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Life Sciences

  • Cabells Whitelist & Blacklist Demonstration; New Web Interface and Features
    Cabells Whitelist & Blacklist Demonstration; New Web Interface and Features Lucas Toutloff Recorded: Jul 17 2017 48 mins
    Cabells introduces two new important features: the Journal Blacklist, the only blacklist of deceptive and predatory academic journals, and Altmetric Reports, a measurement of journal media mention data. Join us to learn more about these and other key resources while getting familiar with the new Cabells brand identity and website interface.

    Join Cabells Senior Project Manager Lucas Toutloff who will present the following:

    •A demonstration of the Journal Whitelist — our curated, searchable database of over 11,000 journals covering 18 disciplines — connecting researchers, librarians, and administrators to verified, reputable publications. Backed by our newly designed journal summaries presenting our suite of journal quality metrics, now including Altmetric Reports.

    •A demonstration of our newly released Journal Blacklist, the industry's only data-driven listing of likely deceptive or fraudulent academic journals. Built on objectivity and transparency, specialists analyze journals against over 60 behavioral indicators to keep the community abreast of the growing threats and to keep researchers protected from exploitative operations.

    •An introduction to the new Cabells brand identity, website interface and features, and redesigned journal entries.
  • CiteScore metrics - New values launched along with some improvements
    CiteScore metrics - New values launched along with some improvements Norman Azoulay, Product Manager, Scopus and Chris James, Product Manager, Research Metrics Recorded: Jul 13 2017 48 mins
    CiteScore 2016 annual values were recently released for over 22,600 titles. Additionally, a number of improvements have been made to CiteScore based on user feedback. Join us for a discussion with time for questions and answers!
  • Developing Simplified Methods for Quantifying Analytes using  SPME
    Developing Simplified Methods for Quantifying Analytes using SPME Robert E. Shirey, M.S.; Principal R&D Scientist Recorded: Jul 13 2017 75 mins
    Solid phase microexatraction or SPME is a green method for extraction of analytes out of a sample. Since SPME is a non-exhaustive extraction technique, some analysts believe that SPME is not quantifiable. This presentation will provide basic information for developing a method to extract and quantify analytes using SPME. Examples will be given on the extraction and quantification of analytes out of various matrices, and SPME will be compared to other extraction techniques such as QuEChERS and SPE. In this webinar, we will discuss some new SPME technologies such as SPME-OC (over-coated) fibers and BioSPME that help to isolate and quantify analytes from interfering compounds in the matrix. Guidelines will be provided for enhancement of precision using SPME.
  • A New Approach to Medical Device Management to Empower Digital Healthcare
    A New Approach to Medical Device Management to Empower Digital Healthcare Silvia Piai, Senior Research Manager, IDC Health Insights Recorded: Jul 13 2017 56 mins
    Connected medical devices are playing a fundamental role in transforming patient care quality and experience and healthcare providers efficiency.

    But as the number and the variety of devices grow within the organization, medical devices and the broader IoT ecosystem become more complex to manage, impacting patient safety, information security, compliance and financial performance.

    In this webinar IDC Health Insights will share its research findings and provide guidance to health executives that want to start harnessing the real value of medical devices, by implementing a evidence based, consistent, controlled and efficient IoT management approach

    About the speaker: Silvia Piai is Senior Research Manager within IDC Health Insights for Europe Middle East and Africa.

    She is responsible for analyzing key trends related to IT strategies and spending in European healthcare organizations, and global Public Health institutions. She advises healthcare organizations and ICT vendors on planning and implementing effective digital health transformation initiatives to drive business innovation.

    Silvia Piai has a more than 10 year experience in healthcare IT research. She started her career as public sector analyst, for then specializing in healthcare and becoming the lead analyst for the European healthcare market for IDC Health Insights. In her role, she focuses on the impact of digital transformation of healthcare and the role of technology in key industry trends as personalization and integration of care.

