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Life Sciences

  • Implementation Strategies and Challenges for SUT at Commercial scale
    Implementation Strategies and Challenges for SUT at Commercial scale Adam Goldstein, Roche/Genentech & Jacob McNeil, Thermo Fisher Scientific Recorded: May 17 2018 73 mins
    For over 10 years, single-use technology (SUT) has been a growing buzzword in the biomanufacturing industry for its advantages in speed, flexibility, and cost. A recent 2015 BioPlan Associates, Inc. industry survey of biopharmaceutical manufacturers, contract manufacturing organizations, industry vendors, and direct material suppliers identified the ‘Top Concerns’ for why biopharmaceutical manufacturers are choosing to increase their use of disposables. The top three reasons were (i) Eliminates cleaning requirements, (ii) Reduces time to get facility up and running, and (iii) Reduces capital investment in facility & equipment. These reasons are no surprise, as elimination of steam in place (SIP) and clean in place (CIP) allows for a reduction of required piping and controls, which in turn significantly decreases capital costs, design engineering, and field installation times.

    While these are some of SUT’s core drivers, their validity among that of many additional drivers have already been analyzed and proven at length. Perhaps the more interesting reasons for the continued focus on SUT are the growing industry trends towards modular flexible facilities and lean manufacturing.

    In order to adapt towards more targeted therapies for niche populations, biopharmaceutical manufacturers will need to produce multiple high potency products, with greater changeovers, and at smaller batch sizes.4 By significantly reducing capital outlay, disposable modular facilities allow for both product and geographical manufacturing flexibility. Production is thus enabled at a lowered associated risk wherever assets are best utilized and production costs minimized, such as in emergent markets.
  • 3D Imaging of 3D Cell Culture Models
    3D Imaging of 3D Cell Culture Models Tom Villani, Ph.D., Ann Rossi, Ph.D. Recorded: May 17 2018 60 mins
    One of the obstacles to working with 3D cell cultures is how to extract meaningful data from them. To address this problem, Visikol has developed their Visikol® HISTO-M™ tissue clearing reagent that allows for complete 3D cell culture characterization using confocal imaging or a 3-fold increase in cells detected using wide-field microscopy. This tissue clearing approach has been developed to be rapid and compatible with multi-well plates so that it can be conducted using automated pipetting robots and high content confocal imaging systems.
    By attending this webinar you will learn about:
    • Methods to enable 3D cell culture
    • Ways to enhance imaging and characterization of 3D spheroids

    Presenter Bios:
    Dr. Tom Villani is the CSO and Co-founder of Visikol Inc and is responsible for the companies scientific strategy. Since launching Visikol with Co-Founders Dr. Michael Johnson and Nick Crider, Dr. Villani has led the development of the Visikol HISTO tissue clearing technology for three-dimensional tissue imaging as well as a suite of digital pathology tools. Visikol has leveraged these technologies in its 3Screen service offering where the company is focused on transforming tissues into actionable insights as a service for primarily pharmaceutical companies.

    Dr. Ann Rossi graduated from the University of Rochester School of Medicine and Dentistry with a Ph.D. in Pharmacology and received postdoctoral training at the University of Chicago. Prior to joining Corning, Ann worked as a Senior Scientist at ARMGO Pharma, Inc., a small private pharmaceutical company, contributing her expertise in calcium signaling toward developing new assays for the company’s screening cascade. Ann is new to Corning Life Sciences as the Applications Lab Manager in Kennebunk, Maine and is drawing on her strong academic and industry research experience to direct the activities of the applications group.
  • Knockdown, Knockout, Validate: Lentivirus delivers payload in vitro and in vivo
    Knockdown, Knockout, Validate: Lentivirus delivers payload in vitro and in vivo Christy Hoffmann Recorded: May 16 2018 35 mins
    Whether you are looking to knockout, knockdown, or overexpress genes, lentiviral transduction is the superior mechanism for delivering genetic cargo into hard to transfect cells and in vivo systems. Lentivirus is a perfect tool for screening applications since the delivered genetic material is constitutively expressed by the cells long-term. We will discuss the flexibility of our expert manufacturing group and present examples of applications suitable with lentivirus.

