Hi [[ session.user.profile.firstName ]]

Medical Research

  • 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.
  • 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.
  • Transforming Radiation Therapy With MR/RT: A Closer Look
    Transforming Radiation Therapy With MR/RT: A Closer Look Susan Lalondrelle and Uwe Oelfke, Institute of Cancer Research/Royal Marsden Hospital Recorded: Apr 12 2018 60 mins
    A new class of radiation devices is emerging that has the potential to transform how cancer is treated through more precise tumour targeting and the adaptation of treatment every time. High-field MR-linac technology integrates the power of state-of-the-art MR imaging with precision radiation technology. It can deliver precisely targeted radiation doses while simultaneously capturing the highest-quality MR images, which will allow clinicians to visualize both tumours and the surrounding healthy tissue at any time during radiation delivery, and adapt the treatment accordingly.

    During this webinar, clinical experts will share their experience with a novel high-field MR-linac. The speakers are currently utilizing this new technology and will present their latest work on the imaging studies that have been undertaken prior to clinical introduction. This work will support the new and rapidly emerging area of MR radiation therapy (MR/RT).

    High-field MR-linac devices based on diagnostic-standard MRI technology will offer many avenues for exploring improvements in radiotherapy, such as shorter treatment regimens or targeted adaptation of the treatment in real time. Also, by integrating precision radiation and MRI technologies, high-field MRI capabilities can be optimally explored to help bring personalized cancer care to radiation therapy.

    Elekta MR-linac is work in progress and not available for sale
  • 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.
  • 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 59 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.*

    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.
  • Current Progress in Approaches for The Safety Assessment of E&L
    Current Progress in Approaches for The Safety Assessment of E&L Kim Li, PhD, DABT, MPH, Amgen Inc.& Erica J. Tullo, Technology Manager, E&L – Analytical Labs, West Pharmaceutical Service Recorded: Apr 6 2018 75 mins
    Title: Current Progress in Approaches for The Safety Assessment of E&L
    Presenter: Kim Li, PhD, DABT, MPH, Amgen Inc
    Summary: This Webinar will review the current progress in the risk management of extractables and leachables (E&L) impurities with focus on protein therapeutics. While toxicology assessments of E&L impurities are maturing toward best practices, their potential impact to product quality requires new approaches from the toxicologist toolbox. This webinar will discuss the in silico prediction of chemical functional groups that pose high risk of covalent binding, potentially leading to structural modifications of proteins and impact to quality attributes.


    Title: A Practical Approach to Extractables and Leachables
    Presenter: Erica J. Tullo, Technology Manager, E&L – Analytical Labs, West Pharmaceutical Service
    Summary: While many realize that regulatory agencies require extractable and leachable (E&L) information, many may not have knowledge of how to design an appropriate extractables study that will lead to proper selection of targets in leachables testing. During the extractables study, it is important to choose the most appropriate solvents and extraction conditions for the type of packaging components under evaluation. It is also important to consider a simulation study in which the entire system is assessed. Since leachables are typically a subset of extractables, the design of the extractables and simulation studies can significantly impact the subsequent leachables method development and monitoring. This presentation will highlight different considerations of each phase of E&L testing.
  • Implementing HDR skin brachytherapy into your practice
    Implementing HDR skin brachytherapy into your practice Dr Michael Kasper and Mr Zoubir Ouhib Recorded: Apr 5 2018 59 mins
    HDR skin brachytherapy can bring added value to any brachytherapy program. Join Dr Michael Kasper and physicist Zoubir Ouhib from the Lynn Cancer Institute to learn more about how to start or add a skin program the right way. Topics will include the necessary equipment, key team members and the general considerations critical to program success.
  • 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.
  • 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
  • Tomotherapy planning in RayStation
    Tomotherapy planning in RayStation Misty Lehman-Davis CMD, BS, RT (R)(T), Senior Application Specialist, RaySearch Americas Recorded: Mar 22 2018 55 mins
    Tomotherapy planning was added into RayStation software in December 2016 as part of the V6 release. This addition allows a seamless planning approach for centers with helical Tomotherapy combined with conventional linacs. For the first time ever, all planning can be done within one treatment planning system. RayStation’s advanced planning modules such as Multicriteria Optimization are well suited for Tomotherapy planning and will be shown. Finally, there are some unique features to the Tomotheraphy optimization that will be described by our in-house expert.
  • UK pharma and integrated health
    UK pharma and integrated health Stephen Dorrell, NHS Confederation, James Roach, Accountable Care Partnership, Essex Andrew Smith, Cobic, Steve Jowett, IQVIA Recorded: Mar 21 2018 64 mins
    The concept of integrated healthcare is not new to the UK, where it has been discussed since the late 1960s.

