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Life Sciences

  • Total Nitrogen Test Kits as an Alternative to TKN, Nitrate, and Nitrite Tests
    Total Nitrogen Test Kits as an Alternative to TKN, Nitrate, and Nitrite Tests Taylor Reynolds; Ed Askew Ph.D. Recorded: Dec 14 2017 48 mins
    Currently the US EPA has not promulgated a method for the analysis of Total Nitrogen (TN). Most states that have TN regulations require permitee's to measure TN as the composite of TKN, Nitrate and Nitrite. This approach is costly, time consuming, and also susceptible to variability based on the methods used for the individual analytes Merck, KGaA, Darmstadt, Germany is excited to announce the introduction of a Total Nitrogen Test Method consisting of a single spectrophotometric test kit. The method has been evaluated in a multilab study and this webinar will present the results of that study as well as an overview of the savings made possible by utilizing this new method for testing Total Nitrogen.
  • Rapid Fontana-Masson Staining
    Rapid Fontana-Masson Staining Vikas Palhan, PhD, Senior R&D Scientist, Emerging Biology - Genomics Recorded: Dec 14 2017 23 mins
    In the continued effort to save you time and simplify your workflow, we’ve developed a Fontana-Masson Staining Kit with a protocol that is 30x faster than the standard protocol. In this webinar, the researcher who developed the kit explains how easy it is to use this new rapid microwave technique. If you need to stain melanin and argentaffin cells in tissue sections, take a few minutes to watch this webinar - and save yourself many more minutes in the future by using this kit.
  • USP : Methods for Moisture Determination and Karl Fisher Titration
    USP : Methods for Moisture Determination and Karl Fisher Titration Bruce Herzig, Sr. Application Scientist, Merck KGaA, Darmstadt, Germany Recorded: Dec 7 2017 32 mins
    Many Pharmacopeia materials contain water as hydrates or in adsorbed form. Therefore the determination of the water content is important to maintaining compliance with the Pharmacopeia guidelines. Generally one of the three methods are given in the monographs, Method I (Titrimetric), Method II (Azeotropic), or Method III (Gravimetric). This poster will discuss the application of these methods to moisture determinations focusing on Karl Fischer techniques.
  • SPME Applications in Food Analysis by means of a New Matrix Compatible Coating
    SPME Applications in Food Analysis by means of a New Matrix Compatible Coating Emanuela Gionfriddo, Ph.D.; Research Associate under Prof. Janusz Pawliszyn, University of Waterloo (ON, Canada) Recorded: Dec 7 2017 65 mins
    The complexity and diversity of food matrices, and the need for clean extracts to be injected into analytical instrumentation may imply the use of tedious and time-consuming sample preparation strategies that often produce significant laboratory waste. The development of a new matrix-compatible solid phase microextraction (SPME) coating, namely PDMS/DVB/PDMS, bearing enhanced antifouling properties, enables the analysis of complex food matrices by direct immersion SPME, and helps to overcome issues related to extensive sample pre-treatment and instrumental contamination. This webinar will focus on recent advances made toward the analysis of contaminants in complex food samples by using the new matrix-compatible SPME coating, and will describe the optimization of important parameters to be considered when performing Direct Immersion SPME (DI-SPME).
  • Evolution and Adoption of Biometrics
    Evolution and Adoption of Biometrics Niosha Kayhani | Cubics and Ruta Sudmantaite from PatSnap Recorded: Dec 6 2017 41 mins
    Biometrics has slowly become more and more present in our everyday lives. We no longer bat an eyelid when our phones require us to use a finger print for a payment or even when its how you get into your gym. So whats the next step?

    Cubic, who are the people behind the payment technology of the London Transport System, have devised a system that can double the “throughput” of an entrance—from 25 people crossing a gate’s threshold per minute, to about 50 or 60. This idea could mean that we would no longer have gates at tube stations across London and instead your phone in combination with your face.

    Niosha Kayhani of Cubic will be taking us through the development of this Technology and also the growing uses and industry that is Biometrics.
  • Driving positive change for patients through collaboration and education
    Driving positive change for patients through collaboration and education Jessica Bateman (UCF); Phyllis Greenberger (HealthyWomen); Steven Gregg (NAFC), Jenny Kite (Astellas US) Recorded: Dec 4 2017 60 mins
    Change Together – www.changetogether.com – will be presenting a live webinar with leading figures from the patient advocacy community, who will debate how we can drive positive change for patients through collaboration and education. This will be helpful for all advocates, as we hear and learn from our expert panel how their organizations are bringing about change.

