News Article | May 11, 2017
DUBLIN--(BUSINESS WIRE)--ICON plc, (NASDAQ: ICLR) a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries, today announced that it has been included in Forbes magazine’s America’s Best Employers list for 2017. Now in its third year, the Forbes list features the top 500 large employers in the US with more than 5,000 employees and the top 300 midsize companies with 1,000 – 5,000 employees. ICON was the highest ranked CRO in the best midsize employers listing. The Forbes list is determined following an independent, online survey of 30,000 employees representing companies from 25 industry sectors. In conjunction with consumer research provider, Statista, employees were consulted anonymously in September 2016 through several online panels to allow them to share their opinions about their employers openly and without any influence from their employer. Respondents were asked to rate their willingness to recommend their own companies on a scale of 0 – 10 and were also asked to name good and bad employers in industry sectors other than their own. “We are proud to be named by Forbes as one of the best employers in America and we are pleased that our employees are recommending ICON as an excellent place to work,” commented Dr. Steve Cutler, Chief Executive Officer, ICON. “We have great people who are committed to helping our clients to accelerate the development of drugs and devices that are saving lives and improving the quality of life of patients right across the globe. We will continue to work hard to ensure that we provide a work environment that engages, rewards and develops our employees so that they can build successful careers at ICON.” ICON plc is a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries. The company specialises in the strategic development, management and analysis of programs that support clinical development - from compound selection to Phase I-IV clinical studies. With headquarters in Dublin, Ireland, ICON currently, operates from 87 locations in 38 countries and has approximately 12,300 employees. Further information is available at www.iconplc.com. This press release contains forward-looking statements. These statements are based on management's current expectations and information currently available, including current economic and industry conditions. These statements are not guarantees of future performance or actual results, and actual results, developments and business decisions may differ from those stated in this press release. The forward-looking statements are subject to future events, risks, uncertainties and other factors that could cause actual results to differ materially from those projected in the statements, including, but not limited to, the ability to enter into new contracts, maintain client relationships, manage the opening of new offices and offering of new services, the integration of new business mergers and acquisitions, as well as economic and global market conditions and other risks and uncertainties detailed from time to time in SEC reports filed by ICON, all of which are difficult to predict and some of which are beyond our control. For these reasons, you should not place undue reliance on these forward-looking statements when making investment decisions. The word "expected" and variations of such words and similar expressions are intended to identify forward-looking statements. Forward-looking statements are only as of the date they are made and we do not undertake any obligation to update publicly any forward-looking statement, either as a result of new information, future events or otherwise. More information about the risks and uncertainties relating to these forward-looking statements may be found in SEC reports filed by ICON, including its Form 20-F, F-1, S-8 and F-3, which are available on the SEC's website at http://www.sec.gov.
PubMed | Eli Lilly and Company, University of Pennsylvania, Eisai Inc, Biomarkable and 13 more.
Type: Journal Article | Journal: Journal of Alzheimer's disease : JAD | Year: 2016
Alzheimers disease (AD) drug development is burdened with the current requirement to conduct large, lengthy, and costly trials to overcome uncertainty in patient progression and effect size on treatment outcome measures. There is an urgent need for the discovery, development, and implementation of novel, objectively measured biomarkers for AD that would aid selection of the appropriate subpopulation of patients in clinical trials, and presumably, improve the likelihood of successfully evaluating innovative treatment options. Amyloid deposition and tau in the brain, which are most commonly assessed either in cerebrospinal fluid (CSF) or by molecular imaging, are consistently and widely accepted. Nonetheless, a clear gap still exists in the accurate identification of subjects that truly have the hallmarks of AD. The Coalition Against Major Diseases (CAMD), one of 12 consortia of the Critical Path Institute (C-Path), aims to streamline drug development for AD and related dementias by advancing regulatory approved drug development tools for clinical trials through precompetitive data sharing and adoption of consensus clinical data standards. This report focuses on the regulatory process for biomarker qualification, briefly comments on how it contrasts with approval or clearance of companion diagnostics, details the qualifications currently available to the field of AD, and highlights the current challenges facing the landscape of CSF biomarkers qualified as hallmarks of AD. Finally, it recommends actions to accelerate regulatory qualification of CSF biomarkers that would, in turn, improve the efficiency of AD therapeutic development.
