How Tom Lemberg of Curebase opened clinical trials to everyone

Tom Lemberg is the founder and CEO of Curebase, a software platform that powers decentralized clinical trials. The company’s solution allows for patient recruitment and clinical data collection nearly anywhere, including at home, at pharmacies, community health clinics, or even drive-through test sites. Patients no longer need to live near a research hospital to participate in a clinical trial — they can participate from home and with their own physician.

Tom graduated from Harvard in 2014 and spent several years in the digital health industry, working for companies like Athena Health and Syapse. He launched Curebase in 2017.

Here, he shares his insights on how covid represented a turning point for clinical trials, and why decentralization is the future of the industry.

What problem were you trying to solve when you founded Curebase?

Clinical trials are a very large industry — there are tens of thousands of clinical trials in the world, it’s a $50 billion industry, and it’s very slow. The vast majority of patients cannot participate in clinical trials, and in our opinion that’s because of where they live. Clinical trials today are operated out of traditional academic hospitals — places like Stanford or UCSF, which are amazing research institutions, but most patients do not live within driving distance of them.

We wanted to expand clinical trials so that any patient, anywhere, could participate. We’ve made clinical trials more accessible to all patients and sped up the process of bringing new medicines to patients.

How did you realize that was a problem?

I’ve worked in health tech my whole career — that’s really what I love to do. I’m a software engineer by training and did my undergrad in computer science, but I’ve always loved to apply my background to health and medicine problems. I did bioinformatics research while at Harvard and worked for a cloud EMR company called Athena Health.

At my last company, Syapse, we were building a clinical trial matching engine that used data from EMRs and genomic testing providers to recommend clinical trials patients could participate in. We matched patients to clinical trials.

We spent a lot time building clinical trial software and working with patients and doctors. But ultimately, our customers were hospitals. I wanted to build something just for patients. Clinical trials really are putting patients first, and I wanted to start a company that did exactly that.

What is the most difficult part of being a founder in the digital health/clinical trials space?

It’s really important to balance having a good product with a good business model. You have to have an amazing product. In healthcare and life sciences, software products often are not best-in-class. So we try to build an absolutely best-in-class product, but at the same time, you have to have an amazing commercial organization.

You can build the best product in the world, but if you haven’t built the right partnerships and found the right customers, no one will use it. I think it’s an interesting balance where you have to do both things excellently.

How is the clinical trials industry evolving?

Our genuine belief is that the clinical trial industry is changing. Traditionally, it hasn’t put the patient first. But the future of the industry puts patients first and allows patients to participate in clinical trials at home and with their own physicians.

The whole industry needs to reinvent itself to make that happen. We need new software that makes it easy for patients to participate in clinical trials, and new regulatory guidance that codifies the best practices for engaging patients directly in clinical trials. The big industries are already rapidly adapting, and that’s partly due to covid. Major corporations, pharmas, biotechs, and device companies have all really taken it upon themselves to innovate as well. Everything is moving toward decentralization, and it’s exciting to be on the front lines of that.

How was the pandemic a turning point for your company?

COVID was really important. It changed the dynamics of the clinical trial industry. We run decentralized clinical trials, where patients steer their own participation. We don’t typically work with traditional academics — most often we go directly to patients and their doctors. This model was pretty cutting-edge when we started, but it became much more mainstream with covid because traditional clinical trials were having trouble getting patients on site. There were travel restrictions, and it wasn’t safe to show up in person at hospitals.

The pharmaceutical industry regulatory bodies quickly adapted and embraced ideas that we had been championing for almost three years. We had built an amazing foundation and customer base, and we had gained the credibility, when we were one of the only companies innovating and on the cutting edge. So we were really well positioned with a huge head start when COVID occurred.

Have you run trials for COVID diagnostics?

We’ve had the privilege of being on the front lines fighting COVID. We’ve run six different COVID studies for diagnostic products and medical devices that have helped diagnose covid and prevent the spread of the disease. It’s a privilege to have been able to help fight the pandemic that way. Again, we were uniquely positioned because we had been running decentralized clinical trials and reaching patients where they live for three years. Now, our industry has accelerated in innovation because of the demands and restrictions placed on it during the pandemic.

Can you give an example?

Luminostics received emergency use authorization from the FDA for their Clip COVID Rapid Antigen Test, using data that we helped them obtain. We did it in a really unique way: through covid-drive through testing sites. If you were a patient in SoCal, you could enroll in a clinical trial at a community COVID drive-through test clinic. So we were able to reach patients right where they live, in their communities, and operationalize clinical trials. We’re changing the geography of where clinical trials are taking place.

What are you most proud of?

Proving that our recruitment is quick. It’s one thing to build a software platform and sign up customers, but I think to actually run clinical trials, get the patients enrolled, and collect their data — that’s been amazing. We’ve been able to drive enrollment rates of 200–300 patients per month into some of our clinical trials. We’ve been able to start trials as quickly as two to four weeks. We’re driving results for our customers.

I think in some industries, you sell your software and people use it, but in our industry, it’s a real challenge to recruit people into clinical trials, get them to enroll, and participate in this complex procedure. But we did it. Time and time again, we’ve enrolled hundreds of patients into clinical trials that we started rapidly, and that’s an amazing thing.

You’re hiring currently. What’s been your approach to that?

There’s a couple of things we’ve done to find the right people. We look for people who are passionate about health and medicine. I think a lot of people have been affected through their personal life, by knowing a patient. Or maybe their parent or other relative works in the medical field. People want to help.

There’s a lot of people out there who want to make an impact on health and medicine. We look for those people; everybody here at Curebase wants the same. And if you have different skills — they could be anything from sales to HR to tech — this is a place where you can use them. For us, that’s been a huge part of our recruiting capability. We’re working on something that’s genuinely meaningful, and a lot of people are looking for that.

What advice do you have for first-time founders?

This has been my whole career: building products for patients and doctors. It’s what I love to do and I saw an immense opportunity that I was passionate about — there really wasn’t going to be a way to stop me from working on it. It is obviously challenging, and there are many ups and downs, but the fact that I truly have conviction and passion for the problems I’m solving means that I’m happy to continue working through them to grow the company. Other folks should make sure they have the passion and conviction for what they’re doing as they embark on their journey.

What’s the future of clinical trials? What’s your ultimate vision for the industry?

It’s still early days here, but my dream for the industry is for patients to enroll in interventional drug trials entirely with their own doctors. So basically, if you’re a patient with a serious condition, you could go online and learn about a new treatment in research that could improve your quality of life, or even save your life.

You’d be in the driver’s seat: you could sign up for the clinical trial online and the drug would be shipped to your physician. The two of you together could use a research treatment that could save your life, and that allows you to contribute to research into a disease that has affected you tremendously. And you could do it all right where you live, from your own home and with your own doctor. I think that’s where the industry will go one day, and we want to be the champions at the front of the pack leading that.

What’s next for Curebase this year?

Our early customers were amazing startups. Now, we’re excited to be launching studies with major enterprise clients who are at the cutting edge of their fields. We’ll be running clinical trials that will involve thousands of patients across a broad range of geographies and therapeutic areas.