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How a new investment is powering a revolution in clinical trial operations

Clinical trials are the engine for pharmaceutical innovation, but their means of capturing and communicating data are stuck
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Clinical trials are the engine for pharmaceutical innovation, but their means of capturing and communicating data are stuck in the past. Recognising an opportunity to develop better tools for clinical trial leaders to share and stream data, YonaLink’s co-founders built a software solution that addresses the interoperability gap in clinical trial operations. Iddo Peleg (CEO, and one of the four co-founders of YonaLink) and Gav Martell (co-founder and vice president of business development) discussed how a recent $6 million funding round led by Debiopharm Innovation Fund will support their mission to transform clinical trials and bring lifesaving therapies to market faster.

While many pieces of the drug development process have digitised to keep pace with the speed of technological advancements, clinical trials continue to lag amidst pharma’s digital transformation. According to Peleg, one of the biggest inefficiencies is in the process of collecting and streaming data from participants at trial sites to the trial organisers.

Today, Peleg explains, much of this process remains manual. Trial sites monitor patients participating in a research programme and enter their data into an electronic health record (EHR) for storage before transferring it to the trial’s electronic data capture (EDC) system. In most cases, the EHRs and EDCs don’t communicate, so in order to share that data with trial organisers, staff members at medical centres must manually copy data between the EHR and an EDC. As an average Phase 3 trial amasses over 3.6 million data points, typing each piece of information into the EDC can take months, Martell says, and inevitable data entry mistakes caused by human error can further delay trial progress.

“The clinical trial market is critical – not only does it bring essential therapies to the marketplace, but it offers lifesaving treatments to people who need them,” Martell explains. Unfortunately, he continued, “the clinical trial industry is stuck in the financial equivalent of writing cheques to people and taking your cheque book to the bank to update your balance.”

YonaLink – co-founded by Peleg and Martell along with chief operations officer Itai Rechnitz and Gil Meir, chief technology officer – offers a technology system to simplify the process of clinical data collection. In doing away with analogue workstreams, the company aims to improve the speed, quality, and interoperability of clinical trials. This unlocks opportunities for more trial sites and patients to participate in research – and speeds the research process to get critical treatments in the hands of patients sooner.

“Accurate data streaming is the key to bringing therapies to market faster than ever before,” Peleg says.

“The clinical trial market is critical – not only does it bring essential therapies to the marketplace, but it offers lifesaving treatments to people who need them.”

 

The problem with clinical trials

“There are lots of inefficiencies in clinical trials,” Peleg explains, “but the biggest gap is in how we collect data from medical centres and transfer it to the EDC.”

This represents a large area of lacking interoperability – the ability for technology systems to “talk” to one another to streamline data transfers. “It’s not a secret,” Martell says, “everyone in the industry knows it’s a problem. The opportunity to find solutions to bridge interoperability challenges is massive.”

Peleg shares that an average of six to eight weeks pass between the moment data is captured in an EHR during a clinical trial and when it’s transferred to the EDC for analysis. In addition, up to 45% of clinical trial budget is dedicated to manual data capture – which includes compensating study coordinators, engaging with contract research organisations (CROs), and accommodating queries and potential in-person visits from regulators as they review and validate the data.

“When I told our investors about these costs, timelines, and workflows, they thought I was joking,” Peleg says. “There’s no other industry where we capture data in this way. We’re trying to register lifesaving therapies, but we have to collect the data manually, and often the FDA and EMA inspectors have to visit trial sites to validate the data. It’s simply a waste of resources.”

Challenges with data collection don’t only pose business problems, but societal and health equity ones, too.

“When it’s so expensive to collect data, only big hospitals and medical centres participate in clinical trials. Only 5% of cancer patients have access to clinical trials. This means that outside of big cities and large medical centres, there are no clinical trials,” Peleg says.

“The global pandemic drove home how important it is to solve this problem on a global level; you have to be able to run clinical trials on a diverse population very rapidly, and the old methodology isn’t working,” Martell adds.

The only way to bridge this gap, Peleg says, is with technology.

“The global pandemic drove home how important it is to solve this problem on a global level; you have to be able to run clinical trials on a diverse population very rapidly, and the old methodology isn’t working.”