    Her analysis offers in-depth coverage of the technologies that provide the most clinical value in terms of quality, cost, time, and agility and are transforming pre-care, point of care (POC), and post-care today. Analyzing the adoption and the investment plans of healthcare organizations, Silvia describes the evolution of healthcare IT and gives key insight on primary factors shaping the industry and the implications for the coming year future.
  • Advanced Cell Culture Technology for Generation of In Vivo-like Tissue Models
    Advanced Cell Culture Technology for Generation of In Vivo-like Tissue Models Stefan Przyborski, PhD - Professor of Cell Technology, Durham University UK Recorded: Jun 30 2017 64 mins
    The benefits of three dimensional (3D) cell culture are widely appreciated. More cell-based technologies are now becoming available that enable researchers to preserve the native 3D structure of cells in vitro. These can be broadly divided into three areas: aggregate-based methods; hydrogels and extra-cellular matrices; and inert scaffold-based technologies. Each has strengths and weaknesses and there is no one technology that satisfies all applications. Tissues in the body are mostly composed of different cell types that are often highly organized in relation to each other. Often cells are arranged in distinct layers that enable signalling and cell-to-cell interactions. Alternatively in tumours, cancer cells form aggregates and tissue masses composed of different cell types. Recreation of these types of architecture will significantly evolve 3D cell culture to a new level where real tissue-like structures can be generated in vitro.

    This webinar will review the alternative approaches available to researchers and provide an overview of their capabilities and example applications. More sophisticated models are developing as 3D cell culture technology becomes established and accepted as a means of creating more physiologically relevant cell-based assays. Methods that are relatively straightforward to use and that recreate the organized structure of real tissues will become valuable research tools for use in discovery, validation studies, and modelling disease.

    Key areas covered:
    • 2D vs 3D cell culture debate
    • Review of alternative approaches and the development of new technologies
    • Challenges facing 3D culture methods, in terms of technologies available and methods used
    • Showcase applications where 3D technology makes a difference
    • Future perspective for 3D cell culture technology and further development
  • How to maximise the value of digital in medtech
    How to maximise the value of digital in medtech Paul Tunnah, pharmaphorum Recorded: Jun 29 2017 64 mins
    With a wealth of market and regulatory changes impacting the medtech sector, it’s time for digital technology to steer the direction of your future business. This expert webinar will evaluate how to strategically embed digital within your own organisation and explore the challenges and the opportunities for transforming customer relationships, driving commercial outcomes.

    – Respond to the changing regulatory environment: how technology empowers your business
    – Build a business case for digital transformation and gain organisational support
    – Strengthen your customer relationships and improve engagement in a diverse payer landscape
    – Learn from pharma (and other industries) to find opportunities and avoid pitfalls
    – Measure impact and return on investment from digital engagement
  • Location Analytics: Use Cases for Improving Visualizations & Reports
    Location Analytics: Use Cases for Improving Visualizations & Reports Rick Styll, Product Management, SAS; AJ Rice, Alliance Manager, Esri Recorded: Jun 29 2017 56 mins
    Nearly 70 percent of business data contains some level of location information. But business analysts rarely use this data within their BI and analytics workflows.

    Location analytics is more than just putting points on a map. It’s part of a much larger picture of using location to provide context in visualizations, reports and analytics. Utilizing geographic data in descriptive and predictive analytics helps companies discover new patterns, identify location-specific opportunities, and get a complete picture before making business decisions.

    In this webinar, Esri and SAS discuss the role that location analytics can play in determining practical next steps for your organization. A product demonstration will be shown as well.

    We’ll answer:
    • How does location analytics add value to BI and analytics initiatives?
    • What are the right uses for location analytics?
    • What pitfalls should organizations consider as they implement processes and technology for analyzing geographic data?
    • Are special skill sets required to use location information?
    • How can organizations best develop a strategy for using geographic data?
  • The Good, The Bad & The Ugly | Choosing a CRO Based on Animal Welfare Compliance
    The Good, The Bad & The Ugly | Choosing a CRO Based on Animal Welfare Compliance Chris Dillon, BA, CPIA, LATG, Executive Director of Compliance & IACUC Chair Recorded: Jun 22 2017 35 mins
    A poor animal welfare program can derail your preclinical research. Join Chris Dillon as he examines the importance of animal welfare as it relates to drug development costs, compliance, and factors for considerations when outsourcing preclinical programs.
  • Winning Westerns: Proven Strategies to Optimize Your Western Blots
    Winning Westerns: Proven Strategies to Optimize Your Western Blots Natasha L. Pirman, Ph.D. Recorded: Jun 21 2017 53 mins
    Does western blotting give you more trouble than expected? Do you feel like your precious samples are being wasted on bad westerns? Join us and find out how you can improve your western blots! In this seminar, you will learn general guidelines for performing and troubleshooting your westerns, such as:

