Federal Crowdsourcing Webinar Series, Episode 10: A precisionFDA Strike for Public Health

Did you know the U.S. Food and Drug Administration (FDA) regulates products that account for roughly 25% of the U.S. economy? That’s right: The agency reviews and approves a lot more than drugs and vaccines. Its purview extends to medical devices, dietary supplements, foods and more—and it’s constantly monitoring for their potential health risks to the public.

All of that monitoring means massive amounts of data. Information and reporting on adverse reactions streams in from numerous sources, including healthcare providers and patients. So, how does FDA detect the “blips” in data that could lead to important public health discoveries?

Enter precisionFDA, a secure, cloud-based platform that aids the study and analysis of large datasets. Established in 2016, precisionFDA harnesses the power of the crowd to advance data science techniques to identify anomalies that may lead to valuable health insights.

Participants will learn how this model is helping FDA to better understand evolving areas of science around large biological data sets and apply that understanding to inform and develop regulatory science standards.

More About the Federal Crowdsourcing Webinar Series

Airing monthly, this series illuminates how U.S. agencies are reaching beyond their typical channels to source talent and enthusiasm to multiply the ideas and perspectives being brought to a particular issue. Don’t miss these previous episodes:

• Episode 9: History Hub, with Kelly Osborn and Darren Cole, NARA
• Episode 8: NASA@WORK, with Carissa Callini and Jeff DOI, NASA
• Episode 7: Crowdsourcing for Code, with Amin Mehr, Code.gov
• Episode 6: FedRAMP Ideation, with Betsy Steele, GSA
• Episode 5: History by the People, with Lauren Algee, Library of Congress
• Episode 4: Open Opportunities, with Lisa Nelson, USAJOBS, OPM
• Episode 3: The Opportunity Project, with Drew Zachary and Lorena Molina-Irizarry, U.S. Census Bureau
• Episode 2: Challenges and Prize Competitions, with Jarah Meador, GSA, and Jessie Buerlein, HHS
• Episode 1: Crowdsourcing and Citizen Science, with John McLaughlin, NOAA, and Sophia B. Liu, USGS

About our Presenters:

Jarah Meador has been leading open innovation programs in government for seven years at the United States Agency for International Development (USAID), U.S. Department of Veterans Affairs (VA), and now as the director of the Challenge.gov and Citizenscience.gov programs at the U.S. General Services Administration (GSA). Jarah came to her role(s) in government via the Science and Technology Policy Fellowship Program of the American Association for the Advancement of Science. Prior to this she was a research scientist focused primarily on radiation biophysics and DNA repair processes.

Elaine Johanson currently serves as the acting director of health informatics within the Office of the Chief Scientist at FDA, where she brings more than 35 years of information technology and health informatics experience. In this position, she utilizes non-traditional mechanisms to share FDA data and to engage external experts in evolving areas of regulatory science. In addition, she facilitates agency-wide participation in international health data and terminology standards, leads the identification and curation of substance information, and the exchange of product labeling information for FDA.

Dr. Emily Boja is a health scientist who will support OHI’s precisionFDA initiative and other informatics endeavors. Prior to joining OHI, she was a Program Director at the Office of Cancer Clinical Proteomic Research, NCI, NIH, providing scientific expertise and leadership in managing the Clinical Proteomic Tumor Analysis Consortium program. In addition, she oversaw the analytical, informatics and regulatory aspects of molecular technologies, platforms and tools via interactions with the FDA and the American Association of Clinical Chemistry, e.g.,, leading the precisionFDA-NCI-CPTAC Multi-Omics Enabled Sample Mislabeling Correction Challenge. Prior to the NCI, she served as a Staff Scientist at the Laboratory of Cardiac Energetics, NHLBI, NIH. She holds a Ph.D. degree in Biochemistry and Molecular Biology from the Medical College of Virginia, Virginia Commonwealth University.

Holly Stephens has 17 years of experience in the design and implementation of genetic and genomic studies in the fields of neuropsychiatry, cardiovascular disease, pharmacogenomics, and oncology. In addition, she has 10 years of molecular genetics laboratory experience and a certification in clinical research.