Recently Biospace’s Mark Terry interviewed Science 37’s Chief Medical Officer Jonathan Cotliar to shine some light on the topic of virtual clinical trials. The vast majority of today’s clinical research is conducted at research sites—whether they be academic medical centers, clinics or other providers—often in metropolitan areas. Accessibility challenges exist in the current research paradigm as many patients live in outlying areas and cannot easily travel into a city to a provider clinic. Moreover, with the advent of cloud computing, big data, mobile and AI we will see a move toward “patient-centered” trials vs. “site-centered” research, or so some predict.
Science 37 developed a “virtual” clinical trial platform on a telehealth platform—validated and hardened to pass pharma sponsor audits and agency inspections. In this article/interview Terry first introduces FDA guidance on improving diversity of patient populations in clinical trials. The focus—involve more historically underrepresented populations—inclusive of this mission is to “Make Trial Participation Less Burdensome for Participants.”
How Can Technology Make A Study Less Burdensome
Terry points to the guidance that states “Reduce the frequency of study visits to those needed to appropriately monitor safety and efficacy and consider whether flexibility in visit windows is possible and whether electronic communication (e.g. telephone/mobile telephone, secured electronic mail, social media platforms) or mobile technology tools can be used to replace site visits and provide investigators with real-time data.”
Science 37’s NORA leveraging a telehealth platform and smart apps brought together a unified approach to managing a remote or virtual trial—with the hopes of making it easier for patients that cannot travel; or face constraints of one type or another—more easily participate in a clinical trial. NORA represents the general movement toward “patient-centered” trials vs. the traditional “site-centered” trials.
Science 37 Interview
The premise behind the founding of this venture (by two physician-scientists) was to make clinical trials more patient-friendlier or patient-centric so as to “add speed to drugs being delivered to the marketplace and gain access to folks who want to participate in clinical trials but were limited by the fact that they were too far from the research site or could not easily leave home.”
NORA: Network Oriented Research Assistant
The tech underpinning of Science 37, designed for clinical trial operations, is loaded on devices and supports telemedicine-based clinician-patient interactions. Cotliar conveyed to Bispace’s Terry that “NORAM allows a lot of these operational considerations to be performed under one roof or platform; point-of-care solutions are embedded, including e-consent, integration with medical devices, bio wearables, and video and telemedicine modules that coordinate research activities in the patients’ homes so doctors, nurses or other stakeholders who are geographically dispersed, can interact together.”
Industry sponsors such as Boehringer Ingelheim, Eli Lilly, Sanofi and UCB have signed up with Science 37’s NORA to conduct decentralized trials.
We recommend the reader visit the link below and visit Biospace to read this interesting interview. We provide the reader some intel on NORA and Science 37.
Science 37 Current Situation
The venture has grown to nearly 200 employees. TrialSite News estimates between 175 to 200 and a spend totaling between $25 to $30 million annually or $2 million to $2.5 million per month. We don’t believe that their revenue recognition has caught up to their spend rates. Based on a review of roles it would appear they are transitioning to attempt to monetize the technology via a range of associated services dollars but investors will not value this cash stream at the same levels as SaaS annuities. Undoubtedly with the change in strategy (more on the PPD participation below) the company will seek to build in higher pricing schemes within bundled CRO contracts as one of possibly a few different strategies.
Science 37 Transition
Founded in 2014, the team has raised a considerable $100+ million in four financing rounds. Founders Belinda Tan and Noah Craft led the charge but with enthusiasm, vigor and scientific flare but with the latest- D round funding they will not be part of the management. But surely the hat gets tipped to these two—they started not only a company but a movement. Two top notch people and professionals.
The Company Prepared for Potential SoftBank Infusion
Last year the company upgraded management with more industry-professionals in anticipation of a massive SoftBank investment infusion. It was reported that Judy Smythe, Bardia Akbari and Niv Caviar jointed the venture as COO, SVP Clinical Operations and CFO respectively. Apparently Japanese investment giant (e.g. Uber, WeWork) had shown a keen interest in science and biotech companies evidenced by recent heavy investments in biotech and health ventures. Other reports reports talked of a $150 million SoftBank potential investment.