    • Choice of different blotting membranes
    • Parameters affecting blotting efficiency
    • Conditions for optimizing your immunodetection
    • Information on SNAP i.d.® 2.0 system: A faster way to perform immunodetection
  • Disruption and maturity: the future directions for biologics in healthcare
    Disruption and maturity: the future directions for biologics in healthcare Paul Tunnah (moderator), Angela McFarlane, Sarah Rickwood, Margaret Dolan and Timothy C. de Gavre Recorded: Jun 20 2017 65 mins
    A digital debate analysing the future for biologics in the UK and the factor affecting market access in this territory. Our expert panel will cover a number of key topics including:

    •Are the savings offered by biosimilars being used to innovate and take advantage of the exciting new biologic technologies or just filling in the NHS potholes?
    •Will the industry continue to invest in cutting-edge research if the UK is not prepared to fund access to it
    •In a post-Brexit world how can the UK continue to be a global leader at the cutting edge of biologics research?
  • Amplified Detection of Proteins and their Interactions using Duolink PLA
    Amplified Detection of Proteins and their Interactions using Duolink PLA Manpreet Mutneja, Ph.D, MBA Sr. Product Manager, Molecular Platforms Life Science Research, MilliporeSigma Recorded: Jun 15 2017 44 mins
    Understanding the movements, modifications and interactions of proteins within a cell is key to unraveling the fundamental tenets of biology. However, the low-level expression of many proteins, combined with the transient nature of their interactions and movements, makes analyzing and understanding these processes quite difficult. Duolink® PLA, which is based on the principles of the proximity ligation assay (PLA), offers a solution to overcome these hurdles and to study the actions of endogenous proteins within cells and tissues. Combining the specificity of antibodies with the sensitivity afforded by rolling circle amplification, Duolink® PLA allows you to detect, visualize, and quantitate proteins and their interactions (even single events) where they happen within cells or tissue, all without overexpression or genetic manipulation. This seminar will cover the basic assay principle and advantages of the Duolink® PLA technology, and discuss recent applications and developments of the technology that make it an excellent tool to understand the fundamental mechanisms of biology, as well as disease states. Applications of Duolink® PLA include the investigation of cellular responses to varying stimuli, receptor dimerization and signalling cascades, post-translational modifications, and regulation of protein expression. New developments include use in flow cytometry and multiplexed detection.
  • Taking Workforce Analytics from Good to Great
    Taking Workforce Analytics from Good to Great Blake Sheldon, Solutions Architect and Sarah Harden, Systems Engineer Recorded: Jun 14 2017 58 mins
    Join SAS experts for this webinar and demo and learn how to take your workforce analytics from good to great. Learn how to put data-driven decisions within everyone’s reach when you empower your HR department with advanced (yet easy-to-use) SAS® analytics, BI and data visualization.
  • Powering pharma’s commercial teams with market access insights
    Powering pharma’s commercial teams with market access insights Paul Tunnah, Leilani Latimer and John Stahl Recorded: Jun 12 2017 63 mins
    Market access is influencing drug development and commercial launch strategy more than ever before, with 85% of prescription drugs in the United States reimbursed through managed care plans. Biopharma companies must take into account a multitude of factors when considering physician prescribing behaviors, and need a more integrated "pull-through" strategy across their teams, from managed markets, to marketing, to field sales. Just as an engine needs a steady supply of fuel to run efficiently, prescriber-facing teams – the commercial engine of life sciences companies – need market access data and insights to accelerate brand success. Today, the challenge is optimizing this fuel supply, as market access and commercial teams often operate in a siloed way with regards to data, market changes and insights.
    Join a vibrant conversation with industry leaders to discuss how the industry is changing and adapting to operationalize market access pull-through for improved commercial success.
  • バイオ医薬品製造におけるシングルユースシステム
    バイオ医薬品製造におけるシングルユースシステム コーニングインターナショナル株式会社ライフサイエンス事業部 石渡孝至 Recorded: Jun 6 2017 77 mins
    バイオロジクスの治験薬製造におけるシングルユース技術導入ポイントであります製品ソリューション、クローズドシステムおよび品質保証体制について概説します。

