MCMi Regulatory Science Symposium

FDA’s Medical Countermeasures Initiative (MCMi) will host the annual MCMi Regulatory Science Symposium June 2-3, 2014 at FDA Headquarters in Silver Springs, Maryland.

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.

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.

The event will also be webcast live and program materials made available. There is no charge for this meeting.