BRF: LLU Cellular Therapy Research Facility - NIH C06 Research Facilities Construction Grant BRF: Loma Linda University Cellular Therapy Research Facility Applicant Institution: Loma Linda University Principal Investigator (PI): Travis Losey, MD Project Manager (PM): Adam Pierce Other Key Personnel: Eric Schilt, MBA; Mark Reeves, MD, PhD; Hisham Abdel-Azim, MD, MS PROJECT SUMMARY ABSTRACT Loma Linda University (LLU) proposes the construction of a shared-use research facility to support cell, gene, and regenerative medicine therapy (CGRMT) research. The project will establish integrated laboratory infrastructure for basic, translational, and clinical research in CGRMT. Research applications will include hematologic and solid malignancies, sickle cell disease, neurodegenerative disorders, primary immunodeficiencies, and other immune-mediated conditions. LLU serves the Inland Empire in southeastern California, a region with more than 4.6 million residents, limited biomedical research infrastructure and a high burden of chronic disease [4]. LLU has as a key strategic priority becoming an NCI designated Comprehensive Cancer Center, and the construction of this facility is a key step in building the infrastructure needed for this Center [6]. LLU has been designated as a Community Care Center of Excellence by the California Institute for Regenerative Medicine (CIRM), reflecting institutional leadership in expanding access to advanced therapies [2]. Southeastern California lacks shared-use CGRMT facilities with GMP-compliant manufacturing and integrated translational research capabilities, constraining investigators from translating basic research, expanding programs and initiating new studies including clinical trials. The proposed facility will address this need and provide > 6,200 square feet of shared-use research space, including controlled laboratory environments, core laboratory resources, and biospecimen-processing infrastructure. The facility will directly support a growing group of NIH, state, and industry-funded investigators, with active projects in cancer biology, immunotherapy, and regenerative medicine (Table 3). Importantly, the facility will enable investigator-initiated IND-enabling studies, local GMP-compliant manufacturing, and expansion of early-phase clinical trials currently dependent on external facilities. Upon opening, the facility will also increase the number of research trials available at LLU by supporting participation in and initiation of additional CIRM-associated clinical studies; CIRM's statewide portfolio currently includes more than one hundred active trials recruiting patients in cell and gene therapy [5]. The objectives of this project are to: (1) establish shared-use CGRMT infrastructure; (2) enable translation from discovery to early-phase clinical application; (3) expand NIH-, CIRM-, and industryfunded research; and (4) provide sustainable research infrastructure for at least 10 years. The expected impact includes increased clinical trial capacity, reduced reliance on external manufacturing facilities, improved access to advanced therapies, and strengthened regional and national contributions to biomedical research.
