Army Antimalarial Drug Development: An Advanced Development Case Study for Tafenoquine.

Malaria is classified as a top-tier infectious disease threat associated with a high risk for mortality among U.S. service members deployed overseas. As malarial drug resistance degrades the efficacy of current gold standard drugs for malarial prophylaxis and treatment, it is vitally important to maintain a robust drug pipeline to discover and develop improved, next-generation antimalarial prevention and treatment tools. The U.S. Army Medical Materiel Development Activity (USAMMDA) manages the medical product development of the malarial drug tafenoquine for malarial prophylaxis to address the threat to U.S. service members. Tafenoquine is an effective prophylactic drug against all parasite life cycle stages and all malaria species that infect humans. Thus, it provides broad capabilities in a single drug for malarial prophylaxis and treatment. Partnerships with industry are a crucial part of USAMMDA's medical product development strategy, by leveraging their drug development experience and manufacturing capabilities to achieve licensure and commercial availability. Additionally, these partnerships capitalize on expertise in the commercial market and help ensure that USAMMDA successfully translates a Department of Defense capability gap into a commercially available product. This article will highlight the strategies used to move this critical antimalarial drug through the development pipeline.

Use of Decision Support Software to Titrate Multiple Daily Injections Yielded Sustained A1c Reductions After 1 Year.

PURPOSE: The purpose was to improve the quality of care of at-risk patients through the addition of connected BG meters and CDSS to improve workflow and thus provide more efficient titration of patient's insulin regimens remotely between office visits in an attempt to treat them to their glucose targets faster and efficiently, and maintain that improvement over time. METHODS: Hardware and software included a real-time cellular-enabled blood glucose (BG) meter and Glytec's Glucommander™ clinical decision support software (CDSS). A quality improvement (QI) project with retrospective before-and-after comparison was conducted. The training period was 90 days and then the project ran for another 11 months. A protocol comprised Glytec CDSS software, which recommends titration intervals from 3 to 28 days as a function of glycemic control, specifically, longer intervals for better control. There were 46 clinic patients. RESULTS: A1C decreased from a baseline average of 10.2% to 7.8% at 3 months, 7.8% at 6 months, 7.8% at 9 months, and 7.2% at 12 months. The baseline-to-final A1C decrease shows a P < .00001 by paired t-test. Out of 36 315 BGs, the average number of BG tests per day was 3.03 during the first 3 months and 2.47 during the final 3 months. The percentage of BGs < 54 mg/dL was 0.33% and the percentage of BGs < 40 mg/dL was 0.05%. CONCLUSIONS: This QI project demonstrated the use of CDSS including its built-in feature of titration interval recommendation can safely and effectively lower A1C for at-risk patients, treat patients to target safely, and maintain those improvements over 12 months of follow-up.