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Life Sciences

  • 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 Paola Braga Recorded: Sep 20 2018 68 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.
  • Librarians’ Role in Evidence-Based Medicine Education for Healthcare Policymaker
    Librarians’ Role in Evidence-Based Medicine Education for Healthcare Policymaker Maylene Qiu, Systematic Review Coordinator and Clinical Liaison Librarian at Biomedical Library, University of Pennsylvania Recorded: Sep 19 2018 54 mins
    NOTE: NEW DATE!

    The practice of evidence-based medicine (EBM) requires retrieving the knowledge from ever-increasing volume of literature. Librarians have supported EBM by offering information searching skills and various tailored training programs.

    While users’ needs constantly drive library’s teaching activities, customizable EBM teaching modules have been developed to respond to different needs of library's constituencies, particularly the policy makers within a university’s healthcare system. This involvement creates a new avenue to convey library’s value.

    About the speaker Maylene Qiu

    Maylene is responsible for developing and providing systematic review services for the patrons principally from the health sciences schools at UPenn and the UPenn Healthcare System. She also serves as the Clinical Liaison Librarian promoting evidence-based medicine information resources and services.

    Before coming to Penn, Maylene was Clinical Reference Librarian at Quillen College of Medicine Library at East Tennessee State University, where she provided services for the clinicians at the Point-of-Care.

    Prior to the library field, she has 10-year experience in pharmaceutical science obtained from working in China, Japan, and Canada. In that career, she commercialized several products in nutrition and agriculture. She earned a B.S. in Pharmaceutical Science from the Nanjing University of Chinese Traditional Medicine, and an M.A. in the Library and Information Science from the University of Wisconsin – Madison.
  • PD-L1 Assays – More than just an antibody
    PD-L1 Assays – More than just an antibody Dr. Michael Flores Recorded: Sep 18 2018 33 mins
    In this webinar, Dr. Flores will summarize the PD-L1 testing assays currently available on market and address the importance of understanding the different scoring algorithms developed for their respective PD-1/PD-L1 immunotherapies. You will learn about a system approach to testing and where to find further information on how to appropriately interpret the specific PD-L1 assay you are working with.
  • Machine Learning and AI with Liferay
    Machine Learning and AI with Liferay Piotr Swiniarski Recorded: Sep 18 2018 43 mins
    Even if both terms are often used in connection with each other, they do not denote the same thing. Nevertheless, Artificial Intelligence (AI) and Machine Learning are already present in our everyday lives: from smart home entertainment solutions such as Amazon Alexa to partially self-driving cars, personalized product recommendations in online commerce, or fraud detection in the financial sector. Also, companies are already heavily committed to the commercial use of this revolutionary technology.

    A practical and simple way for small to medium-sized companies to take advantage of Machine Learning in their day-to-day business is to use it in combination with an enterprise portal software such as Liferay. The idea behind this is that Machine Learning can be used to automate numerous functions and workflows and thus make them more efficient.

    Companies should rely on a competent development partner when using digital platforms such as Liferay. In addition to professional advice on the selection and design of the most suitable solution, you should ensure that this partner provides complete support for the complex integration and ad-aptation of third-party systems.

    The development partner should also ensure that the portal is always up to date and should provide comprehensive support for migration and upgrades as well as training for administrators and users.

    Liferay offers an ideal platform for deploying Machine Learning applications today, and numerous open source solutions are already available for the development of corresponding models. Best of all, companies can easily leverage their existing IT environment without having to invest in additional hardware or server infrastructure.
  • DSF and FTIR as methods for the identification and characterization
    DSF and FTIR as methods for the identification and characterization Marina Kirkitadze , Deputy Director, Head of Biophysics & Conformation Unit, Analytical R&D Biochemist & Kristen Kalbfleisch Recorded: Sep 18 2018 71 mins
    The focus of this presentation is the application of Fourier Transform Infrared Spectroscopy (FTIR) and Differential Scanning Fluorimetry (DSF) methods to characterize vaccine components and their stability. Additionally, FTIR can be applied for the identification of final vaccine products, and DSF can be used to distinguish different formulations of vaccine candidates. These methods, when used in conjuction, provide valuable information regarding characterization and stability in the final stages of vaccine manufacturing.
  • Second Medical Use Patent Opportunities from Personalised Healthcare Inventions
    Second Medical Use Patent Opportunities from Personalised Healthcare Inventions Dr. Laurence Gainey, Patent Director, HGF Recorded: Sep 11 2018 58 mins
    Personalised healthcare (sometimes referred to as precision medicine) is an evolving field in medicine where a therapeutic treatment is tailored to an individual with a particular disease. The patenting of personalised healthcare inventions has proved problematic in a number of jurisdictions, most notably the USA. However, various aspects of these inventions are patentable in Europe.

    This webinar will set the scene as to what personalised healthcare is and will run through the history of second medical use patenting in Europe. Discussing key cases such as G5/83, T1020/03 and G2/08.

    It will then focus on how second medical use patenting can be applied to personalised healthcare inventions and will give examples of claim language that is finding favour at the EPO.
  • Next generation processes: What model works the best in Asia?
    Next generation processes: What model works the best in Asia? Ravishankar Kasturi, Reliance Life Sciences & Britta Manser ,Scientist Continuous Bioprocessing Pall Recorded: Sep 11 2018 58 mins
    Next generation processes: What model works the best in Asia?

    Compare and contrast the available full scale processing technologies, and discover what works the best for manufacturing next generation therapeutic products in Asia.

    Biologics are complex and hard to make, which helps to explain why biotech manufacturing plants are huge and expensive to build. To be competitive, manufacturing must be efficient and cost-effective and should brainstorm economical ways to manufacture biologics.

    Biosimilars are a cost competitive market. Pricing may have a direct impact on market share, and return on investment. The market for biologics, including approved and in pipeline like ADCs, antibodies & antibody fragments present both tremendous opportunity and challenge. Challenges necessitates looking beyond the current platform philosophy for how to modify the process with a goal to increase overall productivity in a flexible manner.

