Biotech startup Lindus Health just made a big splash by adding MIT professor and Moderna co-founder Robert Langer, Sc.D., to its advisory board. Lindus aims to shake up the world of clinical trials with its “anti-CRO” approach that promises faster and more reliable trials for life sciences companies.
The addition of Langer, described as the most cited engineer in history, lends some major credibility to Lindus’ mission. When asked why he decided to come aboard, Langer cited the company’s “innovative approach to clinical trial execution” and technologies that he believes “should be incredibly helpful” to biotech in bringing new therapies to patients quicker.
Lindus combines software, data analytics, and operational expertise to form an “end-to-end” platform for running trials from start to finish. The startup claims it can tap into 30 million electronic health records to accelerate patient recruitment and uses AI to optimize other trial processes.
Cofounder Michael Young said he is “incredibly humbled” to have an advisor with the “unparalleled expertise and visionary contributions” of Langer. He expects the MIT professor’s insights will be an “invaluable asset” as Lindus continues its quest to deliver “innovative and essential” therapies to patients.
In the following Q&A, Langer and Lindus Health co-founder Meri Beckwith share more insights into how they plan on partnering to accelerate clinical trials, and the most critical limitations they see in how trials are typically executed today.
As an advisor to Lindus Health, what specifically about their approach stood out to you as being a potential groundbreaking for biotech and pharma companies ?
Langer: Lindus takes a very tech forward approach to clinical trials. What stands out is their vertical integration of the entire clinical trial process. They have built their own in-house tech platform that powers their CRO services in addition to their own site capabilities. This vertical integration allows them to create substantial efficiencies in the recruitment, data collection, and data processing leading to faster studies.
How do you see Lindus Health’s technology and capabilities helping to address some of the current bottlenecks or issues with traditional clinical trial execution?
Langer: Their technology that directly impacts recruitment speed is impressive. As part of their vertical integration, Lindus has built unique capabilities to access and query over 30M medical records based on study inclusion criteria. These capabilities can produce predictive models for forecasting recruitment pace and can selectively target outreach. Lindus has also been building AI tools to speed up other parts of the clinical trial process, like study start up.
Where do you see the biggest opportunities for improvement in how clinical trials are typically run today, and how is Lindus Health positioned to help drive this change?
Langer: The current incentivization structure often doesn’t work well. Many CROs currently are more profitable when studies are delayed or have issues due to being able to bill hourly. The biggest opportunity is really in Lindus’ ability to speed up the overall study by aligning incentives with drug companies, encouraging innovation and efficiencies, and producing better study experiences on the part of sponsors and patients
Dr. Langer, how might you apply your pioneering expertise in controlled drug delivery and tissue engineering to help Lindus Health streamline clinical trials?
Langer: The key is understanding the pain points that biotech and drug companies in specific therapeutic areas face. As part of my work with Lindus Health, I intend on sharing the specific challenges these companies face and pairing those challenges with the potential solutions Lindus can offer due to their unique position in being able to build their technology and capabilities to meet certain needs relevant to certain types of therapeutic studies.
Could you share any wisdom from your experience co-founding Moderna on how new technologies or processes could help accelerate the development of breakthrough therapies?
Langer: I’ve always embraced looking at new ways of doing things. Breakthrough therapies would not be possible without invention and innovation. The inventive spirit, and perpetually seeking a better way of doing things, will be important to ensure breakthrough therapies get to market faster and safer.
What specific contributions do you envision Robert Langer helping Lindus Health pursue?
Beckwith: Robert’s involvement will help us better design clinical trials, drawing on his wealth of experience from having been involved with dozens of pioneering life science companies.
This experience will also help us Identify market segments that are best fit for our revolutionary model. As a startup we want to remain focused on those therapeutic areas and clinical trial types where we can have the biggest impact.
Together, Lindus Health and Robert will continue innovating in how clinical trials can be best designed to both meet stringent regulatory requirements, while also focusing on getting new treatments into the hands of patients faster.
What is your take on the most critical limitations or challenges facing the efficient execution of clinical trials today?
Beckwith: Industry players, particularly pharma and CROs are responsible for the biggest challenges. Today clinical trials are often conducted in a manner that doesn’t adhere to the latest regulatory guidance on how technology can be used to deliver higher quality data and a better experience for participants. For example, there is an insistence on 100% source data verification while research shows this does not improve data quality or timelines. Robert Langer’s advice and guidance will be critical in helping us find ways to deliver better outcomes for sponsors and patients while improving overall data quality.
Filed Under: Biologics, Biotech, Drug Discovery and Development, Industry 4.0, machine learning and AI