    The key topics our expert panel will be covering are:
    – The power of collaboration
    – Educating and communicating with physicians for better patient care
    – Using social media and paid search to extend online engagement and reach
    – Effecting health policy change at a federal and state level
  • Characterization of sub-visible particles with Amnis imaging flow cytometry
    Characterization of sub-visible particles with Amnis imaging flow cytometry Christine Probst, Application Scientist - Merck KGaA, Darmstadt, Germany Recorded: Nov 30 2017 43 mins
    Multi-spectral imaging flow cytometry (MIFC) is an established analytical method for cellular analysis, however has only recently been evaluated for characterization of sub-visible particles in therapeutic formulations despite numerous favorable attributes including:

    • Simultaneous collection of bright-field, side-scatter, and fluorescent imagery
    • Sensitive detection of particles 100 nm-100 μm
    • High image quality using 20X-60X magnification objectives
    • 100% sampling efficiency using hydrodynamic focusing
    • Small sample volume requirement (20 μL)
    • Linear concentration range up to 100 million/mL
    • Wide flow cell (250 μm) minimizes clogs

    Assorted case studies using MIFC for analysis of protein and vaccine formulations will be presented, with an emphasis on measurements and samples that pose challenges for current techniques- including detection of small and transparent particles, direct analysis of highly concentrated formulations, and fluorescence characterization of particle type, chemical composition, and heterogeneous interactions.
  • The Future of Marketing in Life Sciences: Is your function fit for purpose?
    The Future of Marketing in Life Sciences: Is your function fit for purpose? Dominic Tyer Recorded: Nov 30 2017 54 mins
    The healthcare landscape is rapidly changing as it responds to a multitude of well-known issues. Coupled with emerging digital technologies, these drivers are shaping the industry, moving it towards a more sophisticated, outcomes-driven model that demands a new approach. The new world emerging is one in which value is defined, created and evaluated in a very different way, with marketing playing a critical role.

    On 30 November, EY (a global leader in assurance, tax, transaction and advisory services) in association with PMGroup, will host a free webinar debating the future of marketing in Life Sciences. Is your function fit for purpose?
  • Improving commercial decisions with customer relationship network insights
    Improving commercial decisions with customer relationship network insights Megan Oh (Abbott), Leilani Latimer (Zephyr Health), Paul Tunnah (pharmaphorum) Recorded: Nov 28 2017 62 mins
    Networks of influence are shifting the decision-making process for life sciences companies. It is no longer enough to simply view the profile of a HCP or HCO to understand their value to your organization.

    For life sciences organizations, there is currently a gap in information, understanding, and digital access to these critical customer networks and relationships.

    Relying solely on internal knowledge, field experience or purchased data provides an analog, one-dimensional view of these networks. This limits companies from fully understanding key influencers, referral pathways, speaker and authorship networks and more, which once uncovered can significantly influence customer outreach, messaging and engagement.

    In this webinar, we’ll discuss how companies who embrace a holistic data and network analytics approach to strategic planning and execution can achieve significant competitive advantage, improved customer engagement and faster market penetration.
  • The evolution of pharma social media intelligence
    The evolution of pharma social media intelligence Paul Tunnah(Moderator); Professor Andrew Stephen (University of Oxford); Anurag Abinashi (IQVIA) Recorded: Nov 23 2017 61 mins
    Is your company a fully mature user of intelligence from social media, or is it still not tapping into insights?

    As shown in the consumer world, social media can be a very rich source of insights into customers and markets, and can provide early signals of new trends. Exactly the same is true for patient and health care provider insights, especially when used with other more traditional data sets.
    But understanding how to engage, and how to extract the right data to get actionable insights – and all the while complying with regulations – isn’t so straightforward.

    Life sciences companies in particular, want to put this new data source in context with its already broad range of metrics. Achieving this calls for a step-by-step progression towards social media maturity.
    pharmaphorum is working in collaboration with experts from IQVIA and Professor Andrew Stephen of Oxford University to deliver a topical debate focussed on this field, intended to provide answers to some of the conundrums the industry faces.

    An expert panel will provide practical advice and real-life examples of how pharmaceutical companies can develop maturity in social media intelligence.

    Increase your understanding of how social media can easily be used to ultimately add value

    Learn the tricks - how, when and why marketers from other sectors use social media channels to their advantage

    Hear how leading pharma organisations have embraced social media and have seen real results
  • UNLEARN. RELEARN. REIMAGINE. Smarter communications through behavioral science
    UNLEARN. RELEARN. REIMAGINE. Smarter communications through behavioral science Andrew McConaghie, David Hogben (Complete HealthVizion), Robert Poole (Complete HealthVizion), Bjarke Ebert (Lundbeck) Recorded: Nov 22 2017 69 mins
    How can we create smarter, more effective communications for HCPs and patients? What can be done to challenge the status quo, apply a different mindset to communications, and deliver the best possible patient outcomes?

    In this webinar, we will discuss how multichannel strategy and behavioural science are natural partners in creating smarter, more meaningful, and more effective communications. The premise is simple: if we apply a behavioural mindset, we can determine where to focus our communications for the best effect, design the most appropriate multichannel strategy and content, and put the right metrics in place to measure success.
  • No More LC:  Microextraction Coupled with Direct MS Analysis
    No More LC: Microextraction Coupled with Direct MS Analysis Olga Shimelis, Principal R&D Scientist and R&D Supervisor, Merck KGaA, Darmstadt, Germany Recorded: Nov 16 2017 53 mins
    Mass spectrometry (MS) is an accepted research tool for both academic and industrial laboratories. As MS continues to gain ground in clinical and industrial testing, the requirements for high throughput, high sensitivity and high accuracy analyses put more emphasis on sample preparation. Solid Phase Microextraction (SPME) is well suited for this purpose as it requires minimal sample, provides pre-concentration of analytes, and allows for quantitative determinations.
    This webinar will focus on the use of microextraction devices for direct MS analysis for applications that do not require chromatographic separation. Such analysis often results in very high throughput and more immediate results in comparison to traditional methods. Several Direct MS interfaces will be reviewed. The relevant overview of the literature as applied to the direct MS analysis of microextracted samples will be presented. The presentation also will discuss in more detail the coupling of Direct Analysis Real Time (DART) with a new type of solid phase microextraction devices (known as BioSPME).
  • The Role and Limitations of Sigma Analysis in Lab QC
    The Role and Limitations of Sigma Analysis in Lab QC Jack Montgomery, MLS(ASCP)cm Recorded: Nov 15 2017 54 mins
    Hear Jack Montgomery share his experiences and methodologies in applying sigma analysis to lab quality control at Asante Health, a Truven Health Analytics Top 100 hospital the past four years.