    The current processing paradigm of large manufacturing facilities dedicated to single product production is no longer an effective approach for manufacturing next generation therapeutic products in Asia.

    Cost Effective Biosimilars Manufacturing may include
    Single-use technologies and continuous upstream processes have proven to be cost-efficient options
    Aspects of continuous manufacturing in both upstream and downstream manufacturing are being incorporated thereby increasing yields through a combination of longer production run times, more stable and higher secreting cell lines
    Technologies enabling high productivity, right-sized, small footprint, continuous, and automated operations are being evaluated.
    Adaptive control techniques are set to minimize development timelines and enhance process robustness
    Partnerships will continue to transform biosimilars industry. In order to gain access to developed markets, Indian biosimilar manufacturers are partnering with multiple local established manufacturers and big pharmaceutical companies
  • 爱思唯尔卓越科研在线讲座:在《柳叶刀》上发表论文——专为中国研究人员打造的中文在线讲座!
    爱思唯尔卓越科研在线讲座:在《柳叶刀》上发表论文——专为中国研究人员打造的中文在线讲座! Helena Wang Recorded: Sep 6 2018 64 mins
    与《柳叶刀》亚洲区执行主编王辉(Helena Wang)女士一起学习在高影响力期刊上发表论文的技巧和策略。王辉女士将分享她在整个研究论文发表周期中与研究人员和论文作者合作的经验,介绍如何撰写能够在优质出版物上发表的论文,以及广泛传播研究成果的机会。本次在线研讨会内容精彩纷呈,不容错过,能够让您的研究过程和研究影响再上新台阶。This webinar will be in Mandarin (Chinese).
  • SMC Technology: Detect biomarkers at levels previously undetectable
    SMC Technology: Detect biomarkers at levels previously undetectable Anitaben Tailor Ph.D Recorded: Sep 5 2018 48 mins
    Single molecule counting (SMC™) technology enables accurate measurement of molecules at levels previously undetectable allowing researchers to identify new biomarkers, or assist in therapeutic development with an improved view of efficacy, safety & time course studies. Combining a traditional immunoassay workflow with patented SMC™ technology enables the detection of low-abundance biomarkers, such as proteins and nucleic acids, with unparalleled sensitivity and accuracy, capturing concentrations down to the femtogram/mL level. You will learn how to detect, and monitor changes in, extremely low levels of established disease biomarkers such as cardiac troponin I and cytokines.
  • Unscripted: Straight Talk on Data Protection & Compliance in the GDPR Era
    Unscripted: Straight Talk on Data Protection & Compliance in the GDPR Era Julie Tsai, Sr. Director, Information Security | Crispen Maung | VP Compliance | Sanam Saaber, VP Legal Recorded: Aug 28 2018 58 mins
    Data security, privacy and protection are top of mind right now. But what do you really need to do to stay in compliance and on the right side of regulations?

    Box leaders - Julie Tsai, Sr. Director, Information Security, Crispen Maung, VP Compliance and Sanam Saaber, VP Legal - talk about what data security, governance and protection really mean in the age of global regulation and oversight.

    This is an unscripted conversation — no slides, no pitches, no filters — so get ready for a lively exchange of ideas and points of view from three seasoned pros who helped build the Box model for data privacy, protection and security.

    Here are the talking points for the chat:

    - What does a global data protection strategy actually entail?
    - How should we plan for the next big global compliance regulation?
    - What role should line-of-business chiefs and actual users play in developing your strategy?
  • Data Governance: Achieving Sustainability Among Whiners
    Data Governance: Achieving Sustainability Among Whiners Seth Maislin, Principal Consultant, Earley Information Science & Seth Earley, CEO, Earley Information Science Recorded: Aug 28 2018 61 mins
    Let’s face it - no one likes the ‘G’ word. It’s too often a sour antidote to excitement and nimbleness: Triple checks, security barriers, privacy forms, council reviews. It’s as awful as pulling teeth and paying taxes, right?

    Thankfully it doesn’t have to be, and many organizations have found an effective rhythm for long-term, sustainable data stewardship.

    Join us on Tuesday, August 28th, at 11:00 AM ET as we discuss ‘Data Governance: Achieving Sustainability Among Whiners,’ where we’ll explore how you can implement this necessary rhythm, even if you’re surrounded by governance resistors.

    You will learn:

    1.Good governance is empowering, not (only) a “necessarily evil”
    2.The Effective As: Automation, Assignment, Attitude
    3.Analytics for achieving fast failure (and recovery)

    Speakers:
    Seth Maislin is a Principal Consultant with Earley Information Science. For more than 20 years he has demonstrated strengths in classification and taxonomy, indexing and content modeling, information architecture, search, and usability. He has dedicated the last 10+ years to providing sustaining information management solutions to clients facing real and complex findability challenges.

    Seth Earley is the Founder and CEO of Earley Information Science. An expert with 20+ years experience in Knowledge Strategy, Data and Information Architecture, Search-based Applications and Information Findability solutions. Seth has worked with a diverse roster of Fortune 1000 companies helping them to achieve higher levels of operating performance by making information more findable, usable and valuable through integrated enterprise architectures supporting analytics, e-commerce and customer experience applications.
  • Material Understanding for Continuous Manufacturing of Solid Dosage Forms
    Material Understanding for Continuous Manufacturing of Solid Dosage Forms Dr Yifan Wang, regulatory research scientist, FDA CDER and -Dirk Leister, Head of the Application team Thermo Fisher Scienti Recorded: Aug 23 2018 68 mins
    In continuous manufacturing of solid dosage forms, continued assurance of process performance and product quality is based on accurate and consistent flow of solid materials. Acknowledging the multidimensionality of material flow properties is often the first step to explore the material knowledge space. In addition, modular operations such as feeding and continuous blending often requires additional material testing for better understanding of process dynamics. As a key element of control strategy, tolerance of incoming material variations needs to be considered. The FDA’s Division of Pharmaceutical Quality Research is working to understand the impact of material properties and explore the material knowledge space for continuous manufacturing of solid dosage forms.
  • Evidence-Based Searching and Reporting the Search for Systematic Reviews
    Evidence-Based Searching and Reporting the Search for Systematic Reviews Farhad Shokraneh, University of Nottingham Recorded: Aug 22 2018 63 mins
    Search methods are part of the research methods in systematic reviews and evidence synthesis. Running a robust search requires following the existing evidence in selection of databases and search filters, addition of limitations, and inclusion of a search methodologist in your team. While a proper evidence-based search protocol could reduce waste and increase value in systematic reviewing, proper reporting should make your search a piece of science.

