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.
BioInformant, the only market research firm to exclusively serve the stem cell sector, announces the release of its global strategic report, "Mesenchymal Stem Cells – Advances and Applications."
The biotech company Biovica, inventors of DiviTum and SimplicityBio creators of the Biomarker Optimization Software System (BOSS), have agreed to collaborate to discover and improve multi-biomarker panels for faster and better evaluation of cancers and new oncology drugs.
Sartorius Stedim Biotech (SSB), an international leading supplier for the biopharmaceutical industry, recently introduced the new ambr® 15 fermentation system, an automated micro bioreactor system designed to enhance microbial strain screening with advanced capabilities supporting fed-batch microbial cultures.
Bespak has launched the Syrina 2.25 at PDA Europe 2015. Moreover, Steven Kaufman, Global Business Development Lead at the company, will chair a 1-day specialized industry discussion on innovative combinational products at a workshop taking place during PDA Europe 2015, Universe of Pre-filled Syringes & Injection Devices in Vienna, Austria.
JSR Life Sciences announced today that it will release Amsphere™ A3, a next generation Protein A chromatography resin for advanced protein separation in downstream processing of therapeutic antibodies manufacturing at the IBC Life Sciences' BioProcess International Conference & Exposition.
Recently, Single-Use Bags Are Increasingly Used In All Process Steps Of Biopharmaceutical Manufacturing.
Koppert Biological Systems has developed a biostimulant for arable crops. The product will be officially launched recently during an international seminar on the benefits of microbials in seed treatment and crop growth.
Shimadzu Scientific Instruments (SSI) announces the U.S. release of its LABNIRS functional near-infrared spectroscopy (fNIRS) system.
New Instrument Helps Pharma Labs Comply with Global Quality Requirements
Affymetrix, Inc. announced recently that its Axiom high-throughput genotyping technology was instrumental in two transplantation peer-reviewed publications issued this month by an international team of surgeons and scientists.
Ability Pharmaceuticals, a drug development biopharmaceutical company specialized in oncology, recently announced that it has received from the U.S. Food and Drug Administration (FDA), orphan-drug designation (ODD) for ABTL0812, its PI3K/Akt/mTOR pathway inhibitor, for the treatment of the pediatric cancer neuroblastoma and that it has received positive Scientific Advice from the European Medicines Agency (EMA) for its development in the same indication.
CAMO Software, leaders in multivariate data analysis software, and Stat-Ease, Inc., a leading supplier of design of experiments (DOE) software and services, have released a software bundle for multivariate data analysis and design of experiments; The Unscrambler X Design-Expert Upgrade.
Phillips-Medisize Corp. representatives Bill Welch, Chief Technology Officer, and Janne Turunen, Program Manager, will be part of the Sanofi presentation at the Partnership Opportunities in Drug Delivery (PODD) in Boston.
Crystal Pharmatech, a leader in solid-state chemistry services for drug development. announced that it has raised $10M in Series A funding led by Renren Lianhe Holdings.
EMD Millipore, the Life Science business of Merck KGaA of Darmstadt, Germany, recently introduced enhancements to its industry-leading EMPROVE portfolio of pharmaceutical raw materials.