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Medical Research

  • Learn how Lancet editors decide which papers to accept for publication
    Learn how Lancet editors decide which papers to accept for publication
    Heather Van Epps, Editor-in-Chief The Lancet Rheumatology Recorded: Dec 12 2019 71 mins
    Join Heather Van Epps, Editor-in-Chief of The Lancet Rheumatology, to learn about techniques and strategies for preparing your paper to submit to high-impact journals.

    Heather will share her experiences working with researchers and authors throughout the research publishing cycle. You will learn how to develop papers for submission to publications like the Lancet family of journals.

    Do not miss this engaging webinar―you are invited to join and ask any questions that you feel will benefit your research.

    Don't forget to download your manuscript checklist from the resources section.
  • Clone Wars: An In Depth Look at Mouse vs Rabbit Antibodies
    Clone Wars: An In Depth Look at Mouse vs Rabbit Antibodies
    Faris Omary and Leah Hartman Recorded: Dec 11 2019 40 mins
    Have you ever found yourself wondering which clone of Napsin A to use? What about PAX-8? Or the ongoing dilemma of ordering a mouse monoclonal vs rabbit polyclonal? Then this webinar is for you!
    In this presentation we will explore how antibody's are produced in their corresponding hosts. From there we will identify the main differences between the most popular types of antibodies, including mouse and rabbit monoclonals, and rabbit polyclonals. We will then compare the performance of specific clones that are backed by NordiQC data. We hope this will aid in choosing the best clone for your IHC tests.
  • Microbiology of Gram-negative Bacteria in Cystic Fibrosis
    Microbiology of Gram-negative Bacteria in Cystic Fibrosis
    Professor Dr. Samantha Sottotetti Recorded: Dec 6 2019 20 mins
    Learn about the primary pathogens isolated in cystic fibrosis patients and consider these microorganisms’ relative antimicrobial susceptibility. How do differing intrinsic resistance values from international authorities impact antibiotic management? What interpretive category breakpoints can be used with these opportunistic, environmental pathogenic, non-fermenting, Gram-negative bacteria in cystic fibrosis patients?

    In this workshop, recorded at the 29th European Congress of Clinical Microbiology & Infectious Diseases, Dr. Samantha Sottotetti explains the importance of cystic fibrosis microbiology in Gram-negative, non-fermenting bacteria isolated from the respiratory tract of cystic fibrosis patients.

    After viewing this webinar, you will be able to:

    •Understand what bacteria colonize lungs of cystic fibrosis patients, and how MIC testing is performed
    •Identify characteristics of colonization and phenotypes of P. aeruginosa, the major Gram-negative organism
    •Describe other opportunistic pathogens—including A. xylosidans, S. maltophilia and B. cepacia—and antibiotic resistance for each organism

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

    Ideal For: Microbiologist, Laboratory Director, Physician, Pathologist

    Presenter: Professor Dr. Samantha Sottotetti, Cystic Fibrosis Microbiology Laboratory

    *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.
  • Ask a Corning Scientist: 3D Cell Culture and Bioprocess
    Ask a Corning Scientist: 3D Cell Culture and Bioprocess
    Audrey Bergeron, Applications Scientist & Ann E. Rossi, Ph.D, Senior Bioprocess Applications Scientist, Corning Life Sciences Recorded: Dec 5 2019 31 mins
    Advanced cell culture techniques and scale-up offer exciting research opportunities; however, they also come with complex challenges and questions. Corning Life Sciences knows cells – you might even say it’s in our DNA with over 100 years of experience in the field.

    In this webinar, Corning scientists put their expertise in the areas of 3D cell culture and bioprocess to work as they answered submitted questions from the audience.

    Webinar highlights:
    •Our lab is new to working with spheroids. What are some options for spheroid formation? (2:02 - 4:10)
    •How do you perform media changes in the 96-well Corning spheroid microplate without losing spheroids? (4:11 - 5:49)
    •How do you dissociate single cells from a spheroid for analysis? (5:50 - 6:51)
    •How do you transfer spheroids? (6:54 - 7:30)
    •What is the surface area of the Corning® CellSTACK® 10-layer vessels? (7:56 - 10:02)
    •Is there an easier way to fill Corning CellSTACK 10-layer vessels? (10:03 - 11:33)
    •What is the maximum culture volume for the 5L expansion bag? (11:34 - 13:25)
    •What cell types can I culture in the 5L Erlenmeyer flask? (13:26 - 15:25)

    Live Q&A session with audience (16:10 - 29:30)
    •How do you prevent organoids from sticking to collection tubes?
    •How do I check the cell confluence in a HYPERFlask?
    •And many more questions
  • Leverage PK data in PharmaPendium to inform drug development strategies
    Leverage PK data in PharmaPendium to inform drug development strategies
    Marnix Wieffer Recorded: Dec 5 2019 49 mins
    Pharmacokinetic information from FDA and EMA regulatory documents informs translational and clinical development decisions and may lead to more successful drug development and regulatory approval strategies.

    Pharmacokinetic information from FDA and EMA regulatory documents informs translational and clinical development decisions and may lead to more successful drug development and regulatory approval strategies.
    Join solution marketing manager Dr. Marnix Wieffer for this webinar, where he will discuss how to leverage extracted pharmacokinetic data from literature and FDA/EMA Drug Approval documents to make better-informed decisions on which drugs have the most potential to succeed in clinical development.

    Using PharmaPendium we will
    •Retrieve detailed information on PK parameters on approved drugs
    •Retrieve all data on PK parameter of interest (for example Cmax) on drug acting on the same target I am working on
    •Investigate what is the best translational model to assess Serum protein binding
    •And much more
  • Reaxys training webinar
    Reaxys training webinar
    Dr Marta da Pian Recorded: Dec 5 2019 40 mins
    This webinar will focus on Structure searches in Reaxys.

    - MarvinJS/ChemDraw editor (drawing tools and checkbox panel)
    - Reaction search (product/reagent/catalyst, Atom mapping, Reacting center)
    - Diving into the Result panel
  • Application of Harm Reduction Principles in Australia
    Application of Harm Reduction Principles in Australia
    Mark Dougan, Director, Frost & Sullivan, Dr. Sud Agarwal, Professor Tikki Pangestu Recorded: Dec 5 2019 61 mins
    Harm reduction is a set of public health policies designed to lessen the social, economic, and physical consequences arising from various human behaviors, both legal and illegal. Along with demand reduction and supply reduction, harm reduction is an important harm minimization component in areas such as smoking and the use of illegal drugs, e.g., cannabis.

    In this Frost & Sullivan webinar, we will explore the application of harm minimization and more specific harm reduction measures in Australia. It will include how policies legalizing and regulating medicinal cannabis are impacting the consumption of non-regulated products, and the use of harm reduction approaches to minimize the effects of tobacco consumption.
  • The Science of Healthcare Congresses
    The Science of Healthcare Congresses
    Eva Thalmann, Janssen, Jean-Yves Douillard, ESMO, Katie Koziol and Andrew Moore, Ashfield Meetings & Events Recorded: Dec 3 2019 70 mins
    Research from Ashfield Meetings & Events clearly demonstrates that face-to-face meetings and events form a major part of continuing medical education (CME). National and international congresses have been identified as the primary event to attend by HCPs.