    In this webinar, Jack will discuss the dynamic nature of sigma metrics for clinical chemistry analytes. He will show how they can be improved over time with enhanced monitoring and optimized maintenance schedules. This sensitivity of sigma metrics highlights the notion that sigma methodology is just one of the many tools that should be used for a holistic approach to lab quality.

    By attending this webinar, you will:
    - Understand the practical use of Six Sigma as a lab quality tool
    - Learn about the dynamic nature of sigma metrics and how they can be improved in the lab
    - Gain insights into the additional tools for implementing a multi-faceted total quality program

    P.A.C.E. credit is available for your participation.*

    Presenter:
    Jack Montgomery, MLS(ASCP)cm, is the chemistry technical specialist for Rogue Regional Medical Center—the flagship entity for Asante Health—a growing three-hospital system located in southern Oregon containing a laboratory accredited by the College of American Pathologists. Jack has over 40 years of experience in the clinical laboratory with a special interest in quality control, sigma metrics and method validation.

    *Beckman Coulter, Inc. is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E® Program. These credits are recognized by the State of California. Most programs also provide State of Florida credits (with valid license number). At this time we cannot issue continuing education credits for those who provide healthcare (or work for an institution that provides healthcare) in Massachusetts or Vermont.
  • Can the New generation of perfusion technology compete or replace the convention
    Can the New generation of perfusion technology compete or replace the convention Ankur Bhatnagar & John Bonham-Carter Recorded: Nov 15 2017 76 mins
    Recently, there has been a renewed interest in the field of continuous processing. Some key factors driving this interest are – availability of better cell retention devices, improved cell lines and culture medium capable of supporting high cell densities.

    These factors have contributed mainly in reducing the batch duration for making the required quantity of product, thus reducing the medium requirement and chances of batch failures significantly. With the continuous processing being considered as ‘back-in-the-game’, the question remains: Can the current perfusion technology compete or replace the conventional and widely preferred fed-batch technology?

    Two cases are discussed to compare the performance features of fed-batch and perfusion processes. In both the cases, the product output from perfusion process is significantly higher (2 to 5 folds) than that from fed-batch, due to combination of factors like higher cell density, higher cell specific productivity, lower accumulation of toxic metabolites etc. These cases demonstrate the potential of perfusion process in significantly increasing the product output. However, there are certain challenges and points to be considered before a company decides to switch to a perfusion platform. Some of these are highlighted in the article.
  • iPSCs: The Future of Disease Research
    iPSCs: The Future of Disease Research Dr. Sharon Bahia, Product and Distributor Manager, The European Collection of Authenticated Cell Cultures (ECACC) Recorded: Nov 9 2017 36 mins
    The development of human iPSC technology offers researchers the ability to more accurately generate physiologically relevant models of disease and normal tissues in the laboratory. Advances in iPSC generation have allowed many laboratories to make their own cell lines; however, researchers rarely have the resources needed to establish stocks, undertake quality control and share their own de novo iPSC cell lines with other laboratories. A pre-existing and established iPSC collection therefore allows iPSC researchers to obtain “off the shelf” access to a large, robust and reliable supply of iPS cell lines that represent diverse donor to donor variability and which include disease status normal controls and gene edited cell lines. iPSCs from ECACC are standardised and quality controlled and have the benefit of coming from a trusted and internationally recognised collection with worldwide distribution.
  • Scopus Data for Ranking Organizations
    Scopus Data for Ranking Organizations M'hamed el Aisati, VP Funding, Content & Analytics Recorded: Nov 9 2017 59 mins
    Over the past 10 years, Scopus has emerged as the partner of choice in the fast-developing field of rankings. Join us for a discussion on the importance of A&I data to ranking organizations, and why they choose Scopus.
  • Patent Monetisation: Markets, Litigation and Legislation
    Patent Monetisation: Markets, Litigation and Legislation David Pridham and Brad Sheafe from Dominion Harbor and Jessie Parker from PatSnap Recorded: Nov 8 2017 59 mins
    David Pridham, Chief Executive Officer and Brad Sheafe, Chief Intellectual Property Officer of Dominion Harbor will be taking us through their recent acquisition of the Kodak Patent Portfolio and the steps they are taking to monetise over 4000 patents.

    Unfortunately patent monetisation isn't as simple as selling or licensing, it depends heavily on the other players in the market, where the market is moving and also the litigation and future legislation when it comes to that particular technology.

