Q&A: What attracted Moderna’s Co-founder to the board of Lindus Health?

Earlier this year, Robert S. Langer, Co-founder of Moderna and MIT Professor, made the decision to join the advisory board of Lindus Health, a company labelling itself as an anti-contract research organisation (CRO) and which is dedicated to running faster and more reliable trials for the life sciences industry.  

Here, DDW Editor Reece Armstrong speaks to Professor Langer and Meri Beckwith, Co-founder of Lindus Health about the decision and the company’s goals and strategies.  

RA: What encouraged you to join Lindus Health’s advisory board?

RL: I’m interested in those looking at the challenge of how we accelerate the development and commercialisation of novel therapeutics. The clinical trial process is one of the biggest challenges any organisation faces when looking to bring therapies to the market. Lindus Health directly tackles these issues and seeks to dramatically speed up the clinical trial process. 

RA: We know of the challenges for navigating clinical trials within pharma and the risks they bring to companies. What is it about Lindus Health’s approach that excites you?

RL: Lindus takes a very tech forward approach to clinical trials. What excites me is how they look at the entire clinical trial process, as opposed to a small portion of it. Many of the issues around trial speed are borne out of fragmentation of all the tools needed to execute a study. Lindus’ vertically integrates 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 recruitment, data collection, and data processing leading to faster studies. 

RA: In terms of your own background and experience, what is it you’re looking to bring to Lindus Health?

RL: I approach this from an understanding of the pain points that biotech and drug companies in specific therapeutic areas face. As part of my work with Lindus Health, I am keen on sharing the specific challenges these companies face and pairing those challenges with potential solutions Lindus is able to offer due to its position in being able to build its technology and capabilities to meet certain needs relevant to certain types of therapeutic studies. 

RA: What sets Lindus Health apart from other CROs? 

RL: One of the key differentiators of Lindus is its fixed pricing and milestone-based approach. They offer a fixed quote for the execution of an entire study. Lindus is also able to conduct clinical trials much faster than conventional CROs- it can directly recruit patients from its electronic patient health record data base and has developed machine learning approaches that enable rapid clinical trial design. Lindus has already conducted some 80 clinical trials, recruited over 20,000 patients, and helped secure regulatory approval for a number of products in the US and Europe. Lindus Health is more than just a CRO. I like to think of Lindus Health’s’ offering as an ‘All-In-One CRO’ or ‘CRO-plus’. Nearly all CROs only offer a set of services but require sponsors to work with multiple providers for the software needed to collect and store data, and sites to recruit and manage patients. Lindus is able to provide a true ‘clinical trial in a box’ experience so everything from recruitment, patient management, and study oversight are all done in-house. This helps the company deliver on a faster, more efficient clinical trial. 

RA: In the announcement you mention Lindus Health’s technological and site capabilities. Could you explain how these facets can help companies bring their therapies to patients faster?

RL: Lindus Health’s technology that directly impacts recruitment speed is impressive. As part of its vertical integration, Lindus has built capabilities to access and query over 30M medical records based on study inclusion criteria. With this it produces 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. Lindus also offers in-house site services and can act as its own virtual/hybrid site to recruit patients from much larger geographies than physical sites. These technologies and site service offerings are beyond the scope of what CROs usually offer. 

RA: What are some of the biggest bottlenecks pharmaceutical companies face when conducting a clinical trial?

RL: Recruitment is always a major issue. Sponsors spend a lot of time sourcing many vendors and sites to fully recruit studies, and many studies fail for the sole reason that they are unable to fully enroll the target population. Lindus’ capabilities in recruitment are helping pharmaceutical companies overcome these challenges. 

RA: Considering your career, what are some of the major lessons you’ve learned about the clinical trial process?

RL: I am keen on always looking for ways of improving our approach to clinical trials. I’ve found that too often, once someone has gone through the process of a clinical study, they fall back on doing it the same way every time. 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. 

Questions for Lindus Health’s Founder, Meri Beckwith 

RA: How excited are you to have Robert S. Langer on the advisory board for Lindus Health? 

MB: In short, I’m really excited; 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.  

RA: Why is the current CRO model ‘broken’? 

MB: The typical ‘pay by the hour’ business model means CROs make more money the worse a clinical trial goes! We’ve heard numerous horror stories of CROs finding ways to delay or even sabotage clinical trials. This impacts not only clinical trial sponsors, but ultimately patients and the public. 

This ‘pay by the hour model’ means CROs have no incentive to adopt technology to make clinical trials more efficient, or to provide a better experience for patients, both of which would result in better outcomes for sponsors too. 

RA: What were some of the biggest challenges in developing Lindus Health as an all-in-one CRO? 

MB: Just that – ensuring we could deliver end-to-end clinical trials for leading sponsors, while also ensuring we did this with radically better results than a typical CRO. For us, this meant overall study timelines that were twice as fast as the next fastest CRO and ensuring high quality data. This includes everything from protocol and trial design, through to site and patient feasibility, recruitment, and study execution. We met this challenge by focusing initially on a carefully defined sub-segment of clinical trials, before expanding to more therapeutic areas and types of clinical trial.  

RA: With Robert on the board what is the future looking like for Lindus Health?    

MB: Now that we have Robert on board, the next steps are clear – continue delivering radically faster, more reliable clinical trials for sponsors. With Robert’s help and feedback, we’re adding support for new therapeutic areas. Together, we’re also thinking about slightly longer-term projects that can really transform the way clinical trials are run. For instance, incorporating any statistical analysis plans directly into the study database, so that analyses can be carried out in real time. There’s a lot of potential avenues to explore, but sponsors and patients are rightfully demanding new approaches!  

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