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

2. 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)

3. Upcoming Sessions Nano Tutorial Sessions: Oct 16 th, 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/Nanotechnology  Clinical Pathway Clinical trial grants and contracts FDA Nanotechnology Characterization Lab ASCB Special Session: Dec 1 st, 2007

4. Upcoming NIH Funding Opportunities  Nanoscience and Nanotechnology in Biology and Medicine (R01&R21), Oct. 22 nd, 2007  Biology of Breast Pre-Malignancies (R01), Nov. 17 th, 2007 RFA-CA-07-047 insufficient understanding of normal and pre-cancer biology

5. Upcoming NCI Funding Opportunities  SBIR Solicitation (PHS-2008-1), Nov. 5 th, 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. 27 th, 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

6. 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) In Vitro In Vivo Physicochemical

7. NCL in vivo Characterization Assays  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 Plasma Profile Organ Weights Main Study Hematology Interim Study

8. Current NCL Collaborators

9. Onsite Program Contacts  Larry Nagahara, Ph.D. Nanotechnology Projects Manager  Email: nagaharl@mail.nih.gov  Jerry Lee, Ph.D.  Tech. Dev. Program Officer  Email: leejerry@mail.nih.gov