Governance

  Scientific Oversight Committee
  Personnel
  Performance Measures

Nanotechnology Characterization Laboratory Scientific Oversight Committee

The primary goal of the NCL is to facilitate the accelerated transition of basic nano-biotechnology research to clinical trials. The NCL will therefore adopt a "systems approach" model to support NCI's mission and to meet "customer" requirements.

To elaborate, the specific requirements for entry into the clinic will be defined early on in collaboration with the FDA to the fullest extent possible. The NCL's analytical cascade will then be directly linked to those guidelines. Concurrently, the NCL must get inputs from NIST and the pharmaceutical industry to ensure the nanoparticles' characterization and fabrication are conducive to scale-up and rapid transition to industry.

To oversee these goals, the NCL will assemble a Scientific Oversight Committee with representatives from the supporting organizations (i.e., NCI, NIST, and FDA) and the pharmaceutical, diagnostic and nanotechnology industries.

The Scientific Oversight Committee will be tasked with:

(1)	Recommending and reviewing NCL's prioritization of resources.
(2)	Monitoring NCL activities to avoid duplication of effort with other government entities.
(3)	Facilitating interactions with their respective organizations.

 

Personnel

In addition to the NCL Director and support staff, the scientific disciplines represented at the NCL include immunology, pharmacology and toxicology, and biochemistry.

Brief descriptions for these senior-level positions are listed below:

The Director coordinates and oversees the efforts of all NCL scientists and staff to develop new approaches, methodologies, and standards to characterize nanotechnology-based devices and platforms. He or she coordinates NCL efforts with requirements from scientists and management within intramural and extramural programs at NCI and NIH, with capabilities of other NCI laboratories and with related efforts at FDA and NIST. The Director represents the NCL and NCI at various intra- and inter-agency meetings, working groups, policy forums, and scientific conferences and is responsible for maintaining outreach efforts with academia and industry.

The Immunologist directs characterization related to the nanomaterials' interaction with components of the immune system. In the tissue culture and in vitro environment, this person develops and performs assays to monitor recognition and phagocytosis by leukocytes, opsonization, and other blood contact properties. The Immunologist also performs these assays for animal studies, characterizing the material's effect on hematopoietic tissues and the RES, and monitors any other acute/adverse effects related to the immune system.

The Toxicologist develops and performs assays that serve as pre-clinical surrogates for toxicity. In the laboratory, these assays include monitoring for apoptosis and cytotoxicity in hepatic and kidney cells, and identifying metabolic products and pathways. In animal models, this scientist collaborates with SAIC-Frederick's histopathologist to fully characterize the particle's toxicokinetic properties and assists the NCL's scientists with ADME/Tox, mass balance, and other pharmacodynamic protocols.

The Biochemist develops and conducts assays and protocols that support the material sciences aspects of the NCL. For instance, this scientist develops and oversees protocols that deal with the physical characterization phase of the analytical cascade, such as chromatography, electron microscopy, and elemental composition and purity. When applicable, the Biochemist may modify and optimize the nanoparticle's surface chemistry.

Performance Measures

On the basis of the number of staff, facilities, and supporting equipment, the NCL is anticipated to be able to receive several dozen nanoscaled particles/devices in the first year. However, because of the nanomaterial's inherent toxicity, impurity, or lack of compatibility with biological systems, only a few of these are expected to be nominated for and complete in vivo testing, i.e., the full analytical cascade. The first two phases are intended to act as a screening method for acute toxicity and/or other disqualifying properties. Assuming a 12-month timeline to complete the characterization, the NCL will subject at least six nanoscaled particles/devices to the entire analytical cascade per year. This number may increase to greater than 20 per year as the laboratory expands in personnel and resources.