Refreshing the biologic pipeline 2020.
Ontology highlight
ABSTRACT:
SUBMITTER: Hodgson J
PROVIDER: S-EPMC7842168 | biostudies-literature | 2021 Feb
REPOSITORIES: biostudies-literature
Publications
Similar Datasets
Project description:Interest and research in biologic approaches for tissue healing are exponentially growing for a variety of musculoskeletal conditions. The recent hype concerning musculoskeletal biological therapies (including viscosupplementation, platelet-rich plasma, and cellular therapies, or "stem cells") is driven by several factors, including demand by patients promising regenerative evidence supported by substantial basic and translational work, as well as commercial endeavors that complicate the scientific and lay understanding of biological therapy outcomes. While significant improvements have been made in the field, further basic and preclinical research and well-designed randomized clinical trials are needed to better elucidate the optimal indications, processing techniques, delivery, and outcome assessment. Furthermore, biologic treatments may have potential devastating complications when proper methods or techniques are ignored. For these reasons, an association comprising several scientific societies, named the Biologic Association (BA), was created to foster coordinated efforts and speak with a unified voice, advocating for the responsible use of biologics in the musculoskeletal environment in clinical practice, spearheading the development of standards for treatment and outcomes assessment, and reporting on the safety and efficacy of biologic interventions. This article will introduce the BA and its purpose, provide a summary of the 2020 first annual Biologic Association Summit, and outline the future strategic plan for the BA.
| S-EPMC8191082 | biostudies-literature
Project description:IntroductionAlzheimer's disease (AD) is a growing public health concern affecting millions of patients worldwide and costing billions of dollars annually. We review the pipeline of drugs and biologics in clinical trials for the treatment of AD. We use the Common Alzheimer's and Related Dementias Research Ontology (CADRO) to classify treatment targets and mechanisms of action. We review our annual pipeline reports for the past 5 years to provide longitudinal insight into clinical trials and drug development for AD.MethodsWe reviewed ClinicalTrials.gov as of February 27, 2020, and identified all trials of pharmacologic agents currently being developed for treatment of AD as represented on this widely used U.S. Food and Drug Administration registry.ResultsThere are 121 agents in clinical trials for the treatment of AD. Twenty-nine agents are in 36 Phase 3 trials, 65 agents are in 73 Phase 2 trials, and 27 agents are in 27 Phase 1 trials. Twelve agents in trials target cognitive enhancement and 12 are intended to treat neuropsychiatric and behavioral symptoms. There are 97 agents in disease modification trials. Compared to the 2019 pipeline, there is an increase in the number of disease-modifying agents targeting pathways other than amyloid or tau.DiscussionThe 2020 pipeline has innovations in clinical trials and treatment targets that provide hope for greater success in AD drug development programs. Review of clinical trials over the past 5 years show that there is progressive emphasis on non-amyloid targets, including candidate treatments for inflammation, synapse and neuronal protection, vascular factors, neurogenesis, and epigenetic interventions. There has been a marked growth in repurposed agents in the pipeline.
| S-EPMC7364858 | biostudies-literature
Project description:IntroductionAntimicrobial resistance (AMR) is an emerging global threat. It increases mortality and morbidity and strains healthcare systems. Health care professionals can counter the rising AMR by promoting antibiotic stewardship and facilitating new drug development. Even with the economic and scientific challenges, it is reassuring that new agents continue to be developed.MethodsThis review addresses new antibiotics in the pipeline. We conducted a review of the literature including Medline, Clinicaltrials.org, and relevant pharmaceutical companies for approved and in pipeline antibiotics in phase 3 or new drug application (NDA).ResultsWe found a number of new antibiotics and reviewed their current development status, mode of action, spectra of activity, and indications for which they have been approved. The included studies from phase 3 clinical trials were mainly utilized for the treatment of acute bacterial skin and skin structure infections, community-acquired bacterial pneumonia, and pneumonia acquired in the healthcare settings. The number of these agents is limited against high priority organisms. The identified antibiotics were based mainly on previously known molecules or pre-existing antimicrobial agents.ConclusionThere are a limited number of antibiotics against high priority organisms such as multi-drug-resistant Pseudomonas aeruginosa, and carbapenem-resistant Enterobacteriaceae. New antimicrobial agents directed against the top priority organisms as classified by the World Health Organization are urgently needed.