    The search methods should be reported in a way that anyone who have access to the databases could repeat the search strategies and search methods (reproducibility) and retrieve the same or very similar search results both in terms of content and numbers (replicability). Following the minimum requirement for reporting the search, the team could produce an evidence-based search method that could be re-used by the readers. The team could also share the search results, as part of their research data, to prevent duplicate efforts for the researchers who want to update the review.

    About Speaker:
    Farhad Shokraneh studied Medical Library and Information Science for seven years and was a clinical librarian in an emergency department for a short time. He worked as a research fellow in Research Center for Pharmaceutical Nanotechnology for two years. Farhad later joined Cochrane Schizophrenia Group in University of Nottingham to manage the largest database of schizophrenia trials and to update over 320 Cochrane reviews. He is also a volunteer with 14 Cochrane groups.

    He ran his first systematic review search in 2004 and continued providing search and consultancy services to academic, clinical and policy making teams around the world for over 2,000 grant applications, clinical trials, economic evaluations, rapid reviews, scoping reviews, umbrella reviews, systematic reviews, overviews, health technology assessments, and clinical practice guidelines.
  • Is India Anywhere Closer to Implementing Continuous Bioprocessing
    Is India Anywhere Closer to Implementing Continuous Bioprocessing Narasimha Rao Nedunuri, CEO of CLONZ Biotech, and José Castillo, PhD, CTo and co-founder of Univercells Recorded: Aug 16 2018 66 mins
    Continuous processing has been widely employed in many biological manufacturing processes. In recent years it gained the momentum in the field of Biosimilar manufacturing due to an ever-increasing pressure for reduction in manufacturing costs.
    Potentially, the continuous processing offers Lower Cost of Goods, ease of scalability, and lower manufacturing footprint and hence became a topic of interest to many biosimilar players. Ongoing research on various new technologies for continuous operation, both in upstream and downstream processing may potentially be a game changer. Top on the wish list being, integration of all the multiple unit operations into a single continuous process with real time analytical tools.
    Though there are several challenges to develop and adapt continuous bioprocess, the magnitude of potential benefits are currently driving the research programs worldwide. India , being a significant global player in the biosimilar domain, currently making efforts to adapt these novel processes to make the drugs more cost effective.
  • Using sponsored research as a pathway to licensing early stage technologies
    Using sponsored research as a pathway to licensing early stage technologies Laura Schoppe, President and Owner of Fuentek Recorded: Aug 14 2018 46 mins
    Patent licensing negotiations have an extremely high fail rate- this can be down to unfavourable licensing terms or weak patent portfolios. One of the ways universities and industry are trying to bridge the gap between innovation and commercialisation is by working together much earlier.

    From a university standpoint, their research can be tailored to specific industry needs, as well as having research costs covered. Through the eyes of industry, they can get their hands on the latest research developments, and attract the brightest and talented individuals to their businesses.

    Laura Schoppe, President and Founder of Fuentek, who has years experience helping TTO's improve their chances of commercalisation will be joining us to discuss:

    - How to start sourcing strategic sponsorship deals
    - Where to begin with searching and conversations for partnerships
    - The benefits of this chosen pathway. i.e Minimising risk

    Please note: All viewers will have their data shared with our guest speaker.
  • Software-Defined Microsegmentation for Regulatory Compliance
    Software-Defined Microsegmentation for Regulatory Compliance Bill Parkinson & Jack Koons, Unisys Recorded: Aug 2 2018 60 mins
    Network segmentation is one of the must-have strategies to limit the scope, cost and complexity of compliance. The challenge in segmenting a network with static controls such as firewalls, VLANs, etc is the complexity of management and change. Access Control Lists (ACLs) and firewall rules can easily run into thousands of rules that have to be manually reconfigured every time there is a new application to be rolled out, or changes are introduced in regulations. The result is increased cost and complexity - the very challenge that you were trying to solve.

    In this webcast, Unisys cybersecurity experts will introduce you to a new software-defined network microsegmentation that enables dynamic perimeters to isolate the critical assets without the cost and complexity of static controls. This approach reduces attack surface while also reducing audit scope, cost and management complexity. Microsegmentation is not segmentation. Segmentation is done for network optimization and performance, and should not be confused or conflated with security. Microsegmentation is a security concept first and foremost. Unisys experts will elaborate on microsegmentation concepts with particular emphasis on its use in support of compliance issues. They will then take you through illustrative examples of isolating and securing systems in the context of HIPAA, HITECH and PCI-DSS regulations.

    Attendees of this session will:

    * Gain understanding of key challenges in achieving and maintaining compliance

    * Know the different types of network segmentation and their role - primary, secondary and microsegmentation, etc.

