PALO ALTO, Calif., May 14, 2019 /PRNewswire/ -- Verantos, the market leader in regulatory grade electronic health record (EHR)-based studies, today announced that Dan Riskin, Founder and CEO, will participate in a panel discussion on regulatory-grade real-world evidence (RWE) at ISPOR 2019 in New Orleans, La., May 18–22. Representatives from the U.S. Food and Drug Administration (FDA), Optum Health, and Syneos Health will also take part in the discussion.
The panel is entitled "How is the 'regulatory grade' criterion defined and what does it take for RWE to meet it?" and will take place during breakout session 7 on Tuesday, May 21, from 5-6 p.m.
The panelists will describe the prevailing challenges in using various sources of structured and unstructured real-world data (RWD), ongoing advances in the use of artificial intelligence, as well as advanced modeling and statistical analysis. The panelists will also discuss the evolving perspective at the FDA, in the era of the 21st Century Cures Act, to encourage the development of techniques and methodologies that enable the development of regulatory grade RWE.
Together, the panelists will explore several pressing questions, including:
- How do evidentiary standards vary for differing regulatory decisions?
- What aspects of today's diverse sources of both structured and unstructured RWD (such as non-randomized and biased/confounded nature of the data, data gaps and more) are most troublesome from a regulatory perspective?
- Can ongoing computing and statistical advances adequately address these issues to ensure RWE meets regulatory standards?
"With a rigorous protocol, biopharmaceutical firms can leverage electronic health records to conduct highly accurate observational studies appropriate to support regulatory and reimbursement objectives," said Dan Riskin, MD, MBA, founder and CEO of Verantos. "Given the state of the industry, what defines a rigorous protocol is still under discussion, making this panel important."
This issue is complex as evidentiary standards differ according to the regulatory or reimbursement decision under consideration. Additional complexity derives from the type of real world data, anticipated effect size, and possible impact of the clinical assertion made.
In addition to participating in the panel discussion, the Verantos team will be exhibiting at table 3 at ISPOR. To learn more about how Verantos' solution can understand the entirety of the EHR record to enable advanced clinical studies, visit the team at ISPOR or go to https://verantos.com.
Verantos (https://verantos.com) is the market leader in electronic health record (EHR)-based studies for regulatory and reimbursement use. The company delivers turnkey regulatory grade real-world evidence (RWE) studies for top biopharmaceutical firms. Advanced data sources and artificial intelligence approaches enable studies that would otherwise be inaccurate or not possible using traditional data sources and approaches. Achieving credible RWE studies lowers cost and risk in label expansion, post-marketing surveillance and reimbursement.