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    • Overcoming Analytical Method Development Challenges
      Overcoming Analytical Method Development Challenges Karina Kwok, PhD, Associate Principal Scientist, Laboratory Sciences Mark Wolfe, BS, Senior Research Scientist Recorded: Jul 17 2014 5:00 pm UTC 37 mins
    • Title:
      Overcoming Analytical Method Development Challenges: Analysis of Nonclinical Dose Formulations from hERG Studies

      Abstract:
      The ICH S7B guidelines recommend in vitro assessment for drug-induced prolongation of the QT interval for most small molecule IND submissions. The hERG (human ether-a-go-go-related gene) channel is an inward rectifying potassium channel that controls the cardiac action potential repolarization. Drugs that inhibit the hERG channel have the potential to prolong the cardiac action potential and cause torsade de pointes. A broad range of in vitro concentrations assessments on the hERG channel activity relative to the Cmax plasma levels will give an estimated safety margin for the liability for delayed ventricular repolarization.

      Formulation analysis of the test article in study vehicles are needed to determine the concentration, uniformity, and stability of the formulation. For hERG studies, the vehicle is a physiological salt solution (PSS). Depending on the physicochemical characteristics of the test article, the development of a suitable analytical method for the analysis of the test article in PSS can pose unique challenges in the areas of solubility, stability, and recovery from the formulation for analysis. All challenges require analytical expertise in method development and a methodical approach so that a suitable method can be developed and validated.

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    • Analytical Innovation: How to Build the Next Generation Data Platform
      Analytical Innovation: How to Build the Next Generation Data Platform James Curtis, Senior Analyst, Data Platforms & Analytics, 451 Research & Jacque Istok, Head of Data, Pivotal Recorded: Sep 14 2017 6:00 pm UTC 63 mins
    • There was a time when the Enterprise Data Warehouse (EDW) was the only way to provide a 360-degree analytical view of the business. In recent years many organizations have deployed disparate analytics alternatives to the EDW, including: cloud data warehouses, machine learning frameworks, graph databases, geospatial tools, and other technologies. Often these new deployments have resulted in the creation of analytical silos that are too complex to integrate, seriously limiting global insights and innovation.

      Join guest speaker, 451 Research’s Jim Curtis and Pivotal’s Jacque Istok for an interactive discussion about some of the overarching trends affecting the data warehousing market, as well as how to build a next generation data platform to accelerate business innovation. During this webinar you will learn:

      - The significance of a multi-cloud, infrastructure-agnostic analytics
      - What is working and what isn’t, when it comes to analytics integration
      - The importance of seamlessly integrating all your analytics in one platform
      - How to innovate faster, taking advantage of open source and agile software

      We look forward to you joining us.
      The Pivotal Team

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    • Process analytical Technology for Upstream Bioprocessing
      Process analytical Technology for Upstream Bioprocessing Erica Fratz-Berilla & LCDR Agarabi Upcoming: Mar 5 2018 3:00 pm UTC 75 mins
    • In commercial cell culture bioprocessing, consistent high quality protein is a fundamental goal that is typically accomplished during development through product and process engineering of bioreactor parameters. The FDA’s Center for Drug Evaluation and Research (CDER)’s Office of Biotechnology Products’ upstream bioprocessing laboratory, a part of the Office of Pharmaceutical Quality’s Center of Excellence (COE) in Manufacturing Science and Innovation, studies Process Analytical Technology (PAT) for upstream bioprocessing, focusing on the production of monoclonal antibodies. These capabilities are being leveraged to study continuous bioreactor cell culture production and compatible PAT tools. Case studies are presented that illustrate collaborative laboratory research being conducted on PAT tools for upstream bioprocessing to support regulatory decision making.

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    • The Age of the Digital Insurance Customer and Importance of the Analytical 360
      The Age of the Digital Insurance Customer and Importance of the Analytical 360 Karen Pauli, Strategy Meets Action, Bill Whittemore - Kevin Claybon at Clarity Insights, Cindy Maike, Hortonworks Recorded: May 4 2017 5:00 pm UTC 67 mins
    • Every insurance company regardless of line of business is focused on enabling the digital customer experience with the goal of enhanced profitability, lowering costs and creating stronger customer loyalty. However, many are struggling to achieve this goal challenged a history policy and/or product based business models. Additionally, many continue to use a traditional MDM based approach to solve the customer data. During this roundtable-based webinar we will discuss how to look at your customer operational data, big data and third-party customer data differently. The panel will discuss the differences between an analytical approach vs. an operational approach; how best to account for the differences in dynamic vs. static customer data; and what approaches have been most successful in the insurance industry.

      Speakers:

      Karen Pauli, Principal at Strategy Meets Action
      Bill Whittemore, Associate Partner – Insurance and Financial Services at Clarity Insights
      Kevin Claybon Principal Consultant at Clarity Insights
      Cindy Maike, GM of Insurance Solutions at Hortonworks.

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    • Analytical Strategies for Comparability in Bioprocess Development
      Analytical Strategies for Comparability in Bioprocess Development Christine P. Chan, Ph.D & Joe Barco, Ph.D. Recorded: Mar 28 2017 2:00 pm UTC 71 mins
    • Comparability exercises are commonly required at certain milestones during drug development as well as after product registration when changes are implemented into the manufacturing process. The goal is to evaluate if the product remains highly similar (not necessarily identical) before and after the change in terms of quality and stability and have no adverse impact on safety and efficacy predicted for the patients. This assessment requires product-specific knowledge gathered through drug development, taking a totality-of-evidence approach. The different levels of information are obtained from analytical studies for characterization of the molecule, animal studies for toxicity, pharmacokinetics and pharmacodynamics for pharmacological activities, and clinical studies for safety/tolerability, immunogenicity and efficacy. This Webinar discusses strategies and considerations for analytical characterization of protein structure and function which forms the foundation of the comparability demonstration.