    But what makes congresses such a valuable education channel for time-restricted physicians? This pharmaphorum webinar, in association with Ashfield Meetings & Events, will dive into a unique study of HCP educational and behavioural preferences towards attendance at medical congresses.

    Ashfield Meetings & Events’ The Science of Healthcare Congresses study, involved over 200 HCPs, drawn from a range of therapy areas, from both Europe and the US to ask what really matters to them and share some intriguing insights.

    These encompassed how HCPs value this type of activity, how they apportion their time on-site and engage with the healthcare industry, and how they evaluate a congress once its doors have closed for another year.

    Join our expert panel on Tuesday 3rd December to find out more on:

    • Why physicians attend congresses
    • How to ensure medical education provides value to attendees
    • How pharma can enhance industry symposia

    In addition, our panel will also share the results of an ongoing association and multi-pharmaceutical company research project, designed to standardise and benchmark the evaluation process of all congress medical education activities.
  • Effective and Compliant Literature screening for Pharmacovigilance
    Effective and Compliant Literature screening for Pharmacovigilance
    Jean Dominique Pierret Recorded: Dec 3 2019 47 mins
    Biomedical literature is an important source of adverse event reporting. However, due to the high volume of literature, sub-optimal search strategies and regulatory pressure, pharmaceutical companies and CROs are facing significant challenges around costs, efficiencies, oversight and regulations.

    During this webinar, Dr Jean Dominique Pierret, Customer Consultant Pharmacovigilance at Elsevier, will discuss how, through query design, prioritization technology and outsourcing we can significantly improve efficiency and compliance of literature screening.
    We will explore:
    1.The optimization of queries in literature databases
    2.The benefits if literature workflow management
    3.Efficiency gains through prioritization
    4.How outsourcing can support efficiency gains
  • Importance de la surveillance microbiologique de l'environnement de fabrication
    Importance de la surveillance microbiologique de l'environnement de fabrication
    Christian Poinsot, Président Groupe Icare, Sabine Bessières Recasens Field Marketing Manager Environnemental Monitoring Life Recorded: Dec 3 2019 76 mins
    Il s’agit d’un webinar visant la stratégie de maîtrise de la qualité des dispositifs médicaux stériles avec un renforcement de leur réglementation et l’intérêt croissant de la surveillance environnementale de leurs zones à risque de fabrication donc à atmosphère maitrisée
    Rappel des bases de la surveillance de la biocontamination environnementale -Air Surface Personnel - des zones à atmosphère contrôlée des DM et informations sur le nouveau projet de norme européen EN 17141 sur le contrôle de la biocontamination des salles propres en préparation avec une annexe dédiée.
  • How to apply global brand strategies to every customer interaction
    How to apply global brand strategies to every customer interaction
    Massimiliano Siciliano, Grunenthal, Kasper Jerlang, LEO Pharma, Alejandra Betancourt, Anthill Agency, Dom Tyer, pharmaphorum Recorded: Nov 28 2019 62 mins
    Pharmaceutical companies spend a huge amount of time and resources on creating valuable brand strategies, but when they come to life there’s often a disconnect.

    Strategy and execution can easily drift apart when tactics come to life, making it harder for them to drive business and deliver on the long-term action plans to engage with healthcare professionals.

    This is as true for eDetailing or closed-loop marketing initiatives as it is for multichannel marketing strategies that encompass the latest chatbot technology or innovative digital content platforms.

    To remedy this, those working in pharma on multichannel marketing, brand planning and digital need to apply the human factor to their global brand strategies to achieve the kind of tactics that deliver on strategic goals.

    Focus

    Join Anthill on Thursday 28th November from 13:00 GMT / 14:00 CET for a live expert panel discussion on multichannel marketing, brand planning and how to apply global brand strategies in pharma to every customer interaction for greater HCP reach and return-on-investment.

    In addition to looking at brand planning across pharma, common frustrations for the industry and whether or not brand planning is set up to deliver good multichannel marketing, the webinar will also cover:

    • The most common challenges in the brand planning process
    • How to build executional and strategic understanding across an entire brand plan
    • How to activate your existing channels and create the best channel mix for customers
    • How insight-based multichannel marketing can drive strategy and build new insights for the future

    The pharmaceutical industry has been making great progress in its digital transformation, but boundaries are there to be pushed if companies want to continue to innovate their marketing practices and processes.
  • Monitoring Impurities in Biologics
    Monitoring Impurities in Biologics
    Diane McCarthy, PhD, Senior Scientific Liaison, Global Biologics, US Pharmacopeia  Recorded: Nov 26 2019 60 mins
    The complexity of biotherapeutic products and their manufacturing processes can yield a variety of impurities, which must be monitored and controlled to minimize safety concerns and ensure product quality. These impurities can be broadly grouped into two categories: 1) product-related impurities, such as precursors, aggregates and degradation products, and 2) process-related impurities, such as host cell DNA, host cell protein, and particulates.  This presentation will provide an overview of approaches for monitoring impurities, including a discussion of existing USP standards and standards under development to support impurity testing.

    Presented by Diane McCarthy, PhD, Senior Scientific Liaison, Global Biologics, US Pharmacopeia 

    Dr. McCarthy is a Senior Manager, Science and Standards within USP’s Global Biologics Department. Diane works with stakeholders to identify areas where standards are needed and define and develop new standards. Prior to joining USP, Dr. McCarthy was Senior Scientific Director at Caprion Biosciences, where she focused on the use of mass spectrometry for characterization of biologics and host cell proteins. Her previous roles also included Director of Scientific Affairs at Ezose Sciences, where she focused on identification and quantitation of glycans by mass spectrometry and Global Manager, Biomarker Research Center, at Bio-Rad Laboratories, where she directed translational and biomarker research contracts and collaborations with industry, key consortia, academic, and government groups.
  • The ROSING Study: A New ROS1 IHC Clone (SP384) for ROS1 Rearrangements
    The ROSING Study: A New ROS1 IHC Clone (SP384) for ROS1 Rearrangements
    Fernando Lopez-Rios, MD, PhD, FIAC Recorded: Nov 25 2019 41 mins
    The Lopez-Rios lab and their colleagues throughout Spain have published a very informative study (The ROSING Study) on ROS1 in Journal of Thoracic Oncology. Dr. Fernando Lopez-Rios will be presenting the data from the manuscript and be available for questions following his live presentation.
  • NTRK Rearrangements in Oncology: Diagnostic Strategies and Therapeutic Relevance
    NTRK Rearrangements in Oncology: Diagnostic Strategies and Therapeutic Relevance
    Dr. Eric Konnick Recorded: Nov 21 2019 62 mins
    In this webinar, Dr. Konnick will discuss the biology, background and
    rationale for targeting TRK fusions. You will learn about the clinical
    evidence for TRK inhibitors and issues implementing pan-tumor assays,
    specifically pan-TRK assays.
  • Biopharmaceutical process development – Trends/ Challenges/Opportunities
    Biopharmaceutical process development – Trends/ Challenges/Opportunities
    Kumar Gaurav, AGM (Regulatory Affairs) at Panacea Biotec Ltd and Sudhakar Nagaraj, Principal Scientist, SLS at Pall Biotech Recorded: Nov 20 2019 64 mins
    Presented by Kumar Gaurav, AGM (Regulatory Affairs) at Panacea Biotec Ltd

