Hi [[ session.user.profile.firstName ]]

Life Sciences

  • Upstream Viral Risk Mitigation Strategy for High Titer Biologics Manufacturing
    Upstream Viral Risk Mitigation Strategy for High Titer Biologics Manufacturing
    Aaron Mack, Engineer at Biogen & Dave Kolwyck, Director at Biogen and David Gemmell Senior Process Engineer at Merck Recorded: Oct 17 2019 83 mins
    Presented by Aaron Mack, Engineer at Biogen

    This talk will focus on the risk based approach that Biogen used for determining which raw materials to initially include in its upstream raw material viral risk mitigation portfolio. High Temperature Short Time (HTST) at raw material suppliers is an integral part of this risk mitigation approach. The merits of a risk-based approach to upstream viral safety will be explored, highlighting the HTST pasteurization viral mitigation capability suppliers like Merck have introduced and expanded. Treatment parameters have been detailed in publically available peer reviewed literature and confirmed in specific raw material components prior to implementation in commercial manufacturing processes. Additionally, benefits of decoupling materials with high risk of viral contamination will be reviewed.

    Followed by Implementation of a Robust Upstream Viral Mitigation Strategy for Cell Culture Feeds
    Presented by David Gemmell Senior Process Engineer at Merck (Contact at david.gemmell@emdmillipore.com)

    High temperature short time (HTST) pasteurization is a highly effective method to achieve virus inactivation. This technology has been typically used as an in-house pretreatment tool for high risk bioreactor feeds. The availability of HTST-pretreated feeds minimizes the need to install complex and costly systems in the bioproduction facility, which have significant capital expenditure costs and can become a process bottleneck. The availability and use of complementary virus mitigation strategies minimizes the risk of introducing adventitious agents into the bioreactor, which can impact manufacturing operations and ultimately affect drug supply to patients.

    The webinar details the products and capabilities Merck have developed regarding viral removal utilizing viral filtration or viral inactivation via High Temperature Short Time pasteurization, of high-risk raw material feeds for the biopharmaceutical industries.
  • 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 Nov 7 2019 3:00 am UTC 63 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).
  • FDA Perspective on Aseptic Process Simulation for Cell Therapy Product Manufa...
    FDA Perspective on Aseptic Process Simulation for Cell Therapy Product Manufa...
    Dr Lily Koo, Consumer Safety Officer at FDA and Dr Keen Chung, Principal Scientist (Upstream Process) at Pall Biotech Recorded: Oct 16 2019 83 mins
    FDA Perspective on Aseptic Process Simulation for Cell Therapy Product Manufacturing
    Presented by Dr Lily Koo, Consumer Safety Officer at Food and Drug Administration

    The manufacturing processes for cell therapy products can be highly complex, non-conventional, and product-specific. Aseptic techniques are often required throughout manufacture. The challenge to appropriately and effectively validate aseptic processing requires that industry and regulatory bodies rethink how validation strategies are best applied to this novel class of products. This presentation will address FDA perspective on aseptic process simulation for cell therapy products. It will highlight some unique manufacturing/processing features that are shared among cell therapy products and should be considered during aseptic process simulation study design. The presentation will also cover elements of the traditional validation approach and how they could be appropriately applied to cell therapy manufacturing.

    Followed by Process Control Strategy to Mitigate Contamination Risk of an Aseptic Viral Vector Production
    Presented by Dr Keen Chung, Principal Scientist (Upstream Process) at Pall Biotech

