An explosion in big data is sweeping through the healthcare space, and biopharma companies are eager to capitalize on abundant clinical data from the real world, or real-world evidence (RWE). These five RWE providers are attracting big investments for their potential to streamline precision healthcare and boost drug development.
For regulators, randomized controlled trials are often the strongest sources of evidence that a drug candidate is safe and effective in patients. However, there are also limitations to clinical trials. For example, inclusion and exclusion criteria may fail to capture the full diversity of the population, and they often do not reflect the messy reality of treating patients in practice.
Real-world data is gaining traction as a complement to clinical trials when assessing the impact of a new drug or strategy on healthcare. Information about anonymized patient records and the delivery of routine healthcare in society are analyzed to produce RWE. With the help of rapid advances in analytical technologies such as artificial intelligence (AI) and cloud computing, RWE can provide vital guidance about how particular strategies might work outside of a clinical trial setting and in different patient subgroups.
Regulatory agencies are increasingly accepting RWE in submissions for the approval of new treatments. For instance, the U.S. Food and Drug Administration (FDA) has been providing guidelines on the use of data from electronic health records and registry data to drug developers, and European and Chinese regulators are investigating the potential of RWE.
In addition to regulatory paperwork, RWE can fulfill a myriad of purposes for biopharma companies throughout the drug development process. During the COVID-19 pandemic, for example, RWE was instrumental in investigating important considerations in COVID-19 drug and vaccine development, including predicting COVID hotspots worldwide for selecting clinical trial sites and estimating the effectiveness of vaccines in different demographics.
The multi-faceted power of RWE is attracting massive interest from investors and big pharma to digital software companies in this space, with examples including Roche’s takeover of Flatiron Health for $1.9 billion in 2018 and the acquisition of Genesis Research by the European healthcare investment firm GHO Capital Partners in 2021.
The following five companies are collecting reams of real-world data from healthcare systems to provide RWE services to clients, and have bagged major venture funding rounds in the last few years.
Founded: 2013 | Headquarters: New York
Aetion originated from a team-up of its health-focused founders with technology specialists. The company’s name is derived from a Greek word meaning causality, which reinforces Aetion’s focus on identifying causal relationships in real-world data.
Aetion has built software called the Aetion Evidence Platform (AEP) that can generate RWE from rapid analyses of clinical data, and can be used by a range of stakeholders in healthcare, including biopharma firms, regulators and payers.
Pharmaceutical companies can use the AEP to accelerate the progress of their treatments to market, address requests from regulators and plan clinical trials more efficiently. Regulators, on the other hand, can harness the platform to assist the decision-making process, while payers can use the insights to optimize their coverage plans.
Aetion raised an impressive $110 million in Series C funding in May 2021 to finance the development of its technology. In particular, the firm is using the money to expand its business into Europe and the Asia-Pacific region.
One major feat for Aetion is its ongoing collaboration with the U.S. FDA to pave the way for greater use of RWE in the fight against COVID-19. In January 2023, Aetion teamed up with the U.S. FDA again to reduce health disparities in oncology healthcare.
2. Clarify Health
Founded: 2015 | Headquarters: San Francisco
This company was launched with the aim to deliver big data expertise from the banking and consumer sectors to healthcare and patients.
Clarify Health uses a platform called Atlas to churn through billions of healthcare cases from over 300 million patient journeys, and use AI to deliver predictions based on this real-world data. By stockpiling a massive trove of health data, the company invokes a so-called “Moneyball style” in its healthcare analytics—a term borrowed from the baseball scene when analysts crunched high quantities of performance data to make baseball teams more efficient.
One major application of the Atlas platform is to construct multi-year, longitudinal analyses of patients over time, and predict the impact of social determinants of health, non-medical factors that impact health such as income and social protection, education and employment. Other uses include reducing costs for healthcare providers, exploring innovative payment models, carrying out market research and optimizing the performance of clinics.