    * Gain ccomprehensive understanding of software-defined network microsegmentation and how it can save you cost, effort and the frustration that static controls introduce

    * Apply software-defined network microsegmentation to HIPAA, HITECH and PCI-DSS regulations using illustrative examples
  • NASH Clinical Trials - Challenges and Considerations
    NASH Clinical Trials - Challenges and Considerations Dr. Andrew Roche, PhD, Scientific Director, Global Validation, Scientific Affairs, ICON Recorded: Jul 30 2018 47 mins
    Overview of current challenges associated with NASH Clinical Trials and examination of potential strategies to address during trial design or study execution.
  • 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 Recorded: Jul 26 2018 69 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.
  • Building a Better VDR
    Building a Better VDR Brian Nickel, Sales Engineer @ Box; Riju Khetarpal, Managing Director @ Box; Bijon Mehta, Financial Services @ Box Recorded: Jul 25 2018 53 mins
    The Virtual Data Room (VDR) has become an essential tool for sharing time-sensitive data and intellectual property.

    Join us to learn how to build a better VDR that isn't held back by outdated UI, poor mobile capabilities, missing integrations and lack of collaboration tools.

    Here's what you'll find out:
    -How using Box for VDRs accelerates deal cycles — M&A term sheets, joint ventures, cross-licensing and other collaborations
    -Use cases from Life Sciences and Financial Services
    -How systems integrator MSI uses Box to build VDRs for clients
  • How to create a 5-year M&A plan for dealing with patent cliffs
    How to create a 5-year M&A plan for dealing with patent cliffs Jurgen Vollrath, President at Exponential Technology Counsel Recorded: Jul 25 2018 40 mins
    A ‘Patent cliff’ describes a severe drop in revenue once the patent for a company’s leading product expires. The sharp revenue decline is a result of competitors being able to start developing and selling the product, often at a much lower price.

    As US biopharmaceutical company Celgene struggles to get regulatory approval from the FDA, the company is facing major market, shares and revenue losses, and is facing a phenomenal patent cliff. Furthermore, research from EvaluatePharma reports that an estimated $250 billion in projected sales is at risk between 2018-2024 as many drugs lose exclusivity.

    When it comes to acquisitions, the effects of a dwindling patent term can severely impact the value of your company. So how do you create 5-year plan to prepare for an inevitable patent cliff? We are very excited to welcome back Jurgen Vollrath, President of Exponential Technology Counsel, and customer of PatSnap. ET Counsel, advise clients on IP strategy & business alignment to ensure the most successful M&A and exit outcomes.

    In this webinar, Jurgen will be discussing:

    - Risk vs. reality when it comes to patent cliffs
    - How to create a 5-year M&A plan for your organisation
    - How to find potential acquisition targets
    - Predicting the potential impact a patent cliff could have on your business.
  • High-Throughput Microfluidic Platform for Culture of 3D-Kidney Tissue Models
    High-Throughput Microfluidic Platform for Culture of 3D-Kidney Tissue Models Henriëtte Lanz, Ph.D. Recorded: Jul 24 2018 38 mins
    Drug toxicity remains a major issue in drug discovery and stresses the need for better predictive models. Here, we describe the development of a perfused renal proximal tubule cell (RPTC) model in Mimetas’ OrganoPlates® to predict kidney toxicity. The OrganoPlate® is a microfluidic platform, which enables high-throughput culture of boundary tissues in miniaturized organ models. In OrganoPlates®, ECM gels can be freely patterned in microchambers through the use of PhaseGuide technology. PhaseGuides define channels within microchambers that can be used for ECM deposition or medium perfusion. The microfluidic channel dimensions not only allow solid tissue and barrier formation, but also perfused tubular epithelial vessel structures can be grown. The goal of developing a perfused RPTC model is to reconstruct viable and leak-tight boundaries for performing cytotoxicity, as well as transport and efficacy studies. Human RPTC (SA7K clone, Sigma) were grown against an ECM in a 3channel OrganoPlate®, yielding access to both the apical and basal side. Confocal imaging revealed that the cells formed a tubular structure. Staining showed tight junction formations (ZO-1), cilia pointing into the lumen (acetylated tubulin) and correct polarization with microvilli on the apical side of the tubule (ezrin). Tightness of the boundary over several days was shown by diffusion of a dextran dye added to the lumen of the tubule. Addition of toxic compounds resulted in disruption of the barrier which could be monitored in time. The time point of loss of integrity corresponds with the concentration and the toxic effect of the compound. Furthermore, fluorescent transport assays showed functional transport activity of in- and efflux transporters. The 3D proximal tubules cultured in the OrganoPlate® are suitable for high-throughput toxicity screening, trans-epithelial transport studies, and complex co-culture models to recreate an in vivo-like microenvironment.
  • HPLC Method Development in One and a Half Days Using the Selectivity Concept
    HPLC Method Development in One and a Half Days Using the Selectivity Concept Dr. Frank Michel, Analytical & Chromatography Scientific Advisor, Merck KGaA, Darmstadt, Germany Recorded: Jul 24 2018 63 mins
    Modern HPLC technologies such as UHPLC, monolithic silica or Fused-Core™ particles provide superior separation efficiency and resolution of peaks. But in general resolution is more strongly impacted by selectivity which in turn can be affected by different stationary bonded phases. This presentation will discuss the choice of RP HPLC column chemistries such as RP-Amide, Phenyl, Pentafluorophenyl (F5) or Cyano which can provide alternative selectivities to traditional C18. It will compare their different retention mechanisms and highlight an approach to develop HPLC method within one and a half days.
  • Introducing the CellStreamTM System, A Highly-Sensitive, 7-Laser Flow Cytometer
    Introducing the CellStreamTM System, A Highly-Sensitive, 7-Laser Flow Cytometer Robert Smith-Mccollum and Christine Probst Recorded: Jul 18 2018 40 mins
    MilliporeSigma is excited to launch the new CellStreamTM benchtop flow cytometry system, a highly-customizable, highly-sensitive 7-laser flow cytometer. Its unique optics system and design provides researchers with unparalleled sensitivity and flexibility when analyzing cells and submicron particles. Within the CellStreamTM system, the Amnis® time delay integration (TDI) and camera technology rapidly captures low resolution cell images and transforms them into high-throughput intensity data. Researchers acquire the intensity data they are accustomed to from traditional flow cytometers, but with greater fluorescence sensitivity. Join us in this webinar to take a deeper look inside the instrument design, system performance and software of this exciting new system.
  • Multiplex immunoassay detection of Alzheimer’s disease biomarkers: Session 1
    Multiplex immunoassay detection of Alzheimer’s disease biomarkers: Session 1 Anthony Saporita, PhD Sep 26 2018 1:00 am UTC 75 mins
    Monitoring protein biomarkers in cerebrospinal fluid (CSF) of patients with Alzheimer’s Disease (AD) has been highly beneficial to understanding disease progression.  While several CSF biomarkers can reproducibly distinguish normal and diseased samples, CSF is a difficult biological fluid to obtain in research studies.  The need for blood-based biomarkers of AD has driven a continuous search for novel candidates.  Here we report the development of a multiplex immunoassay to quantitatively measure seven proteins present in both CSF and blood that are involved in neurological disease:  Neurogranin, TREM2, ApoE4, FABP3, Ferritin, angiogenin, and prion protein.  Notably, presence of the APOE4 allele is prominently associated with an increased risk for AD, in comparison to the APOE2 and APOE3 alleles.  Although these ApoE isoforms differ at only one or two amino acids, our assay distinguished ApoE4 with minimal cross-reactivity. Using this novel immunoassay, we measured these 7 biomarkers in CSF, plasma, and serum from AD patients and healthy controls.  Additionally, we developed an ultrasensitive Single Molecule Counting (SMCTM) assay for amyloid beta 1-42 (Aβ42).  This kit could detect the Aβ42 peptide in CSF and plasma at sub-pg/mL concentrations.  This study demonstrates the value of evaluating both novel and established biomarkers of neurodegeneration across distinct sample types.
  • Understanding and Optimizing Headspace SPME
    Understanding and Optimizing Headspace SPME Robert E. Shirey, Principal R&D Scientist, Merck KGaA, Darmstadt Germany Sep 26 2018 1:30 pm UTC 90 mins
    Solid phase microextraction (SPME) is a fast, economical, solvent-free, quantitative method for extraction of analytes out of a sample. When analysing volatile and semi-volatile analytes, extraction may be performed in the headspace, or space surrounding the sample, avoiding direct immersion of the fiber. This presentation will provide method development guidance for the extraction and quantification of analytes using headspace SPME. The mechanism of headspace SPME will be explained in detail. Methods for enhancing extraction efficiency will be described. Advantages of headspace SPME over other common extraction methods will be highlighted.
  • Tracking technology trends to maximise commercialisation value
    Tracking technology trends to maximise commercialisation value Mireya McKee CEO of McKee Innovation Consulting Sep 26 2018 3:00 pm UTC 60 mins
    Technology commercialisation at its core requires for an invention to be applied to a use case in a specific market. Doing this successfully will ensure that you are getting ROI out of your research and inventions. Mireya McKee has over 16 years experience in research, academia and commercialisation and will be talking about how she utilises technology trends to maximise commercialisation value.

