Heartworm disease - Overview, intervention, and industry perspective.
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ABSTRACT:
SUBMITTER: Noack S
PROVIDER: S-EPMC8163879 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:In 2010, the Federal Parliament (Bundestag) of Germany passed a new law (Arzneimittelmarktneuordnungsgesetz, AMNOG) on the regulation of medicinal products that applies to all pharmaceutical products with active ingredients that are launched beginning January 1, 2011. The law describes the process to determine the price at which an approved new product will be reimbursed by the statutory health insurance system. The process consists of two phases. The first phase assesses the additional benefit of the new product versus an appropriate comparator (zweckmäßige Vergleichstherapie, zVT). The second phase involves price negotiation. Focusing on the first phase, this paper investigates requirements of benefit assessment of a new product under this law with special attention on the methods applied by the German authorities on issues such as the choice of the comparator, patient relevant endpoints, subgroup analyses, extent of benefit, determination of net benefit, primary and secondary endpoints, and uncertainty of the additional benefit. We propose alternative approaches to address the requirements in some cases and invite other researchers to help develop solutions in other cases.
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Project description:Vaccination is the most effective measure at preventing influenza virus infections. However, current seasonal influenza vaccines are only protective against closely matched circulating strains. Even with extensive monitoring and annual reformulation our efforts remain one step behind the rapidly evolving virus, often resulting in mismatches and low vaccine effectiveness. Fortunately, many next-generation influenza vaccines are currently in development, utilizing an array of innovative techniques to shorten production time and increase the breadth of protection. This review summarizes the production methods of current vaccines, recent advances that have been made in influenza vaccine research, and highlights potential challenges that are yet to be overcome. Special emphasis is put on the potential role of glycoengineering in influenza vaccine development, and the advantages of removing the glycan shield on influenza surface antigens to increase vaccine immunogenicity. The potential for future development of these novel influenza vaccine candidates is discussed from an industry perspective.
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Project description:Innovations in LED lighting technology have led to tremendous adoption rates and vastly improved the metrics by which they are traditionally evaluated-including color quality, longevity, and energy efficiency to name a few. Additionally, scientific insight has broadened with respect to the biological impact of light, specifically our circadian rhythm. Indoor electric lighting, despite its many attributes, fails to specifically address the biological responses to light. Traditional electric lighting environments are biologically too dim during the day, too bright at night, and with many people spending much of their lives in these environments, it can lead to circadian dysfunction. The lighting industry's biological solution has been to create bluer days and yellower nights, but the technology created to do so caters primarily to the cones. A better call to action is to provide biologically brighter days and biologically darker nights within the built environment. However, current lighting design practices have specified the comfort and utility of electric light. Brighter intensity during the day can often be uncomfortable or glary, and reduced light intensity at night may compromise visual comfort and safety, both of which will affect user compliance. No single lighting solution will effectively create biologically brighter days and biologically darker nights, but rather a variety of parameters need to be considered. This paper discusses the contributions of spectral power distribution, hue or color temperature, spatial distribution, as well as architectural geometry and surface reflectivity, to achieve biologically relevant lighting.
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Project description:The COVID-19 pandemic has brought about unprecedented changes to all facets of the healthcare system, including the diagnostic industry. The pandemic has highlighted both the challenges and strengths of the industry and has also provided valuable insights on how to be better prepared for future pandemics. In this perspective article, we describe the challenges faced by the diagnostic industry in general, particularly the difficulties encountered by Luminex Corporation, a diagnostic assay development and manufacturing company located in Austin, Texas, USA, as well as the mitigation strategies employed. In addition to discussion of the key challenges, the article provides insights on the lessons learned and steps that can be undertaken to better prepare for future outbreaks.
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Project description:BackgroundBiological therapy has revolutionized the treatment of inflammatory bowel disease (IBD). After the expiration of patents for biological innovator products, development of biosimilars increased. CT-P13 was the first biosimilar approved for the same indications as the reference product; however, the approval was based on extrapolated data from rheumatoid arthritis and ankylosing spondylitis. Our aim was to review clinical studies about switching from originator infliximab (IFX-O) to biosimilar infliximab (IXF-B) in IBD, focusing on recently published data and the future of biosimilars.MethodsThe PubMed database was searched for original articles published up to 1 December 2018 reporting data on IFX-B in IBD.ResultsA total of 29 studies assessing switching from IFX-O to IFX-B, 14 assessing induction therapy with IFX-B were found. Efficacy, safety and immunogenicity were discussed. Studies confirm that CT-P13 is safe and equally efficient as the reference product for both induction and maintenance therapy; and that switching from the reference product to biosimilar is non-inferior to continuous biosimilar use. However, efficacy and safety data on Flixabi (SB2) in IBD patients is lacking.ConclusionSwitching from the originator to a biosimilar in patients with IBD is acceptable, although scientific and clinical evidence is lacking regarding reverse switching, multiple switching and cross-switching among biosimilars in IBD patients.
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Project description:Recently, the US Food and Drug Administration and European Medicines Agency have issued new guidance for industry on drug interaction studies, which outline comprehensive recommendations on a broad range of in vitro and in vivo studies to evaluate drug-drug interaction (DDI) potential. This paper aims to provide an overview of these new recommendations and an in-depth scientifically based perspective on issues surrounding some of the recommended approaches in emerging areas, particularly, transporters and complex DDIs. We present a number of theoretical considerations and several case examples to demonstrate complexities in applying (1) the proposed transporter decision trees and associated criteria for studying a broad spectrum of transporters to derive actionable information and (2) the recommended model-based approaches at an early stage of drug development to prospectively predict DDIs involving time-dependent inhibition and mixed inhibition/induction of drug metabolizing enzymes. We hope to convey the need for conducting DDI studies on a case-by-case basis using a holistic scientifically based interrogative approach and to communicate the need for additional research to fill in knowledge gaps in these areas where the science is rapidly evolving to better ensure the safety and efficacy of new therapeutic agents.
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Project description:BackgroundThe technological complexities and broad operational scope of eSource impede coordinated, inter-organizational action on advancing at-scale solutions.MethodsWe introduce an architectural framework for articulating technological considerations across organizations. The architecture neither implies nor endorses solution implementations; rather, it proposes solution functionality based upon principles and good clinical practices.ResultsKey technology considerations include patterns of anticipated use, implications to the current state of clinical trial operations, and the need for new technologies (i.e., IoT, Big Data, Predictive Analytics).ConclusionTechnology considerations drive implications beyond technology-influencing regulatory, process, and ethical realms of clinical research.
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Project description:Industrial-scale bioprocessing underpins much of the production of pharmaceuticals, nutraceuticals, food, and beverage processing industries of the modern world. The profitability of these processes increasingly leverages the economies of scale and scope that are critically dependent on the product yields, titers, and productivity. Most of the processes are controlled using classical control approaches and represent over 90% of the industrial controls used in bioprocessing industries. However, with the advances in the production processes, especially in the biopharmaceutical and nutraceutical industries, monitoring and control of bioprocesses such as fermentations with GMO organisms, and downstream processing has become increasingly complex and the inadequacies of the classical and some of the modern control systems techniques is becoming apparent. Therefore, with increasing research complexity, nonlinearity, and digitization in process, there has been a critical need for advanced process control that is more effective, and easier process intensification and product yield (both by quality and quantity) can be achieved. In this review, industrial aspects of a process and automation along with various commercial control strategies have been extensively discussed to give an insight into the future prospects of industrial development and possible new strategies for process control and automation with a special focus on the biopharmaceutical industry. Supplementary Information The online version contains supplementary material available at 10.1007/s43393-021-00048-6.
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Project description:Fragile X syndrome (FXS) is the leading known cause of inherited intellectual disability and autism spectrum disorder. It is caused by a mutation of the fragile X mental retardation 1 (FMR1) gene, resulting in a deficit of fragile X mental retardation protein (FMRP). The clinical presentation of FXS is variable, and is typically associated with developmental delays, intellectual disability, a wide range of behavioral issues, and certain identifying physical features. Over the past 25 years, researchers have worked to understand the complex relationship between FMRP deficiency and the symptoms of FXS and, in the process, have identified several potential targeted therapeutics, some of which have been tested in clinical trials. Whereas most of the basic research to date has been led by experts at academic institutions, the pharmaceutical industry is becoming increasingly involved with not only the scientific community, but also with patient advocacy organizations, as more promising pharmacological agents are moving into the clinical stages of development. The objective of this review is to provide an industry perspective on the ongoing development of mechanism-based treatments for FXS, including identification of challenges and recommendations for future clinical trials.
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Project description:The efficient progress in nanotechnology has transformed many aspects of food science and the food industry with enhanced investment and market share. Recent advances in nanomaterials and nanodevices such as nanosensors, nano-emulsions, nanopesticides or nanocapsules are intended to bring about innovative applications in the food industry. In this review, the current applications of nanotechnology for packaging, processing, and the enhancement of the nutritional value and shelf life of foods are targeted. In addition, the functionality and applicability of food-related nanotechnologies are also highlighted and critically discussed in order to provide an insight into the development and evaluation of the safety of nanotechnology in the food industry.
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