| S-EPMC8488069 | biostudies-literature
Project description:BackgroundThe majority of current pharmacological treatments for Parkinson's disease (PD) were approved for clinical use in the second half of the last century and they only provide symptomatic relief. Derivatives of these therapies continue to be explored in clinical trials, together with potentially disease modifying therapies that can slow, stop or reverse the condition.ObjectiveTo provide an overview of the pharmacological therapies- both symptomatic and disease modifying- currently being clinically evaluated for PD, with the goal of creating greater awareness and opportunities for collaboration amongst commercial and academic researchers as well as between the research and patient communities.MethodsWe conducted a review of clinical trials of drug therapies for PD using trial data obtained from the ClinicalTrials.gov database and performed a breakdown analysis of studies that were active as of January 21, 2020.ResultsWe identified 145 registered and ongoing clinical trials for therapeutics targeting PD, of which 51 were Phase 1 (35% of the total number of trials), 66 were Phase 2 (46% ), and 28 were Phase 3 (19% ). There were 57 trials (39% ) focused on long-term disease modifying therapies, with the remaining 88 trials (61% ) focused on therapies for symptomatic relief. A total of 50 (34% ) trials were testing repurposed therapies.ConclusionThere is a broad pipeline of both symptomatic and disease modifying therapies currently being tested in clinical trials for PD.
| S-EPMC7458531 | biostudies-literature
Project description:Crude oil pipelines are considered as the lifelines of energy industry. However, accidents of the pipelines can lead to severe public health and environmental concerns, in which greenhouse gas (GHG) emissions, primarily methane, are frequently overlooked. While previous studies examined fugitive emissions in normal operation of crude oil pipelines, emissions resulting from accidents were typically managed separately and were therefore not included in the emission account of oil systems. To bridge this knowledge gap, we employed a bottom-up approach to conducted the first-ever inventory of GHG emissions resulting from crude oil pipeline accidents in the United States at the state level from 1968 to 2020, and leveraged Monte Carlo simulation to estimate the associated uncertainties. Our results reveal that GHG emissions from accidents in gathering pipelines (~720,000 tCO2e) exceed those from transmission pipelines (~290,000 tCO2e), although significantly more accidents have occurred in transmission pipelines (6883 cases) than gathering pipelines (773 cases). Texas accounted for over 40% of total accident-related GHG emissions nationwide. Our study contributes to enhanced accuracy of the GHG account associated with crude oil transport and implementing the data-driven climate mitigation strategies.
| S-EPMC10450021 | biostudies-literature
Project description:Working memory (WM) keeps information temporarily accessible for ongoing cognition. One proposed mechanism to keep information active in WM is refreshing. This mechanism is assumed to operate by bringing memory items into the focus of attention, thereby serially refreshing the content of WM. We report two experiments in which we examine evidence for the spontaneous occurrence of serial refreshing in verbal WM. Participants had to remember series of red letters, while black probe letters were presented between these memory items, with each probe to be judged present in or absent from the list presented so far, as quickly as possible (i.e., the probe-span task). Response times to the probes were used to infer the status of the representations in WM and, in particular, to examine whether the content of the focus of attention changed over time, as would be expected if serial refreshing occurs spontaneously during inter-item pauses. In sharp contrast with this hypothesis, our results indicate that the last-presented memory item remained in the focus of attention during the inter-item pauses of the probe-span task. We discuss how these findings help to define the boundary conditions of spontaneous refreshing of verbal material in WM, and discuss implications for verbal WM maintenance and forgetting.
