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