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.
Anyone involved in clinical work knows investigator engagement is not an easy task. Gathering real-time feedback during a trial, selecting the right investigators, and effectively engaging with sites and investigators can be a monumental challenge.
Earlier this year Invesco Perpetual, an investment firm with holdings in Big Pharma companies including Pfizer, Merck, and GSK, announced a $50 million investment in DrugDev, a data sharing platform for clinical trial doctors with an online network of more than 80,000 clinical trial doctors in 93 countries. DrugDev stated at the time that the money would be used to enhance its clinical trial technology as well as acquire companies with complementary technologies. The first of those companies is CFS Clinical. DrugDev announced it has acquired the company, a provider of business and financial management activities for trials, as part of its plan to help companies control the spiraling cost of clinical trials.
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.
Alcobra Ltd. and Arcturus Therapeutics, Inc., a privately held biotechnology company developing novel RNA medicines, announced the signing of a definitive agreement to merge the two companies in an all-stock transaction. The transaction will result in a combined company focused on developing novel RNA medicines in therapeutic areas including infectious disease, cystic fibrosis, nonalcoholic steatohepatitis (NASH) and rare liver diseases.
This webinar aims to provide an update on the current scientific state, covering both the basic principles of freezing in a freeze drying cycle as well as the recent developments with regard to control of the freezing stage.
Theragnostics, Ltd., a radiopharmaceuticals company developing products for the diagnosis and treatment of cancer, today announced the results of a phase I study evaluating the safety and biodistribution of 68Ga-THP-PSMA PET/CT in patients with prostate cancer, published in The Journal of Nuclear Medicine (JNM).
Lonza recently announced the establishment of the Lonza Collaborative Innovation Center (CIC) in the new Life Science Park in the outskirts of Haifa, Israel.
Lonza has confirmed that its new cell and gene therapy manufacturing facility in Pearland, in the area of Houston, TX (USA), which started construction in May of 2016, is nearing completion and is on schedule to start production in Q1 2018, despite the storms that hit the state of Texas in late August and early September.
Cork has received a significant jobs boost recently with confirmation by JanssenSciences Ireland that it is to invest more than €300M in an expansion of its manufacturing plant at Ringaskiddy that will create 200 new jobs. By Barry Roche
CRB was responsible for designing and building this state-of-the-art facility which produces biologics and biopharmaceuticals for Phase 1-3 clinical studies in cell culture expression systems. The project involved fit-out of approximately 100,000 sq. ft. of space within an existing shell building. The manufacturing area occupies
International bioprocessing solutions provider Parker has announced that it has commenced the manufacture of 2D bioprocess container systems in the UK.
G-CON Manufacturing and LifeAire Systems today announced a collaboration to combine the LifeAire’s air purification technologies within G-CON cleanroom PODs for applications such as cell/tissue culture and gene and cell therapy processes which can benefit from an even higher level of air purity than typically achieved in a cleanroom environment.
Sartorius Stedim Cellca is building a new 30-million-euro Cell Culture Technology Center at Science Park III in Eselsberg situated at the northwestern scientific hub of the city of Ulm, Germany.
Meissner will be hosting a presentation in the BPI Theater on Wednesday (27SEPT2017) at 4:05 PM, located in the Hynes Convention Center. The presentation, “Aseptic Filling via Single-Use Systems,” will be delivered by Max Blomberg, Director of Operations. The presentation will focus on best practices associated with designing single-use systems for use in critical aseptic filling operations. Isolator-based filling systems for final container closure of drug product, as well as RABs-based filling of upstream process fluids, and many operations in between, will be discussed.
MilliporeSigma recently announced an update on its participation in Horizon 2020, the EU Framework Program for Research and Innovation, to improve biopharmaceutical downstream processing.
MilliporeSigma recently announced Millistak+® HC Pro, the first portfolio of high- capacity, fully synthetic depth filters for non-treated Chinese Hamster Ovary (CHO) harvest clarification and downstream filtration applications.
POD facility will now include tablet coating and incorporate GEA’s ConsiGma™ continuous table coater.
GE Healthcare introduces a new Protein A chromatography resin, MabSelect PrismA, which will help biopharmaceutical manufacturers improve their monoclonal antibody (mAb) purification capacity by up to 40 percent.