Dr. Henry Anhalt appointed VP of Medical Affairs and Lead for Diabetes Trials at Science 37; A new era of virtual, site-less clinical trials with telemedicine and connected diabetes devices? – January 6, 2018

Los Angeles-based Science 37 recently announced that industry veteran Dr. Henry Anhalt has joined the team as Vice President of Medical Affairs and Lead for Diabetes Trials. The fascinating company enables “site-less” clinical trials – a trend we hope to see expand in diabetes as connected glucose monitoring and insulin delivery devices proliferate, enabling passive data collection and a whole new era of evidence generation at scale.

Dr. Anhalt will work with sponsors to engage investigators, perform clinical trial feasibility analysis, and provide feedback on protocols, outcomes, and endpoints. Dr. Anhalt brings tremendous research and industry expertise from his time as CMO of the T1D Exchange, medical director of the Artificial Pancreas program at Animas, and senior medical director at Sanofi responsible for the Toujeo launch in the US, as well as in private practice. He is currently the only endocrinologist on staff, but he mentioned during our conversation that the diabetes and metabolism program at Science 37 is “nascent but rapidly growing.” Notably, Dr. Anne Peters is listed as a Physician Expert, and according to Dr. Anhalt, was critical when the company was first looking at the feasibility of conducting diabetes research.

Science 37’s platform enables trial sponsors to access a diverse population through NORA, a research platform and app that leverages video-based telemedicine and a mobile app to engage patients, receive electronic consent, and collect and store data.

In an interview with Dr. Anhalt, he stressed that Science 37 provides end-to-end solutions for clinical trials, developing protocols and technology all within house. Science 37’s nearly 100 investigators collaborate with a broad range of companies and recruit patients with strategic marketing – Dr. Anhalt shared that 87% of eligible patients would like to participate in clinical trials, but less than 3% actually do. Digitizing the process not only increases the speed at which a study is filled, but also the diversity of its participants. Indeed, Apple’s efforts with Research Kit and the new Apple Heart Study confirm this point on access – virtual clinical trials can enroll a far bigger sample size orders of magnitude more quickly than traditional studies.

Dr. Anhalt also noted that Science 37 can offer improved participant diversity, sometimes tenfold more than the level typically expected. Patients can upload their own data via the NORA app, and if more intensive testing is required, Science 37 can dispatch a nurse to the participant. If study supplies are needed, they are shipped to a participant’s home. Nice!

In October, Science 37 announced the completion of a phase 2b, placebo-controlled RCT in acne; notably, the trial was run 100% virtually, a first-if-its-kind study. Could we see this expand to diabetes drugs? Dr. Anhalt was unable to provide details on diabetes studies, but shared that several players have approached Science 37. Indeed, Sanofi is an investor, and the homepage’s partners section includes Lilly, Novartis, Genentech, and Amgen. “Diabetes (Type 1 and 2)” are listed under “Upcoming Research”, and Science 37 is enrolling in a diabetes probiotic study in type 2, a NASH study, and is listed as a trial site on ClinicalTrials.gov for Lilly’s currently-recruiting (just posted) smart pen trial investigating missed meal boluses (n=68; blinded and unblinded CGM).

Given the unique ability we now have in diabetes to continuously measure relevant metrics and transport them digitally, there’s lots of potential for diabetes trials to take advantage of Science 37’s virtual model. We wonder if Science 37 will use CGM data and work to make diabetes apps interoperable with NORA; to this, Dr. Anhalt cited his background in devices and could only reply, “There’s a reason the company hired me.” We have high hopes for more virtual clinical trials in diabetes, decreasing cost and increasing speed, volume, scale, diversity, and convenience.

• What trials could Science 37 help run in diabetes? Perhaps the team could help validate outcomes beyond A1c with connected CGM; directly compare insulin automated with hybrid closed loop vs. smart pens; look at various remote coaching and education programs, paired with BGM vs. CGM; and investigate the impact of different diets with CGM data (taking Adam’s diaTribe carb experiments to scale).  
• Last April, Science 37 raised $35 million in Series C Financing. The round was led by Glynn Capital Management with participation from Google Ventures and Amgen Ventures. Existing investors also participated, including Lux Capital, Redmile Group, dRx Capital (a Qualcomm and Novartis joint investment company), Otsuka, and Sanofi Ventures. Total invested capital since inception is now nearly $73 million.

• Science 37 is currently advertising seven studies open for recruitment on its website, mostly focused in dermatology. Interestingly, the Lilly smart pen study is not listed on Science 37’s website. We’ll continue to monitor this webpage, as we fully expect Science 37’s work to delve further into diabetes.

-- by Maeve Serino, Brian Levine, Adam Brown, and Kelly Close