    Current trends and regulation affecting Biopharmaceutical Industry
    Journey from Lab scale to Commercial –Overcoming Scalability design hurdles
    QbD-Bringing Improvements in Biologics development and Manufacturing Space

    Followed by Quality by Design (QbD) Approach for a Virus Filtration Application
    Presented by Sudhakar Nagaraj, Principal Scientist, SLS – Global Regulatory and  Validation Consulting group at Pall Biotech

    Removal of viruses in bioprocessing applications is a fundamental regulatory requirement, and the use of virus filtration is considered a robust and well accepted component of a virus clearance strategy. With the advent of the International Conference of Harmonization (ICH) Q8 Pharmaceutical Development and Q9 Quality Risk Management guidelines, there is much greater emphasis for filter users to define the filter design space, in addition to performing the mandatory virus filtration validation studies.
    A thorough understanding of the virus filtration design space not only alleviates the risk of viral contamination, but an in-depth understanding of the boundaries of the process parameters ensures the manufacturing process remains in control. In this webinar, we describe an approach to implement QbD principles into virus filtration to create a safe and robust biomanufacturing process.
  • Tutorial for a better understanding of HILIC
    Tutorial for a better understanding of HILIC
    Dr. Frank Michel, Analytical & Chromatography Scientific Advisor, Merck KGaA Darmstadt, Germany Recorded: Nov 19 2019 61 mins
    Interest in chromatography using hydrophilic interaction liquid chromatography (HILIC) has continued to build in recent years. Although HILIC chromatography is known to provide valuable retention and selectivity of polar compounds and provide highly compatible conditions for coupling with mass spectrometry, it is sometimes avoided due to issues surrounding robustness and repeatability. In this webinar stationary and mobile phase selection will be discussed in detail together with the impact of sample solvent and equilibration procedures on retention times. Based on this HILIC method development practices can be improve and better understanding of HILIC is gained.
  • バイオ医薬研究・開発・製造における技術導入ポイントとアプリケーションの紹介
    バイオ医薬研究・開発・製造における技術導入ポイントとアプリケーションの紹介
    コーニングインターナショナル株式会社  ライサイエンス事業部 石渡 孝至 Recorded: Nov 19 2019 61 mins
    ベクター生産や再生医療用細胞の産業応用への期待が高まるにつれ、生存細胞を最大効率で回収することが求められています。そこでシングルユース製品の攪拌システム(旋回・振とう・上下対流)について細胞培養事例を含めて概説します。

    ポイント:
    ・大量培養容器とクローズドシステムソリューション
    ・ポリスチレン製マイクロキャリア法の紹介
    ・品質管理体制 (原料樹脂・溶出物・リーク・滅菌など)
    ・最新の培養事例紹介 (Vero・hMSC・HEK293Tなど)
  • Accuracy of MICs
    Accuracy of MICs
    Sören Gatermann, Abteilung für Medizinische Microbiologie der Ruhr-Universität Bochum Recorded: Nov 18 2019 22 mins
    Understand the challenges you will confront when interpreting antibiotic susceptibility test results based on minimum inhibitory concentration (MIC) accuracy. Ignoring uncertainty introduced through multiple factors—interlaboratory variability, biological differences, incubation temperature fluctuations, time ranges, proximity to breakpoints and others—influences the results of antimicrobial susceptibility test results.

    In the webinar, Accuracy of MICs, recorded at the 29th European Congress of Clinical Microbiology & Infectious Diseases, Professor Dr. Sören Gatermann will review how correct classification of antibiotic resistance demands a persistent, multifaceted approach to analysis.

    After viewing this webinar, you will be able to:

    - Understand the sources of uncertainty in phenotypic antimicrobial susceptibility testing—variability between laboratories, bacterial variation, incubation temperatures, MIC breakpoint interpretation and others
    - Learn about the new “Area of Technical Uncertainty” and other factors involved in setting EUCAST breakpoints
    - Know the reasons behind some EUCAST breakpoints having no susceptible MIC interpretation

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

    Ideal for: Microbiologist, Pharmacist, Medical Director, Laboratory Director, Pathologist, Physician

    Presenter: Sören Gatermann, Abteilung für Medizinische Microbiologie der Ruhr-Universität Bochum

    *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.
  • MIC Surveillance, Resistance Mechanisms and Public Health
    MIC Surveillance, Resistance Mechanisms and Public Health
    Rafael Canton, Hospital Universitario Ramón y Cajal-IRYCIS Recorded: Nov 18 2019 34 mins
    Explore how systematic collection, analysis, interpretation and timely dissemination of minimum inhibitory concentration (MIC) data impacts the planning, implementation and evaluation of public health practice. Understand what impact high-level or low-level resistance mechanisms have on the interpretation of isolates distribution, which may help clinicians go beyond relying solely upon the breakpoints available today.

    In this webinar, recorded at the 29th European Congress of Clinical Microbiology & Infectious Diseases, hear Professor Rafael Canton review why antimicrobial resistance, beyond the human side of medicine, is yet another public health approach clinicians need to address.

    After viewing this webinar, you will be able to:

    - Learn the importance of surveillance of antimicrobial resistance, and the international programs for antimicrobial resistance surveillance
    - Understand the importance of MIC interpretation in public health surveillance, with examples for fluoroquinolones and cephalosporins
    - Know how MICs can assist the user in simplification of complex resistance mechanisms, and the relevance of MICs when using molecular methods for surveillance

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

    Ideal for: Antimicrobial Stewardship Committee Member, Laboratory Director, Microbiologist

    Presenter: Rafael Canton, Hospital Universitario Ramón y Cajal-IRYCIS

    *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.
  • Biopharmaceutical Process Model Evolution – Enabling Process Knowledge Continuum
    Biopharmaceutical Process Model Evolution – Enabling Process Knowledge Continuum
    Saly Romero-Torres, PhD, of Biogen and David Lovett & John Mack of Perceptive Engineering Recorded: Nov 15 2019 67 mins
    Full Title: Biopharmaceutical Process Model Evolution – Enabling Process Knowledge Continuum from an Advanced Process Control Perspective

    Presented by Saly Romero-Torres, PhD, Senior Manager, Advanced Data Analytics, Biogen

    Biogen is adopting modeling maturity models similar to the ones used by high tech industries such as semiconductors, electronics and AI. The focus of this maturity model is to ensure that a plan for model evolution is conceived, and socialized, among SMEs and regulatory agencies early on during process development. This plan is crucial particularly when implementing data driven models that rely on process experience. A well-planned modeling continuum should allow the pharmaceutical industry to realize the benefits from modeling activities early on, while evolving into more mature prescriptive controllers that operate within Established Conditions (EC) and are potentially implemented through Post-Approval Change Management Protocols (PACMPs).

