FEATURED ARTICLES
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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).
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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.
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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.
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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.
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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.
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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.
CLINICAL TRIALS WHITE PAPERS & CASE STUDIES
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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.
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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
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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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Like any process manufacturing organization, Arizona Chemical had amassed a huge number of documents detailing the processes and procedures central to its operations.
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NAPP Pharmaceutical Group, a leader in the field of pain control, had been using the same Documentum/QUMAS-based document management system since 2004 to manage and maintain its SOPs. Unfortunately, by 2010 the system was showing its age.
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Sanofi Pasteur MSD offers the widest range of vaccines of any company doing business in Europe today.
VIDEOS
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Early Phase Market Trends - A Global View Video2/28/2012A look at market trends in the early phase space with PRA’s Willem Jan Drijfhout, Senior VP of Early Development Services and head of PRA’s global early phase and lab operations.
NEWS
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John Witkowski Appointed President & CEO Of Solesis4/9/2024
Solesis, a leader in the custom design, development, and manufacturing of textile- and polymer-based healthcare solutions for the medical device and biopharmaceutical industries, is pleased to announce that John Witkowski has been appointed as the new President & CEO, effective immediately. In this role, Witkowski is responsible for developing the strategic priorities for Solesis and executing world-class business operations to support customers and drive long-term, sustainable growth.
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Honeywell Announces Upcoming Webinar and Conference Schedule3/19/2024
Visit us at Booth 17 to learn more about our unified manufacturing operations platform and how it accelerates innovation and increases efficiency, quality, and compliance.
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Pluri Selected As CDMO By Remedy Cell For Cell-Derived Cell-Free Drug Manufacturing3/14/2024
Pluri Inc. (Nasdaq:PLUR) (TASE:PLUR) ("Pluri" or "the Company"), a leading biotechnology company that transforms cells into solutions, today announced that its CDMO division (PluriCDMO™) has signed a manufacturing agreement with Remedy Cell Ltd, an innovative, biopharmaceutical company developing stem cell-derived, cell-free therapeutics for complex fibrotic conditions.
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List Biotherapeutics And Sacco System Announce Lead Share Agreement3/13/2024
List Biotherapeutics, Inc. (List Bio) and Sacco System Australia Pty Ltd (Sacco) today announced a lead share agreement to introduce and mutually recommend each other’s microbial development and manufacturing services to prospective customers if one party discovers a project that is better suited to the other party’s capability or capacity. No intellectual property will be exchanged between the companies.
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CDMO Resilience Announces Modular Facility Design Investment At RTP Location2/29/2024
National Resilience, Inc. (Resilience), a technology-focused biomanufacturing company dedicated to broadening access to complex medicines, announced the expansion of the company’s clinical and commercial drug product manufacturing capabilities across its network, which includes a biomanufacturing plant in Durham the company acquired in 2021.
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Simtra BioPharma Solutions Announces $250+M Investment To Expand Sterile Fill/Finish Manufacturing Site In Bloomington, Indiana2/28/2024
Simtra BioPharma Solutions (Simtra), a premier injectable contract development and manufacturing organization (CDMO), today announced a $250+ million expansion of its sterile fill/finish manufacturing campus in Bloomington, Indiana.
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5 Biologics Conferences You Won’t Want To Miss In 20242/23/2024
This list of recommended biologics conferences for 2024 can help guide professionals in the biologics industry to the most relevant and influential conferences for their professional goals.
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AES Clean Technology Appoints New Vice President Of Engineering2/22/2024
AES Clean Technology, a leading provider of high-performance modular cleanroom facilities, has appointed Chris Barbieri as Vice President of Engineering.
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WuXi Advanced Therapies Receives FDA Approval To Manufacture Iovance’s AMTAGVI™ (lifileucel) For Advanced Melanoma2/20/2024
WuXi Advanced Therapies (WuXi ATU), a wholly owned subsidiary of WuXi AppTec, today announced that the U.S. Food and Drug Administration (FDA) has approved its Philadelphia site to begin the analytical testing and manufacturing of AMTAGVI for Iovance, which received FDA accelerated approval of its Biologics License Application (BLA) on February 16, 2024.
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Eppendorf Innovation Company Strengthens Access To U.S. Start-Up Scene2/14/2024
The Eppendorf Innovation Company (EpIC) – a division of Eppendorf SE – continues to expand its international network. Through a targeted investment in Osage University Partners (OUP), EpIC will learn about investment opportunities in some of the most cutting-edge startups transitioning their academic discoveries into the commercial world through OUP’s network of university spinouts.
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INCOG BioPharma Services Adds 100 Million Units Of Syringe/Cartridge Capacity2/14/2024
INCOG BioPharma Services, a US-based contract development and manufacturing organization (CDMO) specializing in sterile injectables, is adding a high-speed OPTIMA filling line that will provide an additional 100 million units of syringe and cartridge filling capacity.
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Analytical Platform LabZient™, Expedites The Path To IND For Antibodies2/7/2024
Abzena, the leading end-to-end integrated CDMO for complex biologics and bioconjugates, has announced the launch of its new analytical platform, LabZient™. The standardized and automated platform streamlines the assessment and validation of large molecules, which significantly reduces drug development timelines and resource costs.
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Waisman Biomanufacturing & RoosterBio Announce Collaboration For GMP Manufacturing of Cell & Exosome Therapies2/6/2024
Waisman Biomanufacturing, a leading contract development and manufacturing organization (CDMO) which is strategically part of the University of Wisconsin Madison, announced today a strategic partnership with RoosterBio, Inc., a leading provider of human mesenchymal stem/stromal cells (MSCs), highly engineered media solutions, and bioprocess development services.
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Purolite And Repligen Announce The Commercial Launch Of A Novel CH1 Affinity Resin For The Purification Of Specialized mAbs2/6/2024
Purolite, an Ecolab company and leading manufacturer of synthetic and agarose-based bioprocessing resins, and Repligen Corporation (NASDAQ:RGEN), a life sciences company focused on bioprocessing technology leadership, today announced the commercial launch of Praesto® CH1, a new 70μm (micron) agarose-based affinity resin designed to purify specialized mAbs such as bispecifics and recombinant antibody fragments.
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Novo Holdings To Acquire CDMO Catalent Pharma Solutions For $16.5 Billion2/5/2024
Catalent, Inc. (NYSE: CTLT), a leader in enabling the development and supply of better treatments for patients worldwide, and Novo Holdings, a holding and investment company that is responsible for managing the assets and wealth of the Novo Nordisk Foundation, today announced that they have entered into a merger agreement under which Novo Holdings will acquire Catalent in an all-cash transaction that values Catalent at $16.5 billion on an enterprise value basis.