    During this webinar, we dispel the preconceived misconception that lentivirus is risky or cumbersome to use. As a trusted lentiviral manufacturer, we will share our best practices for handling lentivirus and the simple steps that set you up for success.
  • Emerging biomarkers for the diagnosis of cardiac pathologies
    Emerging biomarkers for the diagnosis of cardiac pathologies Rich Triglia Recorded: May 15 2018 31 mins
    According to the World Health Organization (WHO) cardiovascular diseases (CVD’s) are the leading cause of death accounting for more than 17.3M deaths globally. Modern cardiac diagnostics tests and monitoring techniques are providing ever increasing insight into the health of the human heart. In this presentation we examine some of the new and emerging cardiac biomarkers that could complement existing diagnostic and prognostic methods and have the potential to revolutionize our current understanding of cardiac health.
  • End User Perspective on Setting in-Process in Endotoxin Limits
    End User Perspective on Setting in-Process in Endotoxin Limits Dr Friedrich von Wintzingerode, Roche/Genentech Recorded: May 15 2018 41 mins
    There is a lack of detailed guidance for setting endotoxin in process limits (alert levels and action limits) for biologics. This webinar will present a concept for setting in-process  limits and a case study which allows to understand the underlying rationales and challenges. 
  • Using education and awareness to drive positive change for patients
    Using education and awareness to drive positive change for patients Gwen Nichols (LLS), Kathleen Weis (AAMDSIF), Brian Tomlinson (CancerCare), Gary Nolan (Know AML), Jenny Kite (Astellas) Recorded: May 3 2018 63 mins
    Change Together will be presenting a live webinar with leading figures from the patient advocacy community, who will debate how we can drive positive change for patients through improved education and awareness. This will be helpful for all advocates, as we hear and learn from our expert panel how their organizations are bringing about change.
    The panel and the topics they will be covering are as follows.
    • Dr. Gwen Nichols, Chief Medical Officer of the Leukemia & Lymphoma Society on coordinating the group’s groundbreaking Beat AML Master Trial, which is taking the latest research from the lab to the clinic.
    • Kathleen Weis, Chief Executive Officer of the Aplastic Anemia and MDS International Foundation, on the changing treatment landscape, which is bringing new hope to patients, and how her group is supporting the AML community.
    • Representatives from Know AML, the global AML awareness initiative established in 2017 – Gary Nolan from the Know AML secretariat and Brian Tomlinson, patient advocate committee member and Chief Program Officer at CancerCare – explaining how the project started and the role that patient advocates play in it.
  • The Power of Scopus Data
    The Power of Scopus Data Holly J. Falk-Krzesinski, PhD, Vice President, Research Intelligence Global Strategic Networks, Elsevier Recorded: May 3 2018 60 mins
    Scopus is considered the Gold Standard for research assessment and evaluation purposes by 4,500+ universities and 150+ leading research organizations worldwide. Join as us we discuss the richness of Scopus data and the value it provides for data-driven insight.
  • Identifying Drug-Drug Interactions using PharmaPendium
    Identifying Drug-Drug Interactions using PharmaPendium Sherry Winter, PhD Recorded: May 2 2018 57 mins
    * Note the change of date*
    Learn how to identify and assess drug-drug interactions with extracted pharmacokinetic, metabolising enzyme & transporter data and a powerful Drug-Drug Interaction risk calculator
  • Lymphomas and Leukemias
    Lymphomas and Leukemias Jeff Gordon Recorded: Apr 27 2018 63 mins
    Leukemia and lymphoma are hematologic neoplasms that affect members of all age groups. Each year, over 140,000 people in the US are diagnosed with a hematologic malignancy of some kind. With constant advancement of treatment options, the importance of accurate diagnosis and detection of lymphomas and leukemias becomes more and more relevant to the survival of the patient, and immunohistochemistry has served as a key auxiliary test in determining these diagnoses. This presentation covers many of the basic science, facts, and statistics of hematologic malignancies, as well as the utility of immunohistochemical testing with markers such as CD20, PAX-5, CD61, CD71, Cyclin D1, and SOX-11 in the accurate diagnosis and survival rates of lymphoma and leukemia.
  • Searching for drug safety and benefit-risk evaluations
    Searching for drug safety and benefit-risk evaluations Dr. Jean-Dominique Pierret, Scientific Information Expert Recorded: Apr 25 2018 56 mins
    Scientific literature is one of the largest source of adverse event reports, making it an essential part of pharmacovigilance. Marketing authorization holders are expected to perform systematic literature searches using reference databases and local journals from countries where the medicinal product has a marketing authorization. The retrieved information needs to be collated, analyzed, and communicated at least once a week. However, several challenges are associated with this process. Large amounts of data from various sources, various regulatory requirements, building and maintaining search strategies increase the complexity of literature searches.

    In this webinar, Scientific Information Expert Dr. Jean-Dominique Pierret will give a brief overview of regulatory obligations and usefulness of literature in the drug development process. And then he will introduce how he set up literature search for pharmacovigilance: such as selecting the databases, building the strategy with a focus on early detection of safety issue and benefit/risk assessment. Finally, he will give examples of challenges that may occur during literature search for pharmacovigilance.

    About the speaker:
    Dr. Jean-Dominique Pierret is a Scientific Information Expert and he spent +20 years in the pharmaceutical industry. He is currently working for Galderma R&D. With a strong background in information sciences applied to the biomedical domain, he is involved in the management of a corporate scientific library, in competitive intelligence and in information retrieval. Jean-Dominique is in charge for years of the literature survey for pharmacovigilance.
  • HGST Ultrastar® Serv24-HA NVMe Storage Server
    HGST Ultrastar® Serv24-HA NVMe Storage Server Manfred Berger, HGST - Sr. Mgr. Business Development Platforms EMEAI Recorded: Apr 25 2018 39 mins
    In this webinar Manfred Berger introduces the latest addition to the HGST platform portfolio, the high availability Ultrastar® Serv24-HA NVMe all-flash storage server.

    Combining high performance NVMe™ SSDs and two redundant blade servers based on Intel®’s Purley architecture into one tried and tested unit, the Serv24-HA enables customers to come to market quickly with a multitude of dependable software defined storage solutions or data base servers optimized for high speed search operations, catering to a multitude of industry verticals.
  • Embase for Medical Affairs
    Embase for Medical Affairs Embase Product Manager: Dr. Iveta Petrova Recorded: Apr 19 2018 47 mins
    Medical affairs teams need quick direct access to the latest literature so they can rapidly respond to client inquiries from anywhere. Embase has unique and comprehensive journal and conference coverage, in-depth indexing that makes it easy to find answers and customizable e-mail alerts that send out regular updates to automate the retrieval of information. Embase specialized capabilities ensure not only comprehensive retrieval of relevant information, but also that it is done in an easy and fast way saving time and money.

    In this session, Elsevier's product manager Dr. Iveta Petrova will demonstrate how Embase can support daily tasks, including:

    - How to design a comprehensive EBM search in just a few steps
    - How to follow innovations in your subject field and related KOLs
    - How to make an indirect comparison between two drugs
    - How to identify opportunities for an investigator initiated trial