    Followed a Presentation by David Lovett, Managing Director & John Mack, Engineering Director at Perceptive Engineering
  • Improving diversity and inclusion in research and publishing
    Improving diversity and inclusion in research and publishing
    Dr Lan-Lan Smith, Editor-in-Chief of The Lancet Haematology Recorded: Nov 14 2019 72 mins
    Gender equity is not only a matter of justice and rights, it is crucial for producing the best research and providing the best care to patients. If the fields of science, medicine, and global health are to improve human lives, they must be representative of the societies they serve. The fight for gender equity is everyone’s responsibility: men and women, researchers, clinicians, funders, institutional leaders, and, yes, even medical journals.

    Join Dr Lan-Lan Smith, Editor-in-Chief of The Lancet Haematology, to learn about:
    • Why is gender equity important in research
    • What do statistics say about diversity and inclusion in publishing
    • What initiatives have been started at The Lancet to bridge the gap
  • Boost Your Company’s Growth with Frost & Sullivan’s 2020 Healthcare Predictions
    Boost Your Company’s Growth with Frost & Sullivan’s 2020 Healthcare Predictions
    Reenita Das, Partner, Senior Vice President, Kamaljit Behera, Senior Industry Analyst, Frost & Sullivan Recorded: Nov 12 2019 75 mins
    Amid rising global trade tensions and a sluggish global economic outlook for 2020, the global healthcare market is expected to cross the $2 trillion mark during 2020. The new vision for healthcare for 2020 and beyond will not just focus on access, quality, and affordability but also on predictive, preventive, and outcome-based care models promoting social and financial inclusion.

    With the regulatory uncertainty on digital health applications slowly diminishing, incumbents will explore more focused healthcare applications during 2020. The convergence of artificial intelligence (AI), blockchain, and IoT will further catalyze the space of innovation adoption and related applications in the healthcare realm.

    To help shed light on trends, growth opportunities, and challenges to help you shape your healthcare strategy for 2020, Frost & Sullivan invites you to register for our highly anticipated annual webinar: Boost Your Company’s Growth with Frost & Sullivan’s 2020 Healthcare Predictions and Trends.

    The webinar is critical for the audience to understand:

    1. New opportunities connected to the pharmaceutical, biotechnology, medical technologies, diagnostics, and healthcare IT sectors.
    2. Opportunities that lie within advanced technologies, such as AI, blockchain, IoT, and cloud computing.
    3. Healthcare segments and geographic markets that will demonstrate tremendous growth opportunities during 2020.
    4. The top healthcare market predictions for 2020.
  • Just in Time Release of CAR T Cell Therapies
    Just in Time Release of CAR T Cell Therapies
    Irving Ford, Head of CAR T QC Laboratories at Celgene and Lori Daane, Pharma Microbiology Scientific Director at bioMérieux Recorded: Nov 11 2019 77 mins
    Presented by Irving Ford, Head of CAR T QC Laboratories at Celgene

    The views and opinions expressed during the Webinar are those of the presenter.

    Currently CAR T products typically represent the final treatment option for patients suffering from various forms of cancer. It is critical that CAR T products are manufactured and returned to the patient in an expedited manner. As such manufacturers of CAR T products must adopt and utilize Quality Risk Management (QRM) principles during manufacture, testing, and release.
    Risk based contamination control strategies must be employed from apheresis collection through final product release. A risk assessment, encompassing each step of the manufacturing process, should be performed to highlight potential areas of microbial ingress. Where possible, mitigating actions must be implemented eliminate the risk or to reduce the risk to an acceptable risk level.
    Based on a well-defined and documented microbial contamination control strategy, it should be possible for manufacturers to implement a just-in-time microbiological release strategy. This Webinar will highlight microbial contamination control and testing strategies that can be employed throughout each stage of the manufacturing process that will allow for a potential just in time release of CAR T products.

    Followed by an Industry Perspective presented by Lori Daane, Pharma Microbiology Scientific Director at bioMérieux

    Lori Daane is the Director of Scientific Affairs at bioMérieux and has experience in clinical, environmental and industrial microbiology. She is a technical expert on Rapid and Alternative Methods and participates in the sourcing and evaluation of new technologies and potential partnerships in the field of microbial control. She provides scientific support to the Healthcare Business in North America and is responsible for managing feasibility testing and method development for bioMérieux instruments and culture media products.
  • Viral Safety by Design for Cell and Gene Therapy Products
    Viral Safety by Design for Cell and Gene Therapy Products
    Mark Plavsic, Chief Technology Officer at Lysogene & Archie Lovatt, Life Sciences Biosafety Scientific Director at SGS Recorded: Nov 11 2019 67 mins
    Together with product efficacy, product safety is an essential characteristic of any medicinal product including cell and gene therapy (C&GT) biologics. Adventitious agents (viruses, bacteria, mycoplasma, prions, etc) pose constant risk to these biologics, and, as such they may impact directly product and patient safety. It is therefore of supreme importance to intentionally (by design) employ effective measures across the whole C&GT product manufacturing process to mitigate risk of adventitious agents. This presentation will review various interconnected steps throughout the manufacturing process, from the raw materials to the fill and finish, that would, in concert, help mitigate the risk while providing a high degree of product safety by design.
  • 爱思唯尔卓越科研在线讲座重播:在《柳叶刀》上发表论文——专为中国研究人员打造的中文在线讲座!
    爱思唯尔卓越科研在线讲座重播:在《柳叶刀》上发表论文——专为中国研究人员打造的中文在线讲座!
    Helena Wang Recorded: Nov 7 2019 60 mins
    与《柳叶刀》亚洲区执行主编王辉(Helena Wang)女士一起学习在高影响力期刊上发表论文的技巧和策略。王辉女士分享了她在整个研究论文发表周期中与研究人员和论文作者合作的经验,介绍如何撰写能够在优质出版物上发表的论文,以及广泛传播研究成果的机会。本次研讨会内容精彩纷呈,不容错过,能够让您的研究过程和研究影响再上新台阶。This webinar is in Mandarin (Chinese).
  • オルガノイド培養とハイスループット化の試み
    オルガノイド培養とハイスループット化の試み
    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 江藤哉子 Dec 17 2019 6:00 am UTC 60 mins
    スフェロイドとオルガノイドの違いに始まり、オルガノイドの活用や2020年1月発売予定の新製品、マトリゲル基底膜マトリックス オルガノイド形成用を使用した、3D気道オルガノイドのハイスループット遺伝子発現解析についてお話します。

    <セミナーのポイント>
    オルガノイドとスフェロイドとの違いやオルガノイドの特長について、実例や画像を交えながらご紹介します。
  • Different TTF-1 clones for the diagnosis of lung tumors: primary vs. metastatic
    Different TTF-1 clones for the diagnosis of lung tumors: primary vs. metastatic
    A/Prof. Dr. Sonja Klebe, MD, PhD, FRCPA Dec 18 2019 9:30 pm UTC 60 mins
    Dr. Sonja Klebe of SA Pathology and Flinders University, Australia, will share data from two recently published studies investigating immunohistochemistry using various TTF-1 clones for diagnosis of lung cancer and metastases of other origins. She will discuss the sensitivity and specificity of the different TTF-1 clones and the resulting implications in identifying lung, prostate, and colorectal adenocarcinomas.
  • Predicting drug-drug interactions to reduce adverse event risk
    Predicting drug-drug interactions to reduce adverse event risk
    Marnix Wieffer Jan 16 2020 3:00 pm UTC 45 mins
    Adverse drug reactions (ADRs) are a serious problem worldwide. One reason for the increase in ADRs is the growth in prescription use—especially among aging populations where drug–drug interactions (DDIs) are more likely. Currently, 9 percent of Americans over age 55 take 10 or more prescription drugs, which greatly increases the likelihood of DDIs and ADRs.

