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

4. Examine the Biological and Functional Characteristics of Multicomponent/Combinatorial Aspects of Nanoscaled Therapeutic, Molecular and Clinical Diagnostics, and Detection Platforms

By virtue of their multifunctional capabilities, nanoscale devices can include targeting agents, diagnostic components and therapeutic payloads all within the same platform. These "smart" nanotherapeutics may provide clinicians with the ability to tailor nanoparticles to target specific tissues, release anticancer drugs or deliver in a timed manner, and monitor efficacy in near real time. The NCL will facilitate the advancement of multifunctional nanoscaled platforms primarily by promoting collaborations between otherwise unassociated researchers. Looking to future capabilities, the NCL may conduct its own combinatorial studies to take advantage of the multifunctional potential of nanoparticles. Once a core technology is characterized, for example, the NCL may be in the best position to exploit the modular aspects of nanotechnology's targeting, imaging, therapeutic, and diagnostic components. Although the NCL seeks to enable the larger nanotechnology community to conduct basic research, this intramural approach may be pursued if it is viewed to be in the best interests of the government.

The list of conceivable combinatorial nanodevices is immense, and grows exponentially with each new targeting ligand or novel nanomaterial. An exhaustive characterization of each of these combinations is obviously beyond the scope and resources of the NCL. The NCL will therefore work closely with regulatory entities to identify taxonomies of nanomaterials with similar ADME/Tox profiles. As corporate understanding of nanomaterials' interaction and compatibility with biological systems matures, redundant characterization studies on related categories of nanodevices could be reduced. Additionally, the NCL - in collaboration with the Advanced BioComputing Center (ABCC) at NCI-Frederick, NIST, and the FDA - will develop predictive and engineering modeling tools that may eventually offer in silico alternatives to some aspects of the analytical cascade.