    About the speaker:
    Iveta Petrova holds a Ph.D. from Leiden University for research done on Wnt signaling in the nervous system. For the last three years, she is part of the Embase team. Main focus is addressing specific use cases of Medical Affairs professionals by leveraging the capabilities and peer-reviewed enhanced content of the biomedical database Embase, as well as continuous engagement with customers and market research to further improve and develop tools to support them in their daily responsibilities.
  • Generation of a landing-pad T cell line useful for T cell receptor customization
    Generation of a landing-pad T cell line useful for T cell receptor customization Stacey Ward, PhD Recorded: Apr 18 2018 49 mins
    T cell biology is integral to the study of normal immune regulation as well as cancer biology, Car-T cells, epitope specificity and antigen presentation. However, primary T cells can be difficult to propagate in culture for the length of time necessary for functional assays. In addition, primary T cells express variant T cell receptor (TCR) heterodimers that can be challenging to identify and may not be optimal for downstream studies. We sought to simplify this system using transformed T cells which can be grown in culture for extended periods of time. We engineered a floxed landing pad sequence into the safe harbor AAVS1 genetic locus using CompoZr zinc finger nucleases. Both the promoter and landing pad expression cassette are flanked by unique lox sites, allowing swapping of either the promoter and/or expression cassette as needed. We ensured that only one copy of this sequence was found within the genome to avoid any complications associated with random insertion events. We also generated a landing pad cell line null for the endogenous TCR using Cas9/CRISPR ribonucleotide complexes. Both the TCR alpha and beta loci were rendered null due to non-homologous end joining and the presence of insertions and deletions culminating in premature stop codons were genotyped using next generation sequencing. The absence of a functional TCR was validated using flow cytometry staining for surface TCR and CD3. This cell line was then used to generate a knock-in of the desired exogenous TCR heterodimer to the landing pad locus, verified using flow cytometry staining. These lines will be very useful for a multitude of studies where a researcher needs to express a gene of interest in a discrete genetic locus or wants to generate a panel of TCR expressing cell lines.
  • Generation of a landing-pad T cell line useful for T cell receptor customization
    Generation of a landing-pad T cell line useful for T cell receptor customization Stacey Ward, PhD Recorded: Apr 17 2018 45 mins
    T cell biology is integral to the study of normal immune regulation as well as cancer biology, Car-T cells, epitope specificity and antigen presentation. However, primary T cells can be difficult to propagate in culture for the length of time necessary for functional assays. In addition, primary T cells express variant T cell receptor (TCR) heterodimers that can be challenging to identify and may not be optimal for downstream studies. We sought to simplify this system using transformed T cells which can be grown in culture for extended periods of time. We engineered a floxed landing pad sequence into the safe harbor AAVS1 genetic locus using CompoZr zinc finger nucleases. Both the promoter and landing pad expression cassette are flanked by unique lox sites, allowing swapping of either the promoter and/or expression cassette as needed. We ensured that only one copy of this sequence was found within the genome to avoid any complications associated with random insertion events. We also generated a landing pad cell line null for the endogenous TCR using Cas9/CRISPR ribonucleotide complexes. Both the TCR alpha and beta loci were rendered null due to non-homologous end joining and the presence of insertions and deletions culminating in premature stop codons were genotyped using next generation sequencing. The absence of a functional TCR was validated using flow cytometry staining for surface TCR and CD3. This cell line was then used to generate a knock-in of the desired exogenous TCR heterodimer to the landing pad locus, verified using flow cytometry staining. These lines will be very useful for a multitude of studies where a researcher needs to express a gene of interest in a discrete genetic locus or wants to generate a panel of TCR expressing cell lines.
  • Introduction to the Education Network - EduRN
    Introduction to the Education Network - EduRN Shirley Decker-Lucke Recorded: Apr 11 2018 33 mins
    You are invited to join the Education Research Network (EduRN) – the education community’s platform for sharing early-stage research, including preprints, working papers, and data prior to publication. EduRN is powered by SSRN, the leading working paper repository and preprint server since 1994.
  • In Vitro Transporter Models for ADME-Tox Research
    In Vitro Transporter Models for ADME-Tox Research Joseph Zolnerciks, Ph.D. Recorded: Apr 10 2018 62 mins
    Drug transporters play a pivotal role in mediating the disposition of many drugs. As a result, researchers in the fields of drug discovery and development have shown a steadily rising level of interest in transporter-drug interactions, transporter-mediated drug-drug interactions, and the role of transporters in determining drug toxicity. For the past 18 years, SOLVO Biotechnology has pioneered the development and commercialization of in vitro assay systems to enable the study of drug transporters. One such system commonly employed for this purpose are inside-out membrane vesicles. Generated from cells over-expressing a transporter of interest, these membranes can be used to examine members of the ATP-Binding Cassette (ABC) transporter family, which includes P-glycoprotein (P-gp; MDR1), bile salt export pump (BSEP), breast cancer resistance protein (BCRP), and the multidrug resistance-associated proteins (MRPs). A versatile assay system, transporter-drug interactions can be monitored indirectly using ATPase measurements, or by directly measuring substrate transport using fluorescent or radiolabeled compounds, or by LC-MS detection. The advantages and limitations of this assay system will be discussed, and we will detail how inhibition of transporters involved in bile acid homeostasis is being used for predictive drug-induced liver injury (DILI) studies. In addition, we will examine the role that the lipid composition within the membrane plays on transporter activity within the context of the latest range of SOLVO mammalian membrane vesicles products for transporter research.
  • Getting Started with SAS Certification
    Getting Started with SAS Certification Becky Gray (SAS), Terry Barham (SAS), Matt Scicchitano (SAS), Mark Stevens (SAS) Recorded: Apr 10 2018 52 mins
    SAS Global Certification experts present an introduction to SAS certification topics to help you reach your SAS Certification goals. After watching, learn more at: sas.com/certify
  • The Laboratory’s Role in the National Healthcare Safety Network
    The Laboratory’s Role in the National Healthcare Safety Network Robert L. Sautter, Ph.D., HCLD (ABB), CC Recorded: Apr 9 2018 58 mins
    In this webinar, Dr. Sautter will discuss the important collaboration efforts between the government and healthcare facilities to stop prevalent and dangerous hospital-acquired infections. After the webinar, you will be able to:

    • Explain how the laboratory and the NHSN can work together to lower infection rates in hospitals
    • Learn how to lower rates of infections, such as blood culture contamination, MRSA and C. difficile
    • Identify how pre-analytic culture collection can affect the results of clean catch and catheter-related infections
    • Discuss how laboratories can work together with the NHSN, an infection surveillance program created by the CDC to eliminate HAIs, to identify problem areas and measure the progress of prevention initiatives

    P.A.C.E. credit* is available for your participation at http://qmark.beckmancoulter.com/r/325Safety.html

    Presenter: Dr. Sautter is a teacher, lecturer and industry consultant. He earned his B.S. and M.S. degrees from Eastern Michigan University in the areas of biology and molecular biology, respectively, and his Ph.D., from Wayne State University, in Detroit, Mich., in microbiology. During his career, he held positions as a medical technologist, director of microbiology and medical director for a number of laboratories, before becoming an esteemed consultant for a variety of industry leaders in the area of microbiology.

