February 28-29 FDA Presentations

• Applying Regulatory Science to Advance Development of Innovative, Safe and Effective Biologic Products (PPT - 1.8MB)
  Carolyn A. Wilson, Ph.D.
• Division of Bacterial, Parasitic and Allergenic Products (PPT - 165KB)
  Jay E. Slater, MD
• Laboratory of Mycobacterial Diseases and Cellular Immunology (PPT - 131KB)
  Sheldon Morris, P.I.
• Influenza Virus Vaccine 2012-2013 Strain Selection (PPT - 77KB)
  Jerry P. Weir, Ph.D., Director
• Candidate Vaccine Strains and Potency Reagents for 2012-13 Influenza Season (PPT - 130KB)
  Rajesh K. Gupta, Ph.D.
• Licensure of Pandemic Influenza Vaccines: Demonstration of Effectiveness (PPT - 1MB)
  Marion F. Gruber, PhD, Acting Director
• Licensure of Pandemic Influenza Vaccines: Demonstration of Effectiveness (PPT - 1.5MB)
  Theresa M. Finn, OVRR, CBER, FDA
• Influenza Vaccine Responses (PPT - 1.1MB)
  Zhiping Ye, M.D., Ph.D.

Non-FDA Presentations

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• Influenza Surveillance and Vaccine Effectiveness in the DoD 2011 – 2012 (PDF - 2.1MB)
  MAJ Ronald Burke, DVM, DrPH
• U.S. Influenza Surveillance 2011-2012 Season, Lisa Grohskopf, MD, MPH, CDC (PPTX - 1.8MB)
  Lisa Grohskopf, MD, MPH, CDC
• Influenza Vaccine Manufacturing (PPT - 370KB)
  Elisabeth Neumeier, PhD, DVM
• GSK’s Candidate Influenza A (H5N1) Virus Monovalent Vaccine Regulatory Pathway for Licensure (PDF - 313KB)
  Katalin Abraham, GSK
• Licensing Pandemic Vaccines Novartis Vaccines (PPTX - 363KB)
  Penny Heaton, M.D., Novartis
• Update on Surveillance for Influenza Viruses with Pandemic Potential and Candidate Vaccine Viruses (PPT - 875KB)
  Nancy Cox, PhD, CDC
• HHS Pandemic Influenza Vaccine Program (PPTX - 2MB)
  Robin Robinson, PhD, BARDA, HHS
• Seasonal Influenza and Zoonotic Influenza (PPTX - 4.2MB)
  Nancy Cox, PhD, CDC