Process Overview

The NCL's charter is to serve as a national characterization facility for nanomaterials submitted from academia, industry, and other government laboratories, i.e., intramural and extramural sources. The NCL is not structured to conduct basic material sciences research or fabricate novel nanomaterials. Nanotechnology strategies submitted to the NCL will be subjected to a standardized characterization cascade, developed in collaboration with NIST and the FDA. This "collective" approach allows the NCL to leverage a knowledge base of material sciences information, characterize the material against a panel of standardized assays, and facilitate a nanomaterial's development and translation to clinical application.

The uniqueness of this structured approach is intended to be attractive to developers and producers of nanomaterials because it reduces risk and the expenditure of their resources. For example, a materials scientist or engineer in academia or with a small nanotechnology firm may invent a nanodevice that has potential applications in cancer therapy and diagnostics. This researcher may have minimal expertise in biology, and likely does not have ongoing interaction with the pharmaceutical community. By submitting the nanomaterial to the NCL, the particle/device will be characterized for its compatibility with biological systems and, assuming favorable results will become a candidate for regulatory review. Submission to the NCL's analytical cascade therefore affords universities and small businesses an entry point into pharmaceutical markets, with minimal cost and risk. When appropriate, the NCL may also reimburse scientists for their efforts or may sponsor development of nanoscaled platforms through research contracts.

Similarly, companies already involved in drug discovery would be encouraged to submit their nanoparticles and devices to the NCL because of its pre-clinical interactions with the FDA and the knowledge base generated by a community approach to commercialization of nanomaterial. One source quoted by the FDA points to errors in a material's pre-clinical characterization as a major cause of escalating costs for drug development:

"The main causes of failure in the clinic include safety problems and lack of effectiveness: inability to predict these failures before human testing or early in clinical trials dramatically escalates costs. For example, for a pharmaceutical, a 10-percent improvement in predicting failures before clinical trials could save $100 million in development costs per drug."

(Source: Boston Consulting Group as referenced in Challenge and Opportunity on the Critical Path to New Medical Products)

Finally, companies interested in diagnostic applications would have a resource to use for supporting early development and ensuring proper grounding and links in the exploration of diagnostic nanotechniques for cancer. The NCL would be in a unique position to ensure that when a link between a diagnostic and a new nanotechnology therapeutic appear warranted, both technologies could be evaluated in a concurrent and synergistic manner.

The NCL is intended to accomplish precisely this: reduce the cost and risk associated with the development pathway by standardizing the pre-clinical efficacy and toxicity testing and to facilitate the regulatory review process.