DCP - Biospecimen Processing and Trial Logistics

Biospecimen collection, processing and storage for DCP-sponsored trials and studies The NCI’s DCP is devoted to cancer prevention, detection, and symptom science research. We provide funding and administrative support to clinical and laboratory researchers, community and multidisciplinary teams, and collaborative scientific networks. This unit of work/cost center is for the ongoing collection, processing and storage of biospecimens collecting through DCP sponsored clinical trials and studies. This work involves the planning for specimen collection on studies, including, but not limited to creation and assembly of specimen collection kits, custom postage design, specimen receipt and processing, data entry, repository interface and processing stored specimens for use by extramural investigators. The tasks involve maintenance of freezers including regular checks of specimens and freezers, accession of specimens, record storage, and interaction. The Contractor shall conduct program analysis activities upon request and provide on-site staff to assist in creation of product development plans product development analysis; creation of target product profiles; preclinical strategy; manufacturing capacity analysis; regulatory strategy; clinical development strategy with transition plan to advanced phase clinical testing; candidate down-selection strategy; and market analysis of public-private partnerships. The Contractor shall identify deficiencies in these areas and independently close those deficiencies using their skills and abilities and those of subcontractors. The Contractor shall maintain a Quality Control/Quality Assurance (QC/QA) program to monitor performance, including the development of standard operating procedures (SOPs) for each protocol or process, optimized for maintaining the integrity of human biological material; for monitoring the quality of products; for the operation of the laboratories; and for tracking specimen influx, processing, and efflux. There are approximately ~2.4 million samples from 47 collections/studies with over 20 material types and specimens which include, but are not limited to blood, urine, saliva, biopsy tissue, etc.. Many of these studies have collected specimens with specific clinical and pathologic endpoints of clinical interest for cancer screening and prevention. These studies include research prevention, detection, and symptom science research studies on the following cancer sites: Breast, Prostate, Ovarian, Lung, Colon, Pancreas, Liver, and less common cancers. Project Number: 75N91019D00024-0-759102500016-9 | Fiscal Year: 2025 | NIH Institute/Center: National Cancer Institute (NCI) | Principal Investigator: lynn briscoe | Institution: LEIDOS BIOMEDICAL RESEARCH, INC., FREDERICK, MD | Award Amount: $2,855,659 | Activity Code: N01 View on NIH RePORTER: https://reporter.nih.gov/project-details/11457785