Background: Expression of p95 in HER2-positive breast cancer is potentially a major determinant of trastuzumab resistance because p95 lacks the trastuzumab binding site while retaining kinase activity. Previously, an optimal clinical cutoff for a continuous measurement of p95 expression was defined in a training set of trastuzumabtreated MBC patients (Clin Cancer Res, 16:4226, 2010).
A variety of biomarkers are currently used to help guide treatment decisions for patients with non-small cell lung cancer (NSCLC). These include mutation analysis for the EGFR and KRAS genes, along with gene rearrangement analysis for the ALK and ROS1 loci. In this study we have evaluated the clinical and analytical performance features of these assays in a series of formalin-fixed paraffin-embedded (FFPE) tissue samples.
With the exception of some simple generic assays (such as lymphocyte T/B/NK Immunophenotyping, CD4 counting or progenitor counting) the implementation of pharma-client tailored flow cytometry assays within a multisite, multiplatform environment (central lab / clinical trials setting) in global longitudinal studies involves specific challenges that necessitate special processes and quality control procedures. We already addressed these well before flow cytometric assays became generally adopted in the clinical trials field.
The objective of this study was to identify gene expression biomarkers that are potentially predictive for birinapant response. Birinapant is a novel small molecule that mimics endogenous Smac (Second mitochondrial-derived activator of caspases), by activating the programmed cell death pathways that are dysregulated in cancer cells.
Clinical research firm PRA has announced it will be acquiring privately-held specialty research firm CRI Lifetree. CRI’s focus has been on early stage patient population studies with a focus in Human Abuse Liability (HAL), addiction, pain, psychiatry, neurology, pediatric and infectious disease services.
With three Clinical Pharmacology Centers and over 200 beds, combined with over 20 years of clinical experience, CRI is one of the largest providers of patient population Phase I and confined Phase II-III services in the United States.
Technological advancements in the healthcare sector are bringing about fast-growing volumes of complex, multi-dimensional digital data. Data in this format encompass the 3 v's which define what is now commonly known as 'Big Data' - volume, velocity and variety. As an example, large and complex datasets of medical images continue to arise from global multisite clinical trials conducted to test the efficacy and safety of novel therapies. By Colin Miller
What exactly is an integrated electronic system for clinical trials? Though the term means different things to different people, there are some basic similarities on which the industry can agree
August 2011 cemented a remarkable two months for companion diagnostics, with the FDA posting draft guidance on companion diagnostics in July and then approving two cancer drugs and their accompanying tests weeks later. Zelboraf® and the BRAF mutation test for patients with metastatic melanoma were approved August 17, and Xalkori® and the corresponding Vysis ALK Break Apart FISH Probe Kit, which detects gene rearrangements, were approved just nine days later.
Technology advancements for the clinical trials industry have created cost savings in all areas of the trial process. Web-based systems drive efficiency in trial design, randomization, clinical supply management, and more.
Having grown to a premier research organization with 400 clinical trials to its credit, HCRI’s clinical trial management needs had surpassed the conventional processes it had been using to manage and monitor information and documents related to its clinical studies. The Institute’s 140 users relied on Excel spreadsheets and other manual processes that proved labor-intensive, inefficient, and a barrier to team communication.
Advances in our understanding of cancer have accelerated the development of new diagnostics over the past decade. Now, when assessing the efficacy of an experimental drug, clinical trial teams can supplement traditional markers from tissue biopsies with assessments on circulating tumor cells (CTC). The rollout of such tests has, to date, largely been limited to Western markets, but this is changing. By Ken Pennline, Ph.D., Vice President and, Global Head, Cytometry Services, LabCorp Clinical Trials
Bellicum Pharmaceuticals, Inc., is a biotherapeutics company that develops clinical applications of chemical induction of dimerization (CID), a drug-based remote control technology that extends the physician’s reach beyond the point that a treatment has been administered. Bellicum’s mission is to deliver a new class of controlled cellular immunotherapy products for the treatment of cancer and other serious, life-threatening diseases. With a staff dedicated to this mission, the Houston-based company brings a wealth of experience to conducting clinical trials.
The open house was at the company's new service centre adjacent to the island's Luis Muñoz Marín International Airport (SJU).
International bioprocessing solutions provider Parker domnick hunter has strengthened its ability to serve the European market by launching a single-use manifold manufacturing facility in the UK.
Phillips-Medisize recently announced the completed acquisition of Injectronics Corporation, expanding their facilities to the Northeastern United States.
Recipharm, the contract development and manufacturing organisation (CDMO), has appointed Ann Flodin as General Manager of its wholly owned new subsidiary Recipharm Laboratories Inc. in Research Triangle Park, North Carolina, USA, formerly Cirrus Pharmaceuticals Inc.
Preparing samples by clarification is an essential step prior to nearly all analytical techniques, such as high pressure liquid chromatography (HPLC). This filtration step to eliminate particles is crucial for maintaining the integrity of chromatography columns and for maximizing their operating life time.
CAMO Software announced the release of Batch Modeling recently, a new add-on to their all-in-one Multivariate Data Analysis (MVA) and process monitoring software suite Unscrambler® X.
Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry, announced the launched of a new Released N-Glycan Assay for the in-depth profiling of IgG glycosylation.
Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry, recently has signed a contract to acquire U.S. centrifuge specialist kSep Holdings, Inc. (kSep).
MilliporeSigma has entered a research agreement with the International Vaccine Institute (IVI) of Seoul, South Korea to help develop more robust, scalable vaccine manufacturing processes.
Sartorius, a leading international pharmaceutical and laboratory equipment provider, recently announced the acquisition of U.S. based IntelliCyt Corporation, an award-winning innovator and manufacturer of novel cell screening platforms used in drug discovery.
Finesse Solutions, Inc., a manufacturer of measurement and control solutions for life sciences process applications, in partnership with One Hill Solutions, an innovative software developer in Massachusetts, announced the launch of the SmartLab platform for lab-scale bioprocess optimization.
Pfizer Inc. recently broke ground for its new biologics clinical manufacturing facility in Andover, Massachusetts.
Sartorius Stedim Biotech (SSB) recently introduced the ambr® 250 modular, an innovative benchtop mini bioreactor system for parallel fermentation or cell culture. This system combines a unique single-use bioreactor vessel and expandable system design to offer bioprocess scientists access to advanced benchtop bioreactor technology for process development.
Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry, has launched Virosart® Media for virus retention in cell culture media.
GE Healthcare’s Life Sciences business recently launched the first of a next generation of Biacore systems harnessing Surface Plasmon Resonance (SPR) technology. Biacore 8K marks the start of a new generation of Biacore systems maintaining the high data quality expected from Biacore at high throughput.