FEATURED ARTICLES

  • Quantitative Measurements Of p95 Protein Expression In Tumors From Patients With Metastatic Breast Cancer Treated With Trastuzumab
    Quantitative Measurements Of p95 Protein Expression In Tumors From Patients With Metastatic Breast Cancer Treated With Trastuzumab

    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).

  • Clinical And Analytical Performance Of Non-Small Cell Lung Cancer Biomarkers
    Clinical And Analytical Performance Of Non-Small Cell Lung Cancer Biomarkers

    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.

  • Flow Cytometry For The Pharmaceutical Industry In A Central Lab – Clinical Trials Setting: Specific Challenges And Solutions
    Flow Cytometry For The Pharmaceutical Industry In A Central Lab – Clinical Trials Setting: Specific Challenges And Solutions

    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.

  • Analysis Of Gene Expression Profiling Of Formalin-Fixed And Paraffin-Embedded Tumor Tissues From Preclinical Models And Patient Samples In Early Phase Clinical Trials
    Analysis Of Gene Expression Profiling Of Formalin-Fixed And Paraffin-Embedded Tumor Tissues From Preclinical Models And Patient Samples In Early Phase Clinical Trials

    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.

  • Acquisition Expands Phase I Capabilities
    Acquisition Expands Phase I Capabilities

    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. 

  • Innovative Big Data Research With Big Recognition
    Innovative Big Data Research With Big Recognition

    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

More featured articles...

CLINICAL TRIALS WHITE PAPERS & CASE STUDIES

  • Integrating Electronic Systems In The Clinical Trial Process
    Integrating Electronic Systems In The Clinical Trial Process

    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

  • Expediting Companion Diagnostic Development Through Collaboration
    Expediting Companion Diagnostic Development Through Collaboration

    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.

  • Over $1.3M In Cost Savings For Phase III Clinical Trial
    Over $1.3M In Cost Savings For Phase III Clinical Trial

    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. 

  • Harvard Clinical Research Institute (HCRI) Realizes Efficiencies And Savings On Clinical Trials With BioClinica® OnPoint CTMS
    Harvard Clinical Research Institute (HCRI) Realizes Efficiencies And Savings On Clinical Trials With BioClinica® OnPoint CTMS

    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.

  • Applications For Circulating Tumor Cells To Support Clinical Trials In Asia
    Applications For Circulating Tumor Cells To Support Clinical Trials In Asia

    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

  • Managing The Complete Drug Development Program With The Right eClinical Partner

    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.

More white papers and case studies...

VIDEOS

More videos...

NEWS

  • Air Liquide Announces the Acquisition PDP Couriers

    CRYO International, an Air Liquide group subsidiary specializing in temperature-controlled1 logistics solutions, has just acquired PDP Couriers, a major player in the customized transport of high value- added products for the pharmaceutical and biotechnology industries.

  • Tobira Therapeutics Completes Patient Recruitment For ORION Phase 2a Study

    Tobira Therapeutics, Inc. (NASDAQ: TBRA), a biopharmaceutical company developing novel treatments for non-alcoholic steatohepatitis (NASH) and other serious immuno-inflammatory and fibrotic diseases, announced that it has completed recruitment for the Phase 2a ORION study.

  • PDS Biotechnology Signs Agreement With National Cancer Institute

    PDS Biotechnology (PDS), a clinical-stage biopharmaceutical company focused on developing a pipeline of simpler, safer and more effective cancer immunotherapies based on its novel Versamune® platform, today announced that the Company has signed a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), an Institute of the U.S. National Institutes of Health. 

  • Sartorius Stedim Offers New Crossflow Filtration System For Process Development

    Sartorius Stedim Biotech (SSB), an international leading supplier for the biopharmaceutical industry, announces the launch of SARTOFLOW Smart, the smart and easy benchtop crossflow system for optimized ultra- and diafiltration applications.

  • Sangamo Announces FDA Clearance Of Investigational New Drug Application

    Sangamo BioSciences, Inc. (NASDAQ: SGMO), the leader in therapeutic genome editing, announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for SB-318, a single treatment strategy intended to provide a life-long therapy for Mucopolysaccharidosis Type I (MPS I).

  • Marken The Preferred Partner To Fight Zika Virus

    Marken announced recently they are working with key pharma partners in the race to find a vaccine and treatment for the Zika virus, declared as a public health emergency by the World Health Organization (WHO) earlier this week.

  • Ratan Tata Invests In Invictus Oncology

    Invictus Oncology Private Limited, an innovation-driven oncology company developing next generation cancer therapeutics that are more effective and less toxic, today announced that chairman emeritus of Tata Sons Limited, Mr Ratan N. Tata, has invested in the company as part of the first close of Invictus's Series A financing round, joining existing investors Navam Capital and Aarin Capital.

  • HemaFlo Announces Issuance of Key Patent for NephroFlow

    HemaFlo Therapeutics, Inc. announced today that the United States Patent and Trademark Office (USPTO) has issued US Patent Number 9,119,880 covering the use of NephroFlow to treat acute kidney injury (AKI).

  • Ametek Announces Two Acquisitions

    Brookfield Engineering Broadens AMETEK’s Laboratory Instrumentation Platform ESP/SurgeX Expands AMETEK’s Power Protection Platform

  • ATCC Supporting Zika Virus Research

    ATCC, the premier global biological materials resource and standards organization, is poised to assist the medical and life science researchers that are working to address the evolving concerns around Zika Virus infection.

  • Amarantus Requests Rare Pediatric Disease Designation From FDA

    Amarantus BioScience Holdings, Inc. (OTCQB: AMBS), a biotechnology company focused on developing products for Regenerative Medicine, Neurology and Orphan Diseases, announced that it has requested Rare Pediatric Disease Designation (RPDD) from the US Food and Drug Administration (FDA) for treating retinitis pigmentosa (RP) with MANF.

  • Biosimilars Forum Issues Statement Regarding House Energy & Commerce, Subcommittee on Health Biosimilars Hearing, Launch of New Biosimilars Education Initiative

    The Biosimilars Forum – the nonprofit organization solely dedicated to expanding patient access to biosimilars in the United States – issued the following statement about the Biosimilars hearing before the House Energy and Commerce, Subcommittee on Health and the launch of a new biosimilars education initiative.

  • Beike Biotechnology To Supply 11 Hospitals With Cell Therapy

    Beike Biotechnology, the Shenzhen local government, and various medical institutions attended a ceremony in late 2015 to mark their successful combined efforts to provide integrative, personalized cell therapy in 2016.

  • Phase 3 Study Of BLINCYTO Met Primary Endpoint Of Increased Survival

    Amgen (NASDAQ: AMGN) today announced that the results of a prespecified interim analysis showed that the primary endpoint of improved overall survival was met in the Phase 3 TOWER study.

  • Amgen Announces Positive Results From Phase 3 GAUSS-3 Trial Of Repatha

    Amgen (NASDAQ: AMGN) today announced that the Phase 3 GAUSS-3 (Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3) trial evaluating Repatha® (evolocumab) in patients with high cholesterol who cannot tolerate statins met its co-primary endpoints: mean percent reductions from baseline in low-density lipoprotein cholesterol (LDL-C) at weeks 22 and 24, and the percent reduction from baseline in LDL-C at week 24.

More news...