    *Beckman Coulter Inc. is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. These credits are recognized by the State of California. Most programs also provide State of Florida credits (with valid license number). At this time, we cannot issue continuing education credits for those who provide healthcare (or work for an institution that provides healthcare) in Massachusetts or Vermont.
  • Filtration in Dissolution Testing: Improving Throughput and Reducing Variability
    Filtration in Dissolution Testing: Improving Throughput and Reducing Variability Vivek Joshi, Ph.D. Recorded: Apr 2 2018 53 mins
    In vitro dissolution testing is used to characterize drug compounds throughout their development. In early drug development it is used to support the choice of a particular formulation. During drug production it is a critical component of the quality control process and is used to assess the changes in manufacturing processes or formulation. In order for dissolution results to be meaningful at each stage, the test and the process need to be reliable, consistent, predictive and accurate.

    Filtration as the only sample preparation step plays an important role in the dissolution process, yet this step is often taken for granted. The choice of frits or syringe filters is often based on experience with previous formulations or availability in the lab. Selecting the wrong filter can result in inadequate filtration, low analyte recovery, solvent incompatibility or extractables that reduce accuracy and reproducibility. The wrong pore size or device can result in clogging that can adversely affect throughput and sample processing.

    This seminar describes different membrane characteristics and provides guidance in selecting the right filtration devices for sample preparation following in vitro dissolution. Problems that result from using the wrong filter are presented along with steps one can take to solve each problem. Filter characteristics that affect drug recovery and downstream analysis, such as non-specific binding and extractable levels, are presented. Steps one can take to optimize throughput and reduce downtime are addressed including a discussion on membrane properties and guidance on the use of multi-layer and automation compatible filters. Recommendations are presented for choosing the right sample preparation device that will help improve throughput, reduce sample processing time and enhance test accuracy and reproducibility.
  • Basics of Immunohistochemistry
    Basics of Immunohistochemistry Jeff Gordon, OEM Sales, Merck KGaA, Darmstadt, Germany Recorded: Mar 30 2018 72 mins
    Immunohistochemistry is the technology of detecting cellular and infectious agent proteins in tissue with antibodies and then labeling those antibodies with a chromogen so that they are detectable under a light microscope. This science has become a standard method in diagnostics for classifying neoplasms and detecting infectious microbes. The science and technique behind immunohistochemistry are discussed in this webinar.
  • How To Publish in High Impact Journals
    How To Publish in High Impact Journals Cell Press Editor-in-Chief Robert Eagling and Dr. Rebecca Cooney, North American Executive Editor of The Lancet Recorded: Mar 27 2018 76 mins
    Join Dr. Robert Eagling, Cell Press Editor-in-Chief of Chem, and Dr. Rebecca Cooney, North American Executive Editor of The Lancet, to learn about techniques and strategies for authoring in high-impact journals. Dr. Eagling will present information on authoring with Cell Press, which includes such titles as Cell, Neuron, Chem, Immunity, Joule, and Cancer Cell. In addition, Dr. Cooney will represent publishing in The Lancet premium medical journal portfolio.


    The editors will present their experience working with researchers and authors throughout the research publishing cycle, how to develop papers for premium publications, and the opportunity to broadly disseminate findings. You won’t want to miss this engaging webinar and how it can benefit your research process and impact.
  • Leverage PK data in PharmaPendium to inform drug development strategies
    Leverage PK data in PharmaPendium to inform drug development strategies Sherry Winter, PhD Recorded: Mar 27 2018 48 mins
    Pharmacokinetic information from FDA and EMA regulatory documents informs translational and clinical development decisions and may lead to more successful drug development and regulatory approval strategies.

    In this webinar, we will discuss how to leverage comparative pharmacokinetic information from FDA and EMA Drug Approval documents to make better-informed decisions on which drugs have the most potential to succeed in clinical development.
  • Accelerating Research Innovation with Next-Gen Storage Infrastructure
    Accelerating Research Innovation with Next-Gen Storage Infrastructure Vas Vasiliadis, Chief Customer Officer, Globus Recorded: Mar 22 2018 41 mins
    For research data to be truly useful, it must be easy to access, share and manage without requiring expensive, custom infrastructure. What organizations need is turnkey storage that won't break the bank, with a unified interface for fast, reliable data transfer and sharing.

    This webinar introduces Globus for ActiveScale, a cost-effective solution for on-premise object storage that’s simple to deploy and use. With Globus for ActiveScale, researchers have access to advanced capabilities for managing data across a broad range of systems, while administrators gain a cost-effective, scalable, and durable solution they can deploy quickly to help their researchers innovate faster.

    In this webinar, attendees will:
    - Learn how to deploy and use Globus for ActiveScale
    - See a product demonstration
    - Engage in a live Q&A session with the Globus Chief Customer Officer
  • CRISPR: Updates and trends in opposition and appeal practice before the EPO
    CRISPR: Updates and trends in opposition and appeal practice before the EPO Catherine Coombes (HGF), Dr. Chris Moore (HGF), Peter Scott (WIPR) Recorded: Mar 21 2018 42 mins
    This webinar will be on opposition and appeals practice before the EPO. We’ll be discussing the streamlining of the opposition procedure by the EPO, the changes that we are seeing as a result and will be providing practical tips in view of these changes. The talk will also draw on recent case law.
  • Promoting Open Access Scholarship - SSRN & Bepress Digital Commons
    Promoting Open Access Scholarship - SSRN & Bepress Digital Commons Gregg Gordon Recorded: Mar 21 2018 34 mins
    Gregg Gordon, managing director at SSRN, answering questions for our RPS community about the synergies of SSRN and Bepress.
  • Precision genome editing in macrophage and CD8+ human primary T cells for immuno
    Precision genome editing in macrophage and CD8+ human primary T cells for immuno Laura Daley, PhD May 22 2018 1:00 pm UTC 75 mins
    Innate immune cells play a critical role in cell-mediated immunity and have the potential to serve as cell-based therapies to treat a broad spectrum of immune diseases such as cancer and autoimmune disorders. Modified immune cells, such as genetically engineered CAR-T cells, have proven to be critical in developing new cell-based therapies for these diseases. However, immune cell biology creates challenges during the gene-editing process that lead to hyper-regulated RNA and DNA sensing pathways and enhanced cell death upon introduction of exogenous ribonucleotides. Further, engineering in primary immune cells is often restricted due to their limited expansion capacity. Genetic engineering in immune cells has traditionally relied on random integration of gene-editing components using viral delivery systems. In contrast, genome editing mediated by nucleases, such as CRISPR/Cas9-single guide RNPs, provide a platform for precision editing, and alleviate the potential side effects caused by randomly integrated viral DNA. While RNP gene editing in immune cells is just beginning to be considered by the immune-therapeutics field, our recent advances demonstrate that this approach can be used to create targeted modifications in two key cell types, the macrophage and the CD8+ primary T-cell. In an effort to circumvent challenges with the finite lifespan of primary T-cells, we targeted genes to edit that rendered this cell type “pseudo-immortalized”, allowing additional passages for further downstream genome editing and propagation. In addition, we demonstrated that precision editing can be used to introduce disease relevant SNPs into the macrophage genome, which resist introduction of exogenous ribonucleotides due to the induction of apoptotic pathways. Advances such as these overcome many of the obstacles currently faced with immune cell editing and offer improved gene stability and expression in immune cells and will transform the Immuno-Oncology and Gene Therapy fields.
  • Reducing efficacy-related failures with PharmaPendium
    Reducing efficacy-related failures with PharmaPendium Sherry Winter, PhD May 22 2018 2:00 pm UTC 60 mins
    Join us for this 45-minute webinar that will include in-depth information and demonstrations of how to leverage the comparative data in PharmaPendium to reduce the risk of late-stage failures. With a focus on efficacy, we will discuss how PharmaPendium enables you to:

    •find efficacy weaknesses early,
    •identify the most appropriate preclinical models,
    •improve success rates of Phase I and II clinical trial designs by optimising selection of sample size,
    •primary/secondary endpoint and study design and
    •prepare for more effective regulatory reviews
  • Comparison of Hemoglobin A1c Test Methods in the Clinical Lab
    Comparison of Hemoglobin A1c Test Methods in the Clinical Lab Brooke Medaugh May 22 2018 3:00 pm UTC 30 mins
    Clinical laboratories must provide precise and accurate results while managing increasing test volumes and shrinking reimbursement rates. The importance of HbA1c testing to patient monitoring in diabetes mellitus is well known. However because of the multiple commercially available methodologies, selecting the method that is best for your lab can be a challenge. This webinar will address the current state of HbA1c testing in the clinical laboratory, considerations for each test methodology, and provide a solution for integrating HbA1c testing into existing labs.

    Join this webinar to learn:

    1. What are the common methods of HbA1c detection in use today?
    2. What are the advantages and disadvantages of each?
    3. How do different methods compare?
    4. A potential solution for integrating HbA1c testing into your existing lab workflow.
  • Shine a Spotlight on your Institutional Research
    Shine a Spotlight on your Institutional Research Thought Leader - Traci Grodner May 22 2018 3:00 pm UTC 45 mins
    If you are a researcher, a department dean at a prestigious university or a librarian looking for research tools to help researcher and faculty members save time and create new research faster; you won't want to miss this informative webcast. We invite you to join us on May 22 at 11:00a.m. EDT for our live webcast.

    With research influencing accreditation policies and overall student engagement, now is the time to accelerate your institution's data management plan. When it comes to managing scholarly research, there's a lot that goes into data collection, preservation, and idea sharing.

    Early-Stage Scholarly Research Gets Your Institution in the Spotlight: an introduction to early-stage scholarly research and the value of showcasing your researchers' fundamental ideas, concepts, working papers, in an open-sharing environment while increasing readership of your institution's and/or department's overall community engagement.
    You'll be pleased you tuned-in!
  • Precision genome editing in macrophage and CD8+ human primary T cells for immuno
    Precision genome editing in macrophage and CD8+ human primary T cells for immuno Laura Daley, PhD May 22 2018 5:00 pm UTC 75 mins
    Innate immune cells play a critical role in cell-mediated immunity and have the potential to serve as cell-based therapies to treat a broad spectrum of immune diseases such as cancer and autoimmune disorders. Modified immune cells, such as genetically engineered CAR-T cells, have proven to be critical in developing new cell-based therapies for these diseases. However, immune cell biology creates challenges during the gene-editing process that lead to hyper-regulated RNA and DNA sensing pathways and enhanced cell death upon introduction of exogenous ribonucleotides. Further, engineering in primary immune cells is often restricted due to their limited expansion capacity. Genetic engineering in immune cells has traditionally relied on random integration of gene-editing components using viral delivery systems. In contrast, genome editing mediated by nucleases, such as CRISPR/Cas9-single guide RNPs, provide a platform for precision editing, and alleviate the potential side effects caused by randomly integrated viral DNA. While RNP gene editing in immune cells is just beginning to be considered by the immune-therapeutics field, our recent advances demonstrate that this approach can be used to create targeted modifications in two key cell types, the macrophage and the CD8+ primary T-cell. In an effort to circumvent challenges with the finite lifespan of primary T-cells, we targeted genes to edit that rendered this cell type “pseudo-immortalized”, allowing additional passages for further downstream genome editing and propagation. In addition, we demonstrated that precision editing can be used to introduce disease relevant SNPs into the macrophage genome, which resist introduction of exogenous ribonucleotides due to the induction of apoptotic pathways. Advances such as these overcome many of the obstacles currently faced with immune cell editing and offer improved gene stability and expression in immune cells and will transform the Immuno-Oncology and Gene Therapy fields.
  • Systematic searching with Emtree
    Systematic searching with Emtree Embase Customer Care Representative: Dr. Josephine Zimmermann May 23 2018 2:00 pm UTC 60 mins
    Embase wouldn’t be Embase without Emtree, the life science thesaurus is a hierarchically structured, controlled vocabulary, for Biomedicine and related Life Sciences, providing a consistent description for Embase indexing.

    - It offers indexers a comprehensive vocabulary to describe the content of biomedical data;
    - For database users, it facilitates comprehensive searching and high precision retrieval.

    Emtree has been used to index Embase (including Embase Classic) since 1947, and is unrivalled in its coverage of drug and medical terminology.

