The ability to gather real-time and near real-time data on marine mammal distribution, movement, and habitat use has advanced significantly over the past two decades. These advances have outpaced their adoption into a meaningful, risk-based assessment framework so critically needed to support society's growing demands for a transition to increased reliance on renewable energy. Marine acoustics have the capacity to detect, identify, and locate vocalizations over broad areas. Photogrammetric and image processing increases the ability to visually detect animals from surface or aerial platforms. Ecological models based on long-term observational data coupled with static and remotely sensed oceanographic data are able to predict daily and seasonal habitat suitability. Extensive monitoring around anthropogenic activities, combined with controlled experiments of exposure parameters (i.e., sound), supports better informed decisions on reducing effects. Population models and potential consequence modeling provide the ability to estimate the significance of individual and population exposure. The collective capacities of these emerging technical approaches support a risk ranking and risk management approach to monitoring and mitigating effects on marine mammals related to development activities. The monitoring paradigm related to many offshore energy-related activities, however, has long been spatially limited, situationally myopic, and operationally uncertain. A case evaluation process is used to define and demonstrate the changing paradigm of effective monitoring aimed at protecting living resources and concurrently providing increased certainty that essential activities can proceed efficiently. Recent advances in both technologies and operational approaches are examined to delineate a risk-based paradigm, driven by a diversity of regional data inputs, that is capable of meeting the imperative for timely development of offshore wind energy. Integr Environ Assess Manag 2022;18:939-949. © 2021 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC).
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http://dx.doi.org/10.1002/ieam.4532 | DOI Listing |
Gut Microbes
September 2024
Product Development, Quality, and Supply (PDQS), Seres Therapeutics, Inc., Cambridge, MA, USA.
Advances in microbiome therapeutics have been motivated by a deeper understanding of the role that the gastrointestinal microbiome plays in human health and disease. The FDA approval of two stool-derived live biotherapeutic products (LBPs), REBYOTA® 150 mL enema (fecal microbiota, live-jslm; formerly RBX2660) and VOWST® oral capsules (fecal microbiota spores, live-brpk; formerly SER-109), for the prevention of recurrent CDI in adults following antibiotic treatment for recurrent CDI provides promise and insights for the development of LBPs for other diseases associated with microbiome dysfunction. Donor-derived products carry risk of disease transmission that must be mitigated through a robust donor screening program and downstream manufacturing controls.
View Article and Find Full Text PDFMed Law Rev
January 2025
HBKU Office of the Vice President for Research, Qatar.
This article argues that the integration of artificial intelligence (AI) into healthcare, particularly under the European Union's Artificial Intelligence Act (AI-Act), poses significant implications for the doctor-patient relationship. While historically paternalistic, Western medicine now emphasises patient autonomy within a consumeristic paradigm, aided by technological advancements. However, hospitals worldwide are adopting AI more rapidly than before, potentially reshaping patient care dynamics.
View Article and Find Full Text PDFInt J Pharm X
December 2024
Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993, United States.
Process models are a growing tool for pharmaceutical manufacturing process design and control. The Industry 4.0 paradigm promises to increase the amount of data available to understand manufacturing processes.
View Article and Find Full Text PDFHum Nat
June 2024
Department of General Pediatrics, Neonatology and Pediatric Cardiology, University Hospital Düsseldorf, Heinrich-Heine-University, Düsseldorf, Germany.
Sudden infant death syndrome (SIDS) has been mainly described from a risk perspective, with a focus on endogenous, exogenous, and temporal risk factors that can interact to facilitate lethal outcomes. Here we discuss the limitations that this risk-based paradigm may have, using two of the major risk factors for SIDS, prone sleep position and bed-sharing, as examples. Based on a multipronged theoretical model encompassing evolutionary theory, developmental biology, and cultural mismatch theory, we conceptualize the vulnerability to SIDS as an imbalance between current physiologic-regulatory demands and current protective abilities on the part of the infant.
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