Monday, May 8, 2017
Science37: Using Technology To Enable Remote, Clinical Trials, with Belinda Tan
Story by Benjamin F. Kuo
The world of clinical trials, required to gain regulatory approval for new pharmaceuticals, has always been difficult, with such challenges as finding patients willing to travel to participate in trials, patients willing to carve out the time required for those trials, and issues with reaching a broad patient population. Los Angeles-based Science37 (www.science37.com) is using technology--mobile apps, telemedicine, and more--to overcome those and other challenges. The company is backed by more than $67M in funding from such investors as Glynn Capital Management, GV (formerly Google Ventures), Amgen Ventures, Lux Capital, Redmile Group, dRx Capital (a Qualcomm and Novartis joint investment company), and Sanofi Ventures. We caught up with co-founder and Chief Medical Officer Belinda Tan to learn more about the company.
What is Science37?
Belinda Tan: Science37 is a technology-enabled, clinical research company. What makes us different, is we are mission driven. Our mission is to accelerate the biomedical reach to patients first. What we've done, is we've brought four main pieces together, telemedicine, clinical research, regulatory expertise, and technology to enable transformation in the whole process and way we deliver clinical trails. The main problem, which has been haunting the industry for many years, is that trials take too long, and are too costly. What we are doing has the potential to allow companies to develop more, novel treatments, for conditions, more effectively.
One of the areas where people are starting to look at innovation, is using technology to make trials more accessible to patients. The main problem which we found with trials being so slow, is not being able to recruit patients. One of the major barriers to finding patients is geography. When you think about the traditional clinical research opportunities, they are at the UCLAs and USCs of the world, the major research institutions. However, if you are not a patient within a two hour drive or with access to these clinical settings, you'll never know about a trial and never have the opportunity to participate. Even if you do hear about a trial, most patients are just like you and me. They have jobs, they have kids, they have to deal with day to day activities of life. It's really hard to do the study which requires you to drive weekly to a clinic, find parking, deal with traffic, and wait in a waiting room. All of these barriers are very hard barriers to overcome.
What we've done, is using technology, we are literally bringing these trials to patients in their homes, delivered using mo bile devices. We've handled all the privacy issues, and HIPAA compliance issues, and also have literally worked directly with sponsors to build trials and procedures, so that all of the tests, visits, questionnaires, and data can be collected in a patient's home using a mobile device, and when needed, use a mobile nurse to do a procedure or a local doctor ten minutes away to do the procedures. We also ship drugs to patients, so they don't have to go to a clinic to get those. That's enabling more participation from patients. The industry has been talking about democratizing clinical research, so it's not just restricted to traditional clinic sites, and is not restricted by socioeconomic income and status. What better way to do that then let you participate from wherever you are?
What stage of clinical trials do you focus on?
Belinda Tan: Most of our trials are Phase 2 and Phase 3 studies. We're now starting to plan to open this to Phase 4 studies. These are all the kinds of trials which are more possible to do in the home. Phase I studies typically require patients to be heavily monitored in a clinic, so we don't do many, though we've had some interest from sponsors about some pretty low-risk Phase I studies. Although we haven't closed that off completely, it's not really our focus. We also do a lot of prototyping and proof-of-concepts for sponsors trying to dip their feet into this and to evaluate their IP. We do what is basically a quick-and-dirty prototype, to see what kind of a trial they can design, get some learning, and take it to the next step for a more fully backed Phase 2 trial.
How did you and your co-founder decide to address this area with your startup?
Belinda Tan: My co-founder, Noah Craft and I, were actually both physician-scientists, and both trained here in Southern California. We met many years ago when we both went to UCLA's Medical Scientist training program, a national program that trains MD-PhDs. We both have those dual degrees, and we both have always been curious about trying to change the industry. Even in clinical care, we collaborated quite early on a project. We are both trained as clinical dermatologists, and we were looking to increase access to dermatology in rural communities. That's an area that lends readily to dermatology, because it's much easier to use photos, and use what we call store-and-forward, to send photos and which does not require real-time access to clinicians. We helped to start a company, DirectDerm, where we were able to deliver telemedicine care to patients in Central California and other rural communities where dermatologists were just not accessible. Based on that, and prior work Noah had done at VisualDx, which utilized technology to assist clinicians in making better diagnosis, we used the expertise in telemedicine we've developed, and our background in research, to come together to start this company. I should also mention that a lot of credit goes to our founding team, which also includes experts in regulatory laws, and a lot of other aspects of telemedicine, which really allowed us to build the framework of what we're doing today.
Has there been any issue with the FDA accepting data from this model in clinical studies?
Belinda Tan: We've worked very closely with the sponsors we've already done trials with. Among the big pharma sponsors, many of them are already talking to the FDA about using telemedicine in trials, so this is not news to the FDA. But, it does require executive, even though there's more and more evidence that it's equivalent and safe. The FDA's concern, number one, is safety and efficacy of drugs. In terms of safety, we can all agree that, based on how current clinical research and healthcare delivery works, telemedicine is here to stay. The major payers are all using telemedicine to take care of patients, and it's just a matter of time, before more and more of those guidelines are established, so we can adopt them and use them for clinical research. We've collaborated with the big sponsors, and given them input on how this model will work with telemedicine, in view of their studies. The FDA is aware of that, and now thi sis something that the industry is going to move towards, and they want trials to be more patient friendly, and they want to enable more people to access trials. The other thing I should mention, is that one of the FDA's efforts is to help to increase the diversity of trials. We've all known, for a long time, that clinical trials are primarily Caucasian, and it doesn't reflect the true ethnic background of how America iis made up of. The FDA and scientists know this, and want to make sure the science does not compromise safety if there's a different in the response of Asians, Latinos, Blacks, and so on. The FDA is open to new innovations in technology and telemedicine to help increase diversity and get more minority participation in these studies.
We see you have the backing of Google?
Belinda Tan: We have the backing of GV, which is very specific about saying they are not Google. After our Series B, we got a lot of attention among the different tech investor circules, and particularly the Googles, Facebooks, and Apples of the world, who are all getting into health care. They are all looking at how to use mobile health and how to connect patients using technology. One of our investors put in a call to GV and we had a conversation, which led to the Series C, which we had the fortune to get so quickly.
What's next on your plate?
Belinda Tan: We're hiring like crazy. We have a lot of commitments to some really supportive sponsors, in terms of collaboration. Sanofi is one of the most which has been covered, but we're also talking to similarly large sponsors to set up strategic alliance and partnerships, to work together to make this model work and to scale it internationally. With all this funding, we're hoping to hire as quickly as we can, specifically in clinical operations and technology, and really build out the teams we need to execute on the studies we're planning with our partners and other sponsors we've already been talking to.
Thanks, and good luck!