TL;DR:
- Lindus Health secures $18M in Series A funding for its revolutionary clinical trials platform.
- Lindus aims to streamline clinical trials with a holistic approach, backed by AI and machine learning.
- The startup’s founders draw from personal experiences to address shortcomings in the clinical trial process.
- Lindus focuses on end-to-end solutions, differentiating itself from traditional CROs.
- The company employs machine learning for protocol generation and real-time data analysis.
- Lindus’s data-centric approach improves engagement, recruitment, and data accuracy.
- Peter Thiel’s investment underscores the potential disruption of clinical trial norms.
Main AI News:
In the realm of modern medical research, clinical trials stand as the bedrock, providing the empirical foundation needed to affirm or debunk the safety and effectiveness of novel treatments. Yet, undertaking clinical trials proves an arduous and resource-intensive journey, often spanning years before a treatment gains the green light for widespread use. Lindus Health, a pioneering player in the field, addresses this challenge head-on. Branded as a “next-gen contract research organization” (CRO), Lindus Health is ushering in a paradigm shift in the landscape of clinical trials, streamlining their pace and simplicity. The UK-based startup has recently announced a triumph in securing $18 million through a Series A funding round, led by renowned backers such as Creandum, a notable investor in Spotify, and entrepreneur extraordinaire Peter Thiel.
Founded in London in 2021, Lindus emerged from the experiences and grievances encountered directly by its two visionary founders. Meri Beckwith, previously a venture capitalist at Omers Ventures, wielded firsthand insights into clinical trials through collaborations with healthtech startups. Beckwith shared, “I worked for a bit in venture capital, and I came across companies running their own clinical trials. Everyone was universally frustrated with the outcomes. Everyone just constantly complained about how long clinical trials took, how the outcomes were always bad, and there were always mistakes. So as an investor, I thought this is a really interesting area for investment.“
As the grip of the global pandemic took hold in 2020, Beckwith’s engagement in multiple COVID vaccine studies offered him firsthand glimpses into the labyrinthine clinical trial process. “I was just completely shocked to see how unbelievably dysfunctional that was,” Beckwith recollected. “And this was one of the really big, well-funded phase-three trials. I remember having to download Internet Explorer to even sign up for the clinical trial. The website the CRO had built was on WordPress, and it didn’t have an SSL certificate. And on the clinical trial side, they were just tons of ridiculous errors. So that was a real eye-opener.”
Another of Lindus’s founders, Michael Young, brought his background as a special adviser at Downing Street, where he lent his expertise to the Prime Minister and UK Government on multifarious matters in the life sciences realm. While much attention focused on drug approvals and NHS implementation, the intricate mechanics of clinical trials remained relatively overlooked. Young confessed, “We just weren’t thinking about that at all… We came to the conclusion that THAT is the bottleneck that’s stopping all the really cool R&D stuff that’s happening from getting to patients.”
Lindus Health faces competition from a slew of startups endeavoring to make their mark in the tech-infused clinical trial space. Yet, what sets Lindus apart is its holistic approach to the end-to-end clinical trial process, unlike other entities specializing in specific facets. “The companies we compete with are the big CROs,” Young remarked. “This is a massive market, and tech-first CROs have not yet got a foothold.”
Delving into the context, a contract research organization (CRO) serves as an external entity to which pharmaceutical, biotech, and medical device companies outsource crucial tasks such as clinical research. This practice allows companies to focus their internal efforts solely on core product development while leaving specialized work to third-party experts. The CRO market currently boasts a valuation of $77 billion, with predictions of a 70% expansion over the next five years. Among the key players, IQVIA stands out as a $40 billion heavyweight in the CRO sector, having doubled its market capitalization in recent years.
Typically, a clinical trial encompasses elements like initial trial design, protocol creation, technology platform setup, patient recruitment, program delivery, and data compilation. Given the time-intensive nature of each phase, Lindus aims to streamline this process, except for the ethics and regulatory components overseen by third parties. One focal point lies in refining clinical trial software available in the market. “It’s a cliche that sites (where clinical studies take place) hate the software on the market,” Young observed. “We’ve invested thousands of hours speaking to site users to ensure our tool is intuitive and automates the basic tasks that they do. This results in more engaged sites and therefore faster recruitment and better data.”
