Grand Challenges for Nanomedicine and Nanobiology Workshop Houston, Texas August 27 th , 2007
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Transcript of Grand Challenges for Nanomedicine and Nanobiology Workshop Houston, Texas August 27 th , 2007
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Grand Challenges for Nanomedicine
and Nanobiology Workshop
Houston, Texas
August 27th, 2007
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Personal ThoughtsPersonal 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 SessionsUpcoming 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/Nanotechnology
Clinical Pathway • Clinical trial grants and contracts• FDA • Nanotechnology Characterization Lab
ASCB Special Session: Dec 1st, 2007
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Upcoming NIH Funding OpportunitiesUpcoming NIH Funding Opportunities
Nanoscience and Nanotechnology in Biology and Medicine (R01&R21), 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 OpportunitiesUpcoming 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 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 VitroIn Vivo
Physicochemical
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NCL in vivo Characterization AssaysNCL 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
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0 5 10 15 20 25 30 35 40 45 50
Time (hours)
% In
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3 H /m
L 3H-Liposome3H-Ghost Liposome3H Labeled Carrier + Drug3H Labeled Carrier
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0 5 10 15 20 25 30 35 40 45 50
Time (hours)
% In
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3 H /m
L 3H-Liposome3H-Ghost Liposome3H Labeled Carrier + Drug3H Labeled Carrier
Plasma Profile
SEX
MALE
FEMALE
DOSE GROUP CONTROL + DRUG CONTROL +DRUG
NUMBER OF ANIMALS 3 3 3 3
BODY WEIGHT (gram)a 330+ 53 321 + 73 237 + 31 271 + 81
BRAIN
Absolute Weight gram 1.95+ 0.10 1.94 + 0.05 1.83 + 0.10 1.93 + 0.24
Per Body Weight % 0.60+ 0.07 0.56 + 0.04 0.87 + 0.00 0.89 + 0.09
HEART
Absolute Weight gram 1.30+ 0.21 1.08 + 0.19 0.94 + 0.19 0.89 + 0.09
Per Body Weight % 0.41+ 0.09 0.34 + 0.03 0.39 + 0.05 0.34 + 0.06
Per Brain Weight % 68.32+ 11.42 56.55 + 8.79 51.02 + 8.31 53.67 + 12.42
KIDNEYS
Absolute Weight gram 2.96+ 0.47 2.18 + 0.65 1.66 + 0.21 1.83 + 0.47
Per Body Weight % 0.90+ 0.11 0.68 + 0.08* 0.70 + 0.04 0.68 + 0.04
Per Brain Weight % 152+ 24 114 + 28 90 + 7 113 + 44
LIVER
Absolute Weight gram 16.05+ 2.58 12.61 + 3.07 8.11 + 1.36 10.99 + 3.02
Per Body Weight % 4.94+ 1.08 3.93 + 0.25 3.41 + 0.17 4.08 + 0.10*
Per Brain Weight % 825+ 141 661 + 139 441 + 48 676 + 279
SPLEEN
Absolute Weight gram 0.71+ 0.09 0.51 + 0.05* 0.42 + 0.10 0.57 + 0.15
Per Body Weight % 0.22+ 0.04 0.16 + 0.04 0.18 + 0.02 0.21 + 0.01*
Per Brain Weight % 36.46+ 5.12 27.01 + 4.66 22.97 + 3.90 35.01 + 14.19
LUNG Absolute Weight gram 1.72+ 0.50 1.45 + 0.14 1.30 + 0.18 1.33 + 0.10
Per Body Weight % 0.54+ 0.22 0.46 + 0.08 0.55 + 0.06 0.52 + 0.12
Per Brain Weight % 88+ 27 76.+ 11 71 + 7 80 + 14
Organ Weights Main Study
SEX
MALE
FEMALE
DOSE GROUP CONTROL +DRUG CONTROL +DRUG
NUMBER OF ANIMALS 3 3 3 3 Red Blood Cells
Hematocrit (Hct) % 46.60+1.
27 44.88+0.5
9 43.18+2.4
4 43.80+1.2
5 Hemoglobin Conc. (Hb)
g/dL 15.7+0.4 15.2+0.1 14.7+0.6 15.4+0.2
Mean Corp. Hb. (MCH)
pg 20.7+0.5 21.2+0.1 20.7+0.4 20.87+0.4
5 Mean Corp. Hb. Conc. (MCHC)
g/dL 33.73+0.
81 23.87+17.38
34.2+1.0 35.2+0.61
Mean Corp. Volume (MCV)
fL 61+2 63+1 60+2 59+3
Total Erythrocyte Count (RBC)
M/L
7.61+0.06
7.17+0.08*
7.13+0.41 7.39+0.15
Red Cell Distribution
Width % 18.0+0.5 16.3+0.6* 17.4+0.5 17+0.26
White Blood Cells
Lymphocytes 103/L
7.61+1.54
6.9+2.7 5.9+2.0 3.46+1.45
Macrophage/ Monocytes
103/L
0.23+0.19
0.57+0.68 0.33+0.17 0.10+0.10
Granulocytes 103/L
1.76+0.31
1.15+0.36 0.96+0.36 1.23+0.31
Total Leukocytes (WBC)
103/L
9.60+1.77
8.64+3.70 7.17+2.29 4.78+1.41
Clotting Potential Platelet Count
(PLT) 103/L
807+136 925+75 645+165 249+411
Mean Platelet Volume (MPV)
fL 8.1+0.2 7.6+0.4 7.67+0.84 7.83+0.40
Platelet Distribution
Width (PDW) % 34.1+1.2 34.5+1.6
34.07+2.97
34.13+0.70
Plateletcrit (PLT) % 0.66+0.1
1 0.7+0.03 0.49+0.14 0.75+0.13
Hematology Interim Study
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Current NCL CollaboratorsCurrent NCL Collaborators
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Onsite Program Contacts Onsite Program Contacts
Larry Nagahara, Ph.D.Nanotechnology Projects Manager
Email: [email protected]
Jerry Lee, Ph.D.
Tech. Dev. Program Officer
Email: [email protected]