GD2 CAR-T Cell Therapy Clinical Trial Site Administration and Cell Distribution Logistics
- Solicitation Status Awarded
- Date Awarded
- Research Category Research & Development Services & Subcontracts
- Vendor Name Leidos Biomedical Research, Inc.
- Solicitation Number S21-118
- NCI OA Contract Number 75N91019D00024 – NCI-FFRDC
Description
Leidos Biomed is seeking an organization to manage cellular product distribution logistics for an autologous CAR T-cell study in pediatric neuroblastoma and osteosarcoma. The purpose of this project is to collaborate with an organization that is well-versed in oversight of autologous cellular therapy logistics and site administration to ensure consistent cell therapy collection and cryopreservation processes and procedures across clinical trial sites, ensure standardized processes are developed and maintained for autologous cell chain of custody, ensure shipment of cells are conducted in a controlled and consistent manner to maintain viability and integrity in qualified shipping systems, coordinate timing and cryogenic monitoring of shipments to and from the clinical sites with the clinical staff at these sites and the manufacturing facility, and to ensure all processes and procedures are conducted in accordance with applicable local, state and federal regulations.
Proposal Instructions
Offeror questions are due 2:00 PM (ET) on WEDNESDAY, DECEMBER 16, 2020. Offers are due 2:00 PM (ET) on MONDAY, JANUARY 11, 2021. For the full solicitation package please contact Ms. Heather Housaman at Heather.Housaman@nih.gov.