Clinical trials are an effective method to know if a new treatment is safe and functional in people, says Mike Failly, Founder and Managing Director of Zanteris
One of the benefits of the COVID-19 pandemic was the rapid appearance of drugs to overcome the disease. Scientists, researchers, ministers, and others came together to utilize the expertise already in existence and repurpose some of the research that was being undertaken into similar viruses. It emphasized the importance of clinical trials and showed that new medicines could be accelerated into production when everyone was of the same mind.
“Clinical trials are an effective method to know if a new treatment is safe and functional in people,” says Mike Failly, founder, and CEO of Zanteris. “Emerging healthcare systems can utilise the results of clinical trials to treat patients and avoid harmful side effects, especially whenever there is an unmet need. Clinical trials can also help healthcare systems to maintain intellectual curiosity and search for optimal health services for patients.”
A former scientist with a PhD in Neurobiology, Mike spent the early part of his career working on the proteins and genes of specific rare diseases. “I enjoyed cell signaling, making a sequence and sequencing analyses, but I felt I needed to contribute even more from a medical standpoint and health” he says. This led him to a Geneva University hospital where he worked in Oncology mainly in breast and ovarian cancer. He went on to biotech and clinical research organisation (CRO) where he worked in immunology, cardiology, oncology as well as immuno-oncology.
From there he set up Zanteris to provide client-specific Clinical Operations services to provide the best customer experience and improve study deliverables, as well as team performance. Zanteris is a functional CRO in Clinical Operations, focusing on both the pharmaceutical and biotech industries. Offering Project Management resources, Clinical Operations, and Human Efficiency Consulting, Zanteris plays an integral role in connecting the clinical team with any other internal part of the business.
“Our services can help health systems around the world by providing expert guidance and advice, with the skills and knowledge necessary to improve CRO and/or vendor relationships with an overall focus in performance on their clinical development activities,” he says. This encompasses providing well-qualified human expert resources to support teams and overcome challenges that may delay clinical trials, offering a cost-effective approach to achieving the key performance indicators (KPIs) aligned with health organisation targets and helping pharmaceutical and biotech industries maximise their potential.
Clinical trials and population health
For pharmaceutical and biotech industries, Zanteris specialises in oncology trials. However, their background and expertise allows them to provide support or oversee complex clinical trials and global clinical trials. Examples include EMEA, NA, APAC, and LATAM. Zanteris offers from Phase I to Phase IIIb studies expertise.
“We provide operational support getting new and innovative medicines to patients,” says Mike. “The overall population can benefit from more options for healthcare through clinical trials, including access to potentially life-saving medication and innovative treatment such as CAR-T trials. Healthy volunteers among the overall population can also claim to take part in these trials to contribute to improving science.”
Several considerations go into managing clinical trials, including patient diversity and patient disease prevalence but also standard of care treatment, healthcare expenditure, and technology infrastructure. Other essential data involves project planning details, budget, and regulatory requirements.
Depending on the status of the trial, it can require many resources. Zanteris takes on trials from the initial stages right through to rescue situations. Where some trials may take place in one hospital in a single country, others can consist of 200 sites across 30 countries, requiring as many as 150 people to run it.
“Running a trial requires a lot of experience,” Mike says. “You need top leadership skills to drive your customer and also your team. You need a project manager as a leader and CEO of your project, but also one who shines the light on the team. Your team is the most important element, so you need to protect them to find the perfect balance between making your customer happy and driving the clinical trial. Our core value is integrity, and we are here to provide expertise to our partners.”
Bringing clinical trials to new markets
Zanteris brings a smart approach to new markets by effectively providing Clinical Operations consulting and clinical project research management. The advisory services of Zanteris are specifically designed to support small and medium biopharma market with their outsourcing and clinical operations challenges.
“We decided a few months ago to take a good look at the Middle East where there is a more stable population mix,” he says. “There are also unmet needs and medication because pharmaceutical companies are running clinical trials which are less innovative than the ones we run. I have been working in a very complex rare disease trial and have had exposure to several of these issues, challenges and different opportunities that drive a successful clinical trial, or at least how to mitigate or prevent any issues as part of a risk management strategy.”
For Mike, his job is his passion. “I love to contribute and I’m proud of doing so,” he reveals. “There is nothing better than to contribute to the care of a child. When you are part of history, you can be proud of years of dedication.”