 

Solving interoperability challenges with real-time data and technology

The ability to stream data seamlessly between clinical trial sites and sponsors opens up new opportunities for better trial operations, improved access to research, and faster time to insight. YonaLink’s technology, Martell explains, offers a scalable way to bridge data gaps on a global level.

“On many different levels, we enable easy integration and connection to solve interoperability problems,” Martell says.

For clinical trial managers, Peleg explains, it’s important to access data in real time. As healthcare happens rapidly and continuously, a six-to-eight-week lag in data transferring hinders trial runners from understanding what’s really happening in their study. “Live data is critical for patient safety and for good operations in clinical trials,” Peleg says. “It makes everything more efficient and more accurate.”

Peleg explains how YonaLink’s process enables data streaming in hours rather than weeks and reduces costs tenfold – from thousands of dollars to a few hundred per trial.

“When data can be streamed, and when it’s not expensive to get the data, you can get real-time insight into what’s happening at all trial sites,” Peleg says. “This enables even small hospitals to participate in clinical trials,” thereby allowing patients who may not live near large academic medical centres to enrol in studies.

This represents a significant step toward health equity, with technology enabling the same types of accessibility improvements that we’ve seen benefit other industries. Peleg offers an example from the banking industry: “When you can wire money anywhere in the world, you can do business anywhere in the world. Similarly, when you can stream data, you can make clinical trials accessible to patients anywhere.”

Martell also details the ways data streaming technology can improve workflows for healthcare staff. “Not only are you minimising mistakes, you’re creating happier staff who can now easily manage multiple studies at a time,” Martell says. “This reduces the burden on a health industry that’s already dealing with staffing issues, all while making the lives of staff members easier.”

The multi-layered impact of YonaLink’s work inspires Peleg and Martell to continue to transform clinical trials with their technology and partnerships with pharmaceutical leaders.

“It’s not just about the business impact,” Peleg continues, “it’s about the societal impact, too.”

Leveraging funding to build better clinical trials for the future

With the infusion of capital from Debiopharm Innovation Fund – as well as eHealth Ventures and the European Union, who also participated in the round – YonaLink aims to expand its impact to support more clinical trials around the world. Peleg explains that the company currently focuses on Israel, the United States, and Spain, but will use the funding to expand its network to more clinical trials in more countries. “We want to be seen as a clinical trial hub for any country,” Peleg says.

He calls out a particular opportunity in the United Kingdom, where COVID-19 and other factors have reduced patient access to clinical trials by 44% since 2017.

“The question to ask ourselves is how we can increase patient participation in clinical trials,” Peleg says. “If all medical centres are connected and can stream data, we can build an infrastructure that makes it more attractive to run clinical trials.”

The YonaLink team looks forward to continued collaboration with Debiopharm in the years to come as they grow their collective impact.

“Debiopharm is an amazing company, and it’s exactly the right size to support YonaLink,” Peleg says. “We have direct access to clinical operations, data management, and data science experts who can support us through all the processes to become a global leader in clinical trials.”

“If all medical centres are connected and can stream data, we can build an infrastructure that makes it more attractive to run clinical trials.”

 

Looking ahead: A changing clinical trials landscape

Peleg expects that in the next five years, EHR to EDC linkage and data streaming will be the gold standard for clinical trials.

“When I first started working in clinical trials, people were just moving from paper documentation to EDCs,” Peleg says. “Within a few years, I think no one will want to copy data anymore, they’ll move to streaming.”

Both Peleg and Martell are inspired by the work ahead to transform clinical trials.

“It’s so obvious that this revolution needs to happen, and we feel privileged to be leading in the revolution,” Peleg says.

“We’re helping foster clinical trials into a world where there’s more patient access to clinical trials, and lifesaving therapies can come to market faster,” Martell says. “We’re so excited to be part of this change.”

 

About the interviewees

Iddo Peleg has been immersed in clinical trials for the past two decades in pharma and CROs. His passion for the industry has led him on a mission to solve the largest unmet need in clinical trials – bridging the data gap between patient care and clinical research.

