INDUSTRY NEWS
Biomedical Systems’ electronic clinical outcome assessment (eCOA) technology is used for clinical trials in more than 40 countries for multiple therapeutic areas including respiratory, gastrointestinal, dermatology, oncology, and women’s health. It is the only company providing eCOA technology along with cardiac safety, pulmonary function, and imaging centralized diagnostic services.
“The eCOA market is growing fast, and launching this technology enhances our ability to offer centralized diagnostic services,” said Tim Barrett, chief executive officer at Biomedical Systems. “In 40 years, Biomedical Systems has built a premier global presence based on centralized diagnostic services and logistics excellence. Our eCOA solutions will extend that prompt, reliable global service we’re known for to provide more reliable data while collecting data for primary and secondary endpoints.”
Biomedical Systems’ eCOA technology offers the flexibility, reliability, and robustness of the Android operating system. QR code technology is used to reduce investigators’ burden, improve security, and, more importantly, ease the data capture process. With this platform, Biomedical Systems focused on patients’ ease of use by providing new features that improve compliance and worldwide reliable data transmission using the latest telecommunication technologies. In addition, the company relies on a strong and proactive project management team that is key to successful eCOA trials.
Johnson Matthey Commissions New High Containment Manufacturing Capacity in Edinburgh, UK
Johnson Matthey, a leading provider of pharmaceutical services, active pharmaceutical ingredients (APIs), and catalyst technologies, has announced completion and commissioning of new high containment facilities for potent product manufacture at its Edinburgh, UK site (Macfarlan Smith).
Macfarlan Smith is an established provider of opiates, controlled substance, and highly potent products. The new self-contained, state- of-the-art facility is required to meet existing demand for potent products and provides additional capacity for anticipated future requirements. It features a dedicated finishing room, QC laboratory, and control room. Overall the facility design ensures a safe working environment and assures customers that the necessary manufacturing controls and procedures are in place to produce compounds with OEL less than 30 ng per m3.
“This new facility is a significant addition to our existing capabilities at our site in Edinburgh,” commented Steve Barr, Vice President Business Development Europe. “It enhances our overall capabilities in high containment manufacturing and provides extra capacity to extend our range of high potency products and services. These facilities support Johnson Matthey’s broader assets for the manufacture of highly potent products including our US capacity in West Deptford, NJ and Devens, MA.”
Horizon Discovery Group plc to Support Cancer Research UK’s Stratified Medicine Program
Horizon Discovery Group plc, a leading provider of research tools to support translational genomics and the development of personalized medicines, will provide genomic Reference Materials to support Phase Two of Cancer Research UK’s Stratified Medicine Programme (SMP).
The work will focus on supporting the validation of a Cancer Research UK SMP Next Generation Sequencing (NGS) targeted enrichment panel using Horizon’s HDx human genomic Reference Materials. The NGS project involves multi-gene, multi-aberration tumor analysis and is being run in CPA, GLP, and ISO accredited laboratories, with a UK NEQAS (
www.ukneqas.org.uk) quality assessment. These Reference Materials will support run-to-run and lab-to-lab longitudinal assessment of performance of the NGS technology.
In Phase 2 of the SMP, Cancer Research UK will work with the national Experimental Cancer Medicine Centre (ECMC) network and national genetic testing laboratories to develop a national screening program for lung cancer samples in the NHS. Once screened, these results will be used to place patients on the National Lung Matrix Trial, run by the Cancer Research UK Clinical Trials Unit (CRCTU) in Birmingham, and led by Prof. Gary Middleton.
The scope of the project involves Horizon’s Diagnostics business unit providing renewable, genetically defined Reference Materials representing a range of genetic aberrations and containing defined allelic mutation frequencies. The Reference Materials developed will enable reliable comparison of assay performance across sequencing platforms, targeted assays, and laboratories by providing a common universal reference point.
Many factors contribute to variability in the quality of clinical samples, which is currently a concern within molecular pathology laboratories working towards the clinical application of NGS panels for tumor screening. To address this, Cancer Research UK will use Horizon’s precisely defined formalin compromised Reference Standards to assess the performance of Cancer Research UK’s-SMP NGS, in order to inform any necessary changes in clinical practice surrounding preparation of FFPE samples for downstream NGS analysis.
Dr. Paul Morrill, President, Products, Horizon Discovery, said: “Research programs such as Cancer Research UK’s Stratified Medicine Programme form a vital piece of the puzzle in the drive toward personalized, or stratified, medicine as a routine approach for the testing and treatment of cancer. We are delighted to have been chosen to support Cancer Research UK on the delivery of Phase 2 of this project.”
Dr Ian Walker, Head of Cancer Research UK’s stratified medicine program, commented: “Research into stratified medicine is helping us to understand the genetic changes that drive cancer, and to find out how different cancers respond to treatment. Ensuring accuracy in genetic assessment of tumors is a vital part of this process, and we welcome Horizon’s involvement in assisting Cancer Research UK with taking the Stratified Medicine Programme forwards.”
pharmoutsourcing.com | 71 | March/April 2015
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