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Life Sciences

  • 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.
  • 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.
  • Key components of a comprehensive program for the management of single use techn
    Key components of a comprehensive program for the management of single use techn John Maguire, Shire & Donald Young Thermo Fisher Recorded: Jul 18 2018 74 mins
    As a result of the increased adoption of single-use technologies (SUTs) in biotech manufacturing, companies need to develop and implement programmatic approaches for the management of these systems under regulatory compliance. This webinar discusses the key aspects of such programs, with emphasis on collaboration with suppliers, cost management, as well as practical insights about the use of SUTs.
  • Proficiency Testing Portal Training
    Proficiency Testing Portal Training Jennifer Duhon Recorded: Jul 12 2018 17 mins
    We have taken your feedback shared with us over the years and used this to help improve our service to you. With this new portal, you will find new features including your methods now saved as default, graphical reports, the option to trend your data, as well as the ability to expand and collapse your items on the data entry screen which will allow for quicker loading times. This presentation will go through each feature step by step. If you could like to skip straight to how to enter data, please go to slide 34.
  • How to accelerate your innovation pipeline using Social Impact Investments
    How to accelerate your innovation pipeline using Social Impact Investments Rosemarie Truman from The Center for Advancing Innovation Recorded: Jul 12 2018 45 mins
    Social Impact Investment brings together capital and experience from the public, private and non-for-profit industries to achieve specific social objectives. The return of these investments is measured typically by the social outcomes achieved.

    The Centre of Advancing Innovation is a public-private partnership non-profit focused on identifying breakthrough inventions hidden in portfolios, to maximise investor returns and commercial success. Research performed by the group has highlighted that Social Impact projects accelerate innovation, and result in higher returns.

    In this webinar, Rosemarie Truman, CEO and Founder of CAI will be discussing the positive implications of choosing social impact projects for your business, including:

    - Why they accelerate innovation
    - How these projects can increase your potential investment opportunities for the future
    - The influence on the future funding of projects.
  • Development and Manufacturing of Recombinant Nanoparticle Vaccines
    Development and Manufacturing of Recombinant Nanoparticle Vaccines Atin Tomar, President of CPL Biologicals & Amelie Boulas Of Sartorius Stedim Recorded: Jul 12 2018 67 mins
    A recombinant vaccine technology platform based on highly purified, properly-folded protein antigens in stable well-defined Nanoparticles, enabling efficient and safe manufacture of vaccines against highly pathogenic targets. Nanoparticles are intrinsically immunogenic, producing both durable neutralizing antibodies and cellular immunity. The platform can be utilized for rapid response to potential pandemics as the time from identification of relevant viral gene sequence to final GMP drug product ready for human studies has been demonstrated to take less than 4 months for multiple vaccines.
    The GMP drug substance manufacturing process for the platform largely utilizes single-use technologies. Single-use-technologies and recombinant platform enables the utilization of same manufacturing facility for multiple products with rapid change-over.
  • Raman spectroscopy measurements during Bioprocessing
    Raman spectroscopy measurements during Bioprocessing Nobel Vale, Research Scientist II, Bristol-Myers Squibb and Justin Moretto, Bioprocessing Consultant, Kaiser Optical Systems, Recorded: Jul 11 2018 78 mins
    Raman spectroscopy has been seen as spectroscopic tool used in bioprocessing to monitor and control cell metabolism to optimize quality and yield of titer. This is due to Raman’s insensitivity to water and ability to analyze samples without manipulation. However there are certain challenges for Raman when analyzing a complex and dynamic sample such as a cell culture. This article will describe the different challenges in analyzing in-line Raman data and how to mitigate changes in samples that include changes in fluorescence background, presence of cells/debris in samples, and spectral interference.
  • Introduction to PharmaPendium: Leveraging FDA and EMA drug approval data
    Introduction to PharmaPendium: Leveraging FDA and EMA drug approval data Sherry Winter, PhD Recorded: Jul 11 2018 56 mins
    NOTE the date change.
    Learn how comparative information from FDA and EMA drug approval documents supports critical drug development decisions
  • Object Storage. What it Solves & Why it’s Better for Your Data at Scale.
    Object Storage. What it Solves & Why it’s Better for Your Data at Scale. Mike McWhorter, Senior Technologist, Western Digital Recorded: Jul 10 2018 25 mins
    Most have heard about object storage, but what problem is it solving, and how does it compare to other storage solutions like SAN or NAS? If these are questions you’ve asked yourself this webinar is for you! (Hint: The problem Object Storage solves is scalability.)

