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

3. Identify and Characterize Critical Parameters Related to Nanomaterials' Absorption, Distribution, Metabolism, Excretion, and Toxicity Profiles of Nanomaterials Using Animal Models.

The analytical cascade detailed above is structured to characterize specific nanotechnology strategies that are submitted to the NCL. Concurrent with that effort will be research directed at elucidating the critical parameters that influence nanomaterials' compatibility and effectiveness in biological systems. For instance, a growing body of evidence implicates nanomaterials' size, surface chemistry, fluid dynamics, and hydrophilicity as key parameters contributing to its distribution and excretion. By determining the influence of each of these parameters (i.e., the partial derivative), the NCL will work toward a better understanding of structure activity relationships (i.e., the total derivative). A systematic characterization of these parameters' influence on in vitro/in vivo ADME/Tox profiles will provide empirical data to engineering and predictive models. These modeling tools may predict and recommend functionalization and structural improvements, which can then be incorporated into the next iteration of nanomaterials submitted to the NCL (Figure 3).