The NCL's charter is to serve as a national characterization facility for nanomaterial researchers. There are three avenues for collaborating with the NCL:
- NCL’s Assay Cascade Characterization Service for Oncology Nanomedicines
- A cCRADA Collaboration for Nanotech Research & Development
- Technical Services for select NCL Assays
NCL’s Assay Cascade Characterization Service
NCL’s Assay Cascade Characterization Service is available, by application, to nanotech researchers developing cancer therapies or diagnostics. Nanotechnology strategies accepted into the testing program 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.
Similarly, companies already involved in drug discovery would be encouraged to submit their nanoparticles and devices to the NCL because of its preclinical interactions with the FDA and the knowledge base generated by a community approach to commercialization of nanomaterials. One source quoted by the FDA points to errors in a material's preclinical 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 for supporting early development and ensuring proper grounding and links in the exploration of diagnostic nanotechniques for cancer. The NCL is 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 development by standardizing preclinical testing to facilitate the regulatory review process.
To apply for NCL’s Assay Cascade characterization service, please click here.
In addition to the free Assay Cascade testing service, NCL conducts industry-funded R&D for discovery work (e.g. formulation, optimization, scale-up, bioanalytical methods development, etc.) and characterizes nanoparticles for non-oncology applications.
Collaborations with NCL for these non-Assay Cascade services are conducted under a contractor Cooperative Research and Development Agreements (cCRADA) with Leidos Biomedical Research, Inc. (the Operations and Technical Support Contractor for the Frederick National Laboratory for Cancer Research). The cCRADA is a statutorily based mechanism created under the Federal Technology Transfer Act of 1986 for the purpose of facilitating Government-Industry collaboration and technology transfer.
To date, NCL’s cCRADAs have primarily been with pharmaceutical companies (see stories here and here) including Amgen, AstraZeneca, and Pfizer. The research plan and budget for NCL cCRADA agreements are negotiated on a case-by-case basis, considering NCL’s resources and capabilities, alignment with NCL and NCI’s research interests, and potential impact towards improving nanomedicine R&D. Each cCRADA defines certain obligations for NCL/Leidos Biomedical Research, Inc. and the collaborator. Generally, these obligations focus on intellectual property (IP) and data rights, which may arise pursuant to the studies. Relevant to IP, the cCRADA allows industry partners to obtain exclusive or non-exclusive license rights to any technology developed at NCL, and expedite technology commercialization. NCL does not profit from cCRADA collaborations.
For more information, or to propose a cCRADA collaboration with NCL, please click here.
Technical Services are also funded by the requesting investigator and are available to any interested developer. In contrast to cCRADA collaborations, Technical Services are for assays conducted under pre-defined statements of work and do not involve research and development efforts.
Work for the Technical Services is conducted under Technical Services Agreements (TSA) with Leidos Biomedical Research, Inc, the Operations and Technical Support Contractor for the Frederick National Laboratory for Cancer Research), and fall under the cCRADA statute. More information on the TSAs available from the Frederick National Lab can be found here.
For more information on the Technical Services available from the NCL, please click here.