    In this webinar, Embase Customer Care Representative Dr. Josephine Zimmermann will walk you through:

    - How Emtree is built-up and managed
    - How we index a typical article
    - How drugs, diseases and devices are indexed in Embase

    About the speaker:
    Josephine Zimmermann holds a PhD in Molecular and Structural Chemistry and Physics from University of Grenoble for her research on the synthesis of fluorescent core-shell nanoparticles for medical imaging. Since two years, she works as Customer Care Representative at Elsevier and supports Embase as well as other Life Science Products. She is reporting the voice of the customer by collaborating closely with the Embase team, analyzing tendencies, providing feedback, and helping you with any kind of issues.
  • Custom Assay Development and Services utilizing Single Molecule Counting (SMC™)
    Custom Assay Development and Services utilizing Single Molecule Counting (SMC™) Sarah Hamren, Head of Custom Assays & Sample Testing, Merck KGaA, Darmstadt, Germany May 23 2018 2:00 pm UTC 75 mins
    Single molecule counting (SMC™) technology enables precise measurement of molecules at levels previously undetectable, down to the femtogram/mL levels, allowing researchers to identify new biomarkers, or assist in therapeutic development with an improved view of efficacy, safety & time course studies. When time and resources are limited, Merck KGaA offers a comprehensive portfolio of Custom Services supported by a scientific team with core expertise in SMC™ technology. Learn how our team will partner with you to develop a project specific to your requirements, whether that is fit-for-purpose sample testing, biomarker analysis using our current SMC™ immunoassays, or development and manufacture of an immunoassay for your novel target of interest. Learn how we work with our clients to define and tailor a customized project plan that includes milestone driven tasks, collaborative data review and progress reports. Whether your focus is to expedite your clinical research or to transfer a method to a CRO, we will show you how our services can help you accelerate programs from discovery into clinical trials.
  • Chemical patents: What can they tell us about failing drug discovery?
    Chemical patents: What can they tell us about failing drug discovery? Roshan Jumnah, Chemical IP Data Analyst at PatSnap May 23 2018 3:00 pm UTC 60 mins
    Modern drug discovery appears in many ways to be well-defined with tried-and-tested approaches to acquire success. However, some research processes often lead to very few new discoveries and sometimes stagnation of an entire research area.

    So, does it always have to be this way? One method to re-boot a failing area of research is to employ disruptive chemical methods and thinking to kick-start a process of rejuvenation.

    We invite you to our webinar with Roshan Jumnah, Chemical IP data analyst at PatSnap to explore:

    - Can we identify the reasons why drug discovery is failing?
    - Chemical disruption, its uses, and the impact of this new approach
    - The ways chemical disruption can reverse failing drug discovery in the future.
  • Custom Assay Development & Services utilizing Single Molecule Counting (SMC™)2
    Custom Assay Development & Services utilizing Single Molecule Counting (SMC™)2 Sarah Hamren, Head of Custom Assays & Sample Testing, Merck KGaA, Darmstadt, Germany May 24 2018 12:30 am UTC 75 mins
    Single molecule counting (SMC™) technology enables precise measurement of molecules at levels previously undetectable, down to the femtogram/mL levels, allowing researchers to identify new biomarkers, or assist in therapeutic development with an improved view of efficacy, safety & time course studies. When time and resources are limited, Merck KGaA offers a comprehensive portfolio of Custom Services supported by a scientific team with core expertise in SMC™ technology. Learn how our team will partner with you to develop a project specific to your requirements, whether that is fit-for-purpose sample testing, biomarker analysis using our current SMC™ immunoassays, or development and manufacture of an immunoassay for your novel target of interest. Learn how we work with our clients to define and tailor a customized project plan that includes milestone driven tasks, collaborative data review and progress reports. Whether your focus is to expedite your clinical research or to transfer a method to a CRO, we will show you how our services can help you accelerate programs from discovery into clinical trials.
  • 最新技術  Corning®可溶性マイクロキャリアの培養システムを初公開
    最新技術 Corning®可溶性マイクロキャリアの培養システムを初公開 コーニングインターナショナル株式会社 ライフサイエンス事業部 石渡孝至 May 29 2018 6:30 am UTC 30 mins
    シングルユース技術導入ポイントとなる効果的な細胞培養と分離工程の簡素化を実現するアプリケーションをMSC(間葉系幹細胞)を例に概説します。
  • Current USP Perspectives on a Rapid Sterility Test
    Current USP Perspectives on a Rapid Sterility Test Dr David Roesti, Novartis/USP and Erin Patton, Charles River May 30 2018 1:00 pm UTC 75 mins
    The current growth-based Sterility Tests with at least 14-days incubation is not suitable for short-lived products. An expert panel was formed under the USP General Chapters– Microbiology Expert Committee to provide recommendations on user requirements specifications and candidate technologies based on the URS in the area of rapid sterility tests. Based on the evaluation of the URS, the expert panel made recommendations for appropriate modern/rapid technologies available from multiple vendors. The next step would be to recruit collaborating labs to conduct the proof-of-concept studies that would support drafting of a rapid sterility test chapter in the USP.
  • Beyond the Cel-1 Assay:  Advancements in the Gene Editing Workflow
    Beyond the Cel-1 Assay: Advancements in the Gene Editing Workflow Mark A. Gerber, Jr., Ph.D. May 30 2018 3:00 pm UTC 75 mins
    Gene editing has become a firmly established technology within the discovery sciences arena. With the advent of CRISPR/Cas9 systems, the researcher's ability to find an active nuclease for nearly any region of any genome is now a reality. Even with better nucleases available, those who routinely use gene editing tools to manipulate cell lines encounter other significant challenges that pose a barrier to building the "correct" cell line model. As a well-established partner for custom cell line engineering, we at MilliporeSigma have encountered many of these challenges and have developed and/or implemented a number of methods to circumvent them. Several of these methods and the new tools available for gene editing will be discussed in this webinar, along with a summary of how they have impacted our internal cell line engineering programs.
  • Learn From The Editors - Tips For Impactful Submissions
    Learn From The Editors - Tips For Impactful Submissions Dr. Ella Hinson and Dr. Rebecca Cooney May 31 2018 1:30 pm UTC 75 mins
    Join Dr. Ella Hinson, Senior Editor with Cell Host & Microbe, and Dr. Rebecca Cooney, North American Executive Editor of The Lancet, to learn about techniques and strategies for authoring in high-impact journals. Dr. Hinson will present information on authoring with Cell Press, which includes such titles as Cell, Neuron, Chem, Immunity, Joule, and Cancer Cell. Dr. Cooney will represent publishing in the Lancet family of journals.