    The difference is that now it could really happen. Technology, medicine, regulation and pricing have all evolved to a point where a collaborative, integrated system is not only possible, but desirable – and the data needed for it to become a reality is now available.

    What does this mean for UK pharmaceutical companies that have historically focused on providing medicines and treatments?

    On one hand there are calls for them to change – going beyond being simply a supplier of products and moving into the role of partner, sharing risk to drive great health outcomes.

    On the other hand, the industry’s move into having pipelines that are largely stocked with niche products has created pricing and access questions which are yet to be fully answered.

    Analysing the current situation and looking for potential routes to the future, this high-level IQVIA/pharmaphorum webinar gave an update on the latest developments and debated how pharma can be a catalyst for change at a time when the NHS is under immense pressure to cut costs and become more efficient.

    Insight on these pressing issues was provided by a panel of influential healthcare experts that included former secretary of state for health, and NHS Confederation current chairman, Stephen Dorrell.

    He was joined by:
    James Roach, director, Accountable Care Partnership, West Essex Health and Care System
    Andrew Smith, director, Cobic
    Steve Jowett, country lead for health system engagement, IQVIA

    Watch the digital debate to learn more about:

    The evolving NHS and the STP/ICS model of delivery
    What a collaborative future could look like
    The role of data in the future NHS
    Why the STP/ICS model is important for pharma
  • SUS Leachable Testing: Leachable Study Design for Single-Use Components
    SUS Leachable Testing: Leachable Study Design for Single-Use Components Kathryn McGohan Recorded: Mar 20 2018 69 mins
    The BPOG Leachables Working Group has recently published a Best Practice Guide for Leachables. The Best Practice Guide was developed to help Biopharmaceutical and Vaccines Manufacturers to develop science-based, robust, and efficient approaches to handling the risk of leachable compounds that is associated with increasing use of Single-Use Systems in manufacturing processes. The Best Practice Guide is composed of three parts: the risk assessment model, leachable study design, and analytical methods. This article provides insight into the application of the Best Practices for Leachables Study Design by end users and will include a case study to highlight the importance of the study design.
  • Nano- and Microfabricated Hydrogels for Regenerative Engineering
    Nano- and Microfabricated Hydrogels for Regenerative Engineering Ali Khademhosseini, PhD Recorded: Mar 15 2018 66 mins
    Engineered materials that integrate advances in polymer chemistry, nanotechnology, and biological sciences have the potential to create powerful medical therapies. Our group aims to engineer tissue regenerative therapies using water-containing polymer networks, called hydrogels, that can regulate cell behavior. Specifically, we have developed photocrosslinkable hybrid hydrogels that combine natural biomolecules with nanoparticles to regulate the chemical, biological, mechanical and electrical properties of gels. These functional scaffolds induce the differentiation of stem cells to desired cell types and direct the formation of vascularized heart or bone tissues. Since tissue function is highly dependent on architecture, we have also used microfabrication methods, such as microfluidics, photolithography, bioprinting, and molding, to regulate the architecture of these materials. We have employed these strategies to generate miniaturized tissues. To create tissue complexity, we have also developed directed assembly techniques to compile small tissue modules into larger constructs. It is anticipated that such approaches will lead to the development of next-generation regenerative therapeutics and biomedical devices.
  • NanoRaman: Correlated Tip-Enhanced Optical Spectroscopy and SPM
    NanoRaman: Correlated Tip-Enhanced Optical Spectroscopy and SPM Dr Marc Chaigneau, AFM/Raman product manager Recorded: Mar 8 2018 61 mins
    Raman spectroscopy and confocal Raman microscopy have already proved to be essential characterization tools in many areas of advanced research, with a number of these applications extending into industry. As time moves on, new applications that are not addressed by existing technologies arise. Indeed, at the nanoscale, materials exhibit different properties than at the macro level, often quite dramatically different. The characterization of nanomaterials naturally requires imaging techniques with resolution at the same scale or better, so that local property variations can be discerned and defects properly detected; only with this understanding can the material properties be engineered to meet the performance requirements of next-generation devices.

