FDA is opening up to data gathered outside the hermetically sealed clinical trial setting as regulators recognize the need for a more flexible framework for evaluating treatments, helped along by the 21st Century Cures Act. This move is coinciding with growing expertise among technology providers to tap real-world data sources and analyze them.
Meanwhile, real-world evidence teams are cropping up across biopharma as the industry invests in talent and infrastructure to deploy this sort of data in their R&D efforts. They’re using RWE to identify biomarkers that can be used to select clinical trial patients and tapping patient records to help design and optimize trial protocols, plus help identify optimal trial sites.
Real-world evidence could also serve as a control arm in certain studies—for instance, rare cancers—to reduce trial duration, allow for a smaller number of participants and save money. And, of course, real-world evidence is a natural for post-marketing studies looking to divine long-term patient outcomes and safety.
Regulatory challenges remain, and as a new approach that requires significant investment, real-world evidence use requires the right talent and technology. Where to find that talent and technology, and how to deploy it internally or with partners, are some of the questions companies face. We’ll address these questions and more with the help of current practitioners in the field.
Alok is the Vice President of Life Sciences at Egnyte where he is responsible for building and executing the company's strategy for the life sciences market segment. Alok works across the organization to verticalize our marketing, sales, product, compliance, and account management practices for this domain. Before joining Egnyte, Alok was a YCombinator-backed entrepreneur and started two vertical software-as-a-service companies. Prior to his career in software, Alok spent over 15 years as a scientist: he took part in postdoctoral work at Harvard University with George Whitesides, and has published papers in Nature and Nature Chemistry. Alok holds a PhD from Northwestern University and BS from Cornell University.
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