    Adeno-associated virus (AAV) vectors are potent gene therapy vectors, used to deliver therapeutic transgenes to target tissues. Gene therapy clinical trials often require high titer vector preparations to adequately deliver the therapeutic transgene, in great excess of research-level production utilized in many laboratories. To bring the virus into the pre-clinical and clinical phases, Pall Biotech simplified, optimized and scaled-up the current upstream and downstream process of viral vector production to industrial scales using the fully-closed, single-use Xpansion® multiplate seed train bioreactor and the production packed-bed iCELLis® 500 single-use bioreactor. In these processes, it is important to ensure that steps are built into the process to ensure adequate control of adventitious agents.
  • The CRISPR IP Saga - the latest chapter and looking to the next
    The CRISPR IP Saga - the latest chapter and looking to the next
    Dr Claire Irvine (Partner, HGF), Douglas Drysdale (Partner, HGF) Recorded: Oct 10 2019 67 mins
    CRISPR gene-editing continues to hit the headlines regularly as a ground-breaking technology with many millions now flowing into companies seeking to exploit the technology in both the therapeutic and agricultural fields. Unfortunately, the IP landscape continues to lack clarity with possibility of divergence between Europe and the US.

    This webinar will provide an update on the CRISPR IP saga and seek to shine light on the interplay between the latest chapter in the US, starting with new interference proceedings instigated by the USPTO, and opposition and appeal proceedings affecting key European patents at the European Patent Office. With oral proceeding now scheduled for early February 2020 for the opposition to the basic European patent of the University of California et al. and availability of a non-binding preliminary opinion on the arguments from the opposition board, it is an apt time for review of the main focus of the battle - coverage of CRISPR/Cas9 gene-editing in eukaryotic cells. The webinar will also discuss the considerations for those needing to think about freedom-to–operate in the absence of resolution of a standard for CRISPR gene-editing for therapy and the growing number of
    claims outside the main battle lines.

    This webinar is aimed at those wishing to hear about the latest developments in the CRISPR IP landscape whether in the commercial, academic, legal or patent world. With the CRISPR IP saga not evidently close to the final chapter, it will also provide an opportunity to raise questions which may arise from the on–going lack of clarity.
  • Qualification of Raw Materials Used in the Manufacturing of Cellular Therapies
    Qualification of Raw Materials Used in the Manufacturing of Cellular Therapies
    Jim Richardson, Sr Scientific Liaison at USP and Horst Ruppach, Ph.D. Scientific Director at Charles River Recorded: Oct 7 2019 80 mins
    Presented by Jim Richardson, Sr Scientific Liaison at United States Pharmacopeia

    Dr. Richardson works in the standards pipeline development group within Global Biologics at USP, leading efforts to develop standards for emerging technologies such as cell and gene therapy. In previous roles at Advanced BioScience Laboratories and Foundation Fighting Blindness, he led translational science activities for the development of vaccines and biologics to prevent and treat infectious and retinal diseases. Trained as a virologist, Jim has also held positions responsible for performing viral clearance testing at Viromed Biosafety and AAV vector development and characterization at Genovo/Targeted Genetics. Dr. Richardson earned his Ph.D. in Biomedical Sciences at the Mount Sinai School of Medicine.

    Followed by Viral Safety Aspects of Raw Materials Used in the Production of Biologics Including Cellular Therapy Products
    Presented by Horst Ruppach, Ph.D. Scientific Director Viral Safety at Charles River's Biologics Testing Solutions

    After a short review of regulations/guidance related to viral safety aspects of raw materials the in principle concept for ensuring viral safety will be outlined. The viral risk profile of a raw material is defined based on the source material, the sourcing process and the subsequent manufacturing and/or purification process. Testing for viruses performed on the start material and/or process intermediates is one way to mitigate the viral risk. Different methods for testing will be presented and the pros and cons discussed. Analyzing the viral clearance capacity of the manufacturing process is another important strategy to reduce the viral risk significantly if applicable. There are, however, experimental challenges sometimes which makes it difficult to demonstrate efficient viral clearance even though the treatment is known to be highly efficient.
  • Introduction into PharmaPendium: informed decision making during development
    Introduction into PharmaPendium: informed decision making during development
    Marnix Wieffer Recorded: Oct 3 2019 43 mins
    Optimal decisions making during pharmaceutical development critically relies on high quality data. PharmaPendium is the go-to database to access extracted data from regulatory documents and literature on approved drugs
    Join PharmaPendium Marketing Manager Dr. Marnix Wieffer for this introduction webinar where we will discuss why we need high quality extracted data on marketed drugs during drug development and provide an introduction in:
    -PharmaPendium’s unique document and data content
    -The expert taxonomies that help to unlock critical data
    -The benefits of both searching in full text through regulatory documents and accessing extracted data
    -Example use cases showing how we can work with PharmaPendium to uncover important reviewer insights by full text searching in regulatory documents
    -Gain translational inside by recovering extracted drug safety data
  • The Business Value and Bottom Line Impact of Taxonomy
    The Business Value and Bottom Line Impact of Taxonomy
    Seth Earley, CEO, EIS & Carla Pealer, Taxonomy Consultant, EIS Recorded: Oct 2 2019 52 mins
    Business agility rests upon a well-architected environment of business processes, workflows, and communications.

