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Nimble's innovative approach has already shown incredible potential for revolutionizing medical research and patient care. As a result of the initiative's achievements, numerous abstracts were presented at the annual american association for the study of liver diseases (aasld) conference and the european association for the study of the liver (EASL) conference. Moreover, correspondence was published in the high-impact journal nature medicine highlighting the program's findings to DATE. Strengthening the patient voice with digital measures workshops over the past few years, the FNIH biomarkers consortium has launched a series of digital measures workshops designed to bring regulators, payers, and patients together to streamline digital measure development and implementation processes. The first workshop, which was conducted in february 2020, was instrumental in helping the u.s. Food and DRUG administration (FDA) bring forward the innovative science and technology approaches for new drugs (istand) program. The workshop also helped the FDA redefine its nomenclature around digital health and biomarkers and focus on digital measures. The FNIH biomarkers consortium hosted its second digital measures workshop september 2022 in zurich, switzerland, with a goal of emphasizing patient-centricity in shaping and improving how digital measures are identified, designed, and implemented. This workshop established a global footprint for FNIH and its partners, engaging the european medicines agency (EMA) and other international partners in a way that HADN't been previously possible. A third future workshop will provide the critical link between NIH, regulators, and industry to ensure that ALL players have a seat at the table, that patients are included, and that the field CAN collectively identify processes and checks so that digital health leads to useful tools, not just more gadgets. Research programs for advancing global health preventing sepsis in laboring mothers worldwide maternal and neonatal sepsis is one of the TOP three causes of maternal and newborn deaths globally. To address this pressing issue and urgent global need, the azithromycin prevention in labor use study (a-plus) was conducted by the eunice kennedy shriver national institute of child health and human development (nichd)'s global network for women's and children's health research and was CO-funded by nichd and the FNIH, with support to the FNIH provided by a grant from the BILL & melinda gates foundation. The study assessed low-cost, sustainable interventions to improve maternal and child health in low- and middle-income countries. After a rigorous process of training and pilot-testing, investigators examined the safety and effectiveness of a single ORAL DOSE of azithromycin administered during labor (compared to placebo) in reducing the risk of neonatal and maternal sepsis or death in laboring women. The results were very promising, suggesting that azithromycin CAN reduce the occurrence of maternal sepsis and death by approximately one-third. Following the study, investigators rapidly analyzed the quality of the data and results to enable open access to the findings in a timely manner. An abstract was submitted to the world's premier pregnancy conference, the society for maternal-fetal medicine's annual pregnancy meeting (SMFM). The abstract was accepted and became the #1 late-breaking presentation at the conference in february 2023. The study investigators also submitted a manuscript to the new england journal of medicine (NEJM), which was accepted and published as the conference presentation was being delivered. As a next step, the a-plus investigators will follow up with a subset of the mothers and infants to examine potential antimicrobial resistance at multiple points in time, up to a year after initial delivery, as a further safety measure. The study findings could result in a change to the current standard of care by adding this simple preventive intervention an adjustment that could save millions of lives. Reducing anemia in postpartum women IRON deficiency anemia remains a major contributor to maternal illness and mortality worldwide, and despite numerous efforts, rates of anemia have not decreased in low- and middle-income countries. Thankfully, intravenous IRON treatments have been demonstrated to be a safe, effective intervention to reduce anemia during pregnancy. However, intravenous IRON treatments have not been comprehensively assessed during the postpartum period until now. First launched in november 2022, the prevention of IRON deficiency anemia post-delivery (priority) trial AIMS to determine if a single-DOSE intravenous IRON infusion is more effective than the current standard of care ORAL IRON supplementation among postpartum women with moderate anemia in low- and middle-income countries. In addition to comparing outcomes for treating anemia, researchers are assessing trial participants for important secondary outcomes related to anemia, particularly postpartum depression, which CAN affect maternal quality of life, fatigue, breastfeeding initiation and retention rates, and infant-mother bonding. The study results are expected to be useful for informing national health policies and practices, improving the care of women. Advising on an historic global pandemic treaty at an historic gathering in 2021, 173 member governments of the world health organization (who) resolved to negotiate an international agreement on pandemic preparedness and response. The FNIH, in partnership with who's collaborating center at georgetown university's o'neill institute for national and global health law, convened dozens of leading experts from around the world to provide technical advice and learnings to policymakers, member states, and the public. On the heels of the consortium's report on legal tools for pandemic preparedness, the FNIH and o'neill institute also brought together thought leaders to consider the national sovereignty implications of a pandemic instrument, and to analyze the range of agreements previously deployed to coordinate international activity and how they might inform a treaty addressing catastrophic epidemic events. In addition, the FNIH's kevin a. Klock, who CO-chairs the initiative with the o'neill institute's lawrence o. Gostin, published a series of supporting papers in prominent journals and outlets, including the lancet, journal of the american medical association, STAT, and think global health. A third convening, CO-LED with the joint united nations programme on HIV/AIDS (unaids), commenced in the second half of 2022 and LED to a 2023 report called advancing a world together equitably, which explores existing mechanisms that assert equity as a priority and analyzed how they could be incorporated into a treaty.
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