AN41--Research Services Neural Stem Cell Study for Spinal Cord Injury

The Department of Veterans Affairs intends to award a sole source contract to Pharmaron (San Diego) Lab Services LLC for a one-year period to conduct an In vivo GLP study evaluating the safety, toxicity, and biodistribution of grafting a GMP H9 scNSC Working Cell Bank into athymic rats with spinal cord injury. The vendor will be responsible for the full execution of the study in strict compliance with FDA 21 CFR Part 58, including master protocol development, animal procurement, surgical and post-surgical care, animal perfusion, and generation of a final GLP-compliant report. The study requires rats to be injured, grafted with neural stem cells or controls, and sacrificed at 1, 3, or 9 months post-graft, with time-sensitive, hand-delivered stem cells transported on ice from the VA San Diego Medical Center, necessitating the vendor’s physical proximity to maintain scientific integrity. Pharmaron is designated as the only capable provider due to its unique integration of specialized expertise in neural stem cell therapies, proximity to the VA San Diego facility, and ability to deliver the entire suite of required GLP services under one framework, which no other vendor can match within the required timeline. This sole source procurement is justified under RFO 6.103-1, as no other source can satisfy the agency's critical needs to support regulatory submissions and clinical translation of therapies for spinal cord injury—a condition disproportionately impacting Veterans. The contract falls under NAICS code 541380 with a $19 million size standard and PSC AN41. Interested parties may submit inquiries via email to Ann Marie Stewart, Contracting Officer, until August 10, 2026, though the decision to pursue competition remains at the sole discretion of the VA.