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2014 MCMi Regulatory Science Symposium Agenda

 

Final Agenda* 

In-person registration for this event is closed. A live webcast will be available during event hours, beginning at 9:00 a.m. EDT on June 2, 2014.

 

Monday, June 2, 2014  
8:00    Registration
9:00    Welcome
9:05    Session 1: Advancing Technologies for Product Characterization  
10:35  Break  
10:50  MCM Ignite: A series of rapid, 5-minute presentations on current MCM-related activites
11:30  Lunch/Poster Session
1:15    Keynote Presentation – Dr. Janet Woodcock, FDA/CDER
2:00    Session 2: Animal Models, Biomarkers & Correlates of Protection (moderator: Rebecca Lipsitz)
3:00    Break
3:15    Session 2 continued
4:45    Closing Remarks 

 

Tuesday, June 3, 2014
8:00    Registration
9:00    Welcome
9:05    Keynote Presentation – Dr. Garry Nolan, Stanford University
10:00  Session 3: New Diagnostic Strategies (moderator: Randall Kincaid)
11:30  Break
11:45  MCM Ignite
12:15  Lunch/Poster Session
2:00    Presentation: Dr. Andrea Powell, FDA/CDER: What’s New in Animal Model Development
2:30    Presentation: Melissa Eitzen, UTMB: Mobilizing the 2014 FDA-sponsored UTMB BSL-4 Data Quality Course
2:45    Break 
3:00    Session 4: MCM Surveillance & Assessment (moderator: Carmen Maher)
4:30    Closing remarks 

 

Sessions

Advancing Technologies for Product Characterization

  • FDA/CBER
     -  Konstantin Chumakov: Massively parallel sequencing for monitoring genetic variability of seed viruses for influenza vaccine production (confirmed)
     -  Paul Buehler: Stored Red Blood Cell Transfusion Induced Hemolytic Toxicity:  Mechanisms, Biomarkers and Novel Therapeutic Strategies (confirmed)
  • FDA/CDER
    - Mansoor Khan: Challenges of a pediatric product in stockpiling: Feasibility studies with a pediatric product of oseltamivir phosphate (confirmed)
  • FDA/CDRH
    - Elizabeth Gonzalez: The influence of device design in cleaning biological and chemical contaminants from reusable medical devices (confirmed)

     

Animal Models, Biomarkers & Correlates of Protection

  • FDA/CBER
    - Jennifer Reed: Animal Model Development for Eczema Vaccinatum, a Life-Threatening Smallpox Vaccine Complication (confirmed)
  • FDA/CDER
    - Venkateswara Simhadri: Role of natural killer cells against influenza in presence of humanized monoclonal antibodies (confirmed)
    - Jane Bai: Systems pharmacology for assessing and understanding drug safety (confirmed)
  • FDA/CDRH
    - Cristin Welle: Development and validation of electroencephalographic (EEG) biomarkers for brain injury monitoring (confirmed)
  • NIH
    - Peter Eichacker: The Pathogenesis and Management of Anthrax Sepsis and Septic Shock: Studies in Small and Large Animal Models (confirmed)
     

New Diagnostic Strategies

  • FDA/CBER
    - Jiangqin Zhao: Novel nanoparticle and microfluidics approaches for  detection of viral pathogens in laboratory based and point-of-care settings (confirmed)
    -  Robert Duncan: Evaluation of New Technology Multiplex Tests for Detection of Emerging and Blood Borne Pathogens (confirmed)
  • FDA/CDER
    - Yuansha Chen: Rapid and comprehensive detection of antimicrobial resistance in bacterial pathogens (confirmed)
  • FDA/CDRH
    - Heike Sichtig/Elizabeth Mansfield: Enabling sequence-based technologies for microbial countermeasures and clinical diagnostics (confirmed)

     

MCM Surveillance & Assessment

  • Melissa McClung (Denver Health): Handheld Automated Notification for Drugs and Immunizations (HANDI): Using Mobile Technology to Facilitate MCM Data Collection and Surveillance (confirmed)
  • Jo-Ellen Schweinle (HHS): The BARDA Clinical Study Network’s Role in MCM Surveillance (confirmed)
  • Henry Francis (FDA/CDER): Real-time Application for Portable Interactive Devices (confirmed)
  • Heather Hawley: Harnessing electronic medical records for MCM Surveillance (confirmed)
     

*Subject to change.