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Medical Research

  • 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 Recorded: May 24 2018 36 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 Recorded: May 23 2018 49 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 on the pharmaceutical industry
    - The ways chemical disruption can reverse failing drug discovery in the future.
  • 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 Recorded: May 23 2018 32 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.
  • Systematic searching with Emtree
    Systematic searching with Emtree Embase Customer Care Representative: Dr. Josephine Zimmermann Recorded: May 23 2018 52 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.
  • 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 Recorded: May 22 2018 54 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.
  • Comparison of Hemoglobin A1c Test Methods in the Clinical Lab
    Comparison of Hemoglobin A1c Test Methods in the Clinical Lab Brooke Medaugh Recorded: May 22 2018 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 Leaders - Traci Grodner and Curtis Maggard Recorded: May 22 2018 30 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!
  • Reducing efficacy-related failures with PharmaPendium
    Reducing efficacy-related failures with PharmaPendium Sherry Winter, PhD Recorded: May 22 2018 49 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
  • Integration of Disposable Components into Traditional Stainless-steel Facilities
    Integration of Disposable Components into Traditional Stainless-steel Facilities Ron Bates, Bristol-Myers Squibb and Miriam Monge, Sartorius Stedim Recorded: May 22 2018 81 mins
    This presentation will analyse the benefits and limitations associated with the implementation of single-use technology at a large-scale, multi-product commercial manufacturing facility. By integrating single-use components into a stainless steel facility, a hybrid equipment approach enhances manufacturing flexibility while enabling an accelerated manufacturing cadence.
  • 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 Recorded: May 22 2018 54 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.
  • IOP Publishing - How to get published
    IOP Publishing - How to get published Dr Simon Harris, Managing Editor, IOP Publishing Recorded: May 22 2018 41 mins
    - IOP journals/Open Access new launches
    - Why publish at all?
    - Choosing your journal
    - Writing your paper
    - Top 10 tips for getting published
    - Peer review process
    - Publication ethics
    - Post-acceptance
    - Post-publication
    - Access to IOP journals

    Duration: 45 minutes
    Questions at the end: 15 minutes
  • 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.
  • Steps to successfully manage your IP in China
    Steps to successfully manage your IP in China Ian Harvey from Tsinghua University, Beijing & Imperial College Business School, London Recorded: May 16 2018 57 mins
    Over the last 10 years, China has evolved from a cheap manufacturing engine to one of the worlds largest patent filers. With initiatives like 'Made in China 2025,' we are seeing China set clear goals, moving away from imitation to strategic innovation.

    So what does this mean for your business? Should you see China as a threat or an opportunity? And how can you take advantage of this IP and innovation powerhouse in the future? PatSnap is pleased to welcome back Ian Harvey from Tsinghua University, Beijing & Imperial College Business School, London to share how he thinks many businesses should be managing the opportunities China's innovation holds.

    Other themes explored in this webinar include:

    - What Chinese innovation means for your intellectual property
    - How to track current and emerging competitors in the market
    - What IP litigation in China is really like
  • 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. 
  • Life Beyond Earth
    Life Beyond Earth Dr Seth Shostak Senior Astronomer, Institute Fellow SETI Institute Dr. Colin Coates, Product Manager Research and OEM Recorded: May 10 2018 61 mins
    There has been, until now, no compelling evidence for biology beyond the confines of our own planet. And yet, people who investigate this topic feel confident that – within two decades – we will trip across life forms that are not, and never have been, earthlings. Why are they so optimistic that we will soon find some cosmic confrères, and what might be the implications of such a discovery?
  • Effective FTO searches: How to lay good groundwork before outsourcing
    Effective FTO searches: How to lay good groundwork before outsourcing Dylan O. Adams: Senior patent attorney & Amazon best-selling author Recorded: May 9 2018 52 mins
    Conducting thorough freedom to operate (FTO) searches is an essential part of R&D and IP strategies for many companies. Outsourcing searches to external professionals can be highly effective but can come with its own list of risks and costs.