    Identifying potential drug-drug interaction risk is a key priority for pharmaceutical manufacturers and regulatory authorities. To minimize health risks to clinical trial subjects and patients, assessments should be performed as early as possible in development.
    Join solution marketing manager Dr Marnix Wieffer for this webinar where he will discuss outstanding issues with predicting Drug-drug interaction risk and possible solutions. We run through a couple of live examples that show how PharmaPendium is supporting Drug-drug interaction risk prediction.
    Using PharmaPendium we will investigate
    •What enzymes and transporters act on my drug of interest?
    •What is the DDI risk for drugs that are substrates CYP2D6?
    •What is the DDI risk of my drug under development with Antiarrhythmic drugs?
  • Qualification of Raw Materials and Cell Substrates for Biomanufacturing
    Qualification of Raw Materials and Cell Substrates for Biomanufacturing
    Maura Kibbey Director, Science & Standards at USP and Martin Wisher, Global Head of Regulatory Affairs at Merck Jan 16 2020 3:00 pm UTC 90 mins
    The quality of starting materials is critical for successful pharmaceutical manufacturing strategies. For biomanufacturing the challenges are further amplified due to the use of a wide variety of raw materials, cell lines, and naturally-derived materials with an increased risk for the introduction of unwanted impurities and adventitious agents. This presentation will provide an overview and updates on USP documentary standards containing best practices for qualifying incoming materials, demonstrating viral clearance, cryopreservation, cell banking, and controlling impurities derived from cell substrates for therapeutic proteins.

    Presented by Maura C. Kibbey, Ph.D., Director, Science & Standards, Global Biologics, U.S. Pharmacopeia

    Dr. Maura Kibbey is a Senior Scientific Fellow for Education and Training in USP’s Global Biologics Department. As USP’s refocused its strategy for biologics standards, Dr. Kibbey has collaborated with scientific experts and trainers to bring many more educational offerings to USP’s stakeholders. Not only to demonstrate the utility of these new standards but to also receive more feedback on future standards for advanced therapies. This role builds on her previous responsibilities directing USP scientists developing compendial standards.  Before joining USP, Dr. Kibbey worked for several biotechnology and diagnostic companies in the Washington DC area in scientific, management, marketing, and business development roles, as well as performing cancer research at the National Institutes of Health. Her scientific expertise includes development and validation of many different assay types for measurement of individual molecules, their activities, or binding interactions. She has published over 40 peer-reviewed articles and has been an invited speaker or workshop organizer for numerous scientific conferences.
  • Identification of unknown extractables and leachables using mass spectrometry...
    Identification of unknown extractables and leachables using mass spectrometry...
    Petra Booij, Investigator at GlaxoSmithKline & Dr Kyle D’Silva, Pharma & BioPharma Marketing Leader, Thermo Fisher Scientific Jan 30 2020 3:00 pm UTC 90 mins
    Full Title: Identification of unknown extractables and leachables using mass spectrometry: Identification with confidence?

    Extractable and Leachable (E&L) studies on materials used in the manufacturing process and container closer systems of drug products and drug substances are commonly used to assess the risk for patient exposure. Most often LC-MS or GC-MS is used to detect, identify and then quantify extractables and leachables. In general, an analytical evaluation threshold or reporting threshold is set based on a calculated patient exposure. Substances above the set threshold required further investigation if patient exposure exceeds this. Substances can be identified using mass spectral libraries to enable a toxicological risk assessment which considers the risk of patient exposure. However, how confident are we when we identify a substance using spectral libraries? A match with mass spectral libraries, data from orthogonal techniques, fragmentation data and availability of a certified reference standard can increase the level of confirmation. We will discuss an approach for different levels of identification and how to increase the level of confidence of identified extractables and leachables
  • Identification of Approaches to Simulated Leachable Studies: What are They? W...
    Identification of Approaches to Simulated Leachable Studies: What are They? W...
    Jason Creasey, Analytical Chemist at GSK Feb 3 2020 3:00 pm UTC 90 mins
    Full Title: Identification of Approaches to Simulated Leachable Studies: What are They? When to do Them?

    The term “Simulated leachable studies” is open to interpretation. I hope to provide a definition of this term and in doing so suggest when they can and should be used. The general aim of such studies is to provide an accurate qualitative and quantitative description of the substances which might be present as leachables in a pharmaceutical drug product (DP) derived from container closure system (and sometimes its manufacturing process) when the drug product is stored up to and including its shelf-life. Simulated studies provide an alternative to analysis of leachables directly in the drug product. A simulated study aims to avoid some of the downfalls of leachable analysis such as; inaccurate analysis of leachables due to interference from drug product and/or formulation elements, availability of stored DP samples, reaching required limits of detection in the DP and time / resource constraints associated with complex method development using DP.
    Simulated leachable studies must be able to accurately simulate the expected leachables in a DP and should be carefully crafted to achieve this. The system used for extraction must have similar propensity to leach from materials under study a drug product and care must be taken not to use system which either leach too much (potentially masking other substance) or too little.
  • mAb Industry in China: Biosimilars vs. Innovative Biologics
    mAb Industry in China: Biosimilars vs. Innovative Biologics
    Dr Joe X Zhou CEO Walvax Bio Group & Sarah Wang Head of Segment Marketing Biosimilars and Bioconjugations at Sarotrius China Feb 10 2020 8:00 am UTC 90 mins
    Presented by Dr Joe X Zhou, CEO at Genor Biopharma, Walvax Bio Group

    Following patent cliffs for Erbitux, Rituxan, Sandosta_n and several big blockbusters, Herceptin, Avastin are now among the next biosimilar targets. This is creating huge potential for biosimilars, prompting innovators to shift their focus to target more emerging markets which remain untapped for many companies. In this presentation, Joe will be sharing with you his vision of the biosimilars market with a focus on China. He will also discuss key considerations for mAb and biologics therapeutic development, providing a broad overview of challenges and opportunities presenting in the market.
     
    1.        Landscape changes of mAb therapeutics
    2.        New targets and process/manufacturing innovation
    3.        Key consideration of mAb industry in China
    4.        Case study: Development strategies of PD-1 mAb as anti-tumor therapeutics in China for global market

    Followed by Biosimilar development—how to deal with the similarity challenge

    Presented by Sarah (Xuyu) Wang, Head of Segment Marketing, Biosimilars and Bioconjugations at Sartorius Stedim Biotech

    Globally we have more than 1000 biosimilars in the pipeline till the beginning of 2019, Sales of mAb biosimilars is also taking up as popular targets being approved both in Europe and US. With the 3rd wave of the biosimilar coming the challenges is still ahead---how to keep the similarity from the beginning of the development to the manufacturing stage and cover the whole lifecycle? With the evolving cell line development platform, good analytical strategy and QbD implementation better similarity will be achieved step by step.
  • High-Resolution Characterization of Structure, Interaction, and Miscibility
    High-Resolution Characterization of Structure, Interaction, and Miscibility
    Eric Munson, Professor and Head at Purdue University Feb 11 2020 3:00 pm UTC 90 mins
    Full Title: High-Resolution Characterization of Structure, Interaction, and Miscibility of Drug Products

    The local interactions between a drug and its surrounding environment is critical in both small and large molecule formulations. For small molecules, the drug-polymer interaction is needed to ensure that the drug does not crystallize in an amorphous solid dispersion. For proteins, phase separation in lyophilized formulations will lead to reduced stability and the potential for aggregation. In this presentation, the ability to probe these local structures and interactions in both small and large molecule systems will be shown. Case studies will be presented that demonstrate how structural properties (e.g. degrees of interaction, changes in conformation) can impact functional properties such as crystallization and aggregation.