    再生・細胞医薬を中心にバイオ医薬品の製造開発が急速に進められております。

    幹細胞やヒトES / iPS細胞による再生医療を具現化する際に、最も大きな懸案事項となりますのが“質”、“量”そして“コスト”の問題があります。

    そこでコーニングは、安全、安価かつ簡便な最新シングルユース技術についてレギュレーション、導入事例によるマーケットトレンドを示しながら、トータルソリューションシステムのセルカルチャー(多層式大量培養容器)、チュービング&コネクション(プレアッセンブル特注、無菌接続)、パッケージング(培養 / 回収 / 凍結保存)、データインテグリティ(バーコードによるトレーサビリティ管理)、品質規格(成型施設環境、BSE/TSE、発熱物質(Pyrogen)、USPクラス6規格準拠 / 滅菌保証レベル / エンドトキシン規格 / QC試験)および品質に関するドキュメンテーションサポート(証明書、バリデーションバインダ)に関する情報を概説します。
  • Tools For Assessing Iron Status
    Tools For Assessing Iron Status Eloísa Urrechaga, M.D., Ph.D. Recorded: May 31 2017 42 mins
    In this webinar, Eloísa Urrechaga, M.D., Ph.D., will discuss the importance of iron status assessment in accurately diagnosing and treating anemia. The complexities of anemia require solutions that will help meet the daily challenges of distinguishing iron deficiency anemia (IDA) and isolating anemia of chronic diseases (ACD) from the combined state of IDA/ACD.

    After this webinar, you will be able to:

    • Discuss current advancements in anemia diagnosis
    • More clearly understand the role of accurate iron status assessment
    • Cite the latest research experience with Beckman Coulter analyzers in assessing iron status

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

    Presenter:
    Eloísa Urrechaga, M.D., Ph.D., has more than 30 years of experience in hematology and laboratory medicine. She is a specialist in clinical analysis technology, robotics in hematology, iron and anemia, erythropoiesis and glycohemoglobin. Currently, Dr. Urrechaga is responsible for the hematology laboratory at the Hospital Galdakao-Usansolo in Spain.

    Dr. Urrechaga contributes her expertise to the Spanish Science and Innovation Ministry by assessing new technologies. She also provides counsel to the Health Research Council for the validation of research projects in the Czech Republic and Argentina. In addition, she is a member of several international organizations, such as the World Health Organization Guideline Development Group and European Network for Rare and Congenital Anaemias. Dr. Urrechaga also serves as an editorial board member and scientific reviewer for a number of journals.

    *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. 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.
  • Understanding SEND Requirements
    Understanding SEND Requirements Christy Kubin, BS, Associate Director, SEND; Brian Argo, BS, Associate Director, SEND Recorded: May 31 2017 26 mins
    SEND requirements are now in effect and many companies have implementation questions: Is SEND required for this study? What are the components of a complete SEND dataset package? What should be done with endpoints not modeled in SEND? This webinar will provide answers to those questions and provide best practices for determining how SEND requirements should be applied.
  • Basic Principles of Solid Phase Microextraction (SPME) Method Development
    Basic Principles of Solid Phase Microextraction (SPME) Method Development Emanuela Gionfriddo, Ph.D.; Research Associate under Prof. Janusz Pawliszyn, University of Waterloo (ON, Canada) Recorded: May 31 2017 74 mins
    For the past two decades, Solid Phase Microextraction (SPME) has represented a convenient alternative to conventional sample prep procedures. SPME allows the simultaneous extraction and enrichment of analytes of interest from a given matrix in a single step while avoiding, or drastically minimizing, the use of organic solvents and time-consuming cleanup procedures.
    Like any other analytical method, the various parameters governing the SPME process need to be carefully optimized in order to achieve robustness and sensitivity. However, certain aspects of SPME method development are often overlooked by many users, leading to unsatisfactory performance of the technique.
    This webinar will shed light into several aspects of SPME method development. The presentation will include a theoretical explanation of SPME fundamentals and practical suggestions to overcome common errors and bias encountered when using SPME.
    The webinar is divided in three main sections: 1) optimization of extraction conditions 2) matrix modifications 3) optimization of desorption conditions for gas and liquid chromatography. Each section is divided in various subsections dedicated to each parameter affecting the performance of the SPME technique. The webinar attendees will be guided through comprehensive understanding of the technology and the critical parameters that influence the extraction process with practical examples from already existing methods.
  • Lung Cancer and IHC
    Lung Cancer and IHC Jeff Gordon, Cell Marque- Rocklin, CA Recorded: May 12 2017 67 mins
    Lung cancer is the most commonly diagnosed non-skin cancer in the United States. Each year, over 222,000 people are diagnosed with lung cancer, and over 150,000 succumb each year to the illness, making it also the deadliest cancer in the country. With constant advancement of treatment options, the importance of accurate diagnosis and detection of lung cancer becomes more and more relevant to the survival of the patient. Immunohistochemistry has served as the catalyst for these advancements in lung cancer diagnosis. This presentation covers many of the basic science, facts, and statistics of lung cancer, as well as the utility of immunohistochemical testing with markers such as TTF-1, napsin A, desmoglein-3, and p40 in the accurate diagnosis and survival rates of lung cancer.
  • The future of the clinical trial – collaboration and patient centricity
    The future of the clinical trial – collaboration and patient centricity Jameisha Brown, Eric Delente, Paulo Moreira, Christine Phillips, Andrew McConaghie Recorded: May 3 2017 73 mins
    Growing patient influence combined with new technologies and the requirements of new reimbursement models means clinical research is undergoing rapid transformation. Industry is being compelled to move towards more patient centric solutions to keep up with these changes. With healthcare stakeholders in agreement that patient engagement is key to realising the value of clinical trials, regulators, sponsors, CROs, research funders and publishers are all moving towards more patient-focused models.

