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. 

  • Collaboration Seeks To Simplify Investigator Engagement
    Collaboration Seeks To Simplify Investigator Engagement

    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.

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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. 

  • 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.

  • Compliance Cloud - A Life Science Platform
    Compliance Cloud - A Life Science Platform

    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.

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VIDEOS

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NEWS

  • GE Healthcare’s FlexFactory To Power Dr. Reddy’s Biosimilar Expansion Plans

    GE Healthcare recently announced that Dr. Reddy’s Laboratories Limited will install India’s first-ever FlexFactory, a single-use manufacturing platform to expand the biologics production capacity at its facility in Hyderabad, India.

  • Sartorius Stedim Biotech Partners With Nova Biomedical

    Sartorius Stedim Biotech (SSB), a leading international supplier to the biopharmaceutical industry, recently announced an agreement with Nova Biomedical (Nova), a well-known US manufacturer of cell culture analyzers, to integrate their BioProfile FLEX2 into the ambr multi-parallel bioreactor systems for automated, at-line cell culture analytics.

  • Vivaldi Biosciences Appoints Manfred Reiter, PHD As Senior Vice President, Manufacturing

    Vivaldi Biosciences Inc., a clinical-stage biotechnology company developing genetically attenuated live influenza vaccines for seasonal and pandemic influenza, recently announced the appointment of Manfred Reiter, PhD as Senior Vice President, Manufacturing. Dr. Reiter has responsibility for Vero cell-based production of Vivaldi’s deltaFLU live attenuated influenza vaccines (LAIVs), including process optimization, scale-up, and manufacture in compliance with global quality standards.

  • MilliporeSigma's CHOZN Expression System Selected By SystImmune

    MilliporeSigma, recently announced that its CHOZN expression system will be used by SystImmune, a Seattle-based biotechnology company, for commercial development of a bi-specific antibody therapeutic.

  • MilliporeSigma Launches Industry's First Off-The-Shelf Cell Culture Media For Perfusion Processes

    MilliporeSigma, recently took a significant step toward increasing manufacturing flexibility and enabling higher productivity with the launch of the EX-CELL Advanced HD Perfusion Medium. This first off-the-shelf, high-density cell culture media supports perfusion processes and facilitates high productivity at low perfusion rates, increasing production yield and speed to clinic.

  • Outsourced Pharma Announces San Diego Forum Agenda Following Successful Boston Event

    Outsourced Pharma announced the agenda for its San Diego event at the conclusion of its Boston conference held this past April. An Early Start on Drug Development and Manufacturing Outsourcing is scheduled for August 22-23 at the Hyatt Regency La Jolla. The complete agenda and list of panelists can be found here.

  • MilliporeSigma Collaborates With LabCentral To Foster Biotech Startups

    MilliporeSigma,announced recently that the company will sponsor the Startup Program at LabCentral, a biotechnology incubator, in Cambridge, Massachusetts.

  • Secretary Of Economic Development Of Puerto Rico Visits Sartorius

    Manuel Laboy, Secretary of Economic Development and Commerce of Puerto Rico, received first-hand information at Sartorius Goettingen headquarters about the expansion of its plant in Yauco, Puerto Rico. During a tour of Sartorius Campus, he was impressed by the high quality standards in the company’s research, development and manufacturing operations.

  • Parker domnick hunter To Manufacture Automated Bioprocessing Systems In UK

    International bioprocessing solutions provider Parker domnick hunter – a division of the Parker Hannifin corporation, the global leader in motion and control technologies - has strengthened its European operation by enhancing its manufacturing capabilities at its Birtley, UK site.

  • UK’s Innovation Agency Backs Plasticell To Produce Red Blood Cell Substitute From Pluripotent Stem Cells

    Plasticell, a developer of cell therapies including hematopoietic cell replacement therapies, recently announced it has secured Biomedical Catalyst funding of over £920,000 from Innovate UK to create a safe, effective red blood cell substitute for human clinical transfusion, in collaboration with stem cell scientists at the University of Edinburgh.

  • GE Healthcare Completes Strategic Investment In Zenith Technologies

    Zenith Technologies and GE Healthcare Life Sciences announce recently that GE has completed a strategic minority investment in Irish-owned Zenith Technologies, a leading technology company delivering manufacturing software systems and solutions for the life sciences industry.

  • Bioverativ Appoints Tim Harris Executive Vice President, Research And Development

    Bioverativ Inc., a global biotechnology company focused on the discovery, development and commercialization of innovative therapies for hemophilia and other rare blood disorders, recently announced the appointment of Tim Harris, Ph.D., DSc, as Executive Vice President of Research and Development. Dr. Harris brings more than three decades of scientific and leadership expertise to this role where he will be responsible for leading Bioverativ’s scientific direction, advancing pipeline programs and optimizing research and development operations.

  • Greenfield Manufacturing Facility Concept Design For Vaccine Manufacturer

    Concept Design for this greenfield cGMP vaccine manufacturing facility focused on using commercially proven industry technologies and approaches to challenge existing corporate criteria and reduce capital and operating costs.

  • Architectural And Engineering Services For A Fractionation Facility Expansion

    CRB, teamed with 3HPA, provided architectural and engineering services for the design of the project. CRB was responsible for process, process utility design and automation including equipment layouts, piping design, P&ID schematics and equipment specifications.

  • Facility Design Of An Inhalable Insulin Drug Manufacturing Facility

    This project was the design of a $163 million inhalable dosage manufacturing facility. CRB was the prime consultant for architectural and engineering design, from concept thru commissioning and turnover. The project included the renovation of an existing building and an additional 100,000 sq. ft. of new space. 

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