FDA’s Medical Countermeasures initiative (MCMi) will host their annual Regulatory Science Symposium this week at FDA Headquarters in Silver Springs, Md.
The goals of the event are to exchange ideas on countermeasure development; highlight work on regulatory science as it applies to developing and advancing medical countermeasures; facilitate innovative directions; and inform stakeholders on related scientific progress and achievements.
Registration for in-person attendance is closed, however the event will also be webcast live and program materials made available at no charge.
Highlighted topics include:
- Animal Models, Biomarkers & Correlates of Protection
- Advancing Technologies for Product Characterization
- Massively parallel sequencing for monitoring genetic variability of seed viruses for influenza vaccine
- Evaluation of New Technology Multiplex Tests for Detection of Emerging and Blood Borne Pathogens
- Challenges of a pediatric product in stockpiling: Feasibility studies with a pediatric product of oseltamivir phosphate
- The influence of device design in cleaning biological and chemical contaminants from reusable medical devices
- Animal Model Development for Eczema Vaccinatum, a Life-Threatening Smallpox Vaccine Complication
- Role of natural killer cells against influenza in presence of humanized monoclonal antibodies
- Systems pharmacology for assessing and understanding drug safety
- The Pathogenesis and Management of Anthrax Sepsis and Septic Shock: Studies in Small and Large Animal Models
- Novel nanoparticle and microfluidics approaches for detection of viral pathogens in laboratory based and point-of-care settings
- Evaluation of New Technology Multiplex Tests for Detection of Emerging and Blood Borne Pathogens
- Rapid and comprehensive detection of antimicrobial resistance in bacterial pathogens
- Enabling sequence-based technologies for microbial countermeasures and clinical diagnostics
- Handheld Automated Notification for Drugs and Immunizations (HANDI)
- The BARDA Clinical Study Network’s Role in MCM Surveillance
- Real-time Application for Portable Interactive Devices
- Harnessing electronic medical records for MCM Surveillance
Please visit the FDA’s MCMi Regulatory Science Symposium website for more information. Follow symposium updates on Twitter by searching #FDARegSci, and follow MCMi at @FDA_MCMi.