    With the advent of new methodologies, such as electronic data sources and medical records, recruiting patients for trials now demands extensive collaboration between patients and trial centers to effectively and efficiently run trials. The patient has never been more important.

    To mark Clinical Trials Awareness Week, pharmaphorum, in partnership with INC, will present a live webinar exploring the challenges and solutions of the current environment and how collaboration can benefit research participation, as well as the vital role the patient advocate plays in these matters.
  • Sample Preparation for Food Analysis:  New Technologies and Techniques
    Sample Preparation for Food Analysis: New Technologies and Techniques Jennifer Claus, Product Manager, Franchise Marketing Sample Preparation (Non-Bio) Recorded: Apr 27 2017 75 mins
    In typical analytical workflows, sample preparation accounts for over 60% of the time taken to generate results and 30% of any errors generated. To help analytical chemists maintain the cornerstones of all analytical processes, namely; speed, specificity, sensitivity, and reproducibility, considerable resources have been devoted to the development of new and unique technologies in the sample preparation field. With specific reference to solid phase extraction and solid phase microextraction, this presentation will outline new technologies and techniques developed in sample preparation for food analysis.
  • Life sciences promotional content management for speed, compliance and insight
    Life sciences promotional content management for speed, compliance and insight David Bennett, Andrew McConaghie Recorded: Apr 27 2017 69 mins
    The life sciences landscape is moving at a rapid pace, which in turn is increasing the demands on marketers to create innovative, digital content faster while maintaining industry compliance.

    Veeva Systems recently conducted an annual industry study, focused on content and digital asset management within life sciences. Gleaned from the experiences and opinions of leaders across the life sciences industry, the research uncovers current practices and the industry’s need for more advanced approaches for global marketing and regulatory compliance.

    Join this webinar to hear the key insights from the survey results, and discuss key highlights with host David Bennett, VP Commercial Content Strategy Europe, Veeva.

    From this webinar you will:

    – Learn the current state of commercial content and digital asset management in life sciences promotions
    – Garner an understanding of how your organization compares to the industry
    – Understand how to accelerate your content across the digital supply chain
  • 3 Ways to Retool Your Business with Technology in 2017
    3 Ways to Retool Your Business with Technology in 2017 Andrea Bradbury, Co-Founder and Chief Quality Officer, Suvoda Software; Jeinnfer Royer, Direct Product Marketing, DocuSign Recorded: Apr 25 2017 58 mins
    Nearly 50% of business leaders fear they will become obsolete over the next several years, and nearly 80% feel threatened by digital startups. Why? New technologies and digital strategies are challenging existing business models and forcing companies of all sizes to reimagine patient care, product innovation and distribution models to remain competitive.

    View this on-demand webinar hosted by PharmaVOICE to learn from Andrea Bradbury, Co-Founder and Chief Quality Officer, Suvoda Software, a leader operating at the intersection of life sciences and technology as she shares how she built her business on a digital platform to accelerate her organization’s global expansion while meeting the needs of mobile, digital customers and employees.

    Topics covered include:

    - Streamlining clinical research, sales and HR processes with digital tools
    - Elevating the digital agenda at your organization
    - Scaling technologies globally
    - Applying nimble design models for life science operations
    - Implementing top life sciences trends in 2017
  • When small becomes big: orphan medicines, advances, access and affordability
    When small becomes big: orphan medicines, advances, access and affordability Alastair Kent OBE, Malcolm Qualie, Sheela Upadhyaya, Sarah Rickwood, Moderated by Paul Tunnah Recorded: Apr 10 2017 75 mins
    Over the past few years there has been a shift in the European pharmaceutical market landscape, with a rise in specialty medicines for diseases with narrow patient populations. Indeed, QuintilesIMS forecasts that, between 2013 and 2018, 94% of list price value growth will be in specialty medicines – with orphan drugs at the forefront of this trend.
    On 10 April 2017, QuintilesIMS, in partnership with pharmaphorum presents a unique digital debate, bringing together a panel of senior industry experts, including participants from NICE, NHS England and Genetic Alliance UK to explore the pillars of commercial success for orphan drugs in Europe in the context of changes in reimbursement processes and broader future challenges, like Brexit.
  • Enabling CAR-T Screening in 3D Tumor Spheroids
    Enabling CAR-T Screening in 3D Tumor Spheroids Van Dang, D.V.M., Ph.D., Abhi Saharia, Ph. D., and Audrey Bergeron, Applications Scientist Recorded: Mar 30 2017 62 mins
    Webinar Date & Time: Mar 30 2017 12:00 p.m. EST

