By Nanotechnology Characterization Laboratory (NCL)
The Nanotechnology Characterization Laboratory (NCL) performs preclinical characterization of nanoparticles to facilitate the regulatory review of nanotechnology concepts intended as cancer therapies and diagnostics. This resource is available to US-based researchers in academia, industry, and government to enable further development of their nanotechnology strategies towards clinical applications. The critical infrastructure and characterization services afforded through this program are provided to nanomaterial researchers at no cost and are available through an application process. Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. As part of its Assay Cascade, the NCL will characterize a nanoparticles' physical and chemical attributes, their in vitro biological properties, and their in vivo compatibility using animal models. The NCL uses a standardized characterization cascade, developed in collaboration with the US Food and Drug Administration (FDA) and National Institute of Standards and Technology (NIST). This in-depth characterization spans the areas of physicochemical characterization, in vitro and in vivo immunological characterization, and in vitro and in vivo pharmacology and toxicology. The primary output of NCL's Assay Cascade is data and information related to the nanoparticles' physical and chemical properties, as well as interaction and compatibility with biological systems. These data will be provided to the originating investigator in support of an investigational new drug or investigational device exemption filing. Data can also be used to garner venture capital, for publications, or to seek additional research funding. If a nanotechnology strategy is selected for characterization, NCL's services will be provided at no cost to the submitting investigator. The NCL team, in consultation with the applicant, will design a research plan individually tailored for each nanoformulation, considering the nanoparticle platform, drug, intended clinical indication, dose, and route of administration. The time required to characterize a nanomaterial from receipt through the in vivo phase is anticipated to be about one year. The NCL solicits nanotechnology strategies from academia, industry, and government. Desired nanotechnology proposals include, but are not limited to, strategies that incorporate image contrast agents, cancer therapeutics, and targeting receptors or ligands. Concepts containing nanotechnology formulation of legacy oncology drugs will NOT be considered. Innovative, high-risk, high-reward concepts are invited to apply. Applications are accepted twice per year, with deadlines on the first business days of March and September. 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. Those who submit 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 proposal. The Part 2 proposals are due three months after receipt of the invitation letter and decisions are typically returned in about two weeks. The NCL accepts two types of applications: those seeking characterization of a lead cancer nanotechnology concept and those seeking limited structure-activity relationship studies, method development, or limited scope analysis to aid in lead selection or optimization.
