Evaluation Criteria for Candidate Nanomaterials

Given the large number of candidate nanomaterials that could be submitted to the NCL for characterization, a set of entrance criteria will be applied to candidate nanotechnology strategies to aid in their selection and prioritization. Nanostrategies proposed to the NCL for characterization will be ranked according to the measure of their projected impact on clinical cancer applications and/or furthering nanotechnology's compatibility with biological systems. Specific evaluation criteria include, but are not limited to:

• Previously demonstrated efficacy in vitro and/or in animal models.
• Advantages offered by the strategy over existing cancer therapies or diagnostics.
• Previous physical characterization of the nanomaterial, such as determining
  purity and stability.
• The nanostrategy's manufacturing process and compatibility with scale-up.
• The material's inherent toxicity and/or environmental concerns.
• Plans or approach to transition the strategy to clinical trials
  (e.g., filing the follow-on IND, IDE or pre-IDE).

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