Global News

The Pistoia Alliance AbVance Project hits a key milestone

Friday, November 10, 2017

The Pistoia Alliance, a global, not for profit alliance that works to lower barriers to innovation in life sciences R&D, has announced that its project to increase knowledge of antibody (Ab) structures has reached its first major milestone—12 antibody structures have been deposited into the European Bioinformatics Institute’s (EMBL-EBI) Protein Data Bank (PDB). The goals of the project are to generate novel Ab structures and improve Ab structural data sharing across the life sciences. This will increase researchers’ predictive power and their ability to accurately model Ab structures; considerably reducing the time and cost associated with generating experimental data to support decision-making in drug projects.

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Report: Electronic Trial Master File (eTMF) Market to Touch $190M by 2027

Wednesday, November 8, 2017

Future Market Insights has analyzed numerous aspects of the electronic trial master file (eTMF) market and has included actionable insights in a systematic manner in its new research publication titled, “Electronic Trial Master File (eTMF) Market: Global Industry Analysis (2012-2016) and Opportunity Assessment (2017-2027).” The extensive research study on eTMF market portrays various facets of the global market such as trends, opportunities, value chain analysis, competitive landscape, drivers, restraints, regional analysis along with key recommendations that can be considered by the reader to achieve his/her strategic objectives in the long run. The research study also covers future market projections with respect to value for a period of ten years starting from 2017 till 2027. The comprehensive analysis on each segment and sub segment of the global market portrays a real time picture of the global market scenario.

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Study: Impact of digital health grows, mobile health apps accelerate

Wednesday, November 8, 2017

The impact of Digital Health on patient care is accelerating with the increasing adoption of mobile health apps and wearable sensors. Health-related mobile applications available to consumers now surpass 318,500—nearly double the number available just two years ago—with approximately 200 new apps added to the market each day. This rapid app expansion, coupled with more than 340 consumer wearable devices on the market worldwide, and 571 published efficacy studies, provide evidence of Digital Health’s accelerating innovation and generation of a subset of proven tools to impact human health, according to a new report released today by the IQVIA Institute for Human Data Science.

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Merck, CDRD partner on Canadian life sciences ecosystem

Monday, November 6, 2017

The Canadian scientific community gathered in Ottawa this week to engage in a national dialogue on science, technology and innovation policy at the annual Canadian Science Policy Conference. Just prior to the Keynote Address at this event by the Honorable Kirsty Duncan, Minister of Science, Merck Canada and CDRD (The Centre for Drug Research and Development) announced the establishment of a new $1.5M Merck-CDRD Innovation Fund. This fund will go directly towards the advancement of projects of high therapeutic potential carried out at CDRD in collaboration with academic researchers.

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Wave Life Sciences initiates Duchenne muscular dystrophy clinical trial

Monday, November 6, 2017

Wave Life Sciences, a biotechnology company focused on delivering transformational therapies for patients with serious, genetically-defined diseases, announced the initiation of a global phase I clinical trial for WVE-210201 in Duchenne muscular dystrophy (DMD) patients amenable to exon 51 skipping. This clinical trial marks the next stage in the company’s ongoing commitment to address the significant unmet needs of patients diagnosed with this devastating disease and it is the company’s third clinical trial initiated in 2017.

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Translate Bio appoints Ann Barbier as Chief Medical Officer

Monday, November 6, 2017

Translate Bio, a biotechnology company focused on pioneering the translation of RNA science into therapeutics promoting healthy gene expression in people living with debilitating genetic diseases, announced the appointment of Ann Barbier, M.D., Ph.D., as chief medical officer, effective immediately. Dr. Barbier brings nearly 20 years of drug discovery and development experience to Translate Bio, and will be responsible for leading all clinical research and development, medical affairs and related functions at Translate Bio.

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CluePoints launches risk-based monitoring roadshow in Tokyo

Monday, November 6, 2017

CluePoints, a provider of Risk-Based Monitoring (RBM) and Data Quality Oversight solutions for clinical trials, has further expanded its Late Phase work in Japan by entering into two new partnerships with global top 20 pharmaceutical companies. The collaborations mark the latest success for CluePoints in the region, with its centralized statistical monitoring (CSM) platform having already been used by the Nagoya University School of Medicine for an eight-year phase III Stomach Cancer Adjuvant Multi-Institutional Group Trial (SAMIT).

The new studies will see both sponsors using CluePoints’ solution to check data quality and integrity across all investigative sites and patients. By using advanced statistical methodologies to identify any anomalies or outliers in data, the platform works to target monitoring to the sites and patients where it is most needed. The CluePoints’ solution was used during the SAMIT trial once the committee had recognized that traditional approaches to quality control may not be fully effective. It provided reassurances that the clinical trial protocol had been consistently followed across participating centres.

“Our continued growth in Japan builds on CluePoints’ commitment to becoming the ‘go-to’ Risk-Based Monitoring (RBM) technology in this key market for both regional and global clinical trials,” comments François Torche, CEO, CluePoints. “We are already undertaking analyses of phase III studies in Japan with mid-tier pharmaceutical companies, improving clinical data quality and contributing to the reduction in the overall risk associated with sponsors’ regulatory submissions.”

Keen to build on its presence in the region, CluePoints will host its next RBM Roadshow in Tokyo in November. The event will explore a day-in-the-life of a team responsible for successfully planning and executing RBM, review the growing evidence in favour of the approach and reveal how delegates can lead their organizations’ RBM journey. The event will take place at the Tokyo Belle Salle, Sumitomofudousan Chiyoda on November 9, 2017, from 1:30 – 4:30pm. For more information and to register, please visit http://lp.cluepoints.com/risk-based-monitoring-roadshow-registration

In support of the company’s wider long-term growth strategy across the Asia-Pacific region, CluePoints is undertaking ‘knowledge transfer’ initiatives on behalf of large pharmaceutical companies in both China and Singapore to equip teams of central data scientists to use its software to analyze hundreds of clinical trials. This will drive significant cost and efficiency savings and increase data quality and integrity in line with the new ICH E6 R2 guidance.

Bioclinica acquires MDDX Research & Informatics

Monday, November 6, 2017

Bioclinica, a provider of scientific-enabled Medical Imaging, eHealth and patient-centric solutions supporting clinical research, has acquired Silicon Valley-based MDDX Research & Informatics, adding advanced cloud research image management and submission technologies to its extensive suite of eHealth solutions.

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QuintilesIMS is now IQVIA

Monday, November 6, 2017

QuintilesIMS will be changing its name to IQVIA, a company dedicated to using analytics and science to help healthcare stakeholders find better solutions for their patients. Beginning on November 15, 2017, equity shares of the company will trade on the NYSE under the new name and new ticker symbol “IQV.” Until then, IQVIA will continue to be listed under QuintilesIMS and symbol “Q” per the listing notification requirements of the NYSE. 

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