    So what are the ways you can lay the most effective freedom to operate searching foundations, before contacting a legal professional for their advice?

    PatSnap will be joined patent attorney, and Amazon bestselling author Dylan Adams, for an insightful webinar into how you can lay the most effective groundwork throughout your FTO search, whether you're using an in-house counsel team or an external law firm.

    This webinar will explore key themes including:

    - Where to get started with an FTO search
    - How to effectively communicate your invention to an attorney
    - What an attorney needs to make their searching faster and more effective
  • 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.
  • Developing Novel Microfluidic Devices with Multiphysics Simulation
    Developing Novel Microfluidic Devices with Multiphysics Simulation Robyn Pritchard, Consultant Physicist The Technology Partnership (TTP) and Andrew Young, Technical Manager COMSOL Recorded: Apr 25 2018 55 mins
    If you are interested in using simulation to enhance the development of a microfluidic device, then tune into this webinar with Robyn Pritchard from The Technology Partnership (TTP).

    Cell sorting is a staple of many cell biology labs. The current gold standard, fluorescence-activated cell sorting (FACS), is limited to processing roughly 10,000 cells per second to avoid irreparable damage. For many new advances in cell therapy (e.g., autologous T-cell therapy for cancer), throughput of up to a billion cells in a few hours is essential. TTP set out to break through the current limit by developing a novel microfluidic cell sorter.

    In this webinar, Robyn will discuss how TTP used the COMSOL Multiphysics® software to design and invent the world’s smallest ultrafast microfluidic cell sorter, where the key discovery was the inertial vortex. Robyn will also show how TTP's simulations correspond to reality with their fully working microfluidic chip.

    The webinar will include a live demonstration and conclude with a Q&A session.
  • 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.
  • The Rise of Digital Enterprise: Growth Strategies for Healthcare Companies
    The Rise of Digital Enterprise: Growth Strategies for Healthcare Companies Nitin Naik, Slava Akmaev Chief Analytics Officer, BERG, Guillaume Kerboul, Dassault Systemes; Dr. Thorsten Harzer, QIAGEN May 31 2018 3:00 pm UTC 75 mins
    Digital Transformation is powering growth opportunities in Smart R&D, Patient Engagement, and Healthcare eCommerce. The explosion of patient centricity and technological advancement in big data analytics, cloud and artificial intelligence are putting severe pressures on companies to leverage all types of data (clinical, social media, IOT, etc.) in innovative ways. While the industry is decidedly upbeat on this new trajectory, there are heightened concerns about managing data privacy, especially for data flows outside the traditional ecosystem.

    Key Takeaways:
    • Learn about trends and growth opportunities in the Life sciences IT sector
    • Discuss hot topics, including Smart R&D, Digital Manufacturing, Connected patient and IVD eCommerce (B2C models)
    • Hear from industry leaders about company growth strategies and best practices for implementing digital solutions
    • Gain perspectives on M&A’s and the impact of investments from Big Tech companies
  • 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 Holly Johnson 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
  • 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.
  • 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
  • Digital Therapeutics: Trends and Growth Opportunities
    Digital Therapeutics: Trends and Growth Opportunities Daniel Ruppar, Global Program Director, Victor Camlek, Principal Analyst, Digital Health, Frost & Sullivan Jun 26 2018 6:00 pm UTC 75 mins
    Digital therapeutics presents a significant opportunity for traditional pharmaceutical therapeutics and information technology (IT) capabilities to influence a new approach to increase positive patient outcomes while reducing the overall cost of healthcare.

