The Impact of Information Technology on European Post-Trading

The European post-trading landscape is recently changing fundamentally due to regulatory actions, the financial crisis, and the strong linkage of the global financial markets. The systemic importance of post-trading infrastructures underlines the industry’s significant dependence on safe and efficient processes and thus the importance of reliable IT-systems. Using the Delphi methodology in a study among a multitude of experts from different areas of post-trading, we developed a joint and coherent view of the most important issues relating to IT the post-trading system has to cope with

Deriving a Holistic Performance Measurement System for the European Clearing Industry

European clearing houses are facing competition on their home markets for the first time. In order to meet this new challenge, the management of a clearing house needs to identify its stakeholders and their interests and must define a strategy including financial and non-financial aims. We introduce the Balanced Scorecard as a funded and holistic approach for the management of a clearing house. To meet the specifics of the clearing industry, we present an adjustment and extension of Kaplan and Norton’s original concept. Particularly risk management requires detailed consideration. We therefore add risk management as a separate perspective and integrate competition and IT into the modified Balanced Scorecard. Furthermore, we outline our research model for the validation of the modifications

Deriving a Balanced Scorecard for the European Settlement Industry

The European settlement industry is currently facing competition in cross-border securities settlement. In order to meet the new challenges, the management needs to identify its stakeholders and their interests and must define a clear strategy that includes financial and nonfinancial aims. We apply a stepwise approach to derive a Balanced Scorecard for this particular industry. To meet the specifics of the settlement industry, we adjust and extend the scorecard of Kaplan and Norton’s original concept by introducing IT into the modified BSC and by documenting the need to consider important strategic projects. Furthermore, we outline our research model for the validation of these modifications

Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial

Background: Glucagon-like peptide 1 receptor agonists differ in chemical structure, duration of action, and in their effects on clinical outcomes. The cardiovascular effects of once-weekly albiglutide in type 2 diabetes are unknown. We aimed to determine the safety and efficacy of albiglutide in preventing cardiovascular death, myocardial infarction, or stroke. Methods: We did a double-blind, randomised, placebo-controlled trial in 610 sites across 28 countries. We randomly assigned patients aged 40 years and older with type 2 diabetes and cardiovascular disease (at a 1:1 ratio) to groups that either received a subcutaneous injection of albiglutide (30–50 mg, based on glycaemic response and tolerability) or of a matched volume of placebo once a week, in addition to their standard care. Investigators used an interactive voice or web response system to obtain treatment assignment, and patients and all study investigators were masked to their treatment allocation. We hypothesised that albiglutide would be non-inferior to placebo for the primary outcome of the first occurrence of cardiovascular death, myocardial infarction, or stroke, which was assessed in the intention-to-treat population. If non-inferiority was confirmed by an upper limit of the 95% CI for a hazard ratio of less than 1·30, closed testing for superiority was prespecified. This study is registered with ClinicalTrials.gov, number NCT02465515. Findings: Patients were screened between July 1, 2015, and Nov 24, 2016. 10 793 patients were screened and 9463 participants were enrolled and randomly assigned to groups: 4731 patients were assigned to receive albiglutide and 4732 patients to receive placebo. On Nov 8, 2017, it was determined that 611 primary endpoints and a median follow-up of at least 1·5 years had accrued, and participants returned for a final visit and discontinuation from study treatment; the last patient visit was on March 12, 2018. These 9463 patients, the intention-to-treat population, were evaluated for a median duration of 1·6 years and were assessed for the primary outcome. The primary composite outcome occurred in 338 (7%) of 4731 patients at an incidence rate of 4·6 events per 100 person-years in the albiglutide group and in 428 (9%) of 4732 patients at an incidence rate of 5·9 events per 100 person-years in the placebo group (hazard ratio 0·78, 95% CI 0·68–0·90), which indicated that albiglutide was superior to placebo (p<0·0001 for non-inferiority; p=0·0006 for superiority). The incidence of acute pancreatitis (ten patients in the albiglutide group and seven patients in the placebo group), pancreatic cancer (six patients in the albiglutide group and five patients in the placebo group), medullary thyroid carcinoma (zero patients in both groups), and other serious adverse events did not differ between the two groups. There were three (<1%) deaths in the placebo group that were assessed by investigators, who were masked to study drug assignment, to be treatment-related and two (<1%) deaths in the albiglutide group. Interpretation: In patients with type 2 diabetes and cardiovascular disease, albiglutide was superior to placebo with respect to major adverse cardiovascular events. Evidence-based glucagon-like peptide 1 receptor agonists should therefore be considered as part of a comprehensive strategy to reduce the risk of cardiovascular events in patients with type 2 diabetes. Funding: GlaxoSmithKline

