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.
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 NextDocs Compliance Cloud is a state-of-the-art delivery platform for the NextDocs compliance suite and was built from the ground up for the Life Sciences industry.
In a further step to build its portfolio for the rapidly-growing cell therapy industry, GE Healthcare recently announced an agreement with STEMCELL Technologies Inc. of Vancouver, Canada to provide T-Cell reagents for commercial-scale cell therapy production.
GE Healthcare’s Life Sciences business, a global provider of technologies and expertise to the biopharmaceutical and life sciences industries and Sealed Air Corporation, a global manufacturer of primary films for pharmaceutical solutions, recently announced the expansion of a strategic alliance designed to further the development and innovation in the biopharmaceuticals industry.
CSafe Global announces a significant strategic growth milestone with the manufacture of the 1000th RKN active container.
MilliporeSigma will provide its Provantage® End-to-End development and manufacturing services to Y-mAbs Therapeutics, Inc. in support of Y-mAbs’ monoclonal antibody in late stage clinical development.
Finesse Solutions, Inc., a manufacturer of measurement and control solutions for life science process applications, has enhanced its business operations in Asia by opening a branch office in Seoul, South Korea. Finesse Korea joins other offices already established in Asia – in Singapore and Shanghai – to support the rapidly expanding Asia market.
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.
MilliporeSigma has entered into an agreement with PCAS S.A. (Longjumeau, France) to expand MilliporeSigma’s excipients portfolio. Under the agreement, MilliporeSigma will be the exclusive, global distributor of the Expansorb® line of biocompatible and biodegradable polymers.
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 recently has expanded its industry-leading Emprove risk assessment program to include a selection of products for filtration and single-use processing.