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.
Phillips-Medisize Corporation recently announced the appointment of Richard Even as General Manager of BioPharma and the medical campus in Menomonie Wisconsin. This is the latest in a series of strategic hires driven by the company’s continued growth in biopharma drug delivery devices, consumable diagnostics, and medical devices.
Cryoport, Inc. (NASDAQ: CYRX) ("Company"), the world's leading cryogenic logistics company for the life sciences industry, today announced that it will provide global logistics support to International Stem Cell Corporation's (OTCQB: ISCO) ("ISCO") for its Phase I clinical trial in Australia for the treatment of moderate to severe Parkinson's disease.
GlobalVision, the world leader in the development of innovative proofreading technologies, recently announced that it will be demonstrating for the first time at drupa 2016 the integration of its Quality Control Platform into Esko’s Automation Engine 16.
Sartorius Stedim Biotech (SSB) recently announced a poster presented at BPI Europe, entitled, ‘A novel automated micro bioreactor for high density fed batch microbial screening applications’ is now available online.
JHL Biotech (JHL), a biopharmaceutical company, opened the world’s first KUBio biopharmaceutical manufacturing facility with single-use bioprocessing technology at a ribbon-cutting ceremony in Wuhan, China today.
Personal Genome Diagnostics Inc. (PGDx), a provider of advanced cancer genome testing products and services, today announced that Douglas Ward has joined the company as Chief Executive Officer and a member of the board of directors.
AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) updated the IMBRUVICA® (ibrutinib) Prescribing Information (PI) to include new data from two Phase 3 trials supporting its expanded use in patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL)..
Avelas Biosciences, Inc., a clinical stage oncology-focused company dedicated to improving cancer patient care from diagnosis through treatment, today announced positive interim results from a Phase 1b trial of its AVB-620 surgical marker in women with primary, non-recurrent breast cancer undergoing surgery.
Global Vision will be showcasing its all-in-one Quality Control Platform at drupa 2016, offering intuitive tools for inspecting text, graphics, Braille, and barcodes.
Bill Downs CEO of SP Industries, Inc. (SP) has announced the appointment of Ian Whitehall as Chief Sales Officer managing and directing all global sales programs for the company’s three divisions, SP Scientific, SP Scienceware and SP Ableware.
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.
Beckman Coulter Life Sciences is unveiling a fast, low sample volume bioanalyte analyzer, the Vi-CELL MetaFLEX*, at INTERPHEX 2016. This year’s event, showcasing pharmaceutical and bioprocessing innovation, is held in the Jacob K. Javits Convention Center, New York, April 26-28 2016.
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.