    Some of the topics discussed in this webinar will be:

    * How to track technology trends
    * What can patents tell us about technology trends
    * Technology adoption cycle
    * How technology readiness levels can affect commercialisation opportunities
  • Multiplex immunoassay detection of Alzheimer’s disease biomarkers: Session 2
    Multiplex immunoassay detection of Alzheimer’s disease biomarkers: Session 2 Anthony Saporita, PhD Sep 26 2018 3:00 pm UTC 75 mins
    Monitoring protein biomarkers in cerebrospinal fluid (CSF) of patients with Alzheimer’s Disease (AD) has been highly beneficial to understanding disease progression. While several CSF biomarkers can reproducibly distinguish normal and diseased samples, CSF is a difficult biological fluid to obtain in research studies. The need for blood-based biomarkers of AD has driven a continuous search for novel candidates. Here we report the development of a multiplex immunoassay to quantitatively measure seven proteins present in both CSF and blood that are involved in neurological disease: Neurogranin, TREM2, ApoE4, FABP3, Ferritin, angiogenin, and prion protein. Notably, presence of the APOE4 allele is prominently associated with an increased risk for AD, in comparison to the APOE2 and APOE3 alleles. Although these ApoE isoforms differ at only one or two amino acids, our assay distinguished ApoE4 with minimal cross-reactivity. Using this novel immunoassay, we measured these 7 biomarkers in CSF, plasma, and serum from AD patients and healthy controls. Additionally, we developed an ultrasensitive Single Molecule Counting (SMCTM) assay for amyloid beta 1-42 (Aβ42). This kit could detect the Aβ42 peptide in CSF and plasma at sub-pg/mL concentrations. This study demonstrates the value of evaluating both novel and established biomarkers of neurodegeneration across distinct sample types.
  • Developability Assessment of Therapeutic Proteins – A Toolbox for Tackling Incre
    Developability Assessment of Therapeutic Proteins – A Toolbox for Tackling Incre Thorsten Lorenz, Team Head Developability Assessment Biologics, Novartis and Beate Kern, Product Manager, NanoTemper Sep 27 2018 8:00 am UTC 75 mins
    Title: Developability Assessment of Therapeutic Proteins – A Toolbox for Tackling Increasing Complexity
    Presenter: Thorsten Lorenz, Team Head Developability Assessment Biologics, Novartis

    Early lead selection of biotherapeutics during preclinical development requires careful characterization of a variety of molecule properties to reduce the risk for encountering unexpected obstacles during technical development. The diversity and increasing complexity of new protein formats requires a change from former platform approaches often applied for antibodies, to project specific strategies. The developability assessment concept applied at Novartis combines information addressing various technical areas, such as expression, aggregation propensity, process fit, stability, physicochemical properties, etc. This integrated concept prior to lead selection provides a thorough, yet resource efficient approach to select suitable candidates.
  • From Homegrown to Commercial PIM: Transition Strategies for Success
    From Homegrown to Commercial PIM: Transition Strategies for Success Alison Tran, Client Partner, EIS; Chantal Schweizer, Principal Consultant, EIS Sep 27 2018 5:00 pm UTC 60 mins
    As your business and product data complexity grows, so too may your need for an enhanced PIM system that accounts for numerous operating units, separate companies, global operations, and more.