    This webinar will cover:

    - The analytical approach (using technology to help assess the opportunity)
    - The go-to-market strategy development
    - How to present this strategy to potential buyers without being exposed to litigation risks
    - Building global partnerships to maximise the monetisation potential of the portfolio in a heterogeneous, world-wide marketplace
    - Managing prosecution, maintenance, divestiture and abandonment
  • Single-Use & Stainless Steel BioReactors: Quality Factors for Consideration
    Single-Use & Stainless Steel BioReactors: Quality Factors for Consideration Dr Trevor Deeks, Principal and Consultant of Deeks Pharmaceutical Consulting Services, LLC Recorded: Nov 8 2017 76 mins
    Single-use (SU) systems are now in common use in pharmaceutical bioprocessing, as well as in other related technologies such as the manufacture of diagnostics and other biological products, and their popularity is increasing. Some types of SU systems have been in use for many decades now. The earliest SU systems being disposable filter cartridges that do not require a stainless steel (SS) filter housing. This present article seeks to focus in particular on SU bioreactors for cell culture and bacterial fermentation for the purpose of producing therapeutic proteins, monoclonal antibodies and vaccines. SU bioreactors are of particular value in early phase (Clinical Phases 1 and 2) GMP manufacturing. In some cases their use has now stretched through into commercial processing, albeit that the scale of operation is currently limited and in general the largest commercially available SU bioreactors are around 2000L working volume (WV). However, the small footprint that they require, and the reduction in investment needed for support services and utilities, means that the scale limitations can be overcome to a significant degree by having multiple SU bioreactors operating in parallel within a facility. The harvest from multiple bioreactors can be pooled for downstream processing, or each harvest can be processed as a separate batch, based upon considerations of the risks versus the economies of pooling.
  • Improving outcomes through industry partnership - the Cancer Vanguard learnings
    Improving outcomes through industry partnership - the Cancer Vanguard learnings Paul Tunnah(moderator)Steve Jowett(QuintilesIMS)Rob Duncombe(Christie NHS Foundation Trust)Stuart Hill(Merck)Mike Ringe(ABPI) Recorded: Nov 6 2017 68 mins
    The Cancer Vanguard is a bold initiative setup to take leadership in the delivery of the National Cancer Strategy – Achieving World-Class Cancer Outcomes published in 2015 with a key aim of designing and implementing new and increasingly patient centric models of care in Cancer that can benefit and be adopted by the wider national cancer system.
    In summer 2016 the Cancer Vanguard medicines optimisation team launched the ‘Pharma Challenge’ as an opportunity for the pharma and life sciences industry to identify innovative ways in which it could work in partnership with the NHS to improve the effective use of NHS resources, enhance the NHS’ understanding of the patient experience and make medicines optimisation part of routine practice. Four projects were taken forward including a partnership between the Cancer Vanguard, QuintilesIMS, Merck and uMotif,
    This unique example of partnership working across the health system is focussed on the service at large, not just the pill, and uses leading edge data analytics to analyse, benchmark and visualise the current state of the cancer pathways within the Cancer Vanguard Trusts. Furthermore it encompasses multiple aspects of the service provision ranging from patient outcomes and experiences, the flow of treatment and the usage of medicine in order to inform an evidence based and patient centric approach to service redesign and resource optimisation.
  • OncoCilAir™: A 3D human in vitro model for lung cancer research
    OncoCilAir™: A 3D human in vitro model for lung cancer research Samuel Constant, PhD, Co-founder, CEO Recorded: Nov 2 2017 38 mins
    In this special webinar, our guest presenter Samuel Constant Ph.D., Co-founder, CEO for OncoTheis will review:

    - Novel in vitro tests for modelling lung cancer
    - A model that allows long term monitoring of toxicity or efficacy on respiratory tract
    - How OncoCilAir™ is a 3D human airway epithelium with tumors reconstituted in vitro

    Abstract:
    With more than 1 million deaths worldwide per year, lung cancer remains an area of unmet needs. Realistic human 3D models are required to improve preclinical predictivity. To that end, OncoTheis has engineered a novel in vitro lung cancer model, OncoCilAir™, which combines a functional reconstituted human airway epithelium, human lung fibroblasts and lung adenocarcinoma cell lines. Because of its unique lifespan (>3 month) and its dual composition (healthy and cancerous human tissues), OncoCilAir™ allows for the concurrent testing of the efficacy of drug candidates against malignant cells and their non-toxicity against healthy tissues. Accordingly, a first proof of concept study performed on a panel of anti-cancer drugs including the investigational drugs selumetinib and Mekinist® demonstrated that OncoCilAir™ carrying the KRASG12S mutation showed responsiveness in agreement with first clinical reported results, validating this unique tissue model as a predictive tool for anticancer drug efficacy evaluation. OncoTheis has now extended the model to EGFR mutations. Results showed that OncoCilAir™ EGFRdel19 is sensitive to Tarceva® and Iressa® treatments and provides a useful model to decipher in vitro mechanisms of resistance.
  • Characterisation of Host-Cell Proteins using Mass Spectrometry Enables Effective
    Characterisation of Host-Cell Proteins using Mass Spectrometry Enables Effective Dr Li Zang, Dr Chongfeng Xu and Dr Stephen Tate Recorded: Oct 31 2017 60 mins
    Common mammalian cell lines used for biopharmaceutical production include Chinese Hamster Ovary (CHO), NS0 and Human Embryonic Kidney (HEK) cells. Each of these cell lines has been found with over 20,000 genes coded in their genome, which can result in over 10,000 proteins expressed at the same time in these cells. These proteins can be secreted from the living host cells or released to the cell culture supernatant upon lysis of the host cells during the cell culture. Biopharmaceuticals produced using these cell lines can be co-purified with a subset of the host-cell proteins (HCPs) in the cell culture supernatant.

