Addressing vaccine and biologics safety
The FDA’s Center for Biologics Evaluation and Research (CBER) recently reached a five-year agreement with the life sciences segment of Optum to provide data and expertise to evaluate and research biologics and vaccines.
This collaboration will support the Biologics Effectiveness and Safety (BEST) system as it seeks to:
- Build data, analytics, infrastructure for an active, large-scale, efficient surveillance system for biologic products
- Develop innovative methods to utilize electronic health records effectively and establish automated adverse events reporting, utilizing natural language processing and artificial intelligence.
Data representing tens of millions of lives will support the new program
Optum will provide access to de-identified claims and electronic health record (EHR) data representing tens of millions of lives. This real-world data offers longitudinal views of patient experiences, is detailed enough to support clinical decision making, and is available in near-real time.
“We are thrilled by this opportunity to work so closely with the FDA on this important initiative,” said Sheenu Kachru, CEO of Optum Life Sciences. “The BEST system is a great example of a public-private partnership that is working to make sure vaccines and biologics are safe and effective for all.”
Multi-level support throughout research study
The Optum epidemiology group is also working closely with the FDA to define the study topics, identify the optimal data and analytic approach, develop the study protocol, review/interpret the results and prepare the results for publication.
“Optum has long been a trusted partner with the FDA on the Sentinel Initiative,” said John Seeger, leading epidemiologist and chief science officer at Optum Life Sciences. “We see this new development as an extension of this effort and another way we can contribute to public health through the safety and effectiveness of vaccines and biologics.”
BEST fulfills the FDA Amendments Act of 2007 requirement for an active postmarket risk and analysis system covering at least 100 million persons. It supports the FDA’s broader mandate outlined in the 21st Century Cures Act.
BEST also supports the reauthorization of the Prescription Drug User Fee Act by advancing postmarket drug safety evaluation through expansion of the Sentinel System and Integration into FDA regulatory activities.1