91 research outputs found
Dengue Vaccines Regulatory Pathways: A Report on Two Meetings with Regulators of Developing Countries
Richard Mahoney and colleagues summarize two recent meetings convened by the Pediatric Dengue Vaccine Initiative and the Developing Countries' Vaccine Regulators Network on regulatory issues that need to be addressed before licensing dengue vaccines
Wissenschaftliche Monitoringkonzepte für die Deutsche Bucht (WIMO) - Abschlussbericht
The state and development of coastal marine systems and an understanding of the interaction of
organisms, sea floor, water column, and biochemical and physical processes can only be obtained by
a combination of long-term monitoring and modelling approaches of different complexity. A need for the development and evaluation of monitoring strategies is driven by a framework of different
European and German regulations. The research project WIMO (Scientific Monitoring Concepts for the German Bight) has developed concepts and methods that aim at a fundamental scientific understanding of marine systems and also meet monitoring requirements of European legislation and regulations like the EU Marine Strategy Framework Directive. In this final report examples of common descriptors of ecosystem state like seabed integrity, eutrophication, and biodiversity are discussed. It has been assessed to what extent established measuring procedures used to survey the characteristics of the sea floor, and newly developed technologies are eligible for governmental monitoring. The significance of integrative modelling for linking and visualising results of measurements and
models is illustrated. It is shown how new concepts have been implemented into governmental monitoring in the form of web based data sheets. These insights enable continuous analyses and developments in the future
Setting our sights on infectious diseases
In May 2019, the Wellcome Centre for Anti-Infectives Research (WCAIR) at the University of Dundee, UK, held an international conference with the aim of discussing some key questions around discovering new medicines for infectious diseases and a particular focus on diseases affecting Low and Middle Income Countries. There is an urgent need for new drugs to treat most infectious diseases. We were keen to see if there were lessons that we could learn across different disease areas and between the preclinical and clinical phases with the aim of exploring how we can improve and speed up the drug discovery, translational, and clinical development processes. We started with an introductory session on the current situation and then worked backward from clinical development to combination therapy, pharmacokinetic/pharmacodynamic (PK/PD) studies, drug discovery pathways, and new starting points and targets. This Viewpoint aims to capture some of the learnings
- …