Search

This paper reviews the current situation in the field of pharmacogenetics/pharmacogenomics (PGx) in Europe. High expectations surrounding the clinical application of PGx remain largely unmet, as only a limited number of such applications have actually reached the market and clinical practice. Thus, the potential impact of PGx-based diagnostics on healthcare and its socio-economic implications are still unclear. With the aim of shedding some light on these uncertainties, the Institute for Prospective Technological Studies (IPTS) of the European Commission’s Joint Research Centre (JRC) has conducted a review of the ‘state of the art’ and a further analysis on the use of pharmacogenetics diagnostics for preventing toxic drug reactions and improving drug efficacy in Europe. The paper presents highlights from the JRC-IPTS studies and discusses possibilities for improving translation of PGx research in Europe by comparing some experiences in the USA. We also illustrate the related barriers for the clinical uptake of PGx in Europe with specific case-studies. Most of the barriers identified extend beyond the European context. This reflects the global problems of scarcity of data demonstrating proven clinical validity or utility and favorable cost-effectiveness studies to support the clinical application of PGx diagnostic tests in the clinical setting. Another key barrier is the lack of incentives for the private sector to invest in the development and licensing of PGx diagnostic tests for improving the safety and efficacy of out-of-patent drugs. It therefore seems that one key aspect where policy can affect the clinical uptake of PGx is via sustaining large-scale industry-academia collaborations for developing and proving the utility of PGx diagnostics. Copyright © 2009 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

The background to this debate is now well-known: an EU policy decision to tighten controls on the devices and diagnostics sector led to the adoption of a regulation in 2017 with a schedule for implementation over coming years – a timetable extended still further by last-minute legislation in early 2022, to provide the sector and regulators with more time to adapt to the changes. Discussions among experts organised in April by the European Alliance for Personalized Medicine (EAPM) exposed continuing challenges that cannot be fully resolved by the recent deferral of implementation deadlines. One salient problem is that there is little awareness of the In Vitro Diagnostic Regulation (IVDR) across Europe, and only limited awareness of the different structures of national systems involved in implementing IVDR, with consequent risks for patient and consumer access to in vitro diagnostics (IVDs). The tentative conclusion from these consultations is that despite a will across the sector to seek workable solutions, the obstacles remain formidable, and the potential solutions so far proposed remain more a matter of aspirations than of clear pathways. [ABSTRACT FROM AUTHOR]

Abstract: The exploitation of ITER tokamak will require diagnostics for machine protection, inputs to plasma control systems, evaluation and analysis of plasma parameters and performances. The equatorial visible/infrared wide angle viewing system and the radial neutron camera are the two main diagnostics of Procurement Package 11 (PP11), one of the diagnostic procurements under the responsibility of Europe, which also contains Equatorial Port Plug 1 and seven other diagnostics supplied by Europe or other ITER partners and integrated in the same Port Plug. Significant progress has recently been made in the development of the equatorial visible/infrared wide angle viewing system and the radial neutron camera. This paper gives an overview of the major technical achievements on these two diagnostics and points out the urgent needed R&D activities. [Copyright &y& Elsevier]

Operation of devices and machinery under various climatic conditions has an impact on determination of operational reliability parameters in designing, projecting and construction of devices and machinery.The work deals with determining the criteria of the special technique (selected electrical parts) operation under extreme conditions. The end of the work summarizes experiences by servicing and repairs of the special technique (selected electrical parts) under climatic conditions out of Europe. [ABSTRACT FROM AUTHOR]

Experiments with the atmospheric component of the ECMWF Integrated Forecasting System (IFS) have been carried out to study the origin of the atmospheric circulation anomalies that led to the unusually cold European winter of 2005/06. Experiments with prescribed sea surface temperature (SST) and sea ice fields fail to reproduce the observed atmospheric circulation anomalies suggesting that the role of SST and sea ice was either not very important or the atmospheric response to SST and sea ice was not very well captured by the ECMWF model. Additional experiments are carried out in which certain regions of the atmosphere are relaxed toward analysis data thereby artificially suppressing the development of forecast error. The relaxation experiments suggest that both tropospheric circulation anomalies in the Euro–Atlantic region and the anomalously weak stratospheric polar vortex can be explained by tropical circulation anomalies. Separate relaxation experiments for the tropical stratosphere and tropical troposphere highlight the role of the easterly phase of quasi-biennial oscillation (QBO) and, most importantly, tropospheric circulation anomalies, especially over South America and the tropical Atlantic. From the results presented in this study, it is argued that the relaxation technique is a powerful diagnostic tool to understand possible remote origins of seasonal-mean anomalies. [ABSTRACT FROM AUTHOR]

Reassortment contributes to the evolution of RNA viruses with segmented genomes, including Bluetongue virus (BTV). Recently, co-circulation of natural and vaccine BTV variants in Europe, and their ensuing reassortment, were proposed to promote appearance of novel European BTV strains, with potential implications for pathogenicity, spread and vaccination policies. Similarly, the geographical features of the Mediterranean basin, which spans over portions of three continents, may facilitate the appearance of clinically relevant reassortants via co-circulation of BTV strains of African, Asian and European origins. In August–October 2017, BTV serotype 6 (BTV-6) was identified in young animals exhibiting classical clinical signs of Bluetongue (BT) at Israeli sheep and cattle farms. Sequencing and pairwise analysis of this Israeli BTV-6 isolate revealed the closest sequence homology of its serotype-defining Segment 2 was with that of South African reference BTV-6 strain 5011 (93.88% identity). In contrast, the other viral segments showed highest homology (97.0%–99.47% identity) with BTV-3, -4 and -9 of Mediterranean and African origins. Specifically, four viral segments were nearly identical (99.13%–99.47%), with Tunisian and Italian BTV-3 strains (TUN2016 and SAD2018, correspondingly). Together, our data suggest that Mediterranean co-circulation and reassortment of BTV-3 and BTV-6 drove the emergence of a novel and virulent BTV-6 strain [ABSTRACT FROM AUTHOR]

The field of hepatitis C ( HCV) therapy is moving inexorably towards a time when interferon is no longer part of routine HCV treatment. 2015 will see at least two interferon-free directly acting antiviral ( DAA) treatments licensed in Europe and the USA. For those parts of the world that can afford it, this will mean the potential for treatment of those who have either failed interferon-based therapy or have been unable to tolerate the side-effects that commonly accompany treatment. [ABSTRACT FROM AUTHOR]