Summer 2019 newsletter
Verantos and Amgen collaborate on regulatory grade RWE
The firms announced their collaboration in using advanced data sources and artificial intelligence (AI) to achieve high-accuracy observational studies. Initial work has demonstrated high accuracy in cohort definition of inclusion criteria, exclusion criteria, exposures, and outcomes with sensitivity increased from 50 percent to more than 90 percent for most cohorts. Verantos and Amgen plan to submit initial findings from their partnership for peer-reviewed publication in 2019.
To learn more about the collaboration, please read the news release.
Verantos in the news
Verantos explores advanced RWE with FDA, Optum and Syneos Health at ISPOR 2019
Verantos, FDA, Optum Labs, and Syneos Health discussed valid RWE to support regulatory and reimbursement objectives during a panel at ISPOR 2019 in New Orleans, LA in May. One key takeaway from the discussion can be summed up in a comment from the FDA: Is RWE fit for use? If not, full stop, there's your answer. There's no need to go further. The panel highlighted the importance of data quality and data validity when clinical assertions are made.
Let's talk advanced RWE at DIA
Verantos will be exhibiting at DIA's Innovators Hub booth 2400 on June 24-26. Talk to Verantos about the following RWE topics:
- Understand regulatory-grade criterion and what it will take for RWE to meet it.
- Understand the benefit of using advanced data sources for regulatory and reimbursement purposes.
- Learn how synthetic control arms can add to your evidence generation strategies.
- Learn about advanced RWE studies for label expansions and post-marketing commitments.
Visit us at the Innovators Hub booth 2400.
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