    Eric Munson of Purdue University

    Eric Munson, Ph.D., is currently Professor and Head of the Department of Industrial and Physical Pharmacy at Purdue University. He received his B.A. degree from Augustana College in Sioux Falls, South Dakota, in 1987. After studying one year in Munich, Germany, on a Fulbright Fellowship, he received his Ph.D. in 1993 from Texas A&M University, and was a postdoctoral fellow at the University of California, Berkeley in 1994. He was in the Chemistry Department at the University of Minnesota before moving in 2001 to the Pharmaceutical Chemistry Department at the University of Kansas, to the Pharmaceutical Sciences Department at the University of Kentucky in 2010, where he was the Patrick DeLuca Endowed Professor in Pharmaceutical Technology. In 2018 he moved to Purdue University to become Professor and Head of the department. His research program is focused on the characterization of pharmaceutical solids using a variety of analytical techniques, with an emphasis on solid-state NMR spectroscopy. Dr. Munson is a coinventor on three patents and has published more than 100 research, review, and book chapters.
  • Rapid Microbial Methods - Reap Benefits And Avoiding Pitfalls
    Rapid Microbial Methods - Reap Benefits And Avoiding Pitfalls
    Andrew Bartko, Research Leader at Battelle Memorial Institute Feb 13 2020 3:00 pm UTC 90 mins
    An overview of the design, validation and implementation of RMM.
    Regulatory advice for RMM implementation
    3 key takeaways from a case study of RMM implementation
  • MES-Integrating Technology, Quality and Compliance – Opportunities, Challenges
    MES-Integrating Technology, Quality and Compliance – Opportunities, Challenges
    Sachin Bhandari, GM, Head IT CSV at Sun Pharma Feb 18 2020 9:30 am UTC 90 mins
    Full Title: MES –Integrating Technology, Quality and Compliance – Opportunities, Challenges and Strategies.

    Defining the role of MES in using technology to achieve compliance.
    Addressing challenges in implementation of MES in current scenario with focus on Indian companies.
    Technology taking the compliance and quality framework to the next level.
    Organizational strategies to leverage the Power of technology by implementing MES.
  • Hybrid Models: The Best of Both (Mechanistic & Empirical) Worlds to Accelerate..
    Hybrid Models: The Best of Both (Mechanistic & Empirical) Worlds to Accelerate..
    Christian Airiau, PhD, Global Head Data Sciences, Biologics Development at Sanofi Feb 19 2020 3:00 pm UTC 90 mins
    Full Title: Hybrid Models: The Best of Both (Mechanistic & Empirical) Worlds to Accelerate and De-Risk Process Development

    Presented by Christian Airiau, PhD, Global Head Data Sciences, Biologics Development at Sanofi

    Process optimization through the use of modeling is a key objective to accelerate and de-risk process development. A critical step to improve our process development, process monitoring and process control is to understand the strength and limitations of each types of modeling approaches. Using the most relevant empirical approaches - from DoE to Multivariate Analysis - and the mechanistic understanding we have about our processes – Kinetics, thermodynamics – we are rethinking the way we conduct process development.
  • The Journey Of Implementing Advanced Process Control In the Pharmaceutical...
    The Journey Of Implementing Advanced Process Control In the Pharmaceutical...
    Olav Lyngberg, PhD, Sr. Scientific Fellow, Advanced Technology, Technical Operations at Janssen Pharmaceuticals Mar 2 2020 3:00 pm UTC 90 mins
    Full Title: The Journey Of Implementing Advanced Process Control In the Pharmaceutical Industry

    Presented by Olav Lyngberg, PhD, Sr. Scientific Fellow, Advanced Technology, Technical Operations at Janssen Pharmaceuticals

    The presentation shares the journey that Janssen is taking as it progresses its strategy on Advanced Process Control (APC). Within Janssen we aspire to improve our Manufacturing Technology Organization’s performance on key metrics such as cost of goods, on time and in full product delivery, production cycle time, and right first-time. Improving these metrics require a comprehensive technology strategy that addresses all the metrics together. Janssen’ s strategy has three pillars. 1: process intensification, 2: modular and flexible designs, and 3: process digitalization and advanced process control. Each pillar contributes differently to the key metrics but in aggregate make it possible to reach our goals.

    APC is a critical component of the technology strategy. It is an enabler for process intensification and modular and flexible designs. As a stand-alone tool APC can bring significant reductions in deviations and impact right first-time performance. Additionally, it is possible to improve cost and cycle time modestly in exciting processes. We will highlight areas where APC is being used in open loop control. In these applications there is much value to a manufacturing organization in enabling smoother operations and helping operators making sense of complex data.
  • Sampling Devices for In-line near Infrared Spectroscopy Monitoring of Powder Ble
    Sampling Devices for In-line near Infrared Spectroscopy Monitoring of Powder Ble
    Anders Sparén Associate Principal Scientist at AstraZeneca and Ed Gooding, MicroNIR Photonic Applications Specialist at VIAVI Mar 3 2020 2:00 pm UTC 90 mins
    Presented by Anders Sparén, Associate Principal Scientist at AstraZeneca

    The use of process analytical technology (PAT) in the pharmaceutical industry has significantly increased as an effect of regulatory guidelines and the transition towards continuous manufacturing of oral solid dosage forms. In the direct compression process, the most common way to assess homogeneity of powder blends is after the final mixing operation, followed by end-point testing of tablets. However, focusing on the homogeneity of powder blends does not consider the potential of segregation during material storage and powder transport and also faces severe sampling issues.

    In this study, NIR spectroscopy was used to study powder blend homogeneity at two positions in the continuous manufacturing process; after the first blender and in the tablet press feed-frame. The focus of the study was on sample presentation at the two positions, and several sampling devices were tested, in order to improve the quality of the NIR measurements. These were made in laboratory settings that simulated in-line measurements in a vertical tube between the two blenders and in the feed frame of the tablet press. A model formulation consisting of powder mixtures of a drug substance, mannitol, microcrystalline cellulose (MCC), croscarmellose sodium (NaCMC) and sodium stearyl fumarate (NaSF) was used for the experiments. A design of experiments, where the API was varied at five levels while MCC, NaCMC and NaSF were varied at two levels, was used for the calibration powder blends.

    Orthogonal partial least squares (OPLS) calibration models for the NIR measurements in the two positions were developed and validated with independent test sets. The results for the sampling devices tested are compared and the future implementation in the continuous manufacturing equipment is discussed.

