The urgency to eliminate the pain and suffering associated with cancer is fueling research into novel therapies at a blistering pace. Through exquisitely targeted and multifunctional approaches, nano-technology in particular holds great promise for enhancing cancer therapy. This promise, however, will never be realized if the safety of the nanomaterial is not demonstrated to allay public concern and if the regulatory structure is not in place to allow proper evaluation of the science. Without such a framework, the return on investment will be uncertain and progress will undoubtedly be stalled. The effort to develop a standardized set of protocols to characterize nanomaterials and their biological effects will provide a foundation for future regulation and will lead to a body of knowledge that will guide the design of safer nanotechnology products.

The biologic activity and toxicity of nanoscale particles are dependent on many parameters not typically examined for conventional small molecule therapeutics: size, shape, surface chemistry, stability of outer coating, agglomeration state, etc., and many conventional properties, such as stability or biodistribution, must be analyzed using a very different set of protocols and/or instrumentation. Emerging data from studies on nanoparticles engineered for medical use will build toward a consensus of instrumentation and experimental methodology needed to reproducibly determine the pharmacology and safety of these novel products.

The greatest challenge may not be in the development of new screening technologies, but in the ability to promulgate an accepted set of characterization protocols throughout the Nano Bio industry. The Nanotechnology Characterization Laboratory at the National Cancer Institute is working together with the FDA, NIST, and other regulatory and standards-setting organizations to establish the standard assays and technologies needed for timely delivery of safe and effective nanotechnology products.

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