When you’re looking to make changes to how clinical trials are run, it’s helpful to work with one of the top minds in the industry. By welcoming Robert Langer to its advisory board, that’s exactly what Lindus Health hopes to do.
Langer, an MIT professor and co-founder of Moderna, is the author of more than 1,500 scientific articles, holds hundreds of patents and has helped build an array of biotechnology firms.
Langer’s addition to the advisory board of contract research organization Lindus, which calls itself “the anti-CRO,” positions the company to address some of the most pressing challenges in clinical research. Langer’s mind for biotech business may also help the company experiment on the standard CRO model.
Since the COVID-19 pandemic, traditional clinical trials have become more flexible, according to industry research from WCG. With clinical trial starts expected to increase and new technologies emerging at a rapid clip, CROs like Lindus are exploring ways to stay ahead.
Change is coming
Langer knows well where CROs often fall short.
“I think CROs haven’t changed much [in the last decade],” Langer said in an email interview. “There are some recent attempts to incorporate AI and virtual clinical trial techniques to increase efficiencies and expand reach of studies [but] in general CRO processes have remained unchanged.”
Lindus aims to remove some of those longstanding bottlenecks in the clinical trial process. And Langer isn’t the only big name with a hand in Lindus’ path forward — the company has raised more than $24 million from Peter Thiel as well as other technology and biopharmaceutial investors.
Part of Lindus’ strategy involves a new financial model to share the risk of clinical testing.
“The incentives of CROs are currently totally misaligned with sponsors and with patients — CROs typically earn more money from projects that are delayed, due to their billable hour business model,” said Meri Beckwith, co-founder of Lindus, in an email.
Founded in 2021, Lindus consulted with Langer on what would become the company’s business plan. Beckwith said Langer was critical in shaping a model based on hitting clinical milestones so the CRO and the drugmaker have the same goal. Milestones can also help share the risk since the contractor and the client are both in the same boat, Beckwith said.
“Sponsors are understandably risk-averse,” Beckwith said. “No one gets fired for hiring [CRO giant] Iqvia.”
Under one roof
Langer also sees the end-to-end nature of Lindus’ model as an advantage.
“By building their own robust tech platform and internal site capabilities, they have been able to streamline clinical trial execution,” Langer said.
For example, software that allows for quicker study configuration can help get a trial started. And since recruitment is often a bottleneck — many studies don’t recruit on time, according to Langer — expanding a program’s reach through virtual assistance and access to electronic medical records can grow the patient pool faster.
Lindus has also developed machine learning software to write study protocols and capture data with AI monitors.
“[Langer]’s involvement will help us better design clinical trials,” Beckwith said, noting Lindus is identifying market segments that work best with its model. “He has consistently been at the forefront of new modalities like gene therapy, tissue engineering and transdermal drug delivery.”