Grand Challenges for Nanomedicine

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• Grand Challenges for Nanomedicine
• and Nanobiology Workshop
• Houston, Texas
• August 27th, 2007

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Personal Thoughts

• Targeted Delivery (Timing)
• EPR
• Tumor vasculature
• Potential for clinical impact versus clinical
  translation
• Diagnostics and Nanotechnology?
• Training and Team Science
• Multi-PI R01s
• NIH Pathway to Independence Award (K99/R00)
• Mentored Research Scientist Development Award
  (K01)
• Mentored Clinical Scientist Development Award
  (K08)
• Clinical Oncology Training Grants (K12)

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Upcoming Sessions

• Nano Tutorial Sessions Oct 16th, 2007
• Tutorial Session 1 Cells, Tissues, and Organs
  Basic Principles of Functional Histology and
  Pathology
• Tutorial Session 2 Basic Cancer Biology
• Tutorial Session 3 Animal Models
• Tutorial Session 4 Biodistribution of
  Nanoparticles
• Tutorial Session 5 Materials Science/Nanotechnolo
  gy
• Clinical Pathway
• Clinical trial grants and contracts
• FDA
• Nanotechnology Characterization Lab
• ASCB Special Session Dec 1st, 2007

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Upcoming NIH Funding Opportunities

• Nanoscience and Nanotechnology in Biology and
  Medicine (R01R21), Oct. 22nd, 2007
• Biology of Breast Pre-Malignancies (R01), Nov.
  17th, 2007
• RFA-CA-07-047
• insufficient understanding of normal and
  pre-cancer biology

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Upcoming NCI Funding Opportunities

• SBIR Solicitation (PHS-2008-1), Nov. 5th, 2007
• Topic 241 Multifunctional Therapeutics Based on
  Nanotechnology
• Topic 252 Nanotechnology Imaging and Sensing
  Platforms for Improved Diagnosis of Cancer
• Multidisciplinary Development and Training in
  Cancer Nanotechnology Award (F32/F33), TBA
• Innovative Molecular Analysis Technologies IMAT
  (R21/R33), Sept. 27th, 2007
• Innovative Technologies for the Molecular
  Analysis of Cancer RFA-CA-07-033
• Application of Emerging Technologies for Cancer
  Research RFA-CA-07-035

nano.cancer.gov
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Nanotechnology Characterization Lab (NCL)Role
and Updates

• The NCL developed and standardized analytical
  cascade that tests the pre-clinical toxicology,
  pharmacology, and efficacy of nanoparticles and
  devices.
• Next submission date (9/1/2007 and 12/1/2007)

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NCL in vivo Characterization Assays
Plasma Profile

• Initial disposition study
• Tissue Distribution
• Clearance
• Half-life
• Systemic exposure (plasma AUC)  
• Immunotoxicity
• 28 day screen
• Immunogenicity (repeat-dose tox study)   
• Dose -Range Finding Toxicity
• Blood Chemistry
• Hematology
• Histopathology
• Gross Pathology
• GLP Studies
• PK/ADME
• Expanded Single Dose Acute Tox

Organ Weights Main Study
Hematology Interim Study
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Current NCL Collaborators
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Onsite Program Contacts

• Larry Nagahara, Ph.D.Nanotechnology Projects
  Manager
• Email  nagaharl_at_mail.nih.gov
• Jerry Lee, Ph.D.
• Tech. Dev. Program Officer
• Email leejerry_at_mail.nih.gov