    The editors will present their experience working with researchers and authors throughout the research publishing cycle, how to develop papers for premium publications, and the opportunity to broadly disseminate findings.
  • Duolink PLA Technology: How to detect and quantify protein interactions
    Duolink PLA Technology: How to detect and quantify protein interactions Cláudia Emanuele, Ph.D. and Tracy Adair-Kirk, Ph.D. Jun 1 2018 4:00 pm UTC 90 mins
    Duolink® proximity ligation assay (PLA) technology allows you to visualize protein interactions with cellular localization and quantities by amplifying signals corresponding to single and post-translational protein events. With 1000x sensitivity and high specificity, this protein detection technology allows to visualize protein functions, all within a native cell. The PLA method provides:
    - Visual protein interactions – both stable and transient
    - Endogenous protein detection – no overexpression or genetic manipulation
    - High specificity – use of two antibodies/probes eliminates false positives
    - Single molecule sensitivity – rolling circle amplification makes proteins visible
    - No special equipment needed – standard immunofluorescence methods

    This webinar will review how to Work with PLA technology and provide an overview of their potential along with example applications.

    Topics covered:
    - How to work with Duolink PLA technology
    - Overview of most relevant applications using Duolink
    - Product offering to run an assay with PLA using Immunofluorescence or Flow Cytometry
  • Extractable Study Design & Data Evaluation of Polymeric Product Contact Material
    Extractable Study Design & Data Evaluation of Polymeric Product Contact Material Dr. Ping Wang, Principal Scientist, Janssen R&D & Dr Nixdorf, SGS Group Jun 5 2018 2:00 pm UTC 75 mins
    Concerns over the safety and drug product qualities due to extractables and leachables (E&L) from polymeric Product Contact Materials (PCM), especially single use systems, in the manufacturing, packaging and delivery of biologics have increased in recent years. Based on surveys and author’s experience, almost all major regulatory agencies require the E&L risk assessment of PCM for new biologics license applications (BLA). To ensure the E&L data are suitable for the assessment of intended application of the PCM, the health authorities are paying close attention to the study design, analytical assays employed, and how the extractable data being used to conduct a safety risk assessment of the materials. The key to the success is to ensure the study design and data interpretation is product and process specific. The lack of relevant E&L data from suppliers presents end-users a great challenge. Strategies of developing relevant extractable data and applying that in the toxicological evaluation will be discussed.
  • Current State and Future Prospects for Primary Human  Hepatocytes in Basic Resea
    Current State and Future Prospects for Primary Human Hepatocytes in Basic Resea Edward L. LeCluyse, Ph.D. Jun 5 2018 5:00 pm UTC 75 mins
    This presentation will focus on the current trends in hepatic culture technologies and considerations for how they are impacted by the quality and performance of the cell materials used. The current state-of-the-art in procurement, production and characterization of primary hepatocytes for in vitro research applications will be reviewed, and measures for improving the validation and qualification of hepatic cells for specific applications also will be proposed.
  • Finding the Common Road to Quality for Single Use Materials
    Finding the Common Road to Quality for Single Use Materials Dr Trishna Ray-Chaudhuri, Genentech & Dr Hélène Pora & Dr James Hathcock of Pall Biotech | Jun 6 2018 4:00 pm UTC 75 mins
    - GMP requirements touch every single use assembly used in clinical studies to commercial manufacturing.  The drug product produced in clinical studies are given to patients.

    - GMP practices followed in producing the single use assemblies will ensure that there is no risk to patients in clinical trials and future commercial products. 

    IF WE CAN”T PROVE GMP WHAT HAPPENS?

    -Single use assemblies will not be accepted by regulatory agencies and internal quality departments as an alternative to stainless steel tanks.

    -The perception will continue that there is inadequate quality controls on single use assemblies as GMP practices are not adequately followed.

    - Implementation of single will be inhibited
  • Scientific Data Explosion: Adapting IT Infrastructure So Research Can Thrive
    Scientific Data Explosion: Adapting IT Infrastructure So Research Can Thrive Adam Kraut, BioTeam - Scott Jeschonek, Avere Systems - Tim Carroll, Microsoft Azure Jun 6 2018 7:00 pm UTC 60 mins
    The advancements in scientific computing and healthcare are coming fast—from next generation sequencing onto precision medicine, “big data” and artificial intelligence. We’re embarking on a massive convergence of clinical analysis and information systems, and many are not prepared. With these advancements in technologies, comes higher demand for both compute and storage to degrees difficult to comprehend. An NCBI published study predicts that up to 40 exabytes of storage capacity will be needed by 2025 just to support the growth of sequenced human genomes.
    Adapting to this exciting shift in science will require changes in the way we think about IT infrastructure. In this webinar, BioTeam’s Adam Kraut will discuss…

    •How science changes faster than IT infrastructure, and what we can do to keep pace.
    •Converged infrastructures and their impact on research productivity.
    •How machine learning and microservices are changing the way we architect Cloud solutions.

    In addition, you’ll hear how companies are already supporting HPC workloads in hybrid cloud environments to increase analytic throughput efficiently. These workloads supply adaptability to changing research needs, integration into existing resources, and scalability to support growing demand for both compute and storage capacity.
  • More on the Unique Selectivity of Ionic Liquid GC Stationary Phases
    More on the Unique Selectivity of Ionic Liquid GC Stationary Phases Len Sidisky Jun 7 2018 3:00 pm UTC 75 mins
    Over the years, extensive evaluations of columns manufactured with ionic liquid stationary phases have occurred. Their main strength was discovered to be unique selectivity. This selectivity is made possible due to the various combinations of cations and anions that are available along with spacer groups used to prepare these germinal
    dicationic phases. Columns prepared with di- or tricationic phases have the ability to perform many of the same applications as columns made with polysiloxane polymer or polyethylene glycol stationary phases of similar polarity, but with slight elution order changes. Many times this results in increased resolution and/or shorter run times. This webinar will compare and contrast the selectivity of the ionic liquids stationary phases with
    traditional phases of similar or like selectivity’s for applications with a
    variety of different sample types from a number of industries including
    petrochemical, pharmaceutical, environmental, food and beverage and flavor and fragrance.
  • Preview of USP’s Informational Chapter , Guidelines on the Endotoxins Test
    Preview of USP’s Informational Chapter , Guidelines on the Endotoxins Test Karen Zink McCullough of MMI Associates & Kevin L. Williams of BioMérieux Jun 11 2018 2:00 pm UTC 75 mins
    Title: Preview of USP’s Informational Chapter, Guidelines on the Endotoxins Test
    Presenter: Karen Zink McCullough, MMI Associates
    The retirement of FDA’s 1987 Guideline on LAL testing left a number of gaps in the written body of knowledge
    on LAL testing. Some of these gaps include: Guidance on RSE:CSE standardization, Guidance on Training,
    Guidance on OOS test results, and Calculation of Endotoxin Limits. The proposed chapter, that will appear in the
    July/August issue of Pharmacopeial Forum, provides information and recommendations on these topics and
    more. This Webinar will provide an overview of the contents of this new informational chapter.