    So how does taxonomy fit in? It’s everywhere - taxonomy is the foundational building block that improves efficiencies, collaboration, and cost reductions across the enterprise. And the more agile you are, the better opportunity you have to compete and win.

    In this webcat you will learn:

    • Industry-agnostic best practices to boost your bottom line and beat your competition through taxonomy design and semantic integration
    • How taxonomy design enables customer acquisition, search relevancy, structured data, faster time to market, asset reuse, and more.

    Speaker: Carla Pealer, Consultant, Earley Information Science
  • Cost Considerations for the Application of Continuous Processing
    Cost Considerations for the Application of Continuous Processing
    Narasimha Rao Nedunuri, CEO of CLONZ Biotech and Tania Pereira Chilima, Product Manager at Univercells Recorded: Oct 2 2019 63 mins
    Cost contribution of continuous manufacturing both in operational and capital expenditure in Monoclonal antibody production.
    Evaluating cost of production per gram conventional fed batch vs continuous process.
    Key considerations for adapting continuous process for the production of Biosimilar MAbs.

    Presented by Narasimha Rao Nedunuri, CEO of CLONZ Biotech

    Narasimha Rao Nedunuri is one of the founding members of CLONZ Biotech, a Biosimilar Monoclonal Antibody company based in Genome Valley, Hyderabad, India.
    He is currently serving the company as the Managing Director & CEO .
    Nedunuri, a Molecular Biologist turned Entrepreneur has 18 years of experience in the field of Life Sciences Research including Cancer Biology, Proteomics, and Molecular diagnostics. He also had business experience in a USA based company, with the responsibility of establishing a business division for its Indian subsidiary.
    At CLONZ , a 7 year old start-up, along with the co-promoters coming from recognized leaders who launched complex Biosimilar MAbs, driving the company to emerge as a significant Global Biosimilar MAb company.

    Followed by a presentation by Tania Pereira Chilima, Product Manager at Univercells

    Tania Pereira Chilima is a Product Manager at Univercells, responsible for the NevoLine platform for cost-effective viral production. She completed her Bachelors’ degree in Biochemical engineering with focus on protein manufacture at the University College London. She was then awarded an Engineering doctorate, also at the University College London, looking at building and applying decisional tools to help guide the cell therapy industry in selecting commercialization strategies (process, facility design, reimbursement strategies etc.). Her post-doc was sponsored by the Bill & Melinda Gates Foundation, focused on identifying the optimal manufacturing strategies to deliver low cost vaccines.
  • Disaster Recovery
    Disaster Recovery
    Jeff Gilmer Recorded: Oct 1 2019 61 mins
    If a disaster were to strike, would you be able to successfully recover your network?

    Disaster recovery focuses on the ability of an organization to recover from a technology outage. This can be loss of a single technology or a catastrophic event. Many companies have a need to quickly gain a better understanding of their Disaster Recovery capabilities, future options, and strategies.

    Join us as we explore the differences between Emergency Management, Business Continuance, and Disaster Recovery Planning.

    You will learn how to prioritize the recovery of your organization's services by understanding all the steps in a successful recovery plan. We will also cover what is required to recover those services including facilities, IT, financial, and resources.

    Don't wait until it's too late. Know what to expect in the event of a disaster.