    Chimeric antigen receptor (CAR)-T cells, which are engineered to recognize target cell surface antigens expressed on tumor cells, have shown promise to affect complete remission in patients with B-cell malignancies. However, applying this approach to target solid tumors has resulted in adverse effects in clinical studies. Methods for testing different models of CAR-T cells in vitro can provide further insight into viable antigen targets. Historically, two-dimensional (2D) cell culture models have been used in drug discovery. However, more elaborate, three-dimensional (3D) cell culture models better mimic the in vivo tumor microenvironment and help bridge the gap between in vitro studies and clinical outcomes.

    In this special joint webinar, panelists from ProMab Biotechnologies, DiscoverX, and Corning Life Sciences will present data on a high-throughput, easy-to-use, highly reproducible method for screening CAR-T cells in a 3D cell culture model by combining various technologies.


    Speakers:
    Van Dang, D.V.M., Ph.D.
    Scientist and coordinator for CAR-T research
    ProMab Biotechnologies, Inc.

    Abhi Saharia, Ph. D.
    Director, Cell-based Assays and Biologics
    DiscoverX

    Audrey Bergeron
    Applications Scientist
    Corning Life Sciences
  • 3D Nephrotoxicity applications & Nortis’ microfluidic organ-on-chip technology
    3D Nephrotoxicity applications & Nortis’ microfluidic organ-on-chip technology Dr. Ed Kelly, Dr. Henning Mann Jul 25 2017 3:00 pm UTC 120 mins
    1. The kidney proximal tubule is the primary site of drug-induced nephrotoxicity. I will describe the development of a 3-dimensional flow-directed proximal tubule microphysiological system (MPS). The kidney MPS recapitulates the synthetic, metabolic and transport activities of kidney proximal tubule cells. This MPS is as an ideal platform for ex vivo modeling of nephrotoxicity. Towards this goal, we have evaluated nephrotoxicity in response to challenge with multiple toxicants, including the heavy metal pollutant cadmium, antisense oligonucleotides, the antibiotic polymyxin B and the Chinese herbal product aristolochic acid. We believe that MPS technologies will have major impacts on predictive toxicity testing and human risk assessment. Animal and in vitro systems do not always faithfully recapitulate drug and xenobiotic responses in the clinic or occupational/environmental exposures, respectively. MPS technologies will refine safety assessment and reduce our need for surrogate animal testing. An ultimate goal is to create integrated human MPS organ systems that could replace animal models.

    2. Nortis has developed a technology that is used to recapitulate functional units of human organs in microfluidic devices (chips). Such organ models include vasculature, kidney, and liver models for toxicology studies, blood-brain barrier models for drug transport studies, and vascularized tumor microenvironment models for drug efficacy studies.
  • Top U.S. Security Concerns Revealed - 2017 Unisys Security Index Survey Results
    Top U.S. Security Concerns Revealed - 2017 Unisys Security Index Survey Results Bill Searcy, Vice President for Global Justice, Law Enforcement, and Border Security Solutions, Unisys Jul 27 2017 5:30 pm UTC 60 mins
    U.S. consumers rate national security in relation to war or terrorism as their top security concern, though fears over viruses/malware and hacking are rising dramatically, according to the new Unisys Security Index™ that surveyed more than 13,000 consumers in April 2017 in 13 countries. This study, the only recurring snapshot of security concerns conducted globally, gauges the attitudes of consumers on a wide range of security-related issues.