      Sponsored by Unchained Labs

      Presentation Title: Limber up your lab with better tools for comparing biologics

      There’s no magic bullet when it comes to characterizing a protein by structure or function. Specific tests may work for one molecule but not the next. Instrumentation that provides a high degree of flexibility, balanced with low sample consumption and faster time to result, is crucial to keep up with ever changing laboratory needs. Unchained Labs puts biologics characterization front and center for our instrumentation development. We will discuss how our instruments let researchers be more flexible and efficient, while also providing clear data to help make comparability assessments.

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    • RAID AID: The Analytical Interface Dashboard for ZFS Lustre
      RAID AID: The Analytical Interface Dashboard for ZFS Lustre Rich Brueckner at InsideHPC and Yugendra Guvvala, VP of Technology at RAID Inc Recorded: Dec 16 2016 1:45 am UTC 5 mins
    • Rich Brueckner at InsideHPC discusses the RAID Inc Lustre-tuned cross-platform dashboard. This file system agnostic analytical tool enables centralized self control over the full range of computing resources, such as Lustre ZFS and Intel® Enterprise Edition for Lustre.

      Lustre Over ZFS storage solutions offer greater performance for HPC technical computing, cloud, big data center and high density elastic storage.

      Lustre with ZFS brings a robust, scalable file system with features not available in other file systems. ZFS enables economical storage for Lustre solutions.

      RAID AID provides a comprehensive set of metrics using open-source protocols to measure, monitor and alert for example, monitoring IOPS, latency, capacity for mission critical applications. The AID tool intelligently provides a real-time optimized pipeline in which overlapping workloads run efficiently, reliably, and at the lowest-practical cost.

      Key Features Include:
      •Browser based GUI with alerting and logging
      •Real-time analytics and dashboard level metrics
      •Health and performance monitoring dashboard
      •Component level health information gathering
      •Drive performance monitoring on JBODs
      •System health service alerts
      •Network capable PDUs, UPSs and Switch monitoring
      •Automated Syslog and email notifications
      •Full API integration
      •SMART and SES
      •Firmware updates
      •File system level monitoring (coming soon)
      •Node provisioning (coming soon)

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    • An Analytical Approach to APT
      An Analytical Approach to APT Josh Goldfarb, CTO – Emerging Technologies at FireEye Recorded: Jun 15 2016 1:00 pm UTC 45 mins
    • We hear about Advanced Persistent Threats (APT) all the time, whether in the news or the impact it has on organisations, but how often do we learn something new and actionable?

      Join this webinar with Josh Goldfarb, CTO – Emerging Technologies at FireEye to learn:

      - How are attackers changing the tools, techniques, and procedures that they use?

      - What can organisations do to guard against the threats of today and prepare for the threats of tomorrow?

      - How can taking an analytical approach to APT benefit your organisation and improve its security posture?

      Register today and learn how an analystical approach using threat intelligence and orchestration can improve your organisations security posture

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    • Interactive Analytical Storytelling
      Interactive Analytical Storytelling Robert Tischler, Senior Analyst, BARC & John Sands, Evangelist, Qlik Recorded: Aug 22 2017 4:35 pm UTC 407 mins
    • From gut feeling to fact based decision making.

      While data and the availability of good insights are growing, decisions are often still being made based on gut feeling instead of factual evidence. Engaging people and teams to leveraging the insights into actions is a challenge and Robert Tischler, Senior Analyst from BARC, will explain why Storytelling is the rescue. BARC recently did a survey among European organisations about the current state and future of data storytelling and he will share these learnings with the benefits and next steps to take to apply within your organisation. John Sands from Qlik will then show you how you can interact and collaborate in an easy and transparent way and share a best practice in how Qlik customers successfully leverage Storytelling in their work environment.

      Robert is Managing Director and Senior Analyst at the Business Application Research Center (BARC) Austria. His specialty areas are Business Intelligence Front Ends and process oriented Business Intelligence applications. He supports companies in the software selection process, during the introductory phase and with reviews to optimize architecture and organization. Robert has many years of experience as a project manager of BI projects, hands-on expertise with many BI tools on the front end, as well as in the backend, designing, coaching and implementing reporting, analysis and planning solutions with a focus on self-service BI, Information Design and advanced planning.

      John has ten years of experience of working with Qlik and 20 years' experience in the software industry. He has been involved with Qlik as it evolved into the platform of choice for many enterprise companies. John has presented globally talking about the BI Industry and how the Qlik platform has been such a game changer. He has spoken about mobile technology and how it has changed the face of IT, making people demand quicker software in the workplace, sparking the Bring Your Own Device movement.

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    • Fraud - Changing the game – results from an analytical proof of concept
      Fraud - Changing the game – results from an analytical proof of concept Andy Brown Recorded: Oct 28 2014 2:30 pm UTC 58 mins
    • David Divitt – Changing the game – results from an analytical proof of concept

      This webinar will discuss the exciting results of a major proof of concept that was undertaken between Alaric’s modelling team and a tier 1 UK Issuer. Using self-learning Bayesian models, we were able to not only beat the industry standard and their internal models, but all in a matter of weeks.

      Q&A

      Customer Successes Using Fractals

      - Looking at uses of Fractals in the real world we will see the ways customers are putting our technology to use and how it has benefitted them and their businesses

      Q&A

      Andy Brown - Making use of Data – leverage the power of data to prevent fraud

      - A layered approach to fraud prevention is absolutely necessary in todays sophisticated market. Learn how to take advantage of all the new data available in new payment types using the technology of the Fraud Integration Hub.

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