 

 

Gav Martell has been bringing enterprise software solutions to market for the past 25 years. His career has spanned development, QA, product and project management, operations, business development and all points in between.  He sees a lot of similarities in his work life and his passion as a chef; simplify problems, solve them, and create something amazing.

 

 

About YonaLink

YonaLink equips research teams with the ability to extract up-to-date patient data from an EHR and stream that data into a clinical trial electronic data capture (EDC) system in real time, reducing clinical trial timelines and costs. Headquartered in Boston with R&D operations in Israel, YonaLink is bringing new levels of speed, quality, and efficiency to clinical trial operations across the globe, simplifying the complexity of clinical data collection and validation, and enabling true scalability. The Company’s SaaS platform has the capabilities to stream up-to-date data from any clinical site’s EHR platform, in any part of the world, and populate it within YonaLink’s next generation EDC or other data capture systems. With built-in eConsent and ePRO / eCOA and streaming EHR-to-EDC capabilities, YonaLink’s next generation EDC provides a comprehensive solution for today’s clinical trial needs, bringing EDC and eSource functionality together in a single tool that can be set up within minutes, eliminating integration delays, reducing costs, and accelerating study timelines. Learn more at www.yonalink.com.

 

About Debiopharm Innovation Fund

Debiopharm Innovation Fund, the strategic investment arm of Swiss biopharmaceutical company Debiopharm, provides strategic funding and guidance for companies with an ambition to improve the patient journey and re-imagine how clinical trials are conducted, along with companies offering digital platforms that support cutting-edge drug technologies. Since 2017 Debiopharm has invested in 14 digital health companies, typically leading the investment rounds.

For more information, please visit www.debiopharm.com/digital-health/ or follow @DebiopharmFund on Twitter.

 

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There will soon be one million seats on this popular Amtrak route

“More people are taking the train than ever before,” says Amtrak’s Executive Vice President.

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March 11, 2024

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While the size of the United States makes it hard for it to compete with the inter-city train access available in places like Japan and many European countries, Amtrak trains are a very popular transportation option in certain pockets of the country — so much so that the country’s national railway company is expanding its Northeast Corridor by more than one million seats.

Related: This is what it's like to take a 19-hour train from New York to Chicago

Running from Boston all the way south to Washington, D.C., the route is one of the most popular as it passes through the most densely populated part of the country and serves as a commuter train for those who need to go between East Coast cities such as New York and Philadelphia for business.

Veronika Bondarenko captured this photo of New York’s Moynihan Train Hall. 

Veronika Bondarenko

Amtrak launches new routes, promises travelers ‘additional travel options’

Earlier this month, Amtrak announced that it was adding four additional Northeastern routes to its schedule — two more routes between New York’s Penn Station and Union Station in Washington, D.C. on the weekend, a new early-morning weekday route between New York and Philadelphia’s William H. Gray III 30th Street Station and a weekend route between Philadelphia and Boston’s South Station.

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According to Amtrak, these additions will increase Northeast Corridor’s service by 20% on the weekdays and 10% on the weekends for a total of one million additional seats when counted by how many will ride the corridor over the year.

“More people are taking the train than ever before and we’re proud to offer our customers additional travel options when they ride with us on the Northeast Regional,” Amtrak Executive Vice President and Chief Commercial Officer Eliot Hamlisch said in a statement on the new routes. “The Northeast Regional gets you where you want to go comfortably, conveniently and sustainably as you breeze past traffic on I-95 for a more enjoyable travel experience.”

Here are some of the other Amtrak changes you can expect to see

Amtrak also said that, in the 2023 financial year, the Northeast Corridor had nearly 9.2 million riders — 8% more than it had pre-pandemic and a 29% increase from 2022. The higher demand, particularly during both off-peak hours and the time when many business travelers use to get to work, is pushing Amtrak to invest into this corridor in particular.

To reach more customers, Amtrak has also made several changes to both its routes and pricing system. In the fall of 2023, it introduced a type of new “Night Owl Fare” — if traveling during very late or very early hours, one can go between cities like New York and Philadelphia or Philadelphia and Washington. D.C. for $5 to $15.