The SIB Swiss Institute of Bioinformatics' resources: focus on curated databases

The SIB Swiss Institute of Bioinformatics (www.isb-sib.ch) provides world-class bioinformatics databases, software tools, services and training to the international life science community in academia and industry. These solutions allow life scientists to turn the exponentially growing amount of data into knowledge. Here, we provide an overview of SIB's resources and competence areas, with a strong focus on curated databases and SIB's most popular and widely used resources. In particular, SIB's Bioinformatics resource portal ExPASy features over 150 resources, including UniProtKB/Swiss-Prot, ENZYME, PROSITE, neXtProt, STRING, UniCarbKB, SugarBindDB, SwissRegulon, EPD, arrayMap, Bgee, SWISS-MODEL Repository, OMA, OrthoDB and other databases, which are briefly described in this article

The future of the european post-trading system

THE EUROPEAN POST-TRADING LANDSCAPE IS RECENTLY CHANGING FUNDAMENTALLY DUE TO THE FINANCIAL CRISIS, REGULATORY ACTIONS, AND THE STRONG LINKAGE OF GLOBAL FINANCIAL MARKETS. THE SYSTEMIC IMPORTANCE OF POST-TRADING INFRASTRUCTURES UNDERLINES THE INDUSTRY’S SIGNIFICANT DEPENDENCE ON SAFE AND EFFICIENT RISK MANAGEMENT PROCESSES. USING THE DELPHI METHODOLOGY IN A STUDY AMONG A MULTITUDE OF EXPERTS FROM DIFFERENT AREAS OF POST-TRADING, WE TRIED TO DEVELOP A JOINT AND COHERENT VIEW OF THE MOST IMPORTANT ISSUES FOR THE EUROPEAN POST-TRADING SYSTEM IN THE NEAR FUTURE

Analytical validation of the PAM50-based Prosigna Breast Cancer Prognostic Gene Signature Assay and nCounter Analysis System using formalin-fixed paraffin-embedded breast tumor specimens

Background: NanoString’s Prosigna™ Breast Cancer Prognostic Gene Signature Assay is based on the PAM50 gene expression signature. The test outputs a risk of recurrence (ROR) score, risk category, and intrinsic subtype (Luminal A/B, HER2-enriched, Basal-like). The studies described here were designed to validate the analytical performance of the test on the nCounter Analysis System across multiple laboratories. Methods: Analytical precision was measured by testing five breast tumor RNA samples across 3 sites. Reproducibility was measured by testing replicate tissue sections from 43 FFPE breast tumor blocks across 3 sites following independent pathology review at each site. The RNA input range was validated by comparing assay results at the extremes of the specified range to the nominal RNA input level. Interference was evaluated by including non-tumor tissue into the test. Results: The measured standard deviation (SD) was less than 1 ROR unit within the analytical precision study and the measured total SD was 2.9 ROR units within the reproducibility study. The ROR scores for RNA inputs at the extremes of the range were the same as those at the nominal input level. Assay results were stable in the presence of moderate amounts of surrounding non-tumor tissue (<70% by area). Conclusions: The analytical performance of NanoString’s Prosigna assay has been validated using FFPE breast tumor specimens across multiple clinical testing laboratories.Non UBCPathology and Laboratory Medicine, Department ofMedicine, Faculty ofReviewedFacult