    In this webinar, HORIBA Scientific, the world leader in micro and nanoRaman spectroscopy, will present new nano-imaging capabilities. Tip-enhanced optical spectroscopies (TEOS) such as TERS (tip-enhanced Raman spectroscopy) and TEPL (tip-enhanced photoluminescence) provide a unique capability for the characterization of diverse 0, 1 and 2D materials. We will demonstrate the power and importance of the cross-correlation of nanoscale hyperspectal imaging with data from other scanning-probe techniques such as topography, surface potential, conductivity and photocurrent. We will also discuss how we have extended this technique to other nano-materials as well as semiconducting nanostructures and bio-materials.
  • Process analytical Technology for Upstream Bioprocessing
    Process analytical Technology for Upstream Bioprocessing Erica Fratz-Berilla & LCDR Agarabi Recorded: Mar 5 2018 71 mins
    In commercial cell culture bioprocessing, consistent high quality protein is a fundamental goal that is typically accomplished during development through product and process engineering of bioreactor parameters. The FDA’s Center for Drug Evaluation and Research (CDER)’s Office of Biotechnology Products’ upstream bioprocessing laboratory, a part of the Office of Pharmaceutical Quality’s Center of Excellence (COE) in Manufacturing Science and Innovation, studies Process Analytical Technology (PAT) for upstream bioprocessing, focusing on the production of monoclonal antibodies. These capabilities are being leveraged to study continuous bioreactor cell culture production and compatible PAT tools. Case studies are presented that illustrate collaborative laboratory research being conducted on PAT tools for upstream bioprocessing to support regulatory decision making.
  • Making patent searches more effective with Boolean
    Making patent searches more effective with Boolean Dvorah Graeser from KISSPatents and Ruta Sudmantaite @ PatSnap Recorded: Feb 28 2018 49 mins
    Patent searching is something most IP counsel is very familiar with. It's your day to day when looking at Freedom to Operate, competitive analysis and portfolio management.

    However, it can be hard to predict what you need in a search when you are not a technical expert. In this webinar, we will teach you how to construct the most effective searches using boolean and a few other tips and tricks on how to ensure you include all the technical detail you need.
  • Modelling the Thermoelectric Effect
    Modelling the Thermoelectric Effect Andrew Young, Technical Manager, COMSOL Recorded: Feb 28 2018 59 mins
    If you want to learn how to simulate the thermoelectric effect in the COMSOL Multiphysics® software, then tune into this webinar.

    The thermoelectric effect, which involves the reversible conversion between heat and electricity, is a phenomenon that is used in both heating and cooling applications. The effect is often used in devices such as thermal sensors, energy harvesters and Peltier coolers.

    In this webinar you will learn how to model the coupled phenomenon in COMSOL Multiphysics®. We will discuss the basic theory for heat transfer and electric currents as well as highlight how to account for the Peltier, Seebeck and Thomson effects. During a live demonstration these effects will be combined in a single model.

    This webinar includes a Q&A session during which you can ask questions.
  • HGST SVR2U24 NVMe Storage Server
    HGST SVR2U24 NVMe Storage Server Manfred Berger, HGST - Sr. Mgr. Business Development Platforms EMEAI Recorded: Feb 27 2018 33 mins
    In this webinar Manfred Berger introduces the latest addition to the HGST platform portfolio, the SVR2U24 NVMe all-flash storage server.

