NCL Objectives

1. Establish and Standardize an Analytical Cascade for Nanomaterial Characterization
   
   
2. Facilitate the Clinical Development and Regulatory Review of Nanomaterials for Cancer Clinical Trials
   
   
3. Identify and Characterize Critical Parameters Related to Nanomaterials' Absorption, Distribution, Metabolism, Excretion, and Toxicity Profiles of Nanomaterials Using Animal Models
   
   
4. Examine the Biological and Functional Characteristics of Multicomponent/Combinatorial Aspects of Nanoscaled Therapeutic, Molecular and Clinical Diagnostics, and Detection Platforms
   
   
5. Engage and Facilitate Academic and Industrial-Based Knowledge Sharing of Nanomaterial Performance Data and Behavior Resulting from Pre-Clinical Testing (i.e. Physical Characterization, In Vitro Testing, and In Vivo Pharmaco- and Toxicokinetics)
   
   
6. Interface with Other Nanotechnology Efforts

5. Engage and Facilitate Academic and Industrial-Based Knowledge Sharing of Nanomaterial Performance Data and Behavior Resulting from Pre-Clinical Testing (i.e. Physical Characterization, In Vitro Testing, and In Vivo Pharmaco- and Toxicokinetics)

The NCL is intended to serve as a nexus for cross-disciplinary research, development, and clinical applications of nanotechnology. The NCL will disclose its findings to the scientific community and the public through full use of journal publications, scientific conferences, public forums, the Internet, and press releases. Care will be taken, however, to ensure proprietary information and materials disclosed to the NCL by industry are protected in accordance with the terms of agreement (e.g., Material Transfer Agreement).

The primary output of NCL's analytical cascade will be data and information related to nanomaterials' interaction and compatibility with biological systems. NCL's output will be provided to the originating investigator, and will include all aspects of the analytical cascade for support of an investigator-held IND application and subsequent clinical trials. Depending on the pre-negotiated agreement with the investigator, the NCL may wait up to 60 days prior to making NCL data available to the public domain. This delay allows for the submitting investigator/vendor to file the relevant patent application to further secure their intellectual property (IP). The emphasis of the NCL, however, is to serve as a nexus for transdisciplinary research, development, and clinical applications of nanotechnology. Information, knowledge, tools and methods gleaned from the NCL's analytical cascade must therefore be made readily available to material scientists, engineers, modelers, regulatory bodies, and intramural and extramural cancer researchers.

As mentioned in the above section, the NCL will establish and maintain models, tools, and databases of information generated by the analytical cascade. This knowledge base will be made available in the public domain with the intent of capitalizing on the "collective" approach and efforts. The Cancer Biomedical Informatics Grid (caBIG) is an example of such a mechanism and serves as a model for disseminating data in a standardized format. Resources provided to the scientific community will include:

• Assay data (e.g., pharmacokinetic properties, toxicities, fluid dynamics, and general compatibility with biological systems) and links to publications detailing these results.


• Theoretical, detailed, systems, engineering, and statistical models used in the predictions, comparisons and analyses of the data from nanoparticles/device characterization.


• Links to model descriptions, assumptions, validations, expert users, and vendors.


• Links to scientific and clinical users of those models, whether individuals, institutions, agencies, universities, or companies.


• Cross-referencing and links to related research, results and publications contained in other databases.

Communication between the NCL and its "customers" will also be structured to ensure requirements are met. NCL's customers are the end-users of the characterization data: cancer researchers, the FDA, and the pharmaceutical industry. As an example, the NCL management will meet with FDA representatives on at least a quarterly basis to ensure procedures (i.e., the analytical cascade), data, and quality of nanomaterials are conducive to facilitating clinical applications. Similarly, the NCL will liaison with the nanotechnology, in vitro diagnostic and pharmaceutical industries on a regular basis to facilitate and promote the rapid translation of this technology to market.