Whole-person Assessment of Response and Risk after transformative therapies: In

The National Institutes of Health National Heart, Lung, and Blood Institute is preparing to solicit a research services contract to implement, manage, and support a multi-center longitudinal cohort study of sickle cell disease patients treated with gene therapy or hematopoietic cell transplantation, with responses to a sources sought notice due October 2, 2026, and anticipated contract award for a ten-year period beginning April 2028.

This procurement is limited to small businesses certified under NAICS 541715 (Research and Development in the Physical, Engineering, and Life Sciences); the government reserves the right to determine set-aside eligibility based on responses received. The contractor will build and maintain a cohort of approximately 700 patients with annual longitudinal follow-up for at least five years post-treatment, potentially extending to fifteen years. Core operational responsibilities include program management and coordination, site recruitment and onboarding, participant accrual and tracking, clinical data collection and reporting, patient-reported outcomes operations, participant retention activities, biospecimen collection and coordination, data quality monitoring, and support for independently funded ancillary studies.

The contractor must maintain qualified staff with clinical expertise in sickle cell disease, gene therapy and hematopoietic cell transplantation outcomes, patient-reported outcomes, biospecimen collection, and bioinformatics infrastructure. All work must comply with applicable Federal, NIH, and NHLBI requirements regarding human subjects research, privacy, security, biospecimen handling, and data sharing. The contractor will leverage existing infrastructure from the Center for International Blood and Marrow Research and collaborate with consortium members and other contractors managing related efforts.

Capability statements must not exceed 15 single-sided pages (12-point font minimum), include total employee count, professional qualifications, facilities and equipment description, and relevant prior research experience, and be submitted by 3:00 p.m. EST on October 2, 2026, to Elizabeth Bulger (elizabeth.bulger@nih.gov) and Jessica Williams (jessica.williams3@nih.gov).