    These co-purified HCPs are considered process-related impurities for biopharmaceuticals. The HCPs can cause potential safety risks by introducing anti-HCP response in the patients. Depending on the biological functions of the residual HCPs, other potential impacts reported include lowering the biopharmaceutical protein stability and affecting the efficacy of the biopharmaceutical protein by exacerbating the symptoms.
  • Machine Learning Analytics for Financial Services
    Machine Learning Analytics for Financial Services Rodrigo Fontecilla,Vice President and Global Lead for Analytics, Unisys & Maria Allen, Senior Director & Global Head, Unisys Recorded: Oct 25 2017 61 mins
    Unisys advises banks, non-bank lenders, insurers, and payments providers developing data management and artificial intelligence capabilities. This webinar will showcase client examples applying machine learning and predictive analytics to optimize consumer engagement, identify fraud and cyber security risks, and bring new capabilities to credit modeling.

    About the Speakers:
    Rodrigo Fontecilla is vice president and global lead for analytics for Unisys Federal Systems, where he leads all aspects of software development, system integration, mobile development, and data management focused on the federal government. Rod is responsible for providing leadership, coordination, and oversight on all IT solutions, emerging technologies, and IT services delivery to the federal government. He has more than 25 years of professional experience in the capture, design, development, implementation, and management of information management systems delivering mission-critical IT solutions and has an extensive background and expertise in cloud computing, mobile development, social media, enterprise architecture, data analytics, SOA-based solutions, and IT governance.

    Maria L. Allen is Senior Director and Global Head of Unisys' Financial Services Portfolio Solutions. In this role, Maria is responsible for building new products and services across all regions, platforms and channels ensuring that solutions and services are delivered in a way that enable our clients to meet their strategic goals and objectives.

    For more information on our Advanced Analytics offerings contact us at advancedanalytics@unisys.com and visit http://www.unisys.com/analytics
  • Automation of the in vitro micronucleus assay using imaging flow cytometry
    Automation of the in vitro micronucleus assay using imaging flow cytometry Matthew. A Rodrigues, PhD., Research Scientist with Amnis-Merck KGaA, Darmstadt, Germany Recorded: Oct 24 2017 57 mins
    The in vitro micronucleus assay is one of the most widely used tests to quantify genotoxicity and cytotoxicity, especially as a screening tool in the development of chemicals and pharmaceuticals. Micronuclei (MN) are formed from whole chromosomes or chromosome fragments that lag behind during the metaphase-anaphase transition and are excluded from the main nucleus following division. MN form into small, rounded bodies surrounded by their own nuclear envelope and represent chromosomal mutations that can be used as an endpoint in genotoxicity testing. Typically performed by manual microscopy, the MN assay is laborious and can be subject to scorer bias. To overcome this, automated microscopy and conventional flow cytometry methods have been developed. However, these methods suffer from several limitations such as the requirement to create high quality slides in the case of microscopy and the lack of visual confirmation of MN in the case of flow cytometry. The ImageStream®X (ISX) imaging flow cytometer has the potential to overcome these limitations as it combines the speed, statistical robustness and rare event capture capability of conventional flow cytometry with high resolution fluorescent imagery.
    In this webinar, adaptation of the in vitro MN assay to an imaging flow cytometry-based method will be described. Using the ISX Mark II imaging flow cytometer, images of micronucleated mono- and binucleated cells as well as polynucleated cells can be captured at a high flow rate and automatically identified and scored in the Image Data Exploration and Analysis Software (IDEAS®) that accompanies the ISX. A data analysis template created specifically for this application allows for the determination of both genotoxicity and cytotoxicity following treatment with known clastogens and aneugens. This work is the first demonstration of fully automated method for performing the in vitro MN assay on an imaging flow cytometry platform.
  • Analytics 101 Part 2: Data Exploration & Predictive Modeling
    Analytics 101 Part 2: Data Exploration & Predictive Modeling Molly Jones, SAS Systems Engineer & Jen Lampert, SAS Solutions Architect Recorded: Oct 19 2017 55 mins
    In this webinar, we dive deeper into analytics and talk about the advantages of data exploration and predictive modeling. We’ll also show attendees how to fine-tune the accuracy and precision of those analytic models so you can make critical decisions with confidence.
  • Towards Real Time Release testing: Dissolution prediction of tablets made using
    Towards Real Time Release testing: Dissolution prediction of tablets made using Dr Erik Skibsted Jan 10 2018 3:00 pm UTC 75 mins
    After 50 years of near-stagnation, pharmaceutical manufacturing is experiencing unprecedented scientific and technological innovation. There is a paradigm shift from testing product quality using lengthy off-line (and after-the-fact) assays to quality being tested during the process using online/ at-line measurements. This ability to evaluate and ensure quality of final product based on process data, geared towards making batch release decisions, is known as real time release testing (RTRt). A case study for predicting dissolution profiles of tablets made using CDC is presented. The methodology enables real-time release testing. Four different parameters were varied in the CDC line; API concentration, blender speed, feed frame speed, and compaction force, and their effect on tablet dissolution was investigated. Model dependent and model independent approaches were used to extract information from dissolution profiles. Multivariate regression was built between the information obtained from the NIR as the predictor variables and the dissolution profile parameters as the response. This enabled prediction of dissolution profiles for test samples made using CDC. Alternative RTRt approaches towards dissolution prediction will also be discussed.
  • Gene and Cell Therapy – An Overview of the Current and Changing Regulatory
    Gene and Cell Therapy – An Overview of the Current and Changing Regulatory Mark D. Johnson, MS; Scott E. Boley, PhD, DABT Jan 12 2018 3:00 pm UTC 90 mins
    Gene and Cell Therapy – An Overview of the Current and Changing Regulatory Requirements and Study Design for Nonclinical Safety Evaluation