    Jeff is effective in both restoring and building organizations through improved long-term process improvement and implementation of solid scalable methodologies. Jeff also specializes in communications and regularly presents at seminars/webinars, industry events, and partner-sponsored events. In addition, Jeff has presented Excipio’s results to a variety of private and public sector audiences, including: senior executive teams, state legislatures, city councils, and federal agencies, boards of directors, and small community forums.”
  • Faster, Stronger: The Future of Digital Commons
    Faster, Stronger: The Future of Digital Commons
    Shandon Quinn, VP Product Management, bepress | Elsevier Recorded: Oct 1 2019 56 mins
    Get an exclusive look at what’s in the works for Digital Commons that will make it even more valuable for you and your institution:
    - Populate your Digital Commons IR faster, including the latest update on automated harvesting directly into DC.
    - Demonstrate the impact of your Digital Commons IR more effectively, including the latest preview of a new usage and readership dashboard.
    - Improve your institution’s OA journals published on Digital Commons.
  • Cerebral Organoids as a 3D Model for Glioma
    Cerebral Organoids as a 3D Model for Glioma
    Amanda Linkous, Ph.D. Recorded: Sep 26 2019 50 mins
    The prognosis of patients with glioblastoma (GBM) remains dismal with a median survival of approximately 15 months. Current preclinical GBM models are limited by the lack of a “normal” human microenvironment and the inability of many tumor cell lines to accurately reproduce GBM biology. To address these limitations, our guest presenter and her team have established a unique model system whereby they can retro-engineer patient-specific GBMs using patient-derived glioma stem cells (GSCs) and human embryonic stem cell (hESC)-derived cerebral organoids. Their cerebral organoid glioma (GLICO) model shows that GSCs home toward the human cerebral organoid, and deeply invade and proliferate within the host tissue forming tumors that closely phenocopy patient GBMs. Furthermore, cerebral organoid tumors form rapidly and are supported by an interconnected network of tumor microtubes that aids in the invasion of normal host tissue. This GLICO model provides a new system for modeling primary human GBM ex vivo and for high throughput drug screening.


    Guest Presenter Bio:
    Dr. Amanda Linkous previously served as the Director of the Starr Foundation Cerebral Organoid Translational Core at Weill Cornell Medicine (New York, NY). She completed her postdoctoral training in the Neuro-Oncology Branch at the National Cancer Institute (Bethesda, MD). Dr. Linkous is currently the Scientific Center Manager for the NCI's Center for Systems Biology of Small Cell Lung Cancer (SCLC) at Vanderbilt University, where she is developing similar 3D model systems to study the biology and refractory nature of SCLC (Nashville, TN)
  • 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.
  • Characterization of Biotherapeutics
    Characterization of Biotherapeutics
    Diane McCarthy, PhD, Senior Scientific Liaison, US Pharmacopeia and Kai Scheffler Product Manager at Thermo Fisher Scientific Recorded: Sep 24 2019 76 mins
    By Diane McCarthy, PhD, Senior Scientific Liaison, Global Biologics, US Pharmacopeia

    Biotherapeutic products are typically characterized by multiple orthogonal methods to evaluate product quality and purity, including assessment of aggregates, variants, and degradation products. For monoclonal antibodies and many other biotherapeutics, analysis of post-translational modifications, such as glycosylation, are also important since these modifications can impact the efficacy, stability, and safety of the final product. This presentation will provide an overview of methods and standards used during characterization, with an emphasis on monoclonal antibodies.

