Three decades after becoming friends at Duke University and after years of running separate consulting firms, Ed Tourtellotte and David Kelleher came together in late 2015 to bring to fruition a tech company to help support clinical trials for diseases that had personally affected them.
Now, their company, 4G Clinical, has snagged more than $230 million in funding from Goldman Sachs Asset Management to expand their randomization and trial supply management (RTSM) technology further into the Asia Pacific region and into more clinical trials.
Kelleher and Tourtellotte were not going to return to school for Ph.D.s in biochemistry to discover new molecules, but they wanted a way to help with the development of treatments for diseases such as multiple sclerosis and triple negative breast cancer, which have impacted the co-founders' families, CEO Kelleher told Fierce Biotech in an interview.
“The proximity to disease and that purpose is super important and is the bedrock of this business," Kelleher said. About a year and a half ago, 4G Clinical was awarded its first MS study and first triple negative breast cancer study in the same week, which was a "pretty emotional time" for the founders, the CEO said.
The funding, disclosed Tuesday, was the result of a lot of inbound interest that led to a quick process involving six "top notch" private equity firms, Kelleher said. “Their brand, their global reach, is something that will undoubtedly help fuel our ambitions," the CEO said, referring to Goldman Sachs.
The investment, which comes on top of more than $7 million raised in 2016 from Schooner Capital, will go toward increasing investments in the Asia-Pacific region, where 4G Clinical has a Tokyo office, as well as boosting resources upstream in protocol development and downstream into patient engagement solutions and similar areas, Kelleher said. 4G Clinical is also late in the recruiting process for a couple senior leadership roles.
After launching its first study in February 2017, 4G Clinical is now used in about 250 concurrent studies across the world, according to the company, and has a goal of reaching 370 live studies by the end of this year, Kelleher said.
With plenty of runway from Goldman Sachs, 4G Clinical has the fuel to continue last year's massive growth, at more than 100%, as the company looks to take market share from legacy RTSM providers like Dassault Systems' Medidata, Parexel, Ennov and ERT's Bioclinica.
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Tourtellotte, 4G's chief technology officer, brings a wealth of experience in the space, having previously sold his interactive response technology (IRT) system to Bioclinica. He also helped build the parameter-based IRT, called Impala, that is used by Pfizer to run about 80% of its clinical trials, Kelleher said.
4G's system is different because of its so-called natural language processing capabilities, which allows for quicker study configuration and easier protocol changes, Kelleher said.
Industry standard is for a sponsor to write a protocol, then give to a vendor to write the system specification for the sponsor to sign off, and then that is given to someone else to configure or build the software from scratch, Kelleher said. 4G, however, takes the protocol and writes the spec in a compressing, specific way for the natural language processing to configure the study immediately, the CEO said.
The system works across trial phases and is not geared toward specific indications, Kelleher said. The company's study portfolio wasn't heavily indexed toward COVID-19 therapeutics and vaccines in 2020, at only 10% to 15%, Kelleher said. That's a positive, he said, because it meant other critical research was not being hindered too badly.
During the beginning of the pandemic, in April 2020, 4G also rolled out a previously designed direct-to-patient capability that Kelleher said the market wasn't asking for prior to COVID-19.
“In most cases, now, when people are designing trials, they’re at least considering that type of scenario where they may need to service a customer at their home. When I think about decentralized clinical trials more broadly, I think it’s going to end up being a hybrid," Kelleher said.