    Title: Regulatory Compliance of Alternative Methods
    Presenter: Kevin L. Williams, BIOMÉRIEUX
    Recombinant Horseshoe Crab Factor C (rFC) tests are endotoxin-specific alternatives to Limulus Amebocyte Lyste
    (LAL). The United States Food and Drug Administration included rFC in their Guidance for Industry in 2012 and in
    2016 the European Pharmacopoeia followed suit. Recently, the Japanese Pharmaceutical and Medical Device
    Agency published a collaborative study demonstrating equivalence between rFC and LAL. This presentation will
    provide an overview of how alternative method validation of rFC methods is conducted in accordance to USP
    chapters < 1225 > and < 85 >.
  • Fully continuous biosimilar manufacturing framework: A case study
    Fully continuous biosimilar manufacturing framework: A case study Samir Varma, Head of Manufacturing, Enzene Biosciences and Lotta Molander, Global Product Manager, GE Healthcare Jun 14 2018 8:30 am UTC 75 mins
    Biologics manufacturing has traditionally been in fed batch mode for the last 2 decades. During the early stages of biologics manufacturing, lower cell line productivity and product instability necessitated the usage of perfusion technology. As productivity increased and mabs became more stable, perfusion was replaced by fedbatch technology, as they were simpler to scale up. However, during the past 2-3 years, the perfusion technology is making a comeback due to the novel continuous chromatography technology. Connecting the perfusion bioreactor to the continuous chromatography system creates a continuous flow of drug substance and promises the following advantages

    The facility footprint for a continuous manufacturing plant would be substantially lower. Our calculations show that a 10-fold reduction in bioreactor size is possible with continuous bioprocessing. So the capacity of a 2000L Fed batch Bioreactor can be achieved by a 200L continuous bioreactor. This reduces the capex by about five fold.
    Consumption of media per amount of DS produced is the same for fedbatch and perfusion, although the cost per liter might be lower for perfusion as it could be a more diluted version of the fedbatch media ,
    Another major cost in bioprocessing is the Protein A resin. A significantly smaller Protein A column could be used in the continuous process and the utilization could be maximized by this strategy.
    As the process is more dynamic in continuous, automation and in-line analytical tools are essential for the successful implementation.
    Enzene Biosciences is on the forefront of the development of the continuous bioprocessing. We are in the processing of building a cGMP plant that would have a fully integrated continuous bioprocess. We have already complete a proof of concept studies in pilot scale (50L)
  • Manufacturing strategies for Biosimilar: A case of continuous capture
    Manufacturing strategies for Biosimilar: A case of continuous capture Solomon Alva, Biocon & Presented by Yvan Ruland, PhD, Technology Director, Asia/Pacific operations, Novasep Asia Jun 15 2018 8:30 am UTC 75 mins
    Continuous manufacturing is an emerging technology in biopharmaceutical industry. The focus of this webinar is a case-study on the benefits of continuous Protein A capture on productivity, capacity utilization and buffer consumption. The potential challenges of adopting the technology such as its integration with cell culture and low pH incubation step has been discussed. There is promise of this technology as an effective platform, and potential of additional savings when considering new generation Protein A resins and in-line concentration technologies.
  • mAb Industry in China: Biosimilars vs. Innovative Biologics
    mAb Industry in China: Biosimilars vs. Innovative Biologics Dr. Joe X Zhou is the CEO of Genor Biopharma, a VP and the R&D head of Walvax Bio Group Jun 18 2018 8:00 am UTC 45 mins
    Following patent cliffs for Erbitux, Rituxan, Sandosta_n and several big blockbusters, Herceptin, Avastin are now among the next biosimilar targets. This is creating huge potential for biosimilars, prompting innovators to shift their focus to target more emerging markets which remain untapped for many companies. In this presentation, Joe will be sharing with you his vision of the biosimilars market with a focus on China. He will also discuss key considerations for mAb and biologics therapeutic development, providing a broad overview of challenges and opportunities presenting in the market.
     
    1.        Landscape changes of mAb therapeutics
    2.        New targets and process/manufacturing innovation
    3.        Key consideration of mAb industry in China
    4.        Case study: Development strategies of PD-1 mAb as anti-tumor therapeutics in China for global market
  • Platform tech development for biosimilar upscaling
    Platform tech development for biosimilar upscaling Dr Hung Fai Poon, President, QuaCell Biotech Ltd Jun 21 2018 8:00 am UTC 75 mins
    Discover strategies to move candidate molecules through development
    Building consistent, straightforward processes with low variability
    Exploring the possibility of using single use, high throughput bioreactors in the upscaling process
  • Challenges in the Development of Continuous Processes for Vaccines
    Challenges in the Development of Continuous Processes for Vaccines Danny Vellom Jun 27 2018 3:00 pm UTC 75 mins
    The development and application of continuous manufacturing processes for vaccines presents both great opportunity as well as significant challenges, both technical and cultural, for the global industry. The key drivers are manufacturing capacity and flexibility, speed to market, and improved quality through the application of Quality-by-Design and Process Analytical Technology (QbD/PAT). Given the diversity of immunogens (toxoids, conjugate and subunit vaccines, live-attenuated and inactivated viruses, VLPs, etc.), and the variety of unique processes currently utilized to produce either single- or multi-component vaccines, it is unlikely that the transition to continuous processing will happen overnight. Additionally, cultural challenges are faced whenever a new mode of operation appears to some as “too different”, especially in a traditionally conservative sector like the developed-world vaccine industry. That said, market forces, global climate change, and Nature’s propensity to fill unoccupied niches with emerging infectious diseases will undoubtedly induce a first round of pioneers to explore this exciting new design space, ultimately leading to a more nimble industry and more and better opportunities for protection for the global population.