    About the speaker:
    Bill Searcy is the Vice President for Global Justice, Law Enforcement, and Border Security Solutions. As a recognized law enforcement solutions expert, he is responsible for developing market strategies, overseeing delivery, ensuring customer satisfaction, and driving business performance to meet goals.​​
    During his 21-year career as a Special Agent with the Federal Bureau of Investigation, Bill was recognized as an innovator who regularly sought new ways to use technology to solve complex problems. He is credited with leading numerous award winning IT initiatives, among them the FBI’s Grid Computing Initiative (Attorney General’s Award for Innovation) and the Next Generation Workstation (FBI Director’s Award).
    Prior to joining Unisys, Bill served as the Deputy Assistant Director of the FBI’s IT Infrastructure Division, where he was responsible for the engineering, development, deployment, and support of the FBI’s worldwide IT enterprise.
    A graduate of the United States Military Academy at West Point, Bill was commissioned as an officer in the U.S. Army where he commanded a Field Artillery battery. He went on to earn a Master of Science in Information Assurance from Norwich University and he is a Certified Information Systems Security Professional (CISSP).
  • Machine Learning Analytics for Engaging Consumers and Limiting Risk in Finance
    Machine Learning Analytics for Engaging Consumers and Limiting Risk in Finance Rodrigo Fontecilla,Vice President and Global Lead for Analytics, Unisys Aug 2 2017 3:00 pm UTC 60 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 Speaker: 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.
  • How PlumX Metrics on Scopus help tell the story of your research
    How PlumX Metrics on Scopus help tell the story of your research Andrea Michalek, Vice President, Product Management, Research Metrics Aug 10 2017 4:00 pm UTC 60 mins
    PlumX Metrics will soon become the primary source of article-level metrics on Scopus. As Plum Analytics’ comprehensive, item-level Metrics, PlumX Metrics provide insights into the ways people interact with individual pieces of research output (articles, conference proceedings, book chapters and many more) in the online environment.
  • The Otic Chronicle │ A Guide to Conducting Nonclinical Auditory Studies
    The Otic Chronicle │ A Guide to Conducting Nonclinical Auditory Studies Rachel Tapp, MS, LATG Aug 17 2017 2:00 pm UTC 90 mins
    Developments for new therapeutics to target various aspects of auditory system dysfunction is on the rise within the drug development industry. Join Rachel as she reviews nonclinical auditory safety programs, including standard and non-standard endpoints. She will also share in-depth answers to common questions regarding species selection and study timelines.
  • New Paradigm of Building Quality during Manufacture - Challenges with Biologics
    New Paradigm of Building Quality during Manufacture - Challenges with Biologics Dr Rajesh K. Gupta Aug 23 2017 2:00 pm UTC 75 mins
    Historically, quality of biological products has been ensured through testing representative samples. Shift in quality paradigm started with implementation of Good Manufacturing Practice (GMP) regulations with current focus on building quality during manufacture. Inherent variability and complexity of biological products pose challenges in implementing Quality by design (QbD) concept. This presentation discusses ways to build quality during manufacture of biological products.
  • 浮遊系細胞培養用シングルユースシステム
    浮遊系細胞培養用シングルユースシステム コーニングインターナショナル株式会社 ライフサイエンス事業部 石渡孝至 Sep 12 2017 6:00 am UTC 75 mins
    抗体ワクチンやウイルス産生のラボスケールから、治験薬製造スケールまでの浮遊系細胞培養用シングルユース製品の導入ポイントについて概説いたします。