    Combining high performance NVMe SSDs and Intel®’s Purley server architecture into one tried and tested unit, the SVR2U24 enables customers to come to market quickly with a multitude of software defined storage solutions or data base servers optimized for high speed search operations, catering to a multitude of industry verticals.
  • Everything You Need to Know About Critical Healthcare Segments
    Everything You Need to Know About Critical Healthcare Segments Sanjeev Kumar (Industry Manager), Natasha Gulati (Industry Manager), Siddharth Shah (Industry Analyst) Recorded: Feb 27 2018 67 mins
    Frost & Sullivan is forecasting another year of disruptions in critical healthcare segments such as diabetes care, smart hospitals, healthcare cloud computing and digital pathology. This webinar will focus on these industries along with insights on key trends influencing the healthcare system, followed by a live question-and-answer session.

    Join Us to Gain Insights on:

    • Future paradigms in diabetes care and harnessing evolutionary trends to improve the quality of life for diabetics
    • Understanding the smart hospital concept and identifying relevant applications and growth opportunities
    • Healthcare cloud computing trends, such as global provider spending on cloud solutions approaching $10 billion by 2021
    • Growth opportunities in the global digital pathology market
  • 2018 Frost & Sullivan Predictions and Outlook for Digital Health
    2018 Frost & Sullivan Predictions and Outlook for Digital Health Daniel Ruppar, Global Program Director, Analysts from Frost & Sullivan's Global Digital Health Team Recorded: Feb 22 2018 51 mins
    Expert Insights You Will Not Want to Miss:

    • Hear market predictions from world-renowned analysts
    • Learn areas of growth and controversy for 2018 in digital health and health IT
    • Discussions on hot areas including AI, Digital Therapeutics and Blockchain
    • Movements of major ICT and Technology companies in their Healthcare strategy
    • Understand the critical vendors to watch for this year
  • Lymphomas and Leukemias
    Lymphomas and Leukemias Jeff Gordon Apr 27 2018 3:00 pm UTC 75 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.
  • The Power of Scopus Data
    The Power of Scopus Data Holly J. Falk-Krzesinski, PhD, Vice President, Research Intelligence Global Strategic Networks, Elsevier May 3 2018 2:00 pm UTC 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.
  • 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) May 3 2018 3:30 pm UTC 75 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.
  • 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 May 4 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 >.
  • How to lay good groundwork before outsourcing an FTO search
    How to lay good groundwork before outsourcing an FTO search Dylan O. Adams, Senior Patent Attorney | Hosted by Ruta Sudmantaite from PatSnap May 9 2018 3:00 pm UTC 60 mins
    We know that companies who innovate and patent new technologies have an array of tools they use to research ideas, project manage and look at patent data. Often large and small organisations will depend on external law firms to complete and sign off final FTO searches. This can be expensive and time-consuming, especially considering that your lawyers won’t be technology experts like yourself.

    So how can you reduce the time and cost and increase the accuracy of your FTO searches? We are joined by Dylan Adams, Patent Attorney and best selling writer to talk about how to lay the groundwork for your FTO, whether you are using an in-house counsel team or an external law firm.

    This webinar will discuss:

    * How to effectively describe your invention to an attorney
    * What an attorney needs to make search quicker
    * Prior art search that can benefit your FTO
  • Life Beyond Earth
    Life Beyond Earth Dr Seth Shostak Senior Astronomer, Institute Fellow SETI Institute Dr. Colin Coates, Product Manager Research and OEM May 10 2018 2:00 pm UTC 60 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?
  • 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 May 10 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.
  • End User Perspective on Setting in-Process Endotoxin Limits
    End User Perspective on Setting in-Process Endotoxin Limits Dr Friedrich von Wintzingerode, Roche/Genentech May 15 2018 8:00 am UTC 75 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. 
  • Emerging biomarkers for the diagnosis of cardiac pathologies
    Emerging biomarkers for the diagnosis of cardiac pathologies Rich Triglia May 15 2018 3:00 pm UTC 75 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.
  • Knockdown, Knockout, Validate: Lentivirus delivers payload in vitro and in vivo
    Knockdown, Knockout, Validate: Lentivirus delivers payload in vitro and in vivo Christy Hoffmann May 16 2018 3:00 pm UTC 75 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.
  • How to manage China: the next innovation and IP powerhouse
    How to manage China: the next innovation and IP powerhouse Ian Harvey from Tsinghua University, Beijing & Imperial College Business School, London May 16 2018 3:00 pm UTC 60 mins
    Over the last 10 years China has evolved from a cheap manufacturing engine to the worlds largest patent filler. Although manufacturing is still huge business we are seeing initiatives like “Made in China 2025” setting clear goals for innovation. This is backed by statistics like more engineering graduates are produced in China than anywhere else in the world.

    So how do you take advantage of this potential threat? This is what Ian Harvey will be discussing in the forthcoming webinar.

    - How is your IP going to be affected by Chinese innovation?
    - How to start tracking competitors in the Chinese market?
    - What is IP litigation really like in China?
  • Current Perspective on Rapid Sterility Test
    Current Perspective on Rapid Sterility Test David Roesti, PhD, Novartis Pharma AG  May 17 2018 2:00 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.
  • 3D Imaging of 3D Cell Culture Models
    3D Imaging of 3D Cell Culture Models Tom Villani, Ph.D., Ann Rossi, Ph.D. May 17 2018 4:00 pm UTC 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.
  • Implementation Strategies and Challenges for SUT at Commercial scale
    Implementation Strategies and Challenges for SUT at Commercial scale Adam Goldstein, Roche/Genentech May 17 2018 5:00 pm UTC 75 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.
  • IOP Publishing - How to get published
    IOP Publishing - How to get published Simon Harris, Managing Editor, IOP Publishing May 22 2018 8:30 am UTC 60 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
  • 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.
  • Integration of Disposable Components into Traditional Stainless-steel Facilities
    Integration of Disposable Components into Traditional Stainless-steel Facilities Ron Bates, Bristol-Myers Squibb May 22 2018 2:00 pm UTC 75 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 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.
  • 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.
  • Environmental Monitoring Trend Analysis Tools
    Environmental Monitoring Trend Analysis Tools Steve Walton May 23 2018 2:00 pm UTC 75 mins
    Qualitative analysis of environmental monitoring data is vital for pharmaceutical quality groups. Essential to identifying evolving microbial trends are the means to effectively parse and analyze EM results. To make the best use of the tools available, they must be used with a full understanding of their value and limitations. In this paper, the pros and cons of several EM trend analysis tools will be presented to aid microbiology experts to qualitatively evaluate EM performance data.
  • Chemical disruptors and their uses in failing drug discovery
    Chemical disruptors and their uses in failing drug discovery Roshan Jumnah and Ruta Sudmantaite @ 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. For example, efforts in combating antibiotic drug resistance usually results in the attempted discovery of new classes of antibiotics.

    However, such unquestioned convention has often, as in the example with antibiotics, led to very few new discoveries and even stagnation of an entire research area. We ask the question: does it have to be this way?

    One method to re-boot a failing area of research is to stop following convention and employ disruptive chemical methods and thinking to kick-start a process of rejuvenation. In this webinar, we will focus on the areas of antibiotic resistance, drug metabolism and accelerated polymer drug discovery, where chemical disruptors and new thinking could impart a positive outcome.

    We will identify the chemical disruptors, their uses and the potential consequences of utilising these methods.
  • 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.
  • Current USP Perspectives on a Rapid Sterility Test
    Current USP Perspectives on a Rapid Sterility Test Dr David Roesti, Novartis/USP May 30 2018 8:00 am 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.
  • 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
  • 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 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.