    Followed by Charge Variant Separation Coupled to High Resolution Mass Spectrometry for Routine mAb Analysis

    By Dr Kai Scheffler, Product Manager at Thermo Fisher Scientific

    Biotherapeutics such as monoclonal antibodies are a heterogeneous mixture of structurally similar molecules that differ in mass and charge, referred to as charge variants. Charge variants result from sequence variations and post-translational modifications such as e.g. deamidation and sialylation resulting in species that are more basic or acidic than the main mAb monomer. The heterogeneity can be revealed by charge-sensitive separation methods, such as ion exchange chromatography. The use of MS-compatible buffers allows for online hyphenation to a mass spectrometer. This hyphenated setup provides the chromatographic resolution of ion exchange chromatography coupled to the identification of the separated variants by mass spectrometry.
    In this webinar we will discuss a charge variant analysis (CVA) workflow that entails ion exchange chromatography using pH gradients for protein elution with online mass detection on a high resolution Orbitrap-based mass spectrometer. This workflow enables routine application to a wide range of antibody samples for comprehensive analysis based on a single injection without the need for sample preparation.
  • How to Utilize Design of Experiments (DoE) Principles for the Development of...
    How to Utilize Design of Experiments (DoE) Principles for the Development of...
    Jeremy Springall PhD, Scientist II, Analytical Sciences, R&D Biopharmaceutical Development, AstraZeneca Recorded: Sep 19 2019 44 mins
    Full Title: How to Utilize Design of Experiments (DoE) Principles for the Development of High Throughput, Robust Methods for the Assessment of Product Quality

    Being able to generate accurate and precise analytical data to provide information on product quality in a timely manner is a great challenge facing analytical groups. By adopting a Design of Experiments (DoE) approach, we can overcome many hurdles facing the implementation and adoption of these high-throughput chromatography methods with the data generated being of comparable quality to that from longer lot release methods.

    Presented by Jeremy Springall PhD, Scientist II, Analytical Sciences, R&D Biopharmaceutical Development, AstraZeneca

    Jeremy Springall has worked in the Analytical Sciences group, part of R&D Biopharmaceutical Development, at AstraZeneca for the past five years. His responsibilities include assess new technologies and work processes to support early and late stage development assets as well as being a CMC analytical team lead on several non-mAb projects currently in the AstraZeneca development pipeline. Previous roles include In-process analytical development scientist at UCB and analytical development scientist at Patheon, both in the UK. He holds a Ph.D. in bioorganic and medicinal chemistry and a BSc in chemistry from the University of Bath, UK.
  • From Concept to Market – Unique approaches in Biomanufacturing
    From Concept to Market – Unique approaches in Biomanufacturing
    Jincai Li, Vice President of WuXi Biologics Kevin Mullen, Sr. Product Manager, Single-Use Systems at Thermo Fisher Scientific Recorded: Sep 18 2019 79 mins
    Presented by Dr. Jincai Li, Vice President of WuXi Biologics

    With the rapid growth of the biotherapeutics industry, the need and challenge for high quality, cost efficient production has been increasing as well. At the same time, the number of approved biologics products are also steadily increasing, and more and more products are being developed by small to mid-size biotech companies, with product market size that vary greatly and therefore leading to varying production scale needs. The presentation will talk about the paradigm shifts in today’s facility design and operations, with multi-purpose facility and smaller, modular facility being favored by many companies. In addition, rapid adoption of disposable technology has enabled faster and lower cost facility design & start-up. With the modular, disposable technologies, the unique “scale-out” approach has the advantage of providing highest flexibility to customers while simultaneously lowering tech transfer and scale-up risks. The presentation will also cover the continuous bioprocessing concept and share WuXi’s efforts on this area.

    Followed by a presentation by Kevin Mullen, Sr. Product Manager, Single-Use Systems at Thermo Fisher Scientific
  • Big Data Strategies for Cell Therapy Manufacturing
    Big Data Strategies for Cell Therapy Manufacturing
    Scott R. Burger, MD, Principal of Advanced Cell & Gene Therapy, LLC and Heidi Hagen, Co-founder and CSO for Vineti Inc Recorded: Sep 17 2019 76 mins
    The quest to retrieve, analyze, and leverage that data has become the new gold rush in life sciences. This presentation will discuss the role of big data in cell therapy process development, real time analytics and commercial scale manufacturing.
  • Alternative And Rapid Microbiological Methods: Microbiology Of The 21st Century
    Alternative And Rapid Microbiological Methods: Microbiology Of The 21st Century
    Dr Benoit Ramond, Head of Microbiology & Sterile Technology, Sanofi and Dr David Jones, Director at Rapid Micro Biosystems Recorded: Sep 12 2019 77 mins
    Today Pharmaceutical industry remains conservative for microbiology testing methods and has reluctance to develop and to use Alternative and Rapid Microbiological Methods (RMM) supported by a number of misunderstandings and prejudgments based on the following myths:
    - RMM are not accepted by regulation authorities,
    - RMM will never replace classical microbial methods,
    - RMM will not offer return on investment (ROI),
    - Data generated from RMMs will exceed current specifications and limits involving increase in batch rejections.

