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Previous large-scale vaccination clinics have been successful before the coronavirus disease 2019 (COVID-19) pandemic; however, owing to the strict storage requirements and pharmaceutical preparation needed for the COVID-19 vaccines, careful thought and planning were necessary to successfully deploy these clinics immediately after vaccine availability. The focus of this manuscript is to describe the development and implementation of COVID-19 vaccination clinics in a large public university, using professionals from within and outside of its health sciences schools.The primary objective of this project was to (1) implement COVID-19 vaccination clinics for university faculty, staff, students, and community members. Additional objectives of the clinics were to (2) actively incorporate pharmacy, nursing, and medical students into the clinic workflow; (3) promote interprofessional collaboration among faculty and students; and (4) assess patient satisfaction.The School of Pharmacy faculty, in conjunction with the Office of Strategic Initiatives, planned and coordinated COVID-19 vaccination clinics from December 2020 to July 2021. Students and faculty from schools of pharmacy, nursing, and medicine were used. COVID-19 vaccinations were offered to university faculty, staff, and students and community members based on the Centers for Disease Control and Prevention priority groups. The clinic processes were designed such that they could be scaled from 100 to 2,000 participants per day.The School of Pharmacy led approach was adjustable depending on the number of patients, continuously monitored and adaptable. The importance of pharmacists as part of the interprofessional health care team was exemplified by faculty and students involved.All patients receiving COVID-19 vaccinations at the clinics were e-mailed anonymous surveys for assessment of the quality of the vaccination encounter after completion of their primary vaccine series.More than 15,000 COVID-19 vaccinations were provided through the clinics from December 2020 to July 2021. Professional staffing totaled 3352 hours for the 48 clinics. Thirty-eight percent of the vaccinated patients responded to the clinic satisfaction survey with predominately excellent ratings.COVID-19 vaccination clinics can be successfully planned and implemented in a scalable fashion in a large university setting using an interprofessional team approach.

Introduction Filgrastim is a human granulocyte colony-stimulating factor (G-CSF). There is limited data on dosing filgrastim in obesity. The objective of this study was to compare filgrastim pharmacokinetic parameters for morbidly obese and non-obese patients after a single subcutaneous dose of filgrastim dosed per actual body weight. Methods This prospective, matched-pair study (NCT01719432) included patients ≥18 years of age, receiving filgrastim at 5 mcg/kg with a weight >190% of their ideal body weight (IBW) for "morbidly obese" patients or within 80-124% of IBW for matched control patients. The control group was prospectively matched for age (within 10 years), degree of neutropenia, and gender. Filgrastim doses were not rounded to vial size, to allow more accurate assessment of exposure. Blood samples were collected at 0 (prior to dose), 2, 4, 6, 8, 12, and 24 hours after the first subcutaneous administration of filgrastim. Results A total of 30 patients were enrolled in this prospective pharmacokinetic study, with 15 patients assigned to each arm. Non-compartmental analysis showed that the systemic clearance (Cl) was 0.111 ± 0.041 mL/min in the morbidly obese group versus 0.124 ± 0.045 mL/min in the non-obese group (p=0.44). Additionally, the mean area under the curve (AUC0-24h ) was 49.3 ± 13.9 ng/mL x min in the morbidly obese group versus 46.3 ± 16.8 ng/mL x min in the non-obese group (p=0.6). No differences were seen in maximum concentrations (Cmax ) between the two groups (morbidly obese: 48.1 ± 14.7 ng/mL vs. non-obese: 49.2 ± 20.7 ng/mL (p=0.87)). The morbidly obese group had a numerically higher, but not statistically significant, increase in time to maximum concentration (Tmax ) compared to the non-obese group (544 ± 145 min vs 436 ± 156 min (p=0.06), respectively). Conclusion Calculating subcutaneous filgrastim doses using actual body weight appears to produce similar systemic exposure in morbidly obese and non-obese patients with severe neutropenia.

Treatment options for patients with multiple myeloma (MM) have increased during the past decade. Despite the significant advances, challenges remain on which combination strategies will provide the optimal response for any given patient. Defining optimal combination strategies and corresponding companion diagnostics, that will guide clinical decisions are required to target relapsed or refractory multiple myeloma (RRMM) in order to improve disease progression, survival and quality of life for patients with MM. Elotuzumab is a humanized monoclonal antibody that targets signaling lymphocytic activation molecule F7 (SLAMF7), approved by the US Food and Drug Administration (FDA) in 2015 and the European Medicines Agency in 2016 for the treatment of MM. SLAMF7 is expressed in normal and malignant plasma cells and has lower expression on natural killer (NK) cells. Experimental evidence indicates that elotuzumab exhibits anti-myeloma activity through 1) antibody-dependent cell-mediated cytotoxicity, 2) enhancing NK cells cytotoxicity and 3) interfering with adhesion of MM cells to bone marrow stem cells (BMSCs). Although elotuzumab has no single agent activity in patients with RRMM who have received one to three prior therapies, the combination of elotuzumab with anti-myeloma agents, such as immunomodulatory drugs-lenalidomide, or proteasome inhibitors (PIs)-bortezomib, remarkably improved the overall response rates and progression-free survival in MM patients with only minimal incremental toxicity. In brief, the clinical data for elotuzumab indicate that targeting SLAMF7 in combination with the use of conventional therapies is feasible and effective with a tolerable safety profile for the treatment of RRMM.

It is well established that the bone marrow microenvironment provides a unique site of sanctuary for hematopoietic diseases that both initiate and progress in this site. The model presented in the current report utilizes human primary bone marrow stromal cells and osteoblasts as two representative cell types from the marrow niche that influence tumor cell phenotype. The in vitro co-culture conditions described for human leukemic cells with these primary niche components support the generation of a chemoresistant subpopulation of tumor cells that can be efficiently recovered from culture for analysis by diverse techniques. A strict feeding schedule to prevent nutrient fluxes followed by gel type 10 cross-linked dextran (G10) particles recovery of the population of tumor cells that have migrated beneath the adherent bone marrow stromal cells (BMSC) or osteoblasts (OB) generating a "phase dim" (PD) population of tumor cells, provides a consistent source of purified therapy resistant leukemic cells. This clinically relevant population of tumor cells can be evaluated by standard methods to investigate apoptotic, metabolic, and cell cycle regulatory pathways as well as providing a more rigorous target in which to test novel therapeutic strategies prior to pre-clinical investigations targeted at minimal residual disease.