Eric Young of TriNetX will take us through the characterization of breakthrough infections for vaccinated individuals, including children, who received both outpatient and inpatient treatment. Sonia Hernandez-Diaz, Harvard T.H. Chan School of Public Health, will share her experience with “Target trial emulation to evaluate COVID-19 vaccination during pregnancy” using RWD from Israel. Carla Rodriguez-Watson will preview of the Real-World Accelerator to evolve the standard of Care and Engagement (RACE) for communities of color.

 Professor Mara Aspinall of the Diagnostic Commons housed at Arizona State University will join us to reflect on the past, present and future of diagnostic tests. Matthew Gee of Siemens will take a look at lessons learned from using real-world data in regulatory submissions for COVID diagnostics tests. Carla Rodriguez-Watson will provide a preview of the Real-World Accelerator to evolve the standard of Care and Engagement (RACE) for communities of color.

In the midst of a global pandemic, the Reagan-Udall Foundation for the FDA, along with Friends of Cancer Research, created an unprecedented regulatory science collaborative to share real-world data and to generate innovative responses on how to deal with COVID-19. 

On October 20, 2022, we highlighted the accomplishments and shared learnings from more than 200 meetings, and 275 expert presentations, including how best to leverage real-world data and improve data interoperability to address current and future health challenges.

Join us Thursday, July 21 at 3 pm ET for the July Therapeutics & Vaccines lab Meeting. We’ll be hearing from Elizabeth Eldridge of Health Catalyst. Liz will be describing the new research project they are taking on at the request of the Evidence Accelerator, looking at the use of dexamethasone in COVID-19 patients. 

In addition, we will be receiving an update on the Real-World Evidence Online Primer.

Join us Thursday, July 21 at noon ET to hear from Dr. Keith Campbell of FDA's Center for Devices and Radiological Health. He'll be speaking about Systemic Harmonization and Interoperability Enhancement for Laboratory Data (SHIELD), a public-private initiative to develop and launch collaborative policies and business models designed to overcome barriers to the interoperability of laboratory data.  Dr. Campbell will be providing an update about SHIELD from FDA’s perspective.

Beyond the learning acceleration of our COVID-19 Evidence Accelerator lab meetings, the Evidence Accelerator model includes “engines” of evidence generation. At the June 16^th Therapeutics and Vaccines meeting, we’ll review the results and performance of one of those engines, and help jump-start a new engine.

Join the COVID-19 Diagnostics Evidence Accelerator  to check-up on what’s happening with the Mayo Clinic. Since Mayo’s (and their research partners at Yale University) participation in our research project looking at use patterns and performance of serological tests, they have continued to track and evaluate use of COVID-19 tests within their health system. We’ll learn how testing patterns have changed, and what information they have gathered (and generated) regarding test performance.

Exploring the Potential for a Public-Private Partnership to Support the Tracking and Monitoring of Antimicrobial Use in Food-Producing Animals

Virtual Public Forum
Tuesday, June 14, 2022
1-3pm Eastern Time

This month we will learn more about the opportunity to ‘listen’ for safety signals in social media from the Sanofi Digital team, as they share some of their advanced analytics and visualization regarding what is being said about COVID vaccine safety, with a particular focus on children.