9th GCC closed forum: CAPA in regulated bioanalysis; method robustness, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, regulatory audit experiences and electronic laboratory notebooks
PubMed | Eurofins, Pharma Medica, Algorithme Pharma Inc., KCAS Inc and 36 more.
Type: Congresses | Journal: Bioanalysis | Year: 2016
The 9th GCCClosed Forum was held just prior to the 2015 Workshop on Recent Issues in Bioanalysis (WRIB) in Miami, FL, USA on 13 April 2015. In attendance were 58 senior-level participants, from eight countries, representing 38 CRO companies offering bioanalytical services. The objective of this meeting was for CRO bioanalytical representatives to meet and discuss scientific and regulatory issues specific to bioanalysis. The issues selected at this years closed forum include CAPA, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, and ELNs. A summary of the industrys best practices and the conclusions from the discussion of these topics is included in this meeting report.
PubMed | Maimonides Medical Center, Syracuse University, Childrens Hospital, Arnold Palmer Hospital and 4 more.
Type: Journal Article | Journal: Clinical pediatrics | Year: 2016
This study was conducted to assess the perception of US pediatric specialists of respiratory syncytial virus (RSV) disease risk and determine their clinical practices regarding immunoprophylaxis for high-risk children. Separate surveys were sent to neonatologists, pediatricians, pediatric pulmonologists, and pediatric cardiologists. Data were collected using structured questions requiring quantitative responses. Most neonatologists and pediatricians (>82.7%) reported a high clinical need for RSV immunoprophylaxis in preterm infants <32 weeks gestational age. Pediatric pulmonologists and pediatric cardiologists suggested that health conditions indicative of chronic lung disease of prematurity and hemodynamically significant congenital heart disease, respectively, confer eligibility for RSV immunoprophylaxis. Agreement with the changes in the 2014 American Academy of Pediatrics guidance for RSV immunoprophylaxis was mixed among respondents from the 4 specialties. Survey findings may provide a basis to improve education about risk for severe RSV disease and evaluate changes in physician use of RSV immunoprophylaxis based on the 2014 guidance.
PubMed | University of Edinburgh, University of Versailles, Allergy and Respiratory Clinic, Ghent University and 6 more.
Type: | Journal: Clinical and translational allergy | Year: 2015
The affliction of allergic rhinitis (AR) has been trivialised in the past. Recent initiatives by the European Academy of Allergy & Clinical Immunology and by the EU parliament seek to rectify that situation. The aim of this study was to provide a comprehensive picture of the burden and unmet need of AR patients.This was a cross-sectional, online, questionnaire-based study (June-July 2011) including symptomatic seasonal AR (SAR) patients (18years) from a panel. SAR episode pattern, severity, medication/co-medication usage, residual symptoms on treatment, number of healthcare visits, absenteeism and presenteeism were collected.One thousand patients were recruited (mild: n=254; moderate/severe: n=746). Patients with moderate/severe disease had significantly more symptomatic episodes/year (8.0 vs 6.0/year; p=0.025) with longer episode-duration (12.5 vs 9.8days; p=0.0041) and more commonly used 2 AR therapies (70.5 vs 56.1%; OR 1.87; p=0.0001), looking for better and faster nasal and ocular symptom relief. The reported symptom burden was high irrespective of treatment, and significantly (p<0.0001) higher in the moderate/severe group. Patients with moderate/severe AR were more likely to visit their GP (1.61 vs 1.19 times/year; OR: 1.49; p=0.0061); due to dissatisfaction with therapy in 35.4% of cases. Patients reported SAR-related absenteeism from work on 4.1days/year (total cost to UK: 1.25 billion/year) and noted presenteeism for a mean of 37.7days/year (vs 21.0days/year; OR 1.71; p=0.0048). Asthma co-morbid patients reported the need to increase their reliever- (1 in 2 patients) and controller-medication (1 in 5 patients) if they did not take their rhinitis medication.This study differentiated between patients with mild and moderate/severe AR, demonstrating a burden of poorly controlled symptoms and high co-medication use. The deficiency in obtaining symptom control with what are currently considered firstline treatments suggests the need for a novel therapeutic approach.