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.
SciGene recently introduced the MicroFISH Assay System, a clinically validated method combining microvolume, multiwell slides with SciGene slide processing instruments to economically perform routine cellular FISH in cytogenetic laboratories.
Meissner will be exhibiting at INTERPHEX New York, in New York City, NY, during the week of April 25, 2016. Meissner will be hosting visitors in booth #2341 from April 26 – 28, at the Jacob Javits Convention Center, during the event.
Astellas today announced key leadership appointments in its Ethics and Compliance and US Legal departments, taking effect April 25.
Amgen (NASDAQ: AMGN) today announced plans to participate in the World Medical Innovation Forum™ on cancer held April 25-27, 2016, in Boston.
Sangamo BioSciences, Inc. (NASDAQ: SGMO), the leader in therapeutic genome editing, announced that data from several ZFP Therapeutic programs will be presented at the 19th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) to be held in Washington, D.C. from May 4-7, 2016.
Lpath, Inc. (NASDAQ: LPTN), the industry leader in bioactive lipid-targeted therapeutics, announced today completion of its Phase 1 double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, immunogenicity and pharmacokinetics of Lpathomab™ in healthy volunteers.
JSR Corporation recently announced the formation and establishment of its Life Sciences Division, JSR Life Sciences (JLS). The newly formed JLS has been established as a business unit for parent company, Tokyo-based JSR Corporation, a company with more than 50 years of success in material and polymer chemistries including marketing latex and magnetic beads to life sciences and diagnostic companies worldwide.
A new industry body, the British Biosimilars Association (BBA), has been formally launched recently with the sole focus of increasing the understanding and use of biosimilar medicines in the UK.
WuXi AppTec, a leading open-access R&D capability and technology platform company serving the pharmaceutical, biotechnology, and medical device industries, today announced that it has acquired Crelux GmbH, a leading structure based drug discovery provider based in Munich, Germany.
CSafe Global forms a new company, opens a new Service Center and welcomes a new Director of Sales in one of the world's foremost pharma production locations.
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Intellia Therapeutics, Inc. announced today a licensing and collaboration agreement to advance CRISPR/Cas gene-editing technology for in vivo therapeutic development.
GE Healthcare’s Life Sciences business recently announced that its European manufacturing and distribution site for sterile liquids has expanded its capabilities to include production of large volumes of buffers, process liquids and cell culture media, and launched a rapid production service for prototype cell culture media and buffers.
At the upcoming annual meeting of the American Association for Cancer Research (New Orleans, April 16-20, 2016) RareCyte, Inc., its collaborators and customers will be presenting results from five collaborative oncology research projects.
Immune Therapeutics, Inc. (OTCQB: IMUN); a clinical-stage international biotechnology company providing immunotherapy solutions for the treatment of diseases, autoimmune diseases, and cancer, announced today it is providing shareholders with a status update of Immune Therapeutics, Inc.'s (IMUN) drug development program in China with long-term partner Hubei Qianjiang Pharmaceutical Co. Ltd (Qianjiang).
Recently, GE Ventures and Mayo Clinic announced the launch of Vitruvian Networks, Inc., an independent platform company committed to accelerating access to cell and gene therapies through advanced, cloud-ready software systems and manufacturing services.