Tech startup Paradigm lands $203M to get more patients into clinical research, accelerate drug trials

A new tech startup wants to disrupt the clinical trial process and landed $203 million to help scale up its technology.

Paradigm, a clinical trials data and patient-matching platform, aims to open up access to research to boost patient recruitment and speed up drug development. The company was conceived by Arch Venture Partners and co-incubated with General Catalyst. Last year, Paradigm also acquired Deep Lens, a clinical trial patient recruitment tech platform focused on oncology, for an undisclosed sum.

Paradigm's series A round marks the third-largest funding round in healthcare so far in 2023, behind Monogram Health's hefty $375 million raise and ShiftKey's $300 million round.

The company plans to use the financing to expand its existing platform and scale its partnerships with health systems and life sciences companies.

Paradigm CEO Kent Thoelke has a long career in life sciences, having spent more than 25 years overseeing drug development and clinical trials at healthcare companies. He saw firsthand the inefficiencies in the current clinical trial process.

"The clinical trials process takes years, and, what was frustrating especially, was that my dad died of a brain tumor and I have multiple family members who have cancer. If a lot of those drugs could come to market years sooner, then think about all those patients' lives that could have been saved," Thoelke said in an interview.

He recognized the need to "change the paradigm" of clinical research, but there was inertia in the industry to make any significant changes. Then COVID-19 hit, and life sciences companies quickly pivoted to using technology for remote clinical trials.

"But they were all kind of temporary measures, and they weren't really deployed at scale," he noted.

While Thoelke was working as chief innovation officer at clinical trials company Icon, Robert Nelson, co-founder and managing director of Arch Venture Partners, reached out to him with a proposal.

"He said, 'What if we just change the whole model? Let's just blow up the model that exists and just reimagine it,'" he said. 

The idea behind Paradigm is to build a technology-enabled, scaled clinical research ecosystem to tackle inefficiencies and enable more patients to have access to clinical research to drive down the timelines and the cost. The Paradigm platform was designed to reduce the operational burden on physicians and healthcare provider organizations and improve access for patients. 

There are significant barriers to patient participation in clinical trials, including lack of access to trials in community settings, restrictive eligibility criteria, burdensome trial protocols and lack of financial support. Healthcare providers, particularly community clinics, are under-resourced to support clinical research at scale and lack an adequate portfolio of therapeutic trials to serve their populations, which exacerbates enrollment disparities.

These access disparities result in trial participants who may not necessarily be representative of the broader patient population the therapy is intended to serve. 

Currently, only 3% to 5% of eligible patients participate in clinical studies, according to data from the Food and Drug Administration (FDA). Participation rates for cancer studies range from 2% to 8%, according to a recent study in the Journal of the National Cancer Institute. 

The industry also is trying to improve the diversity of clinical trial participants. FDA data show that in 2020, 75% of trial participants were white while 11% were Hispanic, 8% were Black and 6% were Asian.

So how does Paradigm aim to tackle these challenges through technology? The company wants to build a seamless infrastructure implemented at community healthcare provider organizations that gives healthcare providers and trial sponsors an opportunity to work together. The idea is to integrate the two worlds of clinical care and research by integrating with providers' electronic health record software. Paradigm's software would then filter relevant information into the clinical trial data.

"Those same data pipes we've created allow us to pull the data from your electronic medical record and populate the electronic data capture forms that provide the data to the pharmaceutical companies," Thoelke said, "Today, all of that is labor-driven. If you're a small- to medium-sized provider, you can't participate. You only have the labor to see your patients and treat them. You don't have the labor to spend 16 hours entering data for clinical trials. We're trying to automate all of that so that now everybody can participate in research. We want to create a technology-enabled layer so that any physician anywhere can put a patient in a study."

He added, "It's a big, long-term play, it's a scaled play. Rather than a technology solution that treats 10,000 or 100,000 patients, this is about reaching 100 million patients or 150 million patients. Fundamentally, it's changing the entire healthcare delivery model so that clinical trials are delivered as part of routine care and not as something separate that sits over here."

Paradigm doesn't charge healthcare providers to use its technology. The company will charge pharmaceutical companies for finding patients and administering the trials.

Thoelke anticipates Paradigm's model will boost patient recruitment into clinical research, which should help to shorten the timelines for developing new therapies.

"So instead of trials taking two or three years, you're doing it in eight or 12 months. For pharma, that cost-benefit model is massive. We're not under any delusions that we're going to change the model tomorrow. For the next year, it's really about growth for us," he said.

The acquisition of Deep Lens, which had an established footprint of several hundred clinical trial sites, according to Thoelke, gave Paradigm a "nice runway."

"It gave us established practices and gave us some revenue but it also saved me a year of building the architecture," he said.

The company is now focused on building out its tech capabilities and will either build or partner with other companies, he noted, and plans to deploy its platform "at scale" in 2024.

Paradigm was able to raise a hefty series A even as the market constricts and investors show more caution after the wild ride in 2020 and 2021.

"Even though the market turned, it wasn't a hard raise for us because people know, fundamentally, that there's just so much opportunity if we can fix healthcare. I don't think anybody believes this is a short fix. If it was, we would raise $5 million or $10 million and launch a tech company. But instead we raised several hundred million, and I think we know we have to raise a lot more," Thoelke said.

Paradigm’s financing was co-led by Arch Venture Partners and General Catalyst and was joined by funds including F-Prime Capital, GV, LUX Capital, Mubadala Capital and Magnetic Ventures along with strategic investors including the American Cancer Society’s BrightEdge fund.

"Clinical research is ready for a reboot," Arch Venture Partners' Nelson, who also serves as Paradigm board co-chair, said in a statement. "Today the system is broken in almost every respect—patient access is too narrow, incentives are misaligned and poor trial design slows development. We saw an opportunity to fundamentally rebuild the system and fix the business model. The Paradigm team has the right experience to overhaul clinical research, and we're committed to supporting their execution of our shared vision.”

Paradigm joins a growing roster of companies targeting the clinical trials space. Other companies that have developed technology to recruit patients and run clinical trials include digital health tech company Huma, Medable, which raised a $304 million series D at a $2.1 billion valuation in 2021, and new startup Crescendo Health, to name a few. Inato also built a platform to help expand the pool of patients for clinical trials.

Even EHR company Epic announced in September its own clinical trials matching program. Major retailers CVS, Walgreens and Kroger also have launched their own clinical trials business arms.

Thoelke points out that Paradigm built an executive team with a deep bench of life sciences and drug development expertise. 

Executives who have joined the company's C-suite include Milind Kamkolkar, who served as Cellarity's chief digital officer along with roles as chief data officer at Sanofi and global head of data science and AI at Novartis; Jonathan Hirsch, the former founder and president of Syapse; Elijah Meerson, former CTO at Orchard and VP of engineering at Flatiron Health; Jay Trepanier, who served as senior vice president of FP&A at PRA Health Sciences and chief operating officer at Science 37; and Kathryn Lang, former VP of outcomes and evidence at Guardant Health and global head of oncology, real-world evidence at Pfizer.