    Nonclinical development of gene and cell therapies has been ongoing for more than three decades, and has been increasing in recent years. In the early days of these efforts, these therapies shared the fate of many novel experimental medicine approaches with progress impeded by severe side effects in treated patients or a failure to demonstrate efficacy in the target patient population. Research over the past decade has resulted in the development of highly sophisticated gene transfer tools with improved safety and therapeutic efficacy. As these tools have been developed, regulatory agencies worldwide have adapted new review processes and developed a wide range of guidance documents to aide researchers in designing rigorous nonclinical studies to ensure the safety, biodistribution and potential benefit of these advanced therapeutics. This presentation will provide an overview of the regulatory guidelines, provide some key considerations in the nonclinical development and testing of cellular and gene therapies, and detail several case studies of these therapeutics.
  • Enabling comprehensive data analytics and process monitoring in Biomanufacturing
    Enabling comprehensive data analytics and process monitoring in Biomanufacturing Robert Dimitri, Hugo Guerra and Gloria Gadea-Lopez, Ph. D Jan 17 2018 3:00 pm UTC 75 mins
    Technical teams rely on the availability of meaningful data and effective tools to perform process monitoring, to conduct root cause analysis and investigations and, most of all, to obtain new insights into their operations. In this article, the authors discuss the implementation and management of a comprehensive system for data analytics at Shire –Lexington, MA site, the lessons learned, and practical advice towards the successful deployment of these key applications.
  • Introduction to searching/using Markush structures from Patents
    Introduction to searching/using Markush structures from Patents Ruta Sudmantaite @ PatSnap Jan 17 2018 4:00 pm UTC 60 mins
    Chemical Patents are often very long and difficult to read. Markush searching can enable you to easily categorize and filter the information you need, giving you the insights that a paper sometimes cannot.

    In this webinar you will learn:

    -How to get started with patent search
    -Basic patent language you need to be aware off
    -How to create Markush searches to yield the best results when researching.
    -Benefits of patent search for your processes
  • Disposables – Suitability and Process Economy In Biopharmaceutical Manufacturing
    Disposables – Suitability and Process Economy In Biopharmaceutical Manufacturing Dr Joachim Walter Jan 24 2018 3:00 pm UTC 75 mins
    Since the introduction of disposables and gaining popularity of Single-use Technology (SUT) for biopharmaceutical manufacturing there is nevertheless an ongoing controversial discussion on the advantages and disadvantages versus a conventional stainless steel environment.

    In a “classical” facility design any validation cost effort can easily be distributed to a considerable number of production runs thus contributing only to a non-decisive amount to the overall production costs. The scale for such plant is nearly unlimited as is the scale of operation. The “flexible” approach using disposables and single-use equipment offers significant advantages regarding changeover work and time thus a high throughput of different processes will definitely take profit as any cleaning and related validation and costly analytics doesn’t apply to a larger extent.

