We ran a Q&A With Michael Young, co-founder of Lindus Health on the challenges of 2024 and the company’s goals for 2025
Achievements and milestones
What are the most significant milestones your company achieved in 2024, and how have they impacted your organization or the industry?
The most important thing is the trials we’re running for our sponsors. We’re operating studies for groundbreaking interventions in oncology, neurology, diagnostics, and other therapeutic areas, and it’s amazing to be part of the process. As a company we grew rapidly in 2024 and gained a lot of attention with our ‘anti-CRO’ proposition. Sponsors are frustrated with the status quo traditional CROs operate under – running trials over-time and over-budget with fragmentation across systems and cross-functional teams. We’re showing researchers it doesn’t have to be that way.
Can you share a breakthrough in R&D or a standout product launch that defined your 2024?
We launched FUSED, a component of our proprietary eClinical platform, Citrus that improves clinical trial efficiency, correctness, and safety from two angles. First, we are building a unified system that understands a study deeply through a fully digitized protocol, eliminating ambiguities and enabling seamless study launch with accelerated analysis. Second, we’re applying AI to ensure our end-to-end system can not only guide and improve trial design from the start, but also proactively identify potential issues once a trial is underway.
Challenges and Lessons
What were the biggest challenges your company faced in 2024, and how did you overcome them?
The funding landscape remains challenging for many sponsors, which inevitably impacts us downstream. On the plus side, companies are starting to look into utilizing more innovative trial designs and automating processes through advanced technologies, which can significantly reduce R&D costs.
Were there any unexpected hurdles in regulatory, clinical, or market dynamics? How have these shaped your strategy moving forward?
Honestly, there haven’t been significant obstacles—the regulatory landscape has been highly supportive of innovative solutions for clinical research. The FDA’s guidance on decentralized clinical trials and related areas is only driving demand for our tech-forward approach to trial execution.
Industry trends
What major industry trends shaped your decisions in 2024, and how do you see those trends evolving?
We’re seeing a lot of growth beyond big pharma, particularly within biotech, medical device, and biopharma. These companies are typically under-served by traditional CROs, creating a unique opportunity for us to innovate within these domains. We anticipate this trend will persist, with big pharma increasingly prioritizing late-stage assets and commercialization efforts.
How did advancements in technology (e.g., AI, digital twin technology) influence your operations or research efforts this year?
This is core to what we do! We’re utilizing AI and other advanced technologies to streamline all aspects of the clinical trial workstream - from protocol development through data delivery. AI has been instrumental for us in predicting trial outcomes, shaping study design, automating manual processes, and much more.
Hopes and goals for 2025
What are your company’s primary goals for 2025, and how do they align with your long-term vision?
Our long-term vision is to be the first-choice research partner for life sciences pioneers, reinventing the way clinical trials are run altogether. 2025 marks a critical step in this journey, as we focus on scaling our operations and investing more in our technology offering to deliver higher quality trials than traditional CROs.
Are there new therapeutic areas, technologies, or markets you aim to explore in the coming year?
We’re continuing to improve our technology to better serve sponsors and our internal operations. This includes refining our AI to improve real-time monitoring, protocol generation and study design, and the delivery of instant biostatistics. These processes will be instrumental in our ability to support adaptive trials, which allow for modifications to study parameters without the need to amend protocols or halt trial activities.
Addressing challenges
What challenges do you foresee for 2025, and how is your company preparing to address them?
Uncertainty stemming from FDA actions and political changes is inevitable, but there will always be a demand for well-designed trials. Our focus remains on continuing to deliver excellence in what we do.
How do you plan to adapt to ongoing regulatory, economic, or geopolitical uncertainties in the year ahead?
Regulators often face undue criticism, when they are, in fact, actively encouraging innovation and advocating for more advanced trial methodologies. Their support is particularly evident in fostering diverse, geographically expansive trial designs that drive inclusivity and robust data collection.