    Followed by an Industry Perspective Presented by Ed Gooding, MicroNIR Photonic Applications Specialist at VIAVI Solutions
  • Real-time Sequencing by FTIR in GMP Oligonucleotide Synthesis
    Real-time Sequencing by FTIR in GMP Oligonucleotide Synthesis
    John-David McElderry, Scientist at Biogen Mar 4 2020 3:00 pm UTC 90 mins
    Presented by John-David McElderry, Scientist at Biogen

    John-David McElderry graduated from University of Michigan with his PhD in 2012 and has been an analytical scientist and PAT expert in the Pharma/Biotech industry for seven years. He started his career at Vertex Pharmaceuticals creating PAT applications for the first continuous DP manufacturing rig and helped develop the first real-time release strategy in the industry. He is currently at Biogen where he has developed PAT-based control strategies for continuous flow chemistry of small-molecule drugs and continuous synthesis of oligonucleotide drugs. He is interested in enabling real-time control of quality attributes in pharmaceutical manufacturing through the application of smart sensors and machine learning.
  • Harnessing the Power of Data Analytics to Derive Process Intelligence for Pharma
    Harnessing the Power of Data Analytics to Derive Process Intelligence for Pharma
    Santosh Whatkar, Senior Manager, Automation and Digital Technology at Pfizer Mar 5 2020 8:00 am UTC 90 mins
    Full Title: Harnessing the Power of Data Analytics to Derive Process Intelligence for Pharma Manufacturing

    Presented by Santosh Whatkar, Senior Manager, Automation and Digital Technology at Pfizer

    At Pfizer Singapore, significance of Data Analytics was realized after a period of 1 and half years when we were able to successfully implement the pilot use cases enabling us with Digital capabilities.

    It would be a sharing with the audience about the Pfizer, Singapore journey of Digital Transformation and the various learnings along the way; which enabled several attributes from teamwork, persistence, believing the vision and doing things differently.  Data Analytics significance was realized after passing through this journey and we were enlightened with the amazing capabilities existing data can have. Although our problem statements existed for several years, the change in perspective of using Digital technologies and existing data enabled us to find robust solutions.

    Below case studies would elaborate more on the enhancing Pfizer’s manufacturing robustness  leveraging on Digital Transformation capabilities –

    Case Studies:

    • Model based real time estimation of loss of drying
    • Model based predictive ability of failure for automated valves
    • Virtual sensors for energy monitoring in manufacturing environment

    Case Study:  

    • Process condition monitoring using Machine Learning
  • In Situ High Speed NIR Imaging to Monitor Form Change and Drug Release from...
    In Situ High Speed NIR Imaging to Monitor Form Change and Drug Release from...
    Patrick Wray, Senior Research Investigator at Bristol-Myers Squibb Mar 10 2020 10:00 am UTC 90 mins
    Full Title: In Situ High Speed NIR Imaging to Monitor Form Change and Drug Release from Rapidly Disintegrating Tablets

    Presented by Patrick Wray, Senior Research Investigator at Bristol-Myers Squibb

    Spectroscopic imaging is a powerful chemically specific and spatially resolved approach which can be used to effectively monitor tablet dissolution. This work employs Raman mapping and Near Infrared (NIR) chemical imaging to examine drug release from model tablet formulations as complementary technologies. Modern pushbroom type NIR imaging systems allow extremely fast acquisition of chemical images. Consequently this allows us to study the chemical and physical changes which occur during drug release from rapidly disintegrating formulations.
    A custom designed flow through cell is used to carry out the tablet dissolutions in such a way that the sample is presented to the optics of the chemical imaging system being used. The cell is compatible for use with NIR, Raman and Mid IR spectrometers.
    Two types or formulations will be presented: Rapidly disintegrating formulations with varying amounts of super disintegrant and tablets containing a model drug exhibiting fast onset of disproportionation in pH neutral conditions.
    The fast NIR imaging system is seen to be capable of monitoring ingress of water into the tablet and the subsequent disintegration of the formulation. Data from the disproportionating formulations has shown the benefit of chemical imaging to improve our understanding of form change in real time.
  • Antisense Oligonucleotide Purification Process: Successes and Challenges During
    Antisense Oligonucleotide Purification Process: Successes and Challenges During
    Robert Gronke, Ph.D., Senior Principal Scientist, Biogen and Thomas Müller-Späth, Ph.D, CTO at YMC ChromaCon Mar 10 2020 2:00 pm UTC 90 mins
    Full Title: Antisense Oligonucleotide Purification Process: Successes and Challenges During Scale-up

    Presented by Robert Gronke, Ph.D., Senior Principal Scientist, Technical Development, Biogen

    Recently, our first full scale GMP batch for an antisense oligonucleotide was manufactured in the newly built synthesis suite at Biogen. A four-step purification process was then carried out in the existing flexible volume manufacturing facility that, up until this point, has been used for manufacturing Biogen’s protein-based parenterals. This was our first test case to demonstrate that Biogen can manufacture ASOs safely, at scale, and achieve high purity and yield. Results are presented on the scalability of the ASO process from bench to GMP scale, highlighting successes and challenges faced with scale-up of the downstream ASO process.

    Followed by an industry perspective presented by Thomas Müller-Späth, Ph.D, CTO at YMC ChromaCon
  • Mitigating Uncertain Times: Challenges with Rapid Detection and Characterization
    Mitigating Uncertain Times: Challenges with Rapid Detection and Characterization
    Douglas E. Kiehl, Research Advisor, Bioproduct, Research & Development at Eli Lily and Company Mar 13 2020 2:00 pm UTC 90 mins
    Full Title: Mitigating Uncertain Times: Challenges with Rapid Detection and Characterization of Biological and Chemical Threats and Accelerated Development of Pharmaceutical Countermeasures for Unanticipated Medical Needs

    Presented by Douglas E. Kiehl, Research Advisor, Bioproduct, Research & Development at Eli Lily and Company

    Potentially catastrophic chemical and biological threats represent deliberate or unintentional actions placing civilian and military personnel at considerable risk. Rapid response requires novel approaches for detection and characterization of chemical and pathogenic biological impurities and effective deployment of life-saving countermeasures with acceptable benefit/risk ratio. Challenges include the development of robust, portable technologies for rapid and reliable threat identification, processes for development, manufacture, review/approval and deployment of countermeasures, and supply chain integrity.
  • IIoT and AI for Digitalizing Pharmaceutical Manufacturing Operations: From....
    IIoT and AI for Digitalizing Pharmaceutical Manufacturing Operations: From....
    Jun Huang, Director/Team Leader, Automation&Control at Pfizer and Amos Dor, Pharma General Manager & CTO at Applied Materials Mar 17 2020 2:00 pm UTC 90 mins
    Full Title: IIoT and AI for Digitalizing Pharmaceutical Manufacturing Operations: From Hype to Reality
    Presented by Jun Huang, Director/Team Leader, Process Monitoring, Automation & Control at Pfizer

    Driven by increased connectivity enabled by Industrial Internet of Things (IIoT) and more sophisticated data gathering and analytics/AI capabilities, manufacturing is ushering in a new era of production, where information technology (IT) and operation technology (OT) are converging to form so-called cyber-physical systems. IIoT and analytics are key complementary driving forces behind digitalization, enabling a securely connected plant and a streamlined flow of data and information between physical production and digital worlds, as well as prescription of data-driven actions pervasively across manufacturing and quality operations. Use case examples will be given to demonstrate how IIoT and analytics are implemented in practice to drive continual improvement in manufacturing visibility, quality and productivity.

