1. Case Studies in Big Data and Analysis
NAS WORKSHOP ON BIG DATA AND ANALYTICS FOR INFECTIOUS DISEASE RESEARCH, OPERATIONS, AND POLICY
May 10, 2016
Luciana Borio, MD
Acting Chief Scientist
Food and Drug Administration

2. FDA Mission FDA is responsible:
Protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.
Advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health.
Regulating the manufacturing, marketing and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.
Fostering the development of medical products to respond to deliberate and naturally emerging public health threats.

3. Food Safety

4. Food Safety Food enters commerce
Routine disease reporting
Astute clinicians observations
Digital disease detection
Clinical & environmental isolates
WGS + Env
Food enters commerce
Source of contamination identified from few cases
3 Environmental Positive Samples by FDA in 2/2014
2 Environmental Positive Samples by FDA in 7/2014

5. Antiviral Drug Resistance

6. Antibacterial Resistance

7. Designing Better Clinical Trials – HABP/VABP
HABP/VABP trials difficult to conduct
Very low enrollment rates
Expensive
Acutely ill patients with urgent need to start treatment
CTTI performing an observational study to identify patients at high risk for developing HABP/VABP
Identifying risk factors for HABP/VABP may allow for
“pre-consent” of high-risk patients
enroll patients into trial earlier after diagnosis of HABP/VABP
adjust inclusion / exclusion criteria to enroll more patients
After learning from observational study – incorporate “new” approaches in one arm of an RCT to see if improves enrollment rates compared to “old” approach