AN41--Research Services Neural Stem Cell Study for Spinal Cord Injury Pre-solicitation Notice with Intent to Sole Source

Special Notice Special Notice Page 3 of 3 Special Notice Special Notice Page 1 of 3 Pre-Solicitation Notice for notice of intent to award a sole source contract. This is not a solicitation. The Department of Veterans Affairs intends to negotiate a sole source contract for a one

1. year period with Pharmaron (San Diego) Lab Services LLC, 2820 Loker Ave E, Carlsbad CA 92010 to provide In vivo safety of neural stem cells grafted in rats with spinal cord injury.

The vendor will be responsible for all aspects of the rat for the In Vivo GLP study performed in full compliance with FDA 21 CFR Part 58, Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies. Rats will be subjected to a spinal cord injury, followed by a neural stem cell or control graft and will be sacrificed at 1, 3, or 9 months post-graft. The Vendor will be responsible for master study protocol, animal procurement, surgical and post-surgical support, animal perfusion and generation of a final GLP study report adhering to FDA 21 CFR Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies guidelines.

The facility must be in driving distance to the VA San Diego to maintain scientific integrity of stem cells with time-sensitive transportation (cells that are transplanted into these animals are prepared in house and must be hand-delivered on ice) and to limit long-distance travel. These requirements are critical to support regulatory submission and clinical translation of therapies addressing spinal cord injury in the Veteran population. The required highly specialized services directly support development of therapies for spinal cord injury (SCI), a condition disproportionately affecting Veterans.

The complexity of neural stem cell therapies introduces heightened regulatory scrutiny, particularly regarding safety and long-term persistence in central nervous system tissues. Given Pharmaron s proximity to the San Diego VA Medical Center, its extensive expertise in stem cell based therapies, and its ability to provide the complete suite of required capabilities within a single, integrated framework specific to neural stem cell based CNS applications, Pharmaron is the only vendor capable of conducting the GLP study necessary to evaluate the safety, toxicity, and biodistribution of grafting a GMP H9 scNSC Working Cell Bank (WCB) in vivo into athymic rats within the required timeline for the ongoing research efforts. Accordingly, this requirement will be procured on a sole source basis, and no solicitation will be posted on SAM.gov Contract Opportunities.

The applicable NAICS code is 541380 (Testing Laboratories and Services), with a $19 million size standard. The Product Service Code (PSC) is AN41. The authority for this action is RFO 6.103-1; Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

Interested parties may submit inquiries regarding this notice by email only to: Ann Marie Stewart Contracting Officer Email: [email on the source notice] The VA will consider all responses received; however, the decision to conduct a competitive procurement based on responses to this notice is solely at the discretion of the Contracting Officer.