    Nevertheless a movement is in progress for the use of new technologies and systems because classical microbial methods, in spite of their long return of experiences and their confidence for the regulatory point of view, have a number of disadvantages such as:

    - Time to results in days to weeks,
    - Results vary with microbial population, media, culture conditions,
    - Lack of reactivity in case of exceeding limit results,
    - Sensitivity could be insufficient giving underestimations in the contamination risk,
    - Existence of confluent growth.

    This webinar provides an overview of the current situation about RMM technologies, regulatory expectations, it proposes some initiatives facilitating the implementation of RMM including a strategy for validation and it gives a projection for the perspectives of the RMMs for the future.
  • Build my knowledge
    Build my knowledge
    Dr. Lara Dick,Dr. Lukasz Porwol and Virginia Ballance. Moderated by Rachel Brennesholtz Recorded: Sep 10 2019 47 mins
    For a researcher, building knowledge is a complex and time-consuming process: finding and evaluating the relevance of information is only the first step; then comes the need to properly collect, organize, retrieve and use literature and data to create a true knowledgebase.
  • Sanofi’s and SGS’S Implementation of BPOG’S Leachable Risk Assessment model...
    Sanofi’s and SGS’S Implementation of BPOG’S Leachable Risk Assessment model...
    Ken Wong, Deputy Director at Sanofi Pasteur and Dujuan Lu, Manager/Global Lead of Extractables & Leachables at SGS Recorded: Sep 10 2019 89 mins
    Full Title: Case Study and Experience on Sanofi's and SGS's Implementation of BPOG's Leachable Risk Assessment Model and Extractable Testing Protocol

    Presented by Ken Wong, Deputy Director at Sanofi Pasteur

    Brief review of the BPOG's Leachable Risk Ranking model. A case study of the leachable risk model implementation into Sanofi will be presented. All changes to specific risk factors and weights changes will be discussed. Finally, the lesson learns and experiences of the risk model performances on several projects will be shared.

    Followed by Case Study and Experience in Extractables and Leachable Studies of Plastic Process Materials – a CRO perspective

    Presented by Dujuan Lu, Manager/Global Lead Extractables & Leachables at SGS Life Sciences

    Extractables and leachables (E&L) from the plastic process materials used during pharmaceutical and biopharmaceutical manufacturing can potentially pose risks to the safety, efficacy, and stability of pharmaceutical and biopharmaceutical products.
    The USP risk assessment model will be briefly reviewed. Challenges regarding design of extractions and analytical evaluation threshold (AET) calculation for process materials will be discussed. A few case studies regarding the E&L studies of process materials will be shared.
  • Replay: Fresh Start for a New School Year: Consulting Services Q&A
    Replay: Fresh Start for a New School Year: Consulting Services Q&A
    Aaron Doran, Sarah Loyd, Jennifer Pesetsky Recorded: Sep 6 2019 38 mins
    Summer is coming to an end, and the smell of pencils is in the air! Whether you have a new repository, new faculty to reach, or new projects to begin, September is the time for a fresh start. On September 5th, join Jennifer Pesetsky, Aaron Doran and Sarah Loyd, of Digital Commons Consulting Services, as they present new ideas for a fresh start and freshening up your institutional repository. Topics include:
    •Redesigning your IR to match your new branding
    •Introducing new faculty to your IR
    •Small improvements for big results
    •Q&A with three CS experts
  • Fresh Start for a New School Year: Consulting Services Q&A
    Fresh Start for a New School Year: Consulting Services Q&A
    Aaron Doran, Sarah Loyd, Jennifer Pesetsky Recorded: Sep 5 2019 39 mins
    Summer is coming to an end, and the smell of pencils is in the air! Whether you have a new repository, new faculty to reach, or new projects to begin, September is the time for a fresh start. On September 5th, join Jennifer Pesetsky, Aaron Doran and Sarah Loyd, of Digital Commons Consulting Services, as they present new ideas for a fresh start and freshening up your institutional repository. Topics include:
    •Redesigning your IR to match your new branding
    •Introducing new faculty to your IR
    •Small improvements for big results
    •Q&A with three CS experts
  • PharmaPendium August release: Unlocking and sharing critical safety insights
    PharmaPendium August release: Unlocking and sharing critical safety insights
    Marnix Wieffer Recorded: Sep 5 2019 47 mins
    Optimal decisions making during pharmaceutical development critically relies on high quality data. PharmaPendium is the go-to database to access extracted data from regulatory documents and literature on approved drugs