    How do you judge whether you are ready to jump from your homegrown solution? And if you’re ready to make the jump, what is the best path to ensure that you transition from one system to another successfully?

    In this session you will learn:

    * The milestones that signal your readiness to take on a commercial PIM
    * Best practices when making the transition to a commercial PIM
    * How to align your PIM strategy to a logical data model

    SPEAKERS
    Alison Tran, EIS, Client Partner, brings over 14 years of business and technology consulting experience in technology adoption, software implementation, organizational redesign, change management and process reengineering.
    Chantal Schweizer, EIS, Principal Consultant, a senior information organization professional with over 10 years experience in product information and taxonomy design.
  • A full overview of different technologies to increase HPLC efficiency & speed
    A full overview of different technologies to increase HPLC efficiency & speed Dr. Frank Michel, Analytical & Chromatography Scientific Advisor, Merck KGaA, Darmstadt, Germany Oct 4 2018 6:00 am UTC 75 mins
    In the recent decades the demand for higher separation efficiency or higher speed in HPLC has increased strongly. The response to this demand was answered by modern HPLC technologies such as UHPLC with sub-2 µm particles, monolithic silica or Fused-Core™ particles. This webinar provides an overview on the factors that influence the speed of the HPLC method. It introduces the different approaches of small HPLC particles, Fused-Core (also known as core-shell) particle technology and monolithic silica rods and discusses the advantages and disadvantages of each approach. The presentation covers the theoretical background of these technologies and multiple examples of applications.
  • Implementing CMC Strategies for scale-up operations in biologics manufacturing
    Implementing CMC Strategies for scale-up operations in biologics manufacturing Dr Anita Krishnan, Lupinand -Dr. Annu Uppal, Global Demo Lead and Advanced Workflow Specialist at SCIEX Oct 5 2018 9:30 am UTC 75 mins
    Biotechnological products are so complex, that manufacturing biologics which are both cost-effective and with best product quality, is a technical challenge. In the context of biosimilar manufacturing at each step, the sponsor should evaluate the extent to which there is residual uncertainty about the biosimilarity of the proposed product. Often there is remnant quality difference beyond the capability of process to address. In such instances, in-depth understanding of the process, impurities, analytical methods, the mechanism of action (MOA) of the drug substance and clinical relevance of any observed structural differences, will help in implementing novel CMC strategies. This talk will examine the elements of biopharmaceutical development that lead to successful licensure of biotherapeutics.
  • Impact of Depth Filtration on Disulfide Bond Reduction during Downstream Process
    Impact of Depth Filtration on Disulfide Bond Reduction during Downstream Process Brian O’ Mara, Senior Research Scientist I, Bristol-Myers Squibb and Alexei Voloshin, Global Application Strategy Specialist Oct 8 2018 4:00 pm UTC 75 mins
    Title:Impact of Depth Filtration on Disulfide Bond Reduction during Downstream Process
    Presenter: Brian O'mara, Senior Research Scientist I, Bristol-Myers Squibb
    • Understand disposable depth filtration technology used in the recovery of antibodies from CHO cell cultures as a unit operation leading to cellular lysis under particular operational conditions • Study how cellular lysis occurring during depth filtration releases endogenous REDOX regulating enzymes and co-factors into the clarified harvest, resulting in the reduction of antibody interchain disulfide bonds • Classify critical process parameters and quality attributes of the clarified harvest to be monitored during filtration development • Discuss risk mitigation strategies to control antibody reduction when using single-use disposable technologies in the recovery of antibodies from CHO cells
  • Realising the biotech promise: addressing the path to market
    Realising the biotech promise: addressing the path to market Steve Bates, BIA, Sheela Upadhyaya, NICE, Fred Jacobs, TYG, Dean Summerfield, IQVIA Oct 9 2018 2:00 pm UTC 75 mins
    Now more than ever before, Biotech is the engine for innovation in medicine, finding, creating and delivering ground-breaking treatments to patients.

    The journey from molecule discovery and development through valuation, funding, regulatory and commercialisation can be a long and complex road to travel though.

    These companies have to navigate a rapidly changing and increasingly complex landscape from pre-clinical valuation through foresight and planning at every stage of the asset life cycle - and at a time when Brexit adds uncertainty about regulatory approval and launch windows.

    Working with IQVIA, pharmaphorum has assembled a specialist panel to discuss these challenges and the most effective routes to overcoming them.

    On Tuesday 9th October at 15:00 BST / 10:00 EST we will present a free-to-attend online debate which will bring these experts together to deliver insight on topics such as market valuation, financing, navigating regulatory hurdles, patient engagement & HTA strategies through to successful commercialisation.
  • Lighten Up!  Long-term imaging with ultra-bright, organic AIE cell trackers
    Lighten Up! Long-term imaging with ultra-bright, organic AIE cell trackers Liu Bin, PhD,Department Head - Department of Chemical and Biomolecular Engineering, National University of Singapore Oct 10 2018 3:00 am UTC 75 mins
    With the recent discovery of a special class of organic compounds with aggregation-induced emission (AIE) characteristics, new opportunities have opened for in vitro and in vivo imaging. In combination with advanced polymer encapsulation technologies, AIE compounds are now available as LuminiCell ultra-bright, organic nanoparticles that enable long-term cell tracking and imaging for applications such as cancer research and stem cell biology.
  • Why free sequence searching tools are putting your R&D at risk
    Why free sequence searching tools are putting your R&D at risk Jessie Parker @ PatSnap Oct 10 2018 3:00 pm UTC 60 mins
    Biotechnology and pharma research is infamous for being a difficult process that often takes a lot of time and an even greater amount of resources. Using free sequence searching tools to identify similarities between your molecule and therapies already on the market, may seem like a good cost-saving initiative.

