# DCP - COPTRG - SELECT/PCPT

> **NIH NIH N01** · LEIDOS BIOMEDICAL RESEARCH, INC. · 2024 · $86,416

## Abstract

The Contractor shall conduct program analysis activities upon request and provide on-site staff to assist in creation of product development plans for vaccines and therapeutics. The Contractor shall provide information and knowledge in areas including but not limited to: product (vaccine or therapeutic) 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.

## Key facts

- **NIH application ID:** 11053288
- **Project number:** 75N91019D00024-P00035-759102000003-32
- **Recipient organization:** LEIDOS BIOMEDICAL RESEARCH, INC.
- **Principal Investigator:** LEONARD FREEDMAN
- **Activity code:** N01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $86,416
- **Award type:** —
- **Project period:** 2020-08-31 → 2024-08-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11053288

## Citation

> US National Institutes of Health, RePORTER application 11053288, DCP - COPTRG - SELECT/PCPT (75N91019D00024-P00035-759102000003-32). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/11053288. Licensed CC0.

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