    Join Senior Technologist Mike McWhorter as he explains how Object Storage differs from SAN, NAS and distributed file systems, the unique technological features which make object storage ideal for archiving, accessing or protecting data (especially unstructured data), and how different industries are using Object Storage today.

    Register today to watch live or for the on-demand recording.
  • Proficiency Testing Portal Training
    Proficiency Testing Portal Training Jennifer Duhon Recorded: Jul 10 2018 17 mins
    We have taken your feedback shared with us over the years and used this to help improve our service to you. With this new portal, you will find new features including your methods now saved as default, graphical reports, the option to trend your data, as well as the ability to expand and collapse your items on the data entry screen which will allow for quicker loading times. This presentation will go through each feature step by step. If you could like to skip straight to how to enter data, please go to slide 34.
  • Soft Tissue Cancer & IHC
    Soft Tissue Cancer & IHC Jeff Gordon Recorded: Jun 29 2018 65 mins
    Soft tissue tumors are a broad group of neoplasms that involve the connective tissue of the body. Each year, over 13,000 people in the US are diagnosed with soft tissue sarcomas and over 5,000 people succumb to the malignancy. Because soft tissue sarcomas are very ambiguous and amorphous, many time sarcomas are classified as an uncertain type. Advances in immunohistochemistry as well as the utility of novel markers such as TFE3, TLE1, MyoD1, and MUC4 have aided pathologists in classifying these soft tissue tumors. This discussion will cover the key facts and statistics about soft tissue tumors and what role IHC plays in these difficult diagnoses.
  • Multiplexed immunofluorescence and digital image analysis for clinical use
    Multiplexed immunofluorescence and digital image analysis for clinical use Mehrnoush Khojasteh, PhD & Lei Tang, PhD Recorded: Jun 28 2018 63 mins
    There is an ever increasing need to understand the role of the Tumor Microenvironment (TME) in Cancer Immunotherapy. In this webinar, Drs. Lei Tang, PhD and Mehrnoush Khojasteh,PhD of Roche Tissue Diagnostics (Ventana Medical Systems, Inc.), present their work on multiplex immunofluorescence staining and digital pathology analysis in a CAP/CLIA certified laboratory. Multiplexed immunohistochemistry (IHC) enables the spatial characterization of TME immune cells and tumor cells by detecting multiple biomarkers while preserving tissue morphology. Co-expression of multiple biomarkers and relative spatial relationships requires whole slide digital pathology image analysis algorithms that are tailored to individual assays and their intended uses. The process described in this presentation demonstrates how multiplexing and digital pathology enable biotech and pharmaceutical research and development teams to explore the potential medical value of specific biomarkers,
  • CRISPR Protein Products
    CRISPR Protein Products Yanfang Jiang, Ph. D. Recorded: Jun 28 2018 32 mins
    MilliporeSigma is a pioneer in commercially offering targeted genome editing tools. With its 14-year experience in the first generation of genome editing tools such as TargeTron® and Zinc Finger Nuclease, MilliporeSigma has emerged as a prominent leader in the development of CRISPR systems, the most flexible and efficient genome editing technology thus far developed. CRISPR-based DNA integration patents have been granted to MilliporSigma in seven regions including Australia, Canada, the European Union, Singapore, Israel, South Korea, and most recently in China. The MilliporeSigma CRISPR portfolio consists of an array of CRISPR products, in both the plasmid, RNA, protein, and lentiviral formats. MilliporeSigma is also the first commercial provider to offer both pooled and arrayed whole human genome CRISPR libraries.

    In this webinar, we will give an introduction to our current CRISPR protein products, including SpCas9 (CAS9PROT), Cas9-D10A nickase (CAS9D10APR), high fidelity eSpCas9 (ESPCAS9POR), catalytically inactive dCas9-FLAG-biotin (DCAS9PROT), and FnCas9 (FNCAS9PROT), focusing on specific enzyme characteristics of each protein and their potential applications for the research community.
  • Strategies to overcome Low Endotoxin Recovery using the conventional LAL assay
    Strategies to overcome Low Endotoxin Recovery using the conventional LAL assay Dr. Ruth Daniels, Janssen & Kevin L. Williams, BIOMÉRIEUX USA, Inc. Recorded: Jun 28 2018 63 mins
    Title: Strategies to overcome Low Endotoxin Recovery using the conventional LAL assay
    Presenter: Dr. Ruth Daniels, Janssen
    This presentation will discuss:
    - Endotoxin hold time studies to identify LER
    - In silico assessment of interfering factors and associated LER mitigation strategies
    - Case study: optimization of product-specific LAL assay to overcome LER