    However, there is a cost of using free tools. They are often inaccurate, lack data completeness and also require you juggle multiple tools to get complete sets of metadata. This leaves a lot of room for error. And when you’re betting millions on each stage of research, this shouldn’t be the case.

    Join us to find out a better way to search sequences and how you can avoid making costly mistakes.
  • Actavis and equivalence – where are we now?
    Actavis and equivalence – where are we now? Douglas Drysdale, partner, HGF Oct 11 2018 2:00 pm UTC 90 mins
    The UK Supreme Court's 2017 decision in Actavis v Eli Lilly introduced a doctrine of equivalents into UK law. In this webinar, we'll discuss the implications of that decision and look at how it is being applied in other cases in the UK courts.
  • Engaging with patient communities – tailoring approaches
    Engaging with patient communities – tailoring approaches Jamie Bearse, Thomas Farrington, Chuck Strand and Jenny Kite Oct 11 2018 3:00 pm UTC 75 mins
    Change Together will be presenting a live webinar with leading figures from the patient advocacy community, who will discuss communication and engagement as well as the different approaches advocacy groups can take to address the unique challenges of their communities. This will be helpful for all advocates, as we hear and learn from our expert panel how their organizations are bringing about change.
  • Digital therapeutics and healthcare innovation
    Digital therapeutics and healthcare innovation Roberto Ascione, Healthware International, Megan Coder, Digital Therapeutics Alliance, Pierre Leurent, Voluntis Oct 12 2018 2:00 pm UTC 75 mins
    Digital technology is transforming the way that healthcare is practiced and delivered, with areas like digital therapeutics forging ahead to complement traditional medical approaches and augment patient care.

    The development of software applications that are available with a prescription took a major step forward last year with the first FDA approval for a mobile medical application with both a safety and efficacy label.

    At the same time as digital therapeutics are breaking new ground there’s a whole ecosystem of digital health innovations that are also tackling healthcare issues in new and imaginative ways.

    From doctor-patient communication to managing healthcare costs, from healthcare monitoring to clinician workflow, the range of digital health tools and services available is rapidly expanding.

    We’ll be looking at how digital and traditional approaches to medicine are being combined to improve patient outcomes.

    This free webinar will also see our expert panel:
    •Consider the current state of play with digital therapeutics and what the future holds for them
    •Discuss how to harness healthcare innovations to involve and engage patients
  • Searching for adverse effects of medical devices in MEDLINE and Embase
    Searching for adverse effects of medical devices in MEDLINE and Embase Dr Su Golder NIHR Research Fellow, Health Sciences, University of York Oct 15 2018 2:00 pm UTC 75 mins
    More info will follow.

    'Searching for adverse effects of medical devices in MEDLINE and Embase”

    •Importance of medical device adverse effects
    •Searching for adverse effects
    •Approaches to searching for medical device adverse effects
    •Search filters
    •Development
    •Application
    •Drawbacks
  • Extractables and leachables testing using a Quality Risk Management approach
    Extractables and leachables testing using a Quality Risk Management approach Dhaval Tapiawala, Pfizer Oct 17 2018 2:00 pm UTC 75 mins
    • Understanding extractables and leachables for better adoption of single use systems
    • Ensuring safety of drug through determining the level of leachables throughout product life cycle
    • Case Study of implementation of standardized testing protocol
  • What can patents teach large molecule scientists in the discovery phase?
    What can patents teach large molecule scientists in the discovery phase? Jessie Parker @ PatSnap Oct 18 2018 3:00 pm UTC 60 mins
    Biotechnology, as a sector, has grown immensely over the last 20 years. Innovation has been at the heart of its growth, with patent filings increasing 25% year-on-year.

    Yet many researchers and scientist are still leaving patentability and freedom to operate searches to the last stages of their innovation process—or even handing over to their IP team. This creates a high-risk environment because all your resources are being plunged into your research, without any indication of its novelty or commercial success.

    Join this webinar to find out how you can harness patent metadata to learn more about the molecules and sequences you are researching, and ultimately increase your innovation ROI.
  • 3D Organ-on-a-chip Applications Using the AIM Biotech Chip
    3D Organ-on-a-chip Applications Using the AIM Biotech Chip Kuan Chee Mun and Mahama Aziz Traore Oct 22 2018 1:00 pm UTC 75 mins
    In vitro 3D cell culture models have emerged as a bridge between conventional 2D cell culture models and the complex & expensive in vivo animal models. By analyzing and comparing the biological behavior of tissues embedded in 3 dimensional hydrogels, results are significantly different from classic 2D cell culture in terms of proliferation, morphology, drug response and gene expression. These differences have been attributed to the topographically complex 3D environment surrounding the cells, where cell adhesion, structure, effector transport and mechanotransduction are substantially altered. A carefully designed 3D model can provide more physiologically relevant information using experimental designs unachievable by conventional 2D assays at a fraction of the cost of in vivo models.
    Current 3D cell culture assays like hanging drop culture often lack the capability to organize different co-cultured cell types in a meaningful way. The application of chemical gradients or flow is usually not possible.
    We are now able to address this issue with a modular microfluidic platform that can co-culture multiple cell types in discrete 3D and 2D channels. Organotypic assays with animal model-like complexities using human cells have been developed for research, drug discovery & diagnostics. These include models for immune checkpoint, T-cell killing efficiency, angiogenesis, metastasis, cell migration, microvascular networks and the blood-brain barrier. Additional applications that focus on a liver model will also be discussed. Drug Induced Liver Injuries (DILI) contributes to drug failures, drug withdrawals and acute liver failures. The liver strongly interacts with other organ systems and in some instances the metabolites secreted by the liver are responsible for other organs' injury. Engineered 3D liver models may increase the physiological relevance of drug toxicity by maintaining the expression levels of key cytochrome P450 enzymes and metabolic activity in liver cells.
  • Making new connections – An overview of new TLC-MS Applications Session 1
    Making new connections – An overview of new TLC-MS Applications Session 1 Michaela Oberle Oct 23 2018 7:00 am UTC 75 mins
    In the last decade the trend for hyphenating different analytical techniques became an more and more important role in analytical labs. Combinations like LC-LC-MS or LC-MS-MS help to solve the analysis of complex samples in a proper way. The Analytical data which could be received are more sensitive focused on special analytes or give a better overview of the whole sample composition.