Lindus harnesses the power of machine learning (ML) to simplify the manual and iterative process of protocol writing, a pivotal early phase of clinical trials. Young explained, “The result is that, despite the best intentions, there can be contradictions or even seemingly sensible additions which hamstring a trial… For example, adding so many exclusion criteria that a trial is almost impossible to recruit for.” Through a “protocol generation” tool and leveraging historical protocols, Lindus generates an initial draft protocol, further refined by a separate model trained on public data. This refined model highlights trial risks and offers suggestions for enhancement.
Central to the clinical trial process is data capture, a domain Lindus supports by allowing trial staff to electronically record data from the outset, employing AI to oversee and manage the process while ensuring data accuracy and completeness. Lindus then aggregates this data in a centralized dashboard. “Clinical trials are in essence just a data collection exercise,” Young remarked. “A standard clinical trial will generate hundreds of thousands to millions of data points. The company running a clinical trial is responsible for ensuring that this data is accurate and that any data that might indicate a risk to patient safety is identified.”
Lindus Health has previously secured around $6 million in funding from investors like Creandum and Peter Thiel. Now, fortified with an additional $18 million, the company gears up for expanded operations across Europe and North America, having already executed over 80 clinical trials since its inception two years ago. Focusing initially on conditions like depression, diabetes, and insomnia, Lindus consciously selects its supported conditions based on various factors. Beckwith explained, “On the practical side, our Northstar — and what differentiates us from a lot of companies in this space — is that we’ve always believed strongly that to have an impact and to make a difference, we need to run the entire clinical trial and displace CROs… What are the simplest clinical trials we can run, where we can still be in charge of the whole clinical trial?“
Lindus has deliberately aimed to address common conditions, initially concentrating on non-drug products with lower trial-related obstacles. Its focus later extended to drug products, with future plans encompassing conditions such as tinnitus, insomnia, menopause, and childhood myopia. Beckwith emphasized the industry’s shift towards niche conditions and rare diseases, inadvertently sidelining more common ailments due to the formidable costs of clinical trials. “So economically, it’s only made sense for them to run those clinical trials where you can get an approval with few patients, and where that approval leads to a huge dollar-value for one course of treatment. So we think that our strongest competitive advantage is that we’ve just made clinical trials, on the whole, much more scalable.”
Backing Lindus are diverse venture capital entities, including Creandum, Firstminute Capital, Seedcamp, Hambro Perks, and Amino Collective. The involvement of Peter Thiel, a stalwart in the health tech arena, garners special attention. Beckwith reflected on Thiel’s unique approach to understanding the market and Lindus’s potential impact, saying, “For example, why the market looks the way it does with the current CROs having a terrible offering, and they have an oligopoly… Essentially, all the questions were framed around, ‘How big could Lindus Health be if we do well.'”
Thiel’s support and investment underline his views on the status quo of clinical trials. While often associated with a libertarian stance, Thiel champions medical progress, epitomized by his investments in numerous biotech ventures in pursuit of extended longevity. His criticisms of the US Food and Drug Administration (FDA) and its impact on drug development have been notable, and his investments have even extended to companies that bypassed FDA oversight by conducting trials offshore.
Nonetheless, the regulatory framework has its purpose, particularly in drug trials, prompting scrutiny of entities aiming to disrupt an industry known for its meticulous oversight. Young assures that Lindus’s focus remains on technical and procedural solutions rather than attempting to revolutionize regulations—a task more apt for larger pharmaceutical companies. “Clinical trial regulations do evolve, but nothing that we’re doing is in a grey area,” Young affirmed. “We definitely think that the regulatory bodies could do more to encourage sponsors to be innovative — but within an existing regulatory framework.“
Conclusion:
Lindus Health’s successful funding round underscores a significant shift in the clinical trials landscape. By focusing on comprehensive solutions and integrating AI-driven processes, Lindus has positioned itself to challenge traditional CROs and expedite the clinical trial journey. This disruption could lead to increased efficiency, engagement, and ultimately, faster and safer treatment development for patients. As the startup gains momentum, it has the potential to reshape how clinical trials are conducted, pushing the industry toward greater innovation and adaptability.