    Despite the potential benefits loudly advertised by the respective industry, these potential advantages derived from single-use equipment and disposables can be significantly diminished by lack of detailed process cost analysis, missing economic analysis and cost comparison between conventional and SU technologies as well as underestimating the cost of long term dependency on consumables. Due to missing appropriate standards, there is a widely non-compatibility between the equipment and consumables of the various suppliers, resulting in a strong dependence on the consumables of a single supplier once a single-use equipment has been purchased, curiously leaving some customers with surprise that they hardly have any room for price negotiations on the required consumables.
    This paper’s focus is on the very different arguments for the application of SU equipment and consumables, including advantages and limitations of SUT, understanding improvement of process robustness, contribution to lean production as well as environmental impact of disposables.
  • The Path to Cost-Effective Turnkey Object Storage
    The Path to Cost-Effective Turnkey Object Storage Vas Vasiliadis, Chief Customer Officer, Globus Jan 25 2018 6:00 pm UTC 45 mins
    For research data to be truly useful, it must be easy to access, share and manage without requiring expensive, custom infrastructure. What organizations need is turnkey storage that won't break the bank, with a unified interface for fast, reliable data transfer and sharing. This webinar introduces Globus for ActiveScale, a cost-effective solution for on-premise object storage that’s simple to deploy and use. With Globus for ActiveScale, researchers have access to advanced capabilities for managing data across a broad range of systems, while administrators gain a cost-effective, scalable, and durable solution they can deploy quickly to help their researchers innovate faster. In this webinar, attendees will learn how to deploy and use Globus for ActiveScale -- the session includes a product demonstration and a Q&A session with the Globus Chief Customer Officer.
  • Do Extractable Protocols Truly Help- An End User Perspective
    Do Extractable Protocols Truly Help- An End User Perspective Ekta Mahajan, Genentech/Roche Feb 5 2018 3:00 pm UTC 75 mins
    Single Use technology is being used more each year in the biotechnology industry. However, extractables and their potential impact on product and patients continue to be one of the biggest challenges. The challenge is augmented by the lack of standardized methodology for suppliers to execute extractable studies that meets end user requirements. The end users are responsible and required by law to assess the impact of extractables and leachables on overall Product Quality and Safety. Due to lack of a standard, customized data had to be generated for/by each end users. This resulted in long lead times, higher costs and inefficient utilization of resources. Typically, the data generation and qualification of single use component can take up to a year, which can impact implementation of single use. BioPhorum Operations Group (BPOG) developed a standardized protocol9 for generating extractable data that would meet user requirements and simplify/reduce implementation time within industry. A standardized protocol gives confidence to suppliers that testing performed by them would meet end user requirements and enable faster implementation. Some suppliers shared the BPOG vision and proactively tested their single use components using BPOG protocol, which has helped expedite the use of their products.
  • Efficient execution of biologics manufacturing – The role of Finite Scheduling
    Efficient execution of biologics manufacturing – The role of Finite Scheduling Gloria Gadea-Lopez, Ph.D., John Maguire and Gerry Glennon Feb 14 2018 3:00 pm UTC 75 mins
    The success of manufacturing relies on the availability of all the resources –personnel, materials, equipment, work instructions - , orchestrated in such a way that the operations proceed in an efficient and predictable manner. This article describes the implementation of a finite scheduling system for biologics production, the foundational work required prior to project launch, lessons learned, and benefits achieved from this deployment.
  • Making patent searches more effective with Boolean
    Making patent searches more effective with Boolean Dvorah Greaser from KISSPatents and Ruta Sudmantaite @ PatSnap Feb 28 2018 4:00 pm UTC 45 mins
    Patent searching is something most IP counsel is very familiar with. It's your day to day when looking at Freedom to Operate, competitive analysis and portfolio management.

    However, it can be hard to predict what you need in a search when you are not a technical expert. In this webinar, we will teach you how to construct the most effective searches using boolean and a few other tips and tricks on how to ensure you include all the technical detail you need.
  • Process analytical Technology for Upstream Bioprocessing
    Process analytical Technology for Upstream Bioprocessing Erica Fratz-Berilla & LCDR Agarabi 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.
  • 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 Mar 7 2018 3:00 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.
  • 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 Mar 14 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.
  • Using patent data to accelerate your Time to Market
    Using patent data to accelerate your Time to Market Ruta Sudmantaite @ PatSnap Mar 14 2018 4:00 pm UTC 60 mins
    Time to Market is an essential metric that R&D teams are measured on. This becomes even more important when we are talking about patented chemicals and processes within the Medical, Pharma and Lifesciences.

    If your competitor beats you to market all the time and money spent on research and development becomes a sunk cost, but how can data change that for you?

    Using patent and journal data you can give your research teams the tools to quickly validate ideas and decide if they are worth pursuing and simultaneously remove the bottleneck that is placed on Data Analysts.