    Join PharmaPendium Marketing Manager Marnix Wieffer to discover the new features of the upcoming PharmaPendium release (week of 19 August) that will support uncovering critical safety insights and effective information sharing. We will discuss:
    1.Gain translational insights through improved Boolean operator drug safety searching
    2.Streamline information exchange through new sharing searches function
    3.Highlight critical post-market data through custom colouring of the FAERS heatmap

    The webinar includes demonstrations of all the new features and a Q&A session for attendees to get further information about PharmaPendium’s drug safety and data sharing workflows
  • The Journey to Lean Implementation for Efficiency Increase
    The Journey to Lean Implementation for Efficiency Increase
    Uwe Voelker, Site Head, Sterile Drug Product Manufacturing at Roche Recorded: Sep 4 2019 43 mins
    Adoption of strategic and systematic use of lean principles to improve operational efficiencies and cost competitiveness
    Systematic reduction of waste, complexity and variability,
    Reduction of order lead time,
    Higher employee satisfaction and engagement tackling the cultural challenges
    Achieving speed and reliability in the manufacturing value chain.

    Presented by Uwe Voelker, Site Head, Sterile Drug Product Manufacturing at Roche

    Uwe Voelker is currently the Site Head (GM) at Roche in Mannheim, leading Pharma Operations (Biologics DP site). He was previously in VP-roles in both Quality and Techn. Operations, local and global roles, a.o. Head of Global Quality Small Molecules, Site Head in a Biologics DP site in Switzerland.
    Uwe is well versed in all aspects of Quality Management; Lean, Operational Excellence and Change management.
  • Design of remote luminescent thermometers for bio-imaging
    Design of remote luminescent thermometers for bio-imaging
    Dr. Markus Suta, Utrecht University Oct 24 2019 1:00 pm UTC 60 mins
    Join Reaxys Prize Club member Dr. Markus Suta for fascinating insights into luminescence thermometry. In this webinar, he describes the development and validation of remote lanthanide-based luminescent thermometers with applications in bio-imaging. Discover why a combination of in silico modelling and wet-lab experiments were essential to the success of the project. Dr. Suta also talks about the importance of efficient literature research to his work.

    In addition, Dr Marta da Pian will give an overview on tips and tricks for using Reaxys.

    We hope you can join us!
  • Showcasing your research: Present the full picture of your research achievements
    Showcasing your research: Present the full picture of your research achievements
    Heather Williams Oct 29 2019 10:00 am UTC 30 mins
    This 30 minute webinar will discuss how Elsevier supports researchers by providing tools to effectively showcase their research profile and increase their visibility, a skill that is vital in the research world.
  • Superior Sample Preparation and GC of Fatty Acid Methyl Esters
    Superior Sample Preparation and GC of Fatty Acid Methyl Esters
    Dr. Frank Michel, Analytical & Chromatography Scientific Advisor, Merck KGaA Darmstadt, Germany Oct 30 2019 7:00 am UTC 75 mins
    Fatty acids are important analytes for nutritional value, product taste/texture, shelf-life and place of origin studies. They are not only relevant in food, but also in clinical, biochemical, industrial, agriculture testing.