    Followed by an Industry Perspective Presented by Amos Dor, Pharma General Manager & CTO at Applied Materials Automation Product Group
  • Implementation Of An Affordable & Scalable Manufacturing Strategy
    Implementation Of An Affordable & Scalable Manufacturing Strategy
    Bastiaan Leewis of MeiraGTx and Ankita Desai of Eppendorf Mar 18 2020 2:00 pm UTC 75 mins
    Full Title: Implementation Of An Affordable And Scalable Manufacturing Strategy For Gene Therapy Products
    Presented by Bastiaan Leewis, MSAT Manager of Industrialization at MeiraGTx

    As a start up with multiple clinical programs within an accelerated track we started designing our processes and aimed to build facilities to ensure therapeutic drug products reach patients as quickly as possible. As scientists and as people this tends to be the main goal, and although there are many challenges to commercializing a therapeutic drug product this is only the first step. To be able to continually serve patients, the company must be set up in a way to be sustainable throughout the clinical phase until revenue can be generated via commercial sales. Understanding the patient and company needs are a key cornerstone for having successful products and a successful company transition from clinical to commercial products. Within this presentation I will illustrate and explain the approach chosen by MeiraGTx for some of the platform components.

    Followed by Bioprocess solutions for upstream bioprocess development and scale-up
    Presented by Ankita Desai, Bioprocess Field Application Specialist at Eppendorf

    Upstream bioprocess development is an integral part of gene therapy product development. Cell culture bioprocess development is usually carried out at small working volumes. This helps save time and resources, because several experiments can be conducted in parallel, costs for media are kept low, and relatively little laboratory space is required. When more material is needed for characterization, trial runs, and finally for commercialization, biopharmaceutical companies transition the process to bench scale and then up to pilot or production scale. In this presentation, we will present bioprocess solutions for parallel process development at small scale. Furthermore, we will discuss bioreactor scalability and address several scaling approaches.
  • Extractable Data Mining: Common Extractables From Polymeric Manufacturing Materi
    Extractable Data Mining: Common Extractables From Polymeric Manufacturing Materi
    Ping Wang, Director at Johnson & Johnson and Donald DeCou, E&L Technology Manager at West Pharmaceutical Services Mar 23 2020 2:00 pm UTC 75 mins
    Full Title: Extractable Data Mining: Common Extractables From Polymeric Manufacturing Materials Used in Biologics Production
    Presented by Ping Wang, Director at Johnson & Johnson

    • Safety assessment of extractables and leachables is often based on assumption that E&L are highly toxic
    • Most common extractables from about 40 sets of study data indicates that none of them is part of “cohort of concern” per ICH M7 guideline.
    • Safety profiles of common extractables from common single use systems can be used to design a risk-based approach for future materials.

    Followed by Current Trends in Extractables and Leachables Testing from Manufacturing Equipment to Single Use Manufacturing Components
    Presented by Donald F. DeCou, Ph.D, Extractables and Leachables Technology Manager at West Pharmaceutical Services

    There are many types of components that a drug formulation may contact during a typical manufacturing process.  This can range from large volume mixing vessels to filters, tubing and other smaller components.  More recently the use of Single Use Systems (SUS) have been steadily increasing during the manufacture, handling and storage of biologics.  Each contact component has the potential to introduce leachable compounds to the drug formulation.  The BioPhorum Operations Group (BPOG) has developed standardized extractables testing protocol for SUS.  This talk will review some of the central concepts of the BPOG protocol as well as current trends in performing extractable, leachable and simulation studies on manufacturing components and single use systems.
  • Control Strategy and a Real Time Release Testing From a Development Line to...
    Control Strategy and a Real Time Release Testing From a Development Line to...
    Tom Van Den Kerkhof Scientist at Johnson & Johnson Mar 25 2020 9:00 am UTC 90 mins
    Full title: Control Strategy and a Real Time Release Testing From a Development Line to Commercial Manufacturing

    Presented by Tom Van Den Kerkhof Scientist at Johnson & Johnson
  • Advanced Raman Spectroscopy Beyond In-Process Glucose Control of Commercial Cell
    Advanced Raman Spectroscopy Beyond In-Process Glucose Control of Commercial Cell
    Dan Hill, Manufacturing Scientist at Biogen Apr 2 2020 2:00 pm UTC 90 mins
    Full Title:Advanced Raman Spectroscopy Beyond In-Process Glucose Control of Commercial Cell Culture Processes

    Presented by Dan Hill, Manufacturing Scientist at Biogen

    The use of in-line Raman spectroscopy as an in-line process analytical technology (PAT), in the biotechnology industry, has matured over the past decade from a technology with promise to a standard tool for real-time, continuous monitoring of cell culture processes. There is an ever-growing body of work demonstrating successful application from metabolite and product quality monitoring to process control in both process development and GMP manufacturing environments. This is due, in part, to advances in technology robustness, user- and integration-interfaces, improved sensitivity, and fluorescence rejection. Organizations are now faced with the difficult task of best leveraging these tools and extracting the most value from them. Thus, defining and executing Raman program strategy is critical to the technology’s long-term success and sustainability.

    This presentation will describe Biogen’s past efforts and strategic direction as it relates to in-line Raman spectroscopy for cell culture operations and how we intend to leverage its capability beyond metabolite monitoring and glucose feedback control to become an essential element of our Advanced Process Control efforts.
  • New Technologies for Improving and Controlling Product Quality, Expression, Time
    New Technologies for Improving and Controlling Product Quality, Expression, Time
    Niki Wong, Principal Research Scientist at AbbVie Operations Singapore Pte Ltd Apr 7 2020 6:00 am UTC 90 mins
    Full Title: New Technologies for Improving and Controlling Product Quality, Expression, Timelines and Yield in Upstream Process Development

    Presented by Niki Wong, Principal Research Scientist at AbbVie Operations Singapore Pte Ltd

    Increasing product demands at competitive pricing drive the need for accelerated product approval timelines, with reduced manufacturing risks and costs. New technologies which can debottleneck upstream process development or improve manufacturability success in early phase process development, translate into cell culture processes with high yield and desired product quality. An overview of different strategies and recent perspectives in upstream process development will be presented.
  • Transformation of Toxicology data into Specific PDE’s
    Transformation of Toxicology data into Specific PDE’s
    Kim Li, PhD, DABT, MPH, Amgen Inc Apr 23 2020 5:00 pm UTC 90 mins
    Presented by Kim Li, PhD, DABT, MPH, Amgen Inc.

    Dr. Li is a board certified toxicologist with broad experience in R&D and Operations. She joined Amgen in 2004 and is currently the lead toxicologist on the extractables and leachables programs on container closure systems, drug delivery devices and single-use bioprocess systems. Kim is the chair of the Extractables and Leachables Safety Information Exchange (ELSIE) consortium. As a member of the Association for the Advancement of Medical Instrumentation (AAMI) Biological Evaluation Committee, Kim serves as the US expert to ISO/TC 194.