Assay Cascade Application Process

Application Process for NCL's Assay Cascade Characterization Program

The NCL solicits applications four times per year, with deadlines on the first business days of March, June, September, and December each year. The application process is conducted in two parts:

Part 1 is a four-page white paper application that describes the concept. The white paper is intended to provide reviewers with an introduction to your nanoformulation, the data previously generated, and areas where NCL could potentially provide further data. Applications are reviewed within 45 days of the application deadline.

Part 2 is a full proposal. The most promising white papers (i.e., nanotechnology strategies) will be asked to submit full proposals for part 2 of the application process. This proposal can be in the form of an oral presentation to the review committee or a written proposal. Invited applicants will be provided comments from the review committee on the evaluation of their white paper that they should address in their part 2. The part 2 proposals are due three months after receipt of the invitation letter and decisions are typically returned in about two weeks.

Download the White Paper Application.

Evaluation Criteria for NCL's Assay Cascade Applications

The primary evaluation criterion for white papers in part 1 is the strategy's previously demonstrated efficacy in a biological system relevant to cancer research (point #1 below). The full evaluation criteria for part 2 full proposals is outlined below.

1. Demonstrated Efficacy in a Biological System 
   Discuss findings from safety and efficacy studies. Studies should include all appropriate controls (e.g., standard of care comparison, nontargeted controls), use a cancer model appropriate to your intended indication, and use the route of administration intended in the clinic. Given the competitive nature of the application process, preference is given to applications that have in vivo efficacy data as opposed to only in vitro data. White papers that address only the material sciences aspects of nanotechnology are not desired.

2. Anticipated Impact of Strategy on Clinical Cancer Therapeutics or Diagnostics
   Describe the projected clinical use of the material and the basic biological mechanisms of action. What is the strategy's "value added" when compared with existing therapeutics and diagnostics? If the strategy has benefits due to targeting or specificity, discuss the specific underlying mechanisms and include data to support these claims. Describe any significant findings related to safety or pharmacology endpoints, comparing these results with current therapeutics or devices.

3. Previous Characterization of Material
   Supply detailed information on assays previously used to characterize the material and the reproducibility of those assays. As part of its Assay Cascade, the NCL will provide an initial screening to determine the variability of basic physical and chemical parameters of the material provided. If the variability is so large that further physical and biological assays will not provide meaningful data, the Assay Cascade will be discontinued for that strategy. The demonstrated ability to control the physical parameters of the material will therefore be a weighted evaluation criterion.

4. Manufacturing Process; Compatibility with Scale-Up
   Briefly describe the manufacturing process and steps used during purification. Discuss impurities that may be present in the final product. Provide information on the cumulative amount of nanomaterial (e.g., milligram, gram, or kilogram) produced to date and the batch-to-batch variability. Discuss potential obstacles associated with producing enough material for preliminary pharmacology and toxicology studies.

5. Inherent Toxicity of Nanotechnology Concept
   Include information on relevant safety issues related to the production, purification, handling and use of the nanomaterial. For example, if the nanomaterial contains a known toxic compound, discuss how the strategy overcomes or mitigates potential adverse health effects.

6. Plan or Strategy to Transition the Concept to Clinical Use
   Information related to teaming with industry, non-profit, academic, or other government partners in the translation effort is of interest to the NCL. If applicable, describe steps previously taken toward translation of the nanomaterial to clinical use. Discuss possible sponsors for future studies or trials and arrangements with commercial production firms. Discuss intellectual property issues related to the material, especially if the material uses licenses or represents an improvement or modification of an existing material or production process. If applicable, a brief summary of similar or closely related antecedents or approaches to the submitted nanomaterial should be described.