    Title: : Addressing LER at the root, with ENDO-RS® sample preparation (demasking) prior to endotoxin assay of choice
    Presenter: Kevin L. Williams, Senior Scientist Endotoxin - BIOMÉRIEUX
    Scientific studies have demonstrated that biologics typically containing protein in high concentrations and non-ionic surfactants, are likely to change the aggregate state of endotoxin in such a way that it is no longer accessible for detection with Factor C-based endotoxin detection methods (LAL and rFC). The ENDO-RS® endotoxin recovery method developed by Hyglos - a bioMérieux company, is a unique toolbox of dedicated reagents for demasking (recovering) endotoxin prior to detection, also for conventional LAL. This presentation covers the mechanism of LER, regulatory requirements, work principle of ENDO-RS, the demasking services of bioMérieux, as well as method application data.
  • How to make digital work in medtech
    How to make digital work in medtech Bryn Davies (Critical Insights), Lars U. Diemer (Agnitio), Markus Ott (Ascensia), Jerome d'Astros (Edwards Lifesciences) Recorded: Jun 21 2018 71 mins
    The rise of mobile devices and apps, not to mention the involvement of non-medical technology players, is creating a wave of irrevocable digital change for medtech.
    It’s transforming how the sector reaches and engages with its stakeholders and customers, and in doing so provides vital opportunities to reshape a company’s commercial model.
    But although the sector can lay claim to some key success stories with digital technology, there remain a number of roadblocks impeding real digital progress for medtech.

    In this webinar we will discuss key digital lessons for medtech from other healthcare sectors, steps to take for a successful digital transformation and how to ensure ROI from digital technology.
    The free webinar will also see our expert panel:
    •Explore the practical impacts of the new medtech business model
    •Re-think the customer experience for payers and HCPs
    •Learn how digital technology enables you to deliver more customer value – while powering commercial success
    •Find out how virtual engagement technologies can make it happen
    •See best practices and use cases from your peers
  • Platform tech development for biosimilar upscaling
    Platform tech development for biosimilar upscaling Dr Hung Fai Poon, President, QuaCell Biotech Ltd and Floris De Smet, Sartorius Stedim Biotech Recorded: Jun 21 2018 68 mins
    Discover strategies to move candidate molecules through development
    Building consistent, straightforward processes with low variability
    Exploring the possibility of using single use, high throughput bioreactors in the upscaling process
  • Systematic reviews with Embase and Mendeley
    Systematic reviews with Embase and Mendeley Xuanyan Xu, Embase Solution Marketing Manager; Max Dumoulin, VP of Institutional Offerings at Elsevie Recorded: Jun 20 2018 51 mins
    (details to be updated)

    - How to use PICO search form in Embase to build effective search for systematic reviews
    - How to use Index miner and Find similar records to support a complex search query building
    - How to use Mendeley for systematic review
  • Short Tutorial: Techniques for Harvesting Adherent Cells
    Short Tutorial: Techniques for Harvesting Adherent Cells Corning Life Sciences Recorded: Jun 18 2018 5 mins
    Harvesting your cells is an important step in maintaining healthy cultures. Good technique will lead to a healthy single cell suspension. There are many harvesting options depending on the cell line and application. In this video, we will discuss some tips/tricks to harvesting cells.
  • 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 Aug 16 2018 8:30 am UTC 75 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.
  • 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 Aug 22 2018 2:00 pm UTC 75 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.
  • 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 Aug 23 2018 2:00 pm UTC 75 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.
  • 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 Aug 28 2018 3:00 pm UTC 60 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.
  • 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 Aug 28 2018 3:00 pm UTC 60 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?
  • SMC Technology: Detect biomarkers at levels previously undetectable
    SMC Technology: Detect biomarkers at levels previously undetectable Anitaben Tailor Ph.D Sep 5 2018 2:00 pm UTC 75 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.
  • 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 Sep 6 2018 11:00 am UTC 75 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).
  • Project and Portfolio Management as a key tool to manage continuous improvement
    Project and Portfolio Management as a key tool to manage continuous improvement Gloria Gadea-Lopez, Ph.D.and Melvin Santos Sep 6 2018 2:00 pm UTC 75 mins
    Continuous improvement, risk mitigation and adherence to compliance rely on the successful execution of key initiatives aligned with an organization’s strategic imperatives. This article summarizes the Project and Portfolio initiatives at Shire’s Biologics manufacturing facility at Shire, Lexington, MA site. In addition to practical advice, the authors discuss the need for sound business processes, alignment with Finance and budget cycles, and play special attention to the importance of resource allocation and management.
  • 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 Badertscher ,Scientist Continuous Bioprocessing Pall Sep 11 2018 8:00 am UTC 75 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
  • Second Medical Use Patent Opportunities from Personalised Healthcare Inventions
    Second Medical Use Patent Opportunities from Personalised Healthcare Inventions Dr. Laurence Gainey, Patent Director, HGF Sep 11 2018 2:00 pm UTC 90 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.
  • Introducing Embase French Local Literature Module
    Introducing Embase French Local Literature Module Yvonne van de Vrede, Embase Product Manager Sep 12 2018 2:00 pm UTC 60 mins
    Please note the new date and time