    Join this webinar to learn how data can be applied to research and how this could cut costs and reduce time to market.
  • SUS Leachable Testing: Leachable Study Design for Single-Use Components
    SUS Leachable Testing: Leachable Study Design for Single-Use Components Kathryn McGohan Mar 20 2018 2:00 pm UTC 75 mins
    The BPOG Leachables Working Group has recently published a Best Practice Guide for Leachables. The Best Practice Guide was developed to help Biopharmaceutical and Vaccines Manufacturers to develop science-based, robust, and efficient approaches to handling the risk of leachable compounds that is associated with increasing use of Single-Use Systems in manufacturing processes. The Best Practice Guide is composed of three parts: the risk assessment model, leachable study design, and analytical methods. This article provides insight into the application of the Best Practices for Leachables Study Design by end users and will include a case study to highlight the importance of the study design.
  • DSF and FTIR as methods for the identification and characterization
    DSF and FTIR as methods for the identification and characterization Marina Kirkitadze and Kristen Kalbfleisch Mar 21 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.
  • Applied Analytical Techniques to Monitor IsoAsp in Biologics Formulation Develop
    Applied Analytical Techniques to Monitor IsoAsp in Biologics Formulation Develop Dominick Gerald DeGrazio, Janssen Apr 10 2018 2:00 pm UTC 75 mins
    The development of a suitable biologic formulation occurs often before analytical methods are validated. Certain chemical modifications are critical to monitor during the development process as they may cause protein instability and reduce biologic efficacy. Aspartic acid isomerization is one such modification, but is arguably the most difficult to detect. Analytical tools to track IsoAsp are discussed that can aid in making formulation decisions before the availability of qualified methods.
  • 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 Mark Maselli Apr 19 2018 2:00 pm UTC 75 mins
    As a result of the increased adoption of single-use technologies (SUTs) in biotech manufacturing, companies need to develop and implement programmatic approaches for the management of these systems under regulatory compliance. This webinar discusses the key aspects of such programs, with emphasis on collaboration with suppliers, cost management, as well as practical insights about the use of SUTs.
  • Quality-By-Design in Spray Drying Processes - Transfer Lab to Production
    Quality-By-Design in Spray Drying Processes - Transfer Lab to Production Sune Klint Andersen, Janssen Pharmaceutica May 10 2018 2:00 pm UTC 75 mins
    Spray drying is a continuous and scalable manufacturing process commonly used in the pharmaceutical industry. Due to its scalable and continuous nature it is possible to apply Quality-by-Design (QbD) and Process Analytical Technologies (PAT) early on in the development of a spray drying process.
    Knowledge gained from QbD e.g. Design-of-Experiments (DoE) and PAT increases process understanding and the knowledge can be readily applied when scaling up the process and in production scale application of PAT i.e. especially with respect to the control strategy.
    The Webinar will discuss the application of QbD early in the development and how the obtained knowledge can be used to optimize transfer of the spray drying process to production scale including PAT strategy.
  • End User Perspective on Setting in-Process Endotoxin Limits
    End User Perspective on Setting in-Process Endotoxin Limits Dr Friedrich von Wintzingerode, Roche/Genentech May 15 2018 8:00 am UTC 75 mins
    There is a lack of detailed guidance for setting endotoxin in process limits (alert levels and action limits) for biologics. This webinar will present a concept for setting in-process  limits and a case study which allows to understand the underlying rationales and challenges. 
  • Current Perspective on Rapid Sterility Test
    Current Perspective on Rapid Sterility Test David Roesti, PhD, Novartis Pharma AG  May 17 2018 2:00 pm UTC 75 mins
    The current growth-based Sterility Tests with at least 14-days incubation is not suitable for short-lived products. An expert panel was formed under the USP General Chapters– Microbiology Expert Committee to provide recommendations on user requirements specifications and candidate technologies based on the URS in the area of rapid sterility tests. Based on the evaluation of the URS, the expert panel made recommendations for appropriate modern/rapid technologies available from multiple vendors. The next step would be to recruit collaborating labs to conduct the proof-of-concept studies that would support drafting of a rapid sterility test chapter in the USP.
  • Implementation Strategies and Challenges for SUT at Commercial scale
    Implementation Strategies and Challenges for SUT at Commercial scale Adam Goldstein, Roche/Genentech May 17 2018 5:00 pm UTC 75 mins
    For over 10 years, single-use technology (SUT) has been a growing buzzword in the biomanufacturing industry for its advantages in speed, flexibility, and cost. A recent 2015 BioPlan Associates, Inc. industry survey of biopharmaceutical manufacturers, contract manufacturing organizations, industry vendors, and direct material suppliers identified the ‘Top Concerns’ for why biopharmaceutical manufacturers are choosing to increase their use of disposables. The top three reasons were (i) Eliminates cleaning requirements, (ii) Reduces time to get facility up and running, and (iii) Reduces capital investment in facility & equipment. These reasons are no surprise, as elimination of steam in place (SIP) and clean in place (CIP) allows for a reduction of required piping and controls, which in turn significantly decreases capital costs, design engineering, and field installation times.

    While these are some of SUT’s core drivers, their validity among that of many additional drivers have already been analyzed and proven at length. Perhaps the more interesting reasons for the continued focus on SUT are the growing industry trends towards modular flexible facilities and lean manufacturing.

    In order to adapt towards more targeted therapies for niche populations, biopharmaceutical manufacturers will need to produce multiple high potency products, with greater changeovers, and at smaller batch sizes.4 By significantly reducing capital outlay, disposable modular facilities allow for both product and geographical manufacturing flexibility. Production is thus enabled at a lowered associated risk wherever assets are best utilized and production costs minimized, such as in emergent markets.
  • Environmental Monitoring Trend Analysis Tools
    Environmental Monitoring Trend Analysis Tools Steve Walton May 23 2018 2:00 pm UTC 75 mins
    Qualitative analysis of environmental monitoring data is vital for pharmaceutical quality groups. Essential to identifying evolving microbial trends are the means to effectively parse and analyze EM results. To make the best use of the tools available, they must be used with a full understanding of their value and limitations. In this paper, the pros and cons of several EM trend analysis tools will be presented to aid microbiology experts to qualitatively evaluate EM performance data.
  • Current USP Perspectives on a Rapid Sterility Test
    Current USP Perspectives on a Rapid Sterility Test Dr David Roesti, Novartis/USP May 30 2018 8:00 am UTC 75 mins
    The current growth-based Sterility Tests with at least 14-days incubation is not suitable for short-lived products. An expert panel was formed under the USP General Chapters– Microbiology Expert Committee to provide recommendations on user requirements specifications and candidate technologies based on the URS in the area of rapid sterility tests. Based on the evaluation of the URS, the expert panel made recommendations for appropriate modern/rapid technologies available from multiple vendors. The next step would be to recruit collaborating labs to conduct the proof-of-concept studies that would support drafting of a rapid sterility test chapter in the USP.