    Key Takeaways:
    · Gain expert insight into the accurate definition of digital therapeutics and market participants.
    · Learn about new solutions from mHealth companies that will combine apps, patient education, professional intervention and peer support to increase patient engagement and medication adherence by augmenting or replacing traditional drug therapeutics.
    · Hear opportunities to utilize digital therapeutics to improve medical workflow and patient communications.
    · Learn about some of the critical milestones related to digital therapeutics.
  • 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.
  • Strategies to overcome Low Endotoxin Recovery using the conventional LAL assay
    Strategies to overcome Low Endotoxin Recovery using the conventional LAL assay Dr. Ruth Daniels, Janssen & Kevin L. Williams, BIOMÉRIEUX USA, Inc. Jun 28 2018 2:00 pm UTC 75 mins
    Title: Strategies to overcome Low Endotoxin Recovery using the conventional LAL assay
    Presenter: Dr. Ruth Daniels, Janssen
    This presentation will discuss:
    - Endotoxin hold time studies to identify LER
    - In silico assessment of interfering factors and associated LER mitigation strategies
    - Case study: optimization of product-specific LAL assay to overcome LER

    Title: Addressing Low Endotoxin Recovery at the root with ENDO-RS® product-specific demasking strategies - Case studies
    Presenter: Kevin L. Williams, BIOMÉRIEUX
    Scientific studies have demonstrated that biologics typically containing protein in high concentrations and non-ionic surfactants, are likely to change the aggregate state of endotoxin in such a way that it is no longer accessible for detection with Factor C-based endotoxin detection methods (LAL and rFC). The ENDO-RS® endotoxin recovery method developed by Hyglos - a bioMérieux company, is a unique toolbox of dedicated reagents for demasking (recovering) endotoxin prior to detection, also for conventional LAL. This presentation covers the mechanism of LER, work principle of ENDO-RS as well as data from concluded protocol development projects on biologics from leading manufacturers.
  • MilliporeSigma CRISPR Protein Products
    MilliporeSigma CRISPR Protein Products Yanfang Jiang, Ph. D. Jun 28 2018 3:00 pm UTC 75 mins
    MilliporeSigma is a pioneer in commercially offering targeted genome editing tools. With its 14-year experience in the first generation of genome editing tools such as TargeTron® and Zinc Finger Nuclease, MilliporeSigma has emerged as a prominent leader in the development of CRISPR systems, the most flexible and efficient genome editing technology thus far developed. CRISPR-based DNA integration patents have been granted to MilliporSigma in seven regions including Australia, Canada, the European Union, Singapore, Israel, South Korea, and most recently in China. The MilliporeSigma CRISPR portfolio consists of an array of CRISPR products, in both the plasmid, RNA, protein, and lentiviral formats. MilliporeSigma is also the first commercial provider to offer both pooled and arrayed whole human genome CRISPR libraries.

