Frederick National Laboratory staff member works to prepare materials to for clinical testing.

Clinical

The Frederick National Laboratory provides support for more than 400 domestic and overseas clinical trials, as well as drug development and production.

Clinical Research Support

The Frederick National Laboratory provides critical support to domestic and international efforts related to cancer, HIV, Ebola, respiratory viruses, and other infectious diseases. Support includes managing laboratory equipment, training personnel, responding to information technology needs, and program/project management. Frederick National Laboratory staff respond urgently to emerging health threats by providing resources and expertise to plan, implement, conduct, and analyze clinical research studies and projects.

Biospecimen Collection and Processing

The laboratory provides clinical and biological monitoring, regulatory support, biospecimen processing and storage, and assay development to clinical programs. Core functions include receipt and distribution of biomaterials for research and clinical testing. Staff are experienced in domestic and international shipments of biospecimens that can be critical for cancer diagnosis and analysis.   

Repositories

As a shared national resource, The Frederick National Laboratory has vast repositories of research materials available to biomedical investigators nationwide. These include more than 15 million biological specimens, frozen tumor samples, research reagents, and genetically engineered mouse models of human cancers. The laboratory provides technical project management to repositories capable of accommodating all types of commercially available biospecimen storage with mechanical freezers and cryogenic units.  

Experimental Design

Various programs at the Frederick National Laboratory provide expertise with experimental design data and results interpretation through consultation, collaboration, training, and technology development and enhancement. Scientists provide extensive knowledge and expertise in a variety of disciplines to analyze data and provide solutions through partnerships with the biomedical industry, academic research institutions, non-profits, and other organizations.

Molecular Characterization of Clinical Specimens

The Molecular Characterization Laboratory (MoCha) consists of histotechnologists, molecular biologists, bioinformaticians, and scientists to support clinical studies and precision medicine initiatives. The laboratory researches clinical specimens by translating comprehensive characterizations of molecular alterations in tumors to help improve patient outcomes.

Patient Support Care

The Frederick National Laboratory’s clinical research team schedules patient appointments, creates clinic schedules, and manages electronic medical records. The program is responsible for patient care, protocol reviews, approvals, compliance, data collection and management, and human subject protection.   

Clinical Pharmacodynamics

Concurrent molecular imaging and pharmacodynamic assay development supported by the Frederick National Laboratory allows for early assessment of potential clinical biomarkers. These processes increase the potential for successful clinical evaluation of agents by discovering the signals of drug action and reaction.

Clinical Issues: Ethics, Regulatory, and Legal

With its regulatory affairs expertise, the lab conducts regulatory review of clinical protocols, informed consent documents, and ensures regulatory compliance for clinical trials. Through regulatory support to investigators, the laboratory provides guidance on product storage, shipping, labeling, and manufacturing issues.  

Process Development for Manufacturing

The Biopharmaceutical Development Program (BDP) has expertise in cell line development, protein/virus isolation and purification, small-to-pilot scale fermentation and cell culture, and formulation/lyophilization—freeze drying to preserve products.

Preclinical and CGMP Manufacturing 

BDP handles Current Good Manufacturing (CGMP)-qualified cell banking, purification, virus production, fill/finish/lyophilization, mammalian cell culture (40-1000 L), and fermentation/bioreactors (100-500 L).