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2014 MCMi Regulatory Science Symposium Webcast



Webcast recordings - June 2-3, 2014


Day 1: June 2, 2014

Session 1: Advancing Technologies for Product Characterization

  • Opening remarks by FDA Acting Chief Scientist Stephen Ostroff, MD
  • Konstantin Chumakov, PhD, DSci, FDA: Massively parallel sequencing for monitoring genetic variability of seed viruses for influenza vaccine production 
  • Paul Buehler, PharmD, PhD, FDA: Stored Red Blood Cell Transfusion Induced Hemolytic Toxicity:  Mechanisms, Biomarkers and Novel Therapeutic Strategies
  • Mansoor Khan, PhD, FDA: Challenges of a pediatric product in stockpiling: Feasibility studies with a pediatric product of oseltamivir phosphate
  • Elizabeth Gonzalez, PhD, FDA: The influence of device design in cleaning biological and chemical contaminants from reusable medical devices


MCM Ignite: A series of rapid, 5-minute presentations on current MCM-related activites


Keynote Presentation – Janet Woodcock, MD, FDA/CDER

Session 2a: Animal Models, Biomarkers & Correlates of Protection, moderated by Rebecca Lipsitz, PhD, FDA

  • Jennifer Reed, PhD, FDA: Animal Model Development for Eczema Vaccinatum, a Life-Threatening Smallpox Vaccine Complication
  • Venkateswara Simhadri, PhD, FDA: Role of natural killer cells against influenza in presence of humanized monoclonal antibodies


Session 2b: Animal Models, Biomarkers & Correlates of Protection

  • Jane Bai, PhD, FDA: Systems pharmacology for assessing and understanding drug safety - FDA/CDRH
  • Cristin Welle, PhD, FDA: Development and validation of electroencephalographic (EEG) biomarkers for brain injury monitoring NIH
  • Peter Eichacker, MD, NIH: The Pathogenesis and Management of Anthrax Sepsis and Septic Shock: Studies in Small and Large Animal Models  



Day 2: June 3, 2014


Welcoming remarks from FDA Commissioner Margaret Hamburg, MD, and Keynote Presentation – Garry Nolan, PhD, Stanford University School of Medicine


Session 3: New Diagnostic Strategies, moderated by Randall Kincaid, PhD, NIH

  • Jiangqin Zhao, MD, PhD, FDA: Novel nanoparticle and microfluidics approaches for  detection of viral pathogens in laboratory based and point-of-care settings
  • Robert Duncan, PhD, FDA: Evaluation of New Technology Multiplex Tests for Detection of Emerging and Blood Borne Pathogens
  • Yuansha Chen, PhD, FDA: Rapid and comprehensive detection of antimicrobial resistance in bacterial pathogens
  • Heike Sichtig, PhD, FDA and Elizabeth Mansfield, PhD, FDA: Enabling sequence-based technologies for microbial countermeasures and clinical diagnosticsFelicia Pradera of the Defence Science and Technology Organisation, Australia, presents during the MCM Ignite Session of the MCMi Regulatory Science Symposium June 3, 2014

MCM Ignite: A series of rapid, 5-minute presentations on current MCM-related activites

Presentations: Andrea Powell, PhD, FDA/CDER: What’s New in Animal Model Development, and Melissa Eitzen, UTMB: Mobilizing the 2014 FDA-sponsored UTMB BSL-4 Data Quality Course 


Session 4: MCM Surveillance & Assessment, moderated by CAPT Carmen Maher, FDA

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