    In this webinar, we will give an introduction to our current CRISPR protein products, including SpCas9 (CAS9PROT), Cas9-D10A nickase (CAS9D10APR), high fidelity eSpCas9 (ESPCAS9POR), catalytically inactive dCas9-FLAG-biotin (DCAS9PROT), and FnCas9 (FNCAS9PROT), focusing on specific enzyme characteristics of each protein and their potential applications for the research community.
  • Soft Tissue Cancer & IHC
    Soft Tissue Cancer & IHC Jeff Gordon Jun 29 2018 3:00 pm UTC 75 mins
    Soft tissue tumors are a broad group of neoplasms that involve the connective tissue of the body. Each year, over 13,000 people in the US are diagnosed with soft tissue sarcomas and over 5,000 people succumb to the malignancy. Because soft tissue sarcomas are very ambiguous and amorphous, many time sarcomas are classified as an uncertain type. Advances in immunohistochemistry as well as the utility of novel markers such as TFE3, TLE1, MyoD1, and MUC4 have aided pathologists in classifying these soft tissue tumors. This discussion will cover the key facts and statistics about soft tissue tumors and what role IHC plays in these difficult diagnoses.
  • Raman spectroscopy measurements during Bioprocessing
    Raman spectroscopy measurements during Bioprocessing Nobel Vale, Research Scientist II, Bristol-Myers Squibb Jul 11 2018 2:00 pm UTC 75 mins
    Raman spectroscopy has been seen as spectroscopic tool used in bioprocessing to monitor and control cell metabolism to optimize quality and yield of titer. This is due to Raman’s insensitivity to water and ability to analyze samples without manipulation. However there are certain challenges for Raman when analyzing a complex and dynamic sample such as a cell culture. This article will describe the different challenges in analyzing in-line Raman data and how to mitigate changes in samples that include changes in fluorescence background, presence of cells/debris in samples, and spectral interference.
  • Development and Manufacturing of Recombinant Nanoparticle Vaccines
    Development and Manufacturing of Recombinant Nanoparticle Vaccines Atin Tomar, CPL Biologicals Jul 12 2018 9:30 am UTC 75 mins
    A recombinant vaccine technology platform based on highly purified, properly-folded protein antigens in stable well-defined Nanoparticles, enabling efficient and safe manufacture of vaccines against highly pathogenic targets. Nanoparticles are intrinsically immunogenic, producing both durable neutralizing antibodies and cellular immunity. The platform can be utilized for rapid response to potential pandemics as the time from identification of relevant viral gene sequence to final GMP drug product ready for human studies has been demonstrated to take less than 4 months for multiple vaccines.
    The GMP drug substance manufacturing process for the platform largely utilizes single-use technologies. Single-use-technologies and recombinant platform enables the utilization of same manufacturing facility for multiple products with rapid change-over.
  • Key components of a comprehensive program for the management of single use techn
    Key components of a comprehensive program for the management of single use techn John Maguire, Shire Jul 18 2018 2:00 pm UTC 75 mins
    As a result of the increased adoption of single-use technologies (SUTs) in biotech manufacturing, companies need to develop and implement programmatic approaches for the management of these systems under regulatory compliance. This webinar discusses the key aspects of such programs, with emphasis on collaboration with suppliers, cost management, as well as practical insights about the use of SUTs.
  • Lifecycle management of single use technologies
    Lifecycle management of single use technologies Francis Verhoeye, Director Single Use Technologies, GSK Vaccines Jul 25 2018 12:00 pm UTC 75 mins
    Single-use technologies (SUTs) are one of the key drivers in the biopharmaceutical industry today and are changing the way we are operating and qualifying our bioprocesses, offering more flexibility and increasing efficiency. However, the extended use of those technologies in commercial operations requires a robust and specific lifecycle management approach. In this context, we have built an improved technical lifecycle management approach involving close partnership with key suppliers, enhanced standardization, early involvement of global manufacturing functions and full compliance with item creation process in order to ensure business continuity and value creation.
  • Quality-By-Design in Spray Drying Processes - Transfer Lab to Production
    Quality-By-Design in Spray Drying Processes - Transfer Lab to Production Sune Klint Andersen, Janssen Pharmaceutica & Filipe Gaspar, Hovione FarmaCiência Jul 25 2018 2:00 pm UTC 75 mins
    Spray drying is a continuous and scalable manufacturing process commonly used in the pharmaceutical industry. Due to its scalable and continuous nature it is possible to apply Quality-by-Design (QbD) and Process Analytical Technologies (PAT) early on in the development of a spray drying process.
    Knowledge gained from QbD e.g. Design-of-Experiments (DoE) and PAT increases process understanding and the knowledge can be readily applied when scaling up the process and in production scale application of PAT i.e. especially with respect to the control strategy.
    The Webinar will discuss the application of QbD early in the development and how the obtained knowledge can be used to optimize transfer of the spray drying process to production scale including PAT strategy.
  • Subvisible Particles Matter, Developments in Regulations and Low Volume Methods
    Subvisible Particles Matter, Developments in Regulations and Low Volume Methods Dr Satish K Singh, Lonza Jul 26 2018 2:00 pm UTC 75 mins
    The need to measure and characterize proteinaceous particles in therapeutic protein products has been emphasized by regulators. USP is a new chapter that addresses the limitations of USP for therapeutic proteins in measurement of subvisible particles. USP is a guidance chapter addressing the task of characterization of particles with the emphasis on proteinaceous particles. Furthermore, regulatory authorities require that sponsors understand the submicron particle size range of the products also. This article will look at latest regulatory developments, key aspects of the measurement of subvisible and submicron particles in biotherapeutics, as well as the utility of low volume methods.