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]