    近年、バイオ医薬品開発に於けるシングルユース製品の市場が活況を呈しております。抗体ワクチン、幹細胞/ヒトiPSや浮遊系細胞による製剤化やバイオバンキン グを具現化する際に、最も大きな懸案事項となりますのが“質”、“量”そして“コスト”の問題があります。そこでコーニングでの安全、安価かつ簡便なシングルユース製品の特徴や仕様についてご紹介致します。
     また治験薬に向けた品質規格や導入事例によるマーケットトレンドを示しながら、トータルソリューションシステムの振盪培養(フラスコ、べセル、バッグ)、チュービング&コネクション(閉鎖系システム、無菌接続)、パッケージング(培養 / 回収 / 凍結保存)および品質規格(施設環境、BSE/TSE、発熱物質(Pyrogen)、USPクラス6規格準拠 / 滅菌保証レベル / エンドトキシン規格 / QC試験)について概説します。
  • Advances in Mass Spectrometry for the Analysis and Bioanalysis of Antibody-Drug
    Advances in Mass Spectrometry for the Analysis and Bioanalysis of Antibody-Drug Arnaud Delobel, PhD Sep 12 2017 2:00 pm UTC 75 mins
    ADCs are complex compounds resulting from the coupling of cytotoxic small molecules to a monoclonal antibody. Their characterization as well as their bioanalysis (quantification in biological fluids) remains challenging. Mass spectrometry at different levels (intact, middle, peptide) can be a valuable tool, and can now be used in a regulated environment thanks to advances in both hardware and software.
  • Cell Line Engineering and the Cell Design Studio
    Cell Line Engineering and the Cell Design Studio Mark Gerber, PhD, Principal R&D Scientist, Supervisor, Cell Design Studio Sep 13 2017 2:00 pm UTC 75 mins
    Gene editing has become a firmly established technology within the discovery sciences arena. With the advent of CRISPR/Cas9 systems, the researcher's ability to find an active nuclease for nearly any region of any genome is now a reality. With even better nucleases available, those who routinely use gene editing tools to manipulate cell lines encounter other significant challenges that pose a barrier to building the "correct" cell line model. This presentation will highlight some of those challenges, and methods that we at Merck KGaA, Darmstadt, Germany have developed and/or implemented to circumvent them. A summary of the various formats of CRISPR/Cas9 tools, and recommendations for when to use each will also be presented.
  • The Future of Pharmaceutical Manufacturing: Flexibility and Sustainability throu
    The Future of Pharmaceutical Manufacturing: Flexibility and Sustainability throu Daniel O. Blackwood & Jeffrey Moriarty of Pfizer, Inc. Oct 18 2017 2:00 pm UTC 75 mins
    Following a decade (or more) of concerted effort by industry, regulator, and academic groups, recent technology investments are now beginning to shape how medicines are being developed and manufactured for the global marketplace. While significant focus has highlighted the emergence of continuous manufacturing processes, three additional trends have also influenced and served as underlying drivers for these technology investments. First, the emergence of scientific advances in targeted biology has created high-value personalized medicines with smaller manufacturing volumes (doses/annum). Second, new regulatory pathways, such as the FDA’s Breakthrough Therapy designation, have accelerated the development and commercialization timelines for these new medicines. Finally, manufacturing localization has extended supply chain networks to serve globally-distributed patient populations throughout the world. Together, these drivers have served to shape the future of pharmaceutical development, manufacturing, and distribution of a variety of different dosage forms. The increasing need for product development speed and commercial supply flexibility through small-footprint, modular equipment trains will be highlighted within this paper, using an immediate-release solid oral dosage form example.
  • Characterisation of Host-Cell Proteins using Mass Spectrometry Enables Effective
    Characterisation of Host-Cell Proteins using Mass Spectrometry Enables Effective Dr Li Zang Oct 31 2017 2:00 pm UTC 75 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.
  • Disposables – Suitability and Process Economy In Biopharmaceutical Manufacturing
    Disposables – Suitability and Process Economy In Biopharmaceutical Manufacturing Dr Joachim Walter Nov 1 2017 2:00 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.
  • Single-Use Stainless Steel BioReactors: Quality Factors for Consideration When S
    Single-Use Stainless Steel BioReactors: Quality Factors for Consideration When S Dr Trevor Deeks, Principal and Consultant of Deeks Pharmaceutical Consulting Services, LLC Nov 8 2017 3:00 pm UTC 75 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.
  • 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 Nov 15 2017 10:00 am UTC 75 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.
  • 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.
  • Environmental Monitoring Trend Analysis Tools
    Environmental Monitoring Trend Analysis Tools Steve Walton Feb 28 2018 3:00 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.
  • Challenges in the Development of Continuous Processes for Vaccines
    Challenges in the Development of Continuous Processes for Vaccines Danny Vellom Jun 27 2018 3:00 pm UTC 75 mins
    The development and application of continuous manufacturing processes for vaccines presents both great opportunity as well as significant challenges, both technical and cultural, for the global industry. The key drivers are manufacturing capacity and flexibility, speed to market, and improved quality through the application of Quality-by-Design and Process Analytical Technology (QbD/PAT). Given the diversity of immunogens (toxoids, conjugate and subunit vaccines, live-attenuated and inactivated viruses, VLPs, etc.), and the variety of unique processes currently utilized to produce either single- or multi-component vaccines, it is unlikely that the transition to continuous processing will happen overnight. Additionally, cultural challenges are faced whenever a new mode of operation appears to some as “too different”, especially in a traditionally conservative sector like the developed-world vaccine industry. That said, market forces, global climate change, and Nature’s propensity to fill unoccupied niches with emerging infectious diseases will undoubtedly induce a first round of pioneers to explore this exciting new design space, ultimately leading to a more nimble industry and more and better opportunities for protection for the global population.