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Monday March 10, 2008

Plenary Keynote Session

  • Plenary Keynote Introduction & Welcome
    Mauro Ferrari, Ph.D., President, Alliance for NanoHealth
    Presentation [PDF]
  • Keynote Speaker
    Norris E. Alderson, Ph.D., Associate Commissioner for Science, Office of the Commissioner, Food & Drug Administration
    Presentation [PDF]
  • Introduction to Panels
    Richard Canady, Ph.D., Senior Health Scientist, Office of the Commissioner, Food & Drug Administration
    Presentation [PDF]
  • Presentation #1
    Nakissa Sadreih, Ph.D., Associate Director for Research Policy and Implementation, Center for Drug Evaluation and Research, U.S. Food & Drug Administration
    Presentation [PDF]
  • Presentation #2
    Jan Simak, Ph.D., Center for Biologics Evaluation and Research, U.S. Food & Drug Administration
    Presentation [PDF]
  • Presentation #3
    Subhas Malghan, Ph.D. Deputy Director, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food& Drug Administration
    Presentation [PDF]

Practical Experience with FDA Review Process for Nanotechnology

  • Presentation #1
    George Mills, M.D., M.B.A., Vice President, Medical Imaging Consulting Perceptive Informatics, /PAREXEL
    Presentation [PDF]
  • Presentation #2
    Larry Tamarkin, Ph.D., President and CEO, CytImmune
    Presentation [PDF]
  • Presentation #3
    Tony Huang, Ph.D., Vice President, Parenteral Technology Development, ALZA Corporation
    Presentation [PDF]
  • Presentation #4
    Scott McNeil, Ph.D., Director, Nanotechnology Characterization Laboratory SAICFrederick, National Cancer Institute-Frederick, National Institutes of Health
    Presentation [PDF]

Tuesday March 11, 2008

Workshop Session I

  • Charge to Workshop Participants
    Wendy Sanhai, Ph.D.,Senior Scientific Advisor, Office of the Commissioner, Food & Drug Administration

    Presentation [PDF]
  • Breakout #1: Preclinical Presentation
    George Mills, M.D., M.B.A., Vice President, Medical Imaging Consulting, Perceptive Informatics, /PAREXEL
  • Breakout #2: Clinical Presentation
    Mark Melkerson, Director, DGRND, Office of Device Evaluation, Food & Drug Administration
    Presentation [PDF]
  • Breakout #3: Manufacturing Presentation
    Vicki Colvin, Ph.D., Professor of Chemistry and Professor of Chemical & Biomolecular Engineering, Rice University
    Presentation [PDF]

Wednesday March 12, 2008

Workshop Session II

  • Presentation of Top Projects
    • Breakout #1: Preclinical Presentation
      Abigail Jacobs, Ph.D., Associate Director for Pharmacology and Toxicology, Office of New Drugs, Food & Drug Administration
      Presentation [PDF]
      Presentation [PDF]
    • Breakout #2: Clinical Presentation
      Mark Melkerson, Director, DGRND, Office of Device Evaluation, Food & Drug Administration
      Presentation [PDF]
    • Breakout #3: Manufacturing Presentation
      Vicki Colvin, Ph.D., Professor of Chemistry and Professor of Chemical & Biomolecular Engineering , Rice University
      Presentation [PDF]
  • Closing Remarks
    Jason Sakamoto, Ph.D., Chief Operating Officer, Alliance for NanoHealth
    Presentation [PDF]
     
 
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