| S-EPMC5886841 | biostudies-literature
Project description:Aim of the studyRegular refresher skill courses are necessary to maintain competence in basic life support. The utilization of these training programs strongly depends on the motivation to learn. Learning motivation may be affected by overconfidence and clinical tribalism, as they both imply a higher competence compared to others, and therefore, a lower demand for training. This study aimed to assess how overconfidence in basic life support competencies affects learning motivation.MethodsWe conducted a cross-sectional, observational, multicenter, anonymous online questionnaire survey using validated psychometric tests for healthcare professionals in Germany. Further, we tested participants' knowledge and attitude regarding international basic life support guidelines. The study was conducted between March and April 2022, and healthcare providers from 22 German emergency medical services and hospitals at all levels were assessed.ResultsOf 2,000 healthcare professionals assessed, 407 completed the assessment (response rate, 20.4%). We confirmed the presence of overconfidence and clinical tribalism (identity differentiation between social groups) among the 407 physicians, nurses, and emergency medical service providers who completed the survey. Three different learning-motivation groups emerged from cluster analysis: "experts" (confident and motivated), "recruitables" (overconfident and motivated), and "unawares" (overconfident and unmotivated). The three groups were present in all professional groups, independent of the frequency of exposure to cardiac arrest and educational level.ConclusionsThese findings showed the presence of overconfidence effects and different learning motivation types in individuals learning basic life support, even in instructors.
| S-EPMC10020094 | biostudies-literature
Project description:Changes in concetration and type of circulating RNA species during diurnal cycle
2025-01-31 | GSE254151 | GEO
Project description:Working memory is the cognitive system that keeps a limited amount of information temporarily accessible for ongoing cognition. One proposed mechanism to keep information active in working memory is refreshing. Refreshing is assumed to operate serially, reactivating memory items one by one by bringing them into the focus of attention during retention. We report two experiments in which we examine evidence for the spontaneous occurrence of serial refreshing in verbal working memory (Experiment 1, using letters as memoranda) and in visuospatial working memory (Experiment 2, using locations as memoranda). Participants had to remember series of red memory items, and black probes were presented between these memory items, with each probe to be judged present in or absent from the list presented so far, as quickly as possible (i.e., the probe-span task). Response times to the probes were used to examine whether the content of the focus of attention changed over time, as would be expected if serial refreshing occurs spontaneously during interitem pauses. Contrary to this hypothesis, our results indicate that the last-presented memory item remained in the focus of attention during the interitem pauses of the probe-span tasks. These findings confirm the boundary conditions of spontaneous serial refreshing that were previously observed for verbal working memory and extend them to visuospatial working memory. Implications for working memory maintenance are discussed.
| S-EPMC10371951 | biostudies-literature
Project description:Prescriptions for biologic therapy for treatment of Crohn's disease (CD) and ulcerative colitis (UC) have increased during the past two decades; however, trends are less clear regarding corticosteroid prescriptions in this context. We designed a cross-sectional study using the IQVIA Ambulatory Electronic Medical Records databases. Weighted linear regressions by age group were used to estimate annual percentage change from 2011 to 2020 in prescriptions for biologics and for corticosteroids among patients with or without biologic prescriptions within the same calendar year. Using 2019 data, we compared patient demographic and lifestyle risk factors using χ2 test for biologic prescriptions and corticosteroids with or without biologics prescriptions. There was an 11% (CD) and 16% (UC) annual increase in the percentage of patients prescribed biologics during the study period. The percentage of patients with biologics prescriptions prescribed corticosteroids decreased by 2% (CD) and 3% (UC) annually after 2015, while the percentage remained unchanged for corticosteroid prescriptions among patients without biologics. In 2019, differences in medication prescriptions existed by patient's demographic and lifestyle factors for patients with CD (n=52,892) and UC (n=52,280), including a higher percentage prescribed biologics among younger patients, men, those with fewer comorbidities, and current alcohol drinkers, and a higher percentage prescribed corticosteroids without biologics among women, those with more comorbidities, and a history of smoking. While medications continue to evolve during the biologic era, it is important to continue to monitor trends and differences in prescription patterns to assess progress toward optimizing treatment for patients with CD or UC.
| S-EPMC10468819 | biostudies-literature