Dr. George Korch, U.S. Department of Health and ... - Farm Foundation

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2009 H1N1 Vaccine Production Timeline: Delayed Delivery of First Doses President’s Council of Advisors on Science and Technology 19
Accelerate Influenza Vaccine Production • Collaborative effort between CDC, NIH, BARDA, FDA • Speed process to optimize seed viruses for vaccine production ─ Combinatorial genetic approaches to optimize gene constellations for new seed stocks • Modernize Potency Testing ─ Alternative methods will be analyzed such as isotopic dilution mass spectrometry, Surface Plasmon Resonance, etc ─ Optimize, validate and apply immune‐capture isotope dilution MS methods • Modernize Sterility Testing ─ Evaluate a variety of rapid microbial contamination systems such as but not limited to Growth Direct System, Scan RDI, etc. for sterility testing of biological products CDC commitment ─ Validate new sterility methods for specificity, robustness, ruggedness and repeatability
Page 1 and 2: Transforming a Medical Countermeasu
Page 3 and 4: Emerging Diseases vs. Public Health
Page 5 and 6: Flu was here…And We Had Prepared
Page 7 and 8: Incidence (per 1,000,000) 4500 4000
Page 9 and 10: Answering President Obama’s Direc
Page 11 and 12: Organizations Contributing to the P
Page 13 and 14: ASPR Anthrax Smallpox Botulism Bact
Page 15 and 16: The MCME Draft Review ‐ Vision
Page 17 and 18: The MCME Review ‐ Key Initiatives
Page 19: Concept Acceleration Program • NI
Page 23 and 24: Production Timelines for Egg and Ce
Page 25: Summary • The Medical Countermeas

Dr. George Korch, U.S. Department of Health and ... - Farm Foundation

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