    In this talk we will give the background of fatty acid analysis and describe some current techniques and new developments for the GC analysis of fatty acids in a variety of applications. A special focus of the webinar is the separation of cis and trans isomers by either a sample prep approach using SPE or by improved GC approaches.
  • Cost & Management of Oncology Combination Regimens
    Cost & Management of Oncology Combination Regimens
    Marcia Palmer, Allen W. Becker, Anthony Chiefari, Howard Deutsch, Nicolle Hamilton, ZS Associates Oct 30 2019 2:00 pm UTC 90 mins
    Overview
    Oncology treatment increasingly involves combinations of novel oral and biologic drugs. While combo approaches aren’t new, there are significant cost implications of combining high priced innovator drugs (versus older, generic chemotherapies).

    Payers are in a difficult spot regarding the cost and management of these regimens. Traditional utilization management tools are still difficult to apply in oncology, given no payer wants to be on the front page of a major newspaper for denying treatment. Pathways have not held up to their promise for containing cost.

    Personalized medicine approaches such as biomarkers serve an important role in targeting therapy to the most appropriate patients, thereby reigning in cost. However, there are limitations in the breadth and utility of these tools. For example, PD-1/PDL-1 drugs have shown conflicting outcomes associated with receptor expression – and these drugs are the backbone for many combo regimen programs in clinical development.

    Environment/perception shifts, new approaches to management, indication-based pricing or other novel pricing approaches, and innovative payment models may hold promise for controlling cost in this new era of combination therapy.

    Focus
    Join ZS Associates for a live expert payer panel discussion on the challenges and potential solutions for managing the cost of combo oncology regimens. Topics will include:

    •Perspectives on oncology drug management and combination regimen pricing today
    •Potential payer-driven and pharma-driven solutions to price and cost management for oncology combo regimens
    •What oncology manufacturers should consider in engaging payers in the future

    The live payer webinar, co-moderated by Nicolle Hamilton, ZS Associates and Dominic Tyer, pharmaphorum, will take place on Wednesday, October 30 2019 from 14:00-15:15 GMT/10:00-11:15 ET.
  • Montclair Levels Up: Supporting the Institutional Mission with your Repository
    Montclair Levels Up: Supporting the Institutional Mission with your Repository
    Karen Ramsden and Darren Sweeper, Montclair State University Oct 30 2019 3:00 pm UTC 60 mins
    Montclair State University achieved a major milestone this year, earning the high research activity R2 status by the Carnegie Classification of Institutions of Higher Education. An essential part of their transformation? The institutional repository. On October 30, join Montclair State repository team members Karen Ramsden and Darren Sweeper as they describe the challenges and successes of integrating their IR into a growing culture of research. Topics include:
    -Aligning the institutional repository with strategic goals to give the library a seat at the table
    -Engaging internal and external stakeholders with the IR
    -Outreach to faculty on a changing campus
    -Continuing to leverage the power of the repository over time

    Darren Sweeper is responsible for managing, coordinating and administering all aspects of the Government Documents Department at Montclair State University’s Sprague Library. He is especially interested in data and statistical literacy and how government information can be used to promote life-long learning in the social sciences particularly in education, sociology and the sociology of education. Darren received his BS in Criminal Justice and Sociology, MA in Political Science and Masters in Library and Information Science from Rutgers University.

    Karen Ramsden currently serves as Research and Projects Specialist and Coordinator of Digital Commons for Sprague Library at Montclair State University. In her current position, Karen plays a crucial role in helping to direct and shape the character and overall nature of all library-related projects from conception through development, production, and introduction to the intended audience. Additionally she serves on numerous University-related committees and initiatives, and as lead administrator for Research with Montclair. Karen received a Master’s in Public Administration from Kean University and is currently enrolled in the Master’s Degree Program in Social Research and Analysis at Montclair State