As travel on the same routes during peak hours can reach as much as $300, this was a deliberate move to reach those who have the flexibility of time and might have otherwise preferred more affordable methods of transportation such as the bus. After seeing strong uptake, Amtrak added this type of fare to more Boston routes.

The largest distances, such as the ones between Boston and New York or New York and Washington, are available at the lowest rate for $20.

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The next pandemic? It’s already here for Earth’s wildlife

Bird flu is decimating species already threatened by climate change and habitat loss.

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March 11, 2024

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I am a conservation biologist who studies emerging infectious diseases. When people ask me what I think the next pandemic will be I often say that we are in the midst of one – it’s just afflicting a great many species more than ours.

I am referring to the highly pathogenic strain of avian influenza H5N1 (HPAI H5N1), otherwise known as bird flu, which has killed millions of birds and unknown numbers of mammals, particularly during the past three years.

This is the strain that emerged in domestic geese in China in 1997 and quickly jumped to humans in south-east Asia with a mortality rate of around 40-50%. My research group encountered the virus when it killed a mammal, an endangered Owston’s palm civet, in a captive breeding programme in Cuc Phuong National Park Vietnam in 2005.

How these animals caught bird flu was never confirmed. Their diet is mainly earthworms, so they had not been infected by eating diseased poultry like many captive tigers in the region.

This discovery prompted us to collate all confirmed reports of fatal infection with bird flu to assess just how broad a threat to wildlife this virus might pose.

This is how a newly discovered virus in Chinese poultry came to threaten so much of the world’s biodiversity.

H5N1 originated on a Chinese poultry farm in 1997. ChameleonsEye/Shutterstock

The first signs

Until December 2005, most confirmed infections had been found in a few zoos and rescue centres in Thailand and Cambodia. Our analysis in 2006 showed that nearly half (48%) of all the different groups of birds (known to taxonomists as “orders”) contained a species in which a fatal infection of bird flu had been reported. These 13 orders comprised 84% of all bird species.

We reasoned 20 years ago that the strains of H5N1 circulating were probably highly pathogenic to all bird orders. We also showed that the list of confirmed infected species included those that were globally threatened and that important habitats, such as Vietnam’s Mekong delta, lay close to reported poultry outbreaks.

Mammals known to be susceptible to bird flu during the early 2000s included primates, rodents, pigs and rabbits. Large carnivores such as Bengal tigers and clouded leopards were reported to have been killed, as well as domestic cats.

Our 2006 paper showed the ease with which this virus crossed species barriers and suggested it might one day produce a pandemic-scale threat to global biodiversity.

Unfortunately, our warnings were correct.

A roving sickness

Two decades on, bird flu is killing species from the high Arctic to mainland Antarctica.

In the past couple of years, bird flu has spread rapidly across Europe and infiltrated North and South America, killing millions of poultry and a variety of bird and mammal species. A recent paper found that 26 countries have reported at least 48 mammal species that have died from the virus since 2020, when the latest increase in reported infections started.

Not even the ocean is safe. Since 2020, 13 species of aquatic mammal have succumbed, including American sea lions, porpoises and dolphins, often dying in their thousands in South America. A wide range of scavenging and predatory mammals that live on land are now also confirmed to be susceptible, including mountain lions, lynx, brown, black and polar bears.

The UK alone has lost over 75% of its great skuas and seen a 25% decline in northern gannets. Recent declines in sandwich terns (35%) and common terns (42%) were also largely driven by the virus.

Scientists haven’t managed to completely sequence the virus in all affected species. Research and continuous surveillance could tell us how adaptable it ultimately becomes, and whether it can jump to even more species. We know it can already infect humans – one or more genetic mutations may make it more infectious.

At the crossroads

Between January 1 2003 and December 21 2023, 882 cases of human infection with the H5N1 virus were reported from 23 countries, of which 461 (52%) were fatal.

Of these fatal cases, more than half were in Vietnam, China, Cambodia and Laos. Poultry-to-human infections were first recorded in Cambodia in December 2003. Intermittent cases were reported until 2014, followed by a gap until 2023, yielding 41 deaths from 64 cases. The subtype of H5N1 virus responsible has been detected in poultry in Cambodia since 2014. In the early 2000s, the H5N1 virus circulating had a high human mortality rate, so it is worrying that we are now starting to see people dying after contact with poultry again.

It’s not just H5 subtypes of bird flu that concern humans. The H10N1 virus was originally isolated from wild birds in South Korea, but has also been reported in samples from China and Mongolia.

Recent research found that these particular virus subtypes may be able to jump to humans after they were found to be pathogenic in laboratory mice and ferrets. The first person who was confirmed to be infected with H10N5 died in China on January 27 2024, but this patient was also suffering from seasonal flu (H3N2). They had been exposed to live poultry which also tested positive for H10N5.

Species already threatened with extinction are among those which have died due to bird flu in the past three years. The first deaths from the virus in mainland Antarctica have just been confirmed in skuas, highlighting a looming threat to penguin colonies whose eggs and chicks skuas prey on. Humboldt penguins have already been killed by the virus in Chile.

A colony of king penguins.
Remote penguin colonies are already threatened by climate change. AndreAnita/Shutterstock

How can we stem this tsunami of H5N1 and other avian influenzas? Completely overhaul poultry production on a global scale. Make farms self-sufficient in rearing eggs and chicks instead of exporting them internationally. The trend towards megafarms containing over a million birds must be stopped in its tracks.

To prevent the worst outcomes for this virus, we must revisit its primary source: the incubator of intensive poultry farms.

Diana Bell does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

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This is the biggest money mistake you’re making during travel

A retail expert talks of some common money mistakes travelers make on their trips.

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March 11, 2024

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Travel is expensive. Despite the explosion of travel demand in the two years since the world opened up from the pandemic, survey after survey shows that financial reasons are the biggest factor keeping some from taking their desired trips.

Airfare, accommodation as well as food and entertainment during the trip have all outpaced inflation over the last four years.

Related: This is why we're still spending an insane amount of money on travel

But while there are multiple tricks and “travel hacks” for finding cheaper plane tickets and accommodation, the biggest financial mistake that leads to blown travel budgets is much smaller and more insidious.

A traveler watches a plane takeoff at an airport gate.

Jeshoots on Unsplash

This is what you should (and shouldn’t) spend your money on while abroad

“When it comes to traveling, it's hard to resist buying items so you can have a piece of that memory at home,” Kristen Gall, a retail expert who heads the financial planning section at points-back platform Rakuten, told Travel + Leisure in an interview. “However, it's important to remember that you don't need every souvenir that catches your eye.”

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According to Gall, souvenirs not only have a tendency to add up in price but also weight which can in turn require one to pay for extra weight or even another suitcase at the airport — over the last two months, airlines like Delta  (DAL) , American Airlines  (AAL)  and JetBlue Airways  (JBLU)  have all followed each other in increasing baggage prices to in some cases as much as $60 for a first bag and $100 for a second one.

While such extras may not seem like a lot compared to the thousands one might have spent on the hotel and ticket, they all have what is sometimes known as a “coffee” or “takeout effect” in which small expenses can lead one to overspend by a large amount.

‘Save up for one special thing rather than a bunch of trinkets…’

“When traveling abroad, I recommend only purchasing items that you can't get back at home, or that are small enough to not impact your luggage weight,” Gall said. “If you’re set on bringing home a souvenir, save up for one special thing, rather than wasting your money on a bunch of trinkets you may not think twice about once you return home.”

Along with the immediate costs, there is also the risk of purchasing things that go to waste when returning home from an international vacation. Alcohol is subject to airlines’ liquid rules while certain types of foods, particularly meat and other animal products, can be confiscated by customs. 

While one incident of losing an expensive bottle of liquor or cheese brought back from a country like France will often make travelers forever careful, those who travel internationally less frequently will often be unaware of specific rules and be forced to part with something they spent money on at the airport.

“It's important to keep in mind that you're going to have to travel back with everything you purchased,” Gall continued. “[…] Be careful when buying food or wine, as it may not make it through customs. Foods like chocolate are typically fine, but items like meat and produce are likely prohibited to come back into the country.

Related: Veteran fund manager picks favorite stocks for 2024

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