stock is future-proofing the world’s casinos appeared first on The Market Online Canada.

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Gates-backed PhIII study tuberculosis vaccine study gets underway

A large study of an experimental vaccine for the world’s biggest infectious disease has finally kicked off in South Africa.
The Bill & Melinda Gates…

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March 19, 2024

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A large study of an experimental vaccine for the world’s biggest infectious disease has finally kicked off in South Africa.

The Bill & Melinda Gates Medical Research Institute (MRI) will test a tuberculosis vaccine’s ability to prevent latent infections from causing potentially deadly lung disease. Last summer the nonprofit said it would foot $400 million of the estimated $550 million cost of running the 20,000-person Phase III trial.

It’s a pivotal moment for a vaccine whose origins date back 25 years when scientists identified two proteins that triggered strong immunity to the bacterium that causes tuberculosis. A fusion of those proteins, paired with the tree bark-derived adjuvant that helps power GSK’s shingles shot, comprise the so-called M72 vaccine.

Thomas Scriba

After decades of failures in the field, the vaccine impressed scientists in 2018 when GSK found that it was 54% efficacious at preventing lung disease in a 3,600-person Phase IIb study.

But the Big Pharma decided that a full-blown trial was too expensive to conduct on its own. Gates MRI stepped in to license the vaccine in early 2020, right before the Covid pandemic shifted global vaccine priorities towards the coronavirus, further stalling the tuberculosis shot.

“There’s been frustration that it’s taken so long to get this trial up and running,” Thomas Scriba, deputy director of immunology for the South African Tuberculosis Vaccine Initiative, told Endpoints News last summer.

At last, the vaccine is getting a chance to prove itself in a bigger study. If successful, it could lead to the first new shot for tuberculosis in over a century.

Emilio Emini, CEO of the Gates MRI, told Endpoints that the initial results may come in roughly four to six years. “Hopefully this will galvanize a refocus on TB,” he said. “It’s been ignored for many, many years. We can’t ignore it anymore.”

A substantial impact

Even though an existing vaccine helps protect babies and children against severe tuberculosis, the bacterium responsible for the disease still causes roughly 10 million new cases and 500,000 deaths each year.

Emilio Emini

By vaccinating adolescents and adults who test positive for infections but don’t have symptoms of lung disease, the Gates MRI hopes the shot will help prevent mild infections from becoming severe ones, curtail transmission of the bug, which is predominantly driven by people with lung disease, and reduce deaths.

“The impact would be substantial,” Emini said. But he cautioned that the biology behind mild and severe diseases is still mysterious. “The reality is that no one really knows what keeps it under control.”

The study, which will take place at 60 sites across seven countries, will include some people who are not infected with tuberculosis to ensure that the vaccine is safe in that broader population.

“Having to pre-test everybody is not going to make the vaccine easy to deliver,” Emini said. If the vaccine is ultimately approved, it will likely be used in targeted communities with high tuberculosis, rather than across a whole country, he added. “In practice, you would immunize everybody in those populations.”

Emini described the Gates MRI’s rights to the vaccine as “close to a worldwide license.” GSK retained rights to commercialize the vaccine in certain countries but declined to specify which ones.

A spokesperson for GSK said that the company “has around 30 assets under development specifically for global health … none of which are expected to generate significant return on investment.”

“It is not sustainable or practical in the longer term for GSK to deliver all of these alone. So we continue to work on M72, but in partnership with others,” the spokesperson added.

If the shot works, Emini said that the Gates MRI will sublicense it to a manufacturer that will be responsible for making and marketing the vaccine. The details are still being worked out, he noted.

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