Clarify Health is fuelling its business expansion with $150 million that it raised last year in a Series D round. The firm also acquired two other businesses—Apervita’s Value Optimization Business and Embedded Healthcare—and expanded a collaboration with the data sharing platform Datavant to allow life sciences firms to securely connect their datasets to Atlas.
Founded: 2017 | Headquarters: Cambridge, Massachusetts
ConcertAI is the healthcare-focused sister company of SymphonyAI, which employs AI to assist clients with decisions in sectors such as industrial manufacturing and IT.
ConcertAI’s platforms trawl collections of peer-reviewed articles, regulatory decisions and clinical records to help the firm serve partners including healthcare providers, medical societies, regulators and biopharma companies to improve patient outcomes in the U.S., Europe and Japan. For example, the company claims the industry’s largest independent oncology research database in addition to a vast collection of patient data in the form of medical claims, molecular tests and imaging data.
Using these big data hoards and AI, ConcertAI can facilitate many processes involved in planning clinical trials, including study design, protocol optimization, site selection, feasibility assessment and patient trial matching. It also allows users to query its clinical trial data collections to investigate ways to assess diversity and other characteristics of patient groups.
Following a $150 million Series C round last year, ConcertAI is valued at around $1.9 billion. The company is also deploying its RWE system with a number of partners, including the U.S. FDA, Janssen, Caris Life Sciences, and Bristol Myers Squibb.
4. Tempus Labs
Founded: 2015 | Headquarters: Chicago
Tempus made the headlines in late 2022 with the announcement of a $275 million investment round, taking its total investment income to over $1.3 billion. The technology company focuses on the advancement of precision medicine with the help of AI.
Tempus plans to use the huge investment to scale up its data platform called Lens, with a focus on providing smart diagnostics that are tailored to each patient and help medical professionals to make personalized treatment decisions.
The company holds more than 70 petabytes of data, which include clinical and imaging records matched with genomic data. It is connected to hundreds of institutions to tap into their data and provide them with analytical services.
Tempus is seen by onlookers as very strong in terms of omics data, and is geared towards assisting medical research in oncology. The firm also offers services for comparing patients’ clinical histories and genomic data with trial inclusion and exclusion criteria to make it easier for biopharma companies to launch clinical trials of new medicines.
Tempus is working in concert with many life sciences clients such as Boehringer Ingelheim and GSK, and is part of an industry-wide alliance to support the growing use of RWE in the regulatory process. Other members of the alliance include Aetion, Flatiron Health, Concert Health, Verana Health, and more.
5. Verana Health
Founded: San Francisco | Headquarters: 2018
Verana used to be a tele-ophthalmology company called DigiSight, but pivoted into healthcare data in 2018 and forged alliances with physicians groups to gain access to clinical data.
The company now runs a healthcare data ecosystem that fosters medical innovations by connecting clinical researchers, analysts, and healthcare providers. The patient data that passes through the ecosystem is fed into an AI-guided platform to generate RWE for drug development and clinical trial optimization.
One way Verana’s platform can help users is tracking the market share of different products in various indications and forecast sales performance. It also informs users about physicians’ choices of which medication to give patients, which can help with commercial planning.
Among Verana’s life sciences partners are Genentech, Janssen, Apellis, Regenx Bio, and more. Johnson and Johnson’s venture arm also co-led Verana’s Series E round in early 2022, infusing the RWE company with $150 million to develop its technology, land more deals with physician groups and expand its RWE network.
Jonathan Smith is a freelance science journalist based in the U.K. and Spain. He previously worked in Berlin as reporter and news editor at Labiotech, a website covering the biotech industry. Prior to this, he completed a PhD in behavioral neurobiology at the University of Leicester and freelanced for the U.K. organizations Research Media and Society of Experimental Biology. He also has an undergraduate degree in neuroscience and worked at the pharmaceutical company Eisai for one year on a student placement.