PPD Becomes SoftBank
A very different outcome ensued months later. Rather than a “swing for the fence” model with SoftBank comes a tier 1 CRO positioning to possibly incorporate the entire virtual clinical trial technology stack into its portfolio of offerings (after all PPD acquired Acurian back in 2013 and has since worked to bundle the digital asset into its various patient recruitment offerings). The anticipated investment numbers went from $150 million down to $35 million and the founders were essentially removed for the professionals who will take on the responsibility, but perhaps without that same sense of mission and mandate or sense of purposes that the founders possessed.
A Common Occurrence
This is a common occurrence in startups as often the founders of a venture bring an entrepreneurial passion, energy and associated creative “juices” that allows for a venture to get off the ground to around $5 to even $10 million in revenue. By the time $20 million comes the venture looks quite different and a new range of managerial skills, acumen and experience often are required to help the asset operate and grow to the next level.
This author has been in this category for example and had to deal with a range of investors representing institutions that want methodical, systematic growth—regardless of what is really feasible. For the right salary new management will come on board and lead the charge.
Because after a few rounds of VC financing the situation drastically changes—tremendous pressure is imposed on founders and their staff once the venture capital hits the third round—with the fourth round the air in the office board room can be cut with a knife. Heads will role if those growth targets aren’t met.
Big Pharma is a Tough Place to Operate
Venture capital seeks exponential returns and often a business can only grow at a certain organic rate of growth in a specific market. This is especially the case in the risk averse, conservative world of life science clinical trials—where sales cycles can run from 6 to 15 months. There are exceptions out there—Veeva being a notable one that brilliantly rode the Salesforce CRM wave in big pharma (replacing Oracle Siebel)—and leveraging those dollars to work to churn the next antiquated product—Documentum for enterprise document management including eTMF. But operating in big pharma is a tough business and ultimately consolidators parole to enforce monopolistic tendencies. Veeva had the right mix at the founding level that understood what was to come. Science37 had different DNA.
A Day of Reckoning for Science 37: Time to Plug in and Play with the Ecosystem
The tension comes when that day of reckoning is faced and the VCs seek a new management that don’t have the same bias, perspective and sense of constraint—they seek high double-digit to triple digit growth and investors (that remember simply representing institutional investors—e.g. pension funds, etc.) often seek a different leadership team.
PPD has emerged as the lead in this D round. Also indicative of direction are a strategic alignment with PPD market offerings and of things to come.
Growing Up & Change
The financing press release announced that co-founder and CEO Noah Craft, MD, PhD would step down from the CEO role and that co-founder Tan would also step down as Chief Medical Officer. Craft would remain on the Board of Directors. While the Board searches for a CEO they named Judy Smythe as President (she is currently COO and was brought in when it was anticipated that SoftBank would invest $150 million last year). Moreover as part of this transition PPD’s VP Corp. Dev & Strategy will join the Science 37 Board of Director—more hint of things to come.
In the press release it touts PPD’s “commitment to accelerating patient-centered virtual clinical trials, which remove geographic barriers to patient participation.” Interestingly in addition to the growth capital, it was announced that Science 37 will collaborate with PPD’s Accelerated Enrollment Solutions (a solution that combines the Acurian online recruitment database with the Synexus Global site network—which is claimed to be the “largest site network in the world.”
This indicates that Science 37 is being positioned to fit into PPD’s suite of competitive offerings supporting market differentiation against its tier 1 competitors such as IQVIA, PAREXEL, LabCorp (Covance), PRA Health Sciences, and others.
Founders Craft and Tan got the company off the ground and through a few rounds of financing—now a global CRO has moved into to take a more prominent role.Source: BioSpace