    This webinar should give the attendances an overview of the advantage and strength of (HP)TLC- MS coupling technique along various Applications from different analytical fields using different MS techniques. Tips and tricks for the right handling are be presented, to avoid main basic defaults.
  • Enhancing key PV Solutions to boost the efficiency of drug safety workflows
    Enhancing key PV Solutions to boost the efficiency of drug safety workflows Sherry Winter, Senior Solution Marketing Manager at Elsevier Oct 23 2018 2:00 pm UTC 75 mins
    Databases of peer-reviewed biomedical literature and regulatory documents are crucial sources for pharmacovigilance activities. When monitored properly, they yield drug safety signals that are essential for risk–benefit assessments and adverse event reports. However, both are vast resources that can be challenging to monitor efficiently and accurately, especially if different interfaces are needed to access each database.

    In 2018, Elsevier is enhancing key solutions for pharmaceutical R&D as part of ongoing efforts to improve the comprehensiveness, efficiency, accuracy and compliance of pharmacovigilance-focused research. By ensuring that all relevant information is captured efficiently, the company is helping drug safety and pharmacovigilance teams deliver considerable improvements in health-critical workflows.

    This webinar focuses on 2018 enhancements to Embase, PharmaPendium and QUOSA PV, showing how each solution offers dedicated means to boost the efficiency and accuracy of the monitoring of relevant databases, assessment of captured information, and supervision of the workflow. These enhancements include:
    - A dedicated Embase query form for efficient creation and validation of the complex search strings needed for high-recall, high-precision literature searching
    - An Embase French Local Language Module to extend the reach of Embase into specially selected French-language literature
    - More capabilities in PharmaPendium for searching the FDA Adverse Event Reporting System (FAERS)
    - Even more flexible means to run and oversee GxP-compliant workflows through QUOSA PV, with new functionalities for medical review, signal management and quality assurance. The webinar will address these solutions and enhancements in the context of comprehensive support for the goals of pharmacovigilance.
  • Making new connections – An overview of new TLC-MS Applications Session 2
    Making new connections – An overview of new TLC-MS Applications Session 2 Michaela Oberle Oct 23 2018 2:00 pm UTC 75 mins
    In the last decade the trend for hyphenating different analytical techniques became an more and more important role in analytical labs. Combinations like LC-LC-MS or LC-MS-MS help to solve the analysis of complex samples in a proper way. The Analytical data which could be received are more sensitive focused on special analytes or give a better overview of the whole sample composition.

    This webinar should give the attendances an overview of the advantage and strength of (HP)TLC- MS coupling technique along various Applications from different analytical fields using different MS techniques. Tips and tricks for the right handling are be presented, to avoid main basic defaults.
  • How to take advantage of the Biosimilars Action Plan
    How to take advantage of the Biosimilars Action Plan Jessie Parker @ PatSnap Oct 23 2018 3:00 pm UTC 60 mins
    The Biosimilars Action Plan is intended to boost biosimilar competition in the US. The plan has four main objectives:

    - Improve the efficiency of the biosimilar and the interchangeable product development and approval processes

    - Maximise scientific and regulatory clarity for biosimilar drug manufacturers

    - Develop effective communications to improve understanding of biosimilar drugs among the patient community, providers and payers

    - Support market competition by reducing gaming of FDA requirements or other attempts to slow market competition


    Join this webinar as we discuss the different ways biologics and pharma companies can begin to take advantage of this plan.

    In this webinar, we will discuss:

    - How to create a biosimilar pipeline
    - New FDA approval systems
    - How can both small and large companies be more efficient in their research
  • Emerging Quantum Dot Materials: Synthesis and Application
    Emerging Quantum Dot Materials: Synthesis and Application Osman M. Bakr, PhD Oct 25 2018 1:00 pm UTC 75 mins
    Quantum Dots (QDs) undoubtedly attracted lots of interest with their superior luminescent properties. What is distinct about their luminescent properties is that the wavelengths of emitted light can be precisely tuned by changing of nanoparticle size or composition. Quantum dots possess narrow full width at half maximum (FWHM), high photoluminescence quantum yield (PLQY), emission wavelength tunability through the entire visible and near IR range. In this webinar, we talk about synthesis and application of emerging quantum dots materials: Perovskite and PbS QDs. Perovskite QDs emit light within the visible range, have high PLQY (up to 100 %), narrow FWHM (below 20-25 nm), and are considered as the best alternatives for CdSe and InP QDs for display application. PbS QDs emit light in near IR region with narrow FWHM of absorption and emission, making them ideal in NIR photodetectors and solar cells.
  • Safety First Throughout the Histology Workflow
    Safety First Throughout the Histology Workflow Shalmica Jackson, PhD Oct 25 2018 4:00 pm UTC 75 mins
    From tissue processing to slide coverslipping, the histology workflow is laden with hazardous steps. Chemical sensitizers, strong acids, alkaline substances, and oxidizing agents are routinely used during histological workflows. These classes of chemicals are known to damage and even destroy living tissues. Ensuring the safety of laboratory workers is of the utmost importance. This workshop will present new approaches to help make the histopathology laboratory a safer environment with the use of formalin-free fixatives, phenol-free stains, DBP-free mounting media, IVD-certified ready-to-use reagents, and more.