Dr. Dan Riskin, CEO, Verantos
In 2016, the 21st Century Cures Act was passed in the United States, transforming the use of medical data. The act was passed to support tailored therapy, patient care, and efficient and accelerated medical product development. However, Dr. Dan Riskin—a healthcare expert who also testified before Congress on the 21st Century Cures initiative—felt that to allow real-world evidence (RWE) to increasingly influence the standard of care, the country would need demonstrably high-quality data, rigorous privacy and security measures, and improved evidence validity. He emphasized two significant factors, full electronic health record (EHR) data and artificial intelligence (AI), to better enable tailored therapy and patient benefit. Noting a lack of firms equipped to offer such services at that time, Riskin set up Verantos to provide the most rigorous and credible RWE studies in the industry, using advanced technologies.
Verantos provides turnkey solutions to implement high-validity studies by applying advanced technologies to deliver insights for pharmaceutical firms to use in collaboration with regulators, payers, and providers. It combines advanced data and technology into a secure platform to offer high-validity evidence.
Among the RWE firms, there are two axes of differentiations: Traditional versus advanced techniques and oncology versus non-oncology studies. Oncology studies tend to use advanced techniques including detailed information gathered from narrative records. Thousands of annotators pour through these records every day to enable oncology RWE studies that typically include hundreds of patients. On the other hand, in non-oncology fields such as heart disease and neuroscience, there is no good solution to run advanced RWE studies. These studies typically include thousands of patients, found from millions of patients. Each patient may have thousands of pages of medical records. It is simply not feasible to engage clinicians to review billions of pages of records per study. So, non-oncology RWE has been underserved. Where traditional firms use simple datasets, there are few offerings for non-oncology advanced RWE.
Verantos has addressed this need. By collaborating closely with health systems and applying modern forms of artificial intelligence, Verantos has been able to gain a comprehensive and accurate view of millions of patients. Verantos focuses on the medical sciences, with a specialization in cardiovascular medicine, neuroscience, immunology, and metabolic syndrome. “Our customers seek technological capabilities to run advanced RWE studies during clinical and commercial phases,” mentions Riskin, CEO, Verantos. The clinical phase is the process of understanding the patient population and preparing for the product launch. In the commercial phase, firms look for high-validity studies to enable post-marketing commitments, market access, and clinical decision-making.
In terms of technology use, many firms want high-validity studies. Thus, accuracy must be tested regardless of the technology applied. But, some technologies result in higher accuracy than others. For this reason, Verantos believes that AI, including natural language processing (NLP) and pattern recognition to support inference, is essential to achieve high-accuracy data extraction in healthcare. “In the studies we perform, data accuracy is unparalleled; greater than 85 percent compared to industry norms of 30 to 40 percent,” explains Riskin. “In terms of data provenance, every extracted element and the enriched portion of the patient record can be traced to each condition, medication, lab, and procedure.” The distinctive vision to employ validated AI earned Verantos funding from the National Institutes of Health, the National Science Foundation, and the Food and Drug Administration.
A maven in the RWE field, Verantos offers a boutique experience to its clients throughout pilots and clinical studies to ensure that all stakeholders are engaged with the process, and success criteria are met. Riskin recalls when a leading pharmaceutical firm was expanding its traditional RWE division to incorporate advanced RWE. The customer knew they needed to access EHRs and unstructured data to gain a clear picture of the patient, but they wanted to implement all this through a pilot study and learn the process. Verantos worked with the client, starting with a technology pilot stage to demonstrate high-accuracy, subsequently moving on to a series of clinical studies, understanding patient phenotypes, and performing claims and registry linkage to gain visibility into patient outcomes and resource utilization. After that, the client used these capabilities to enable Phase III efforts and product launch. They also extended to additional therapeutic areas within the enterprise.
Verantos’ future endeavors are to continue in the advanced RWE field and offer the most rigorous, high-validity, and technology-enabled studies in the industry. “We aspire to demonstrate an approach to RWE that matches the rigor of randomized controlled trials, but provides additional insight to help tailor therapy and improve care,” ends Riskin.