    Literature is one of the essential sources to identify high quality ADR reports. Regulatory authorities require companies to monitor major international publications through databases, as well as local, non-English content sources in each of the countries where the drugs are marketed. Currently, the local, non-English content sources is not available in most international literature databases, therefore screening, reviewing and monitoring this type of literature costs extra time, money and creates an additional compliance risk.

    In this webinar, Embase product manager Yvonne van de Vrede will discuss:
    -The challenges in Local Literature Monitoring process for pharmacovigilance, with a focus on the French market
    -The concepts of Embase French Local Literature Module
    -How to use this module in Embase.com to build effective searches to identify the mention of drugs and ADRs in French journals

    About Speaker:
    Yvonne van de Vrede has a degree in Molecular Pharmacology from the Free University in Amsterdam and a French MSc equivalence in Neurosciences from the University Paris VI. She started working for Elsevier in 2002 and has dealt with Embase in different roles: as an Index Quality Manager, a Thesaurus development manager, Account Manager and as a Project Manager. Since 2016, she has worked as Embase Product Manager for the content coverage and development, customer engagement and vendor relationship.
  • 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 Sep 18 2018 2:00 pm UTC 75 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.
  • 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 Sep 19 2018 2:00 pm UTC 60 mins
    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.
  • 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 Sep 20 2018 1:00 pm UTC 75 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.
  • 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.
  • 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.
  • 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
  • Overview of Certification Procedures for Organic Certified Reference Materials
    Overview of Certification Procedures for Organic Certified Reference Materials Ingrid Hayenga, PhD & Markus Obkircher, PhD Sep 27 2018 6:00 am UTC 75 mins
    his webinar highlights the different certification procedures regarding organic standards.

    Certified reference materials (CRMs) are an important and essential part of quality assurance. Laboratories accredited according to ISO 17025 must use CRMs on a regular base to prove their quality.

    For organic compounds, only a very limited number of CRMs from metrological institutes are available, due to this the big challenge is traceability.


    In this webinar, you will learn:
    •The certification process of the organic standard solutions by qNMR from the point of view of a commercial producer of certified reference materials under ISO/IEC 17025 and ISO 17034 accreditation.
  • 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 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.
  • Overview of Certification Procedures for Organic Certified Reference Materials
    Overview of Certification Procedures for Organic Certified Reference Materials Ingrid Hayenga, PhD & Markus Obkircher, PhD Sep 27 2018 2:00 pm UTC 75 mins
    This webinar highlights the different certification procedures regarding organic standards.

    Certified reference materials (CRMs) are an important and essential part of quality assurance. Laboratories accredited according to ISO 17025 must use CRMs on a regular base to prove their quality.

    For organic compounds, only a very limited number of CRMs from metrological institutes are available, due to this the big challenge is traceability.


    In this webinar, you will learn:
    •The certification process of the organic standard solutions by qNMR from the point of view of a commercial producer of certified reference materials under ISO/IEC 17025 and ISO 17034 accreditation.
  • 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 8:30 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
  • 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
  • Application of Multivariate Data Analysis for Process Diagnostic and Root Cause
    Application of Multivariate Data Analysis for Process Diagnostic and Root Cause Ramila Peiris, Ph.D., Manager, Process Modelling and Process Analytical Technology, Sanofi Pasteur Oct 23 2018 2:00 pm UTC 75 mins
    The utilization of Multivariate Data Analysis (MVDA) techniques at Sanofi Pasteur, Toronto site has demonstrated innovative capabilities for improved process understanding, control and diagnostics. Examples from several successful and high impact applications will be presented. These examples cover the application of MVDA techniques in multivariate process control, root cause investigations and process analytical technology (PAT). The areas of application include fermentation, downstream purification and product formulation stages.