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On the cutting edge
May 2015
by Jeffrey Bouley  |  Email the author
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April showers bring May flowers, or so they say. Well, April news releases in my inbox bring May tools and technology offerings covering oncology data collection and management, a quantitative PCR system, next-generation sequencing (NGS) data processing, flow chemistry systems, The Cancer Genome Atlas (TCGA) dataset handling and biosimulation.

Streamlining data collection and management for cancer trials
 
NEW YORK—Medidata, a leading global provider of cloud-based solutions for clinical research in life sciences, and Cancer Research UK, the world’s largest charitable funder for cancer research, recently announced that the Medidata Clinical Cloud has been selected to support the charity’s groundbreaking drug discovery research.
 
In collaboration with academic and industry partners, Cancer Research UK’s Centre for Drug Development (CDD) translates new discoveries in the lab into cutting-edge new cancer treatments for patients. To further this work, the CDD is leveraging Medidata’s cloud-based technology for electronic data capture and management (Medidata Rave) to conduct faster and safer clinical trials at institutes, universities and hospitals across the United Kingdom.
 
“Medidata’s cloud-based platform provides us with the flexibility and scalability we need to accelerate progress across all our trials,” said Dr. Nigel Blackburn, director of the CDD. “Having immediate access to high-quality data will ultimately help us shorten trial delivery times, reduce costs and maximize the output of studies so that we can accelerate progress and bring new treatments to cancer patients sooner.”
 
Using Medidata’s cloud-based data management and capture system, the CDD will make clinical data from its future trials easily accessible to researchers in real time, streamlining the process of setting up and running cancer trials. By providing a standardized, central system for data entry, the Medidata platform will improve data quality, allow clinicians to easily monitor patients’ safety and enable more insightful decision making across all CDD trials.
 

Procter & Gamble to use WaferGen gene expression tech
 
FREMONT, Calif.—WaferGen Bio-systems Inc. announced in late March an industrial partnership with Procter & Gamble whereby Procter & Gamble will utilize WaferGen's SmartChip MyDesign quantitative PCR System to conduct various gene expression and other studies.
 
"We are very pleased that, following a thorough evaluation of multiple technologies, Procter & Gamble has selected our SmartChip MyDesign System for use in a number of gene expression and other studies," said Dr. Ivan Trifunovich, president and CEO of WaferGen. "We believe our technology is superior to other products in a number of applications, including gene expression assays. The adoption of WaferGen's technology by a major industrial company, such as Procter & Gamble, further underscores the critical advantages of our SmartChip solution. The platform's key features for customers are its flexible configurations, and the ability to efficiently dispense assays in the customers' own labs.”
 
Relative to competitive offerings, WaferGen believes that the SmartChip MyDesign System has best-in-class flexibility, high levels of sensitivity without the need for preamplification and a very low cost per reaction. WaferGen previously announced successful proof-of-concept studies utilizing their SmartChip technology for single-cell analysis, and intends to offer an early-access program in the second quarter of 2015, followed by a commercial product launch before the end of 2015. The single-cell offering is expected to provide an important broadening of the platform's utility, with integrated workflows into NGS and quantitative PCR.
 

Macrogen selects GENALICE MAP for large-scale genome analysis
 
HARDERWIJK, The Netherlands—Mid-March saw biomedical big data solutions company GENALICE and South Korean personalized medicine and biotechnology company Macrogen Inc. announce that Macrogen has chosen GENALICE MAP to reinforce its big data processing and analysis capacity for large-scale genome analysis and clinical sequencing services. GENALICE MAP is an NGS data processing solution that reportedly processes genomics data up to 100 times faster than conventional tools.
 
“Macrogen has strengthened its competitive edge in the research market by providing Illumina’s HiSeq X Ten platform-based large-scale whole-human genome sequencing service, and is trying to establish the leading position in the clinical sequencing market. A high-quality and fast pipeline for data processing and analysis is critical for providing better services for our customers as the genomics data production is soaring,” explained Macrogen CEO Hyonyong Chong. “After a period of extensive evaluations on quality and consultation of some of our customers, we are convinced of the quality and stability of GENALICE MAP. With GENALICE MAP, we can run our HiSeq X Ten systems to full capacity without having to build a large IT infrastructure, and immediately share the results with our customers using a secure network connection instead of hard drives.”
 

Syrris sees best-ever sales of product lines
 
ROYSTON, U.K.—Syrris, a global provider of laboratory-scale and flow chemistry systems, reports that it “continues to go from strength to strength, achieving sales growth of 18 percent during 2014 and best-ever sales of all its product lines—the modular Atlas and Globe batch reactors, bespoke custom reactor systems and the revolutionary Asia range of flow chemistry products—culminating in the company’s most successful year to date.”
 
Sales of Asia flow chemistry systems have increased by more than £1 million ($1.5 million) year-on-year, aided by the release of several innovative modules during 2014, the company reports—the Asia Tube Cooler and Asia Cryo Controller modules for sub-ambient reactions down to ­68 °C and ­100 °C respectively, and the Asia Flux, which combines continuous flow processes and electrochemistry. In addition, Syrris received a significant grant from the Advanced Manufacturing Supply Chain Initiative toward further development of novel flow chemistry systems. The company also continued its popular educational program, hosting workshops in Denmark, Sweden, Switzerland, the United States, the United Kingdom, Canada, Germany, Belgium, France, Mexico and Japan.
 

Station X simplifies use of TCGA
 
MARCO ISLAND, Fla. & SAN FRANCISCO—Station X Inc., a developer of technologies intended to make large-scale human genome management and analysis easier, recently announced that researchers can now utilize the open-access data from TCGA through the company’s secure cloud-based GenePool platform.
 
“TCGA is a national treasure, and we wanted to make it easier for researchers to access and use for clinically focused applications,” said Richard Goold, CEO of Station X. “Station X provides the most comprehensive and user-friendly version of TCGA datasets, which includes the genomic profiles of more than 10,000 patients and 27 cancer types and all of the patient and sample metadata curated by Station X, making high-quality data mining possible.”
 
Currently, researchers wanting to incorporate information from TCGA into their workflows must download data stored at multiple locations, integrate them with their own data and then process this collection on powerful computational systems. This workflow has become untenable for most labs given the enormous growth of TCGA and other large-scale sequencing datasets, Station X maintains.
 
To mitigate the daunting challenges inherent in managing and analyzing vast amounts of genomic data, Station X has built a cloud-based software as a service platform called GenePool. GenePool provides a persistent, secure and curated repository for storing, cataloging and accessing cancer genome sequence, alignment, sequence variation, expression, copy number and structural variation information from the TCGA consortium.
 

 
Japanese regulatory agency licenses Certara’s Phoenix and Simcyp software
 
PRINCETON, N.J.—Certara, a global biosimulation technology-enabled drug development and drug safety consulting company, announced earlier this year that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) is equipping its pharmacometrics team with Certara’s Phoenix biosimulation solutions and its Simcyp Population-based Simulator. PMDA joins FDA and several other global regulatory agencies in increasing its reliance on biosimulation for investigational new drug and new drug approval reviews.
 
“Biosimulation is now consistently relied upon by regulatory agencies’ pharmacometrics teams in preclinical, clinical and post-approval drug development decisions,” said Certara CEO Dr. Edmundo Muniz. “Furthermore, a paper and survey from the International Consortium for Innovation and Quality in Pharmaceutical Development published by the American Association of Pharmaceutical Scientists last month stated that Phoenix was used by 100 percent of the 22 leading pharmaceutical companies surveyed, and 86 percent of them were using Simcyp.”
 
More recently, Certara also announced the launch of version 2.0 of its Cardiac Safety Simulator (CSS), which has become a standalone product for the first time. CSS is currently being used by several leading pharma companies, two of which collaborated with Certara on its development.
 
“By enabling early cardiotoxicity risk to be measured more precisely, Certara’s Cardiac Safety Simulator is allowing biopharmaceutical companies to make more informed go/no-go decisions regarding their new drug candidates,” said Muniz.
 
Code: E051527

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