Advancements in precision medicine offer the potential to transform healthcare and create customized medical solutions for patients.
Mario Papillon, CEO of Cerba Research, discusses how his organization is supporting patients and helping them receive unique treatments more quickly by delivering efficient clinical trials.
This dynamic approach, in combination with worldwide access to industry-leading laboratories, has a key factor in the fight against Covid-19 and will remain an essential feature in the new reality in which future clinical trials will have to be performed.
The clinical research environment is becoming progressively more complex. Over the past ten years, there has been a trend in drug development towards high-priced personalized medicine.
Biomarkers have become a crucial part of the drug discovery process, assisting in the significant improvement in the rate of successful trials.
Consequently, pharmaceutical and biotech companies are under pressure to expedite drug discovery while simultaneously reducing costs.
Financially, it just doesn’t make sense. You can spend over €2 bn developing medication and only have a 30% chance of success. That’s where biomarkers make a lot of sense as they can double, sometimes even triple, your chance of finding the right medication.”
Mario Papillon, CEO, Cerba Research
Enhancing the efficiency of clinical trials is at the core of what Cerba Research does.
The company, which was recently formed by the merger of three leading providers – of central laboratory services, in vitro diagnostics (IVD), and biomarker research respectively – is part of Cerba Healthcare, a global network of medical biology laboratories with an extended history of innovation.
In 2007 we acquired Barc, our central lab. Parallel to this, we created a branch called Cerba Xpert to help IVD companies by supplying them with samples and carrying out testing and validation for them.”
Mario Papillon, CEO, Cerba Research
In 2018, the acquisition of a third company was completed, in line with the trend towards personalized medicine across the industry. “HISTALIM specializes in immunohistochemistry [IHC], identifying biomarkers at the tissue level,” explains Papillon.
“Developing biomarkers helps to identify the right patient, to give the right treatment at the right dose and for the right duration.”
Tri-headed
It was at this juncture in time that merging the three entities would offer key benefits for all their clients. “We realized that if we put all these services together, we could use companion diagnostics and, therefore, increase our efficiency,” states Papillon.
“Bringing them [the three previously independent companies] under one umbrella meant we could help our clients from the pre-clinical to the post-approval stage of their medications.”
By developing unique assays for their clients and identifying the right biomarkers, the company has the capacity to perform accelerated research and speed up the programs to market.
“It’s a real advantage of the merger,” says Papillon. “Our capability has definitely increased. We’re now able to offer our clients a better, more continuous service.”
Data mining can also play a key role in optimizing clinical trials. “The industry is using data to help make decisions and recruit patients,” explains Papillon.
“We have been investing in data mining at the central lab, which has helped us to pinpoint which hospitals have been enrolling in the past. And also, in examining medical lab data like regular medical tests, where patients are not necessarily participating in trials. We have access to 25 million patients a year. There are very few laboratories that can claim that.”
The outburst of the Covid-19 pandemic has had a considerable influence on global clinical trials, irrespective of national virus-reaction performance. “It completely threw everything sideways,” says Papillon.
“Everything that was not judged to be essential has been delayed. Trials have been put on hold. Now it’s restarting, and the key question is: how do we restart in a different environment?”
The industry has encountered an exceptional series of challenges in recent months, and several solutions must be united before progress in the sector can be made. “First of all, our clients need to make sure their workforce is healthy,” states Papillon.
“We have a corporate service to test staff [for Covid19] – in both virology and serology. After this, patients that have active Covid-19 must be identified and excluded from trials. You need to know that the patient is not infected.”
Cerba Research has been performing vital work, taking complete advantage of its network of industry-leading laboratories.
“Right at the beginning of the pandemic, we were receiving samples in our specialty labs to be tested,” explains Papillon. “We carried out over 10,000 tests a day and were able to deliver this volume very quickly.”
As well as developing and performing tests, Cerba has been evaluating existing tests to distinguish between high and low-quality assays. “Because we do a lot of IVD work, we were able to test the tests,” says Papillon.
“It was surprising to see how many of them have very poor sensitivity and selectivity. You would test someone thinking they were positive, but they would turn out not to be because of the poor quality of the original test.”
The show must go on
In March, the global average of new patient enrolment in clinical trials suffered a 65% year-on-year decrease. Researchers must now figure out how to structure trials and recruit participants in the changing Covid-19 environment.
Visits to patients in their homes and virtual trials may become more and more common. “Our clients need to think about how to recruit and follow up with patients in a way that protects both the patients and medical staff,” explains Papillon.
“This is where we can definitely help by sending staff to patient homes to take blood samples, as well as offering our collection point.”
Rather than going to a hospital, patients are therefore less exposed and are not placing additional strain on the healthcare system. It is imperative to ensure that the right infrastructure is in place to allow clinical trials to continue, even during pandemics.
We had two teams in some countries – three in others – that would alternate and ensure business continuity. This meant that our clients were protected, and their samples were received and analyzed on time.”
Mario Papillon, CEO, Cerba Research
The company was able to assist its clients to design new protocols during the pandemic. “We are able to tell companies which endpoints they should use and how they should be interpreted when developing vaccines and treatments for coronavirus,” he explains.
The company’s global footprint has been crucial as the virus has spread across the globe: “We have epidemiology data because we are testing affected regions day in-day out,” says Papillon. “We know how many new patients there are and can recommend which hospitals to use.”
Collaboration is vital, and he insists: “We’ve been approached by governments in France, Belgium, South Africa and the US, to share data and help build kits, collect samples and develop software to track the samples in terms of when they were received, dispatched and analyzed.”
“Covid-19 has taught us that science is important, but when you have a pandemic, collaboration is critical. We have been able to work with governments, private companies, hospitals and universities to combine our forces and respond quickly in an efficient way.”
Cerba Research is one-third of the international, multidisciplinary Cerba Healthcare network. Image Credit: Cerba Research
While Covid-19 has been a major priority, Papillon is all too aware of the need to persist with existing trials. “Surprisingly, trials for serious diseases – such as malaria, tuberculosis and even oncology trials – have slowed down,” he explains.
“These diseases are not waiting for Covid-19 to resolve. We need to keep treating these patients. To do this you have to have the right infrastructure, and I think our global footprint and scientific approach allows us to do this as we’re able to move operations from one country to another.”
Looking to the future, Papillon and his colleagues have planned to expand research on immuno-oncology biomarkers and anti-infectives. “For us, the expansion of platforms like NGS [next-generation sequencing], IHC and flow cytometry are really important,” he says.
“We’re also looking towards winter when there will be different viral infections coming up and we will need to differentiate between flu infections and Covid infections. Virology work will be essential.”
While Cerba Research already has a presence in Europe, Australia, Asia and the Americas, the company plans to extend its work to where it is most needed. “Africa has 20% of the global population and only 5% of clinical trials,” says Papillon.
“It’s a really huge imbalance. We have the advantage of being part of Cerba Healthcare, so we’re present in 13 countries in Africa, and we have access to these patients. They’re craving pharmaceutical investment to have access to these new treatments. It’s definitely something we would like to put on the agenda.”
The capacity to leverage a global patient base while adopting pioneering techniques in precision medicine has allowed Cerba Research to assist pharmaceutical and biotech companies worldwide, helping them optimize their clinical trials and speed up product development. Global crises show just how crucial this type of work is.
About Cerba Research
For over 35 years, Cerba Research has been setting the industry standard for exemplary clinical trial conduct. Today, across five continents, with a focus on precision medicine, we are changing the paradigm of the central lab’s role in complex clinical research.
From protocol inception through development and to market, our passionate experts deliver the highest quality specialized and personalized laboratory and diagnostic solutions. Partner with us for the most efficient strategy to actualize your biotech and pharmaceutical products sooner and improve the lives of patients worldwide.
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