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Why CEOs need advanced education and training for optimizing decisions in the development of innovative medicinal products? justification and recommendation.
Front Pharmacol
December 2024
Charité - Universitätsmedizin Berlin, Institute of Clinical Pharmacology and Toxicology, Berlin, Germany.
Chief executives have been educated and trained how to handle business, to take executive decisions, and take care of financial and human resources in favor of the company they are leading. CEOs (chief executive officers) of innovative pharmaceutical businesses, among others, have only seldomly been trained to understand the immense time periods involved between decisions and their moment of impact, and the skills and languages used by their internal and external R&D (research and development) staff. R&D staff and regulators, however, have undergone full training, and are usually capable of understanding each other across their various specialties (among them compound finding, quality, safety, efficacy, efficiency, risk assessment and management).
View Article and Find Full Text PDFCognitive flexibility and sociality in Guinea baboons (Papio papio).
PLoS One
December 2024
Centre de Recherche en Psychologie et Neurosciences, CNRS UMR 7077, Aix-Marseille Université, Marseille, France.
Cognitive flexibility is an executive function playing an important role in problem solving and the adaptation to contextual changes. While most studies investigated the contribution of cognitive flexibility to solve problems in the physical domain, the current study on baboons (Papio papio) investigated its contribution to sociality. The current study verified whether there is a relationship between cognitive flexibility at the individual level and the position of the individuals within their social group.
View Article and Find Full Text PDFScientific and Regulatory Lessons Learnt on Building a Chemistry, Manufacturing, and Controls (CMC) Package for COVID-19 Variant Vaccine Updates in the EU-A Regulator's Perspective.
Vaccines (Basel)
October 2024
European Medicines Agency, Human Division, Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands.
During the COVID-19 pandemic, eight COVID-19 vaccines were authorised in the European Union (EU); as a result of emerging SARS-CoV-2 variants and waning immunity, some of these have been adapted to broaden the immunity against circulating variants. The pace at which variants emerge challenges the technical feasibility to make adapted vaccines available in a suitable timeframe and in sufficient quantities. Despite the current absence of a clear-cut seasonal spread for COVID-19, the EU regulatory approach thus far is a pragmatic approach following a pathway similar to that of seasonal influenza.
View Article and Find Full Text PDFRoles of Glyco-Redox in Epithelial Mesenchymal Transition and Mesenchymal Epithelial Transition, Cancer, and Various Diseases.
Antioxid Redox Signal
November 2024
Department of Biochemistry, Sapporo Medical University School of Medicine, Sapporo, Japan.
Reduction-oxidation (redox) regulation is an important biological phenomenon that provides a balance between antioxidants and the generation of reactive oxygen species and reactive nitrogen species under pathophysiological conditions. Structural and functional changes in glycans are also important as post-translational modifications of proteins. The integration of glycobiology and redox biology, called glyco-redox has provided new insights into the mechanisms of epithelial-mesenchymal transition (EMT)/mesenchymal-epithelial transition (MET), cancer, and various diseases including Alzheimer's disease, chronic obstructive lung disease, type 2 diabetes, interstitial pneumonitis, and ulcerative colitis.
View Article and Find Full Text PDFA stringent failure: Regulators do not use available tools to protect aquatic ecosystems from clearcut forestry impacts in New Zealand.
J Environ Manage
November 2024
Department of Environmental Management, Lincoln University, PO Box 85 084 Lincoln University 7647, Canterbury, New Zealand.
Effective regulation of land-use activities in steepland areas is crucial to protect downstream ecologies and human life as intense rainfall disturbances become more frequent globally. In Aotearoa New Zealand extensive synchronous clear-cutting of Pinus radiata monocultures on steep convergent landforms, and associated earthworks, causes ongoing accelerated erosion, excessive sedimentation, and debris-laden landslides after adverse weather events. This study examines the implementation of national forestry regulations established in 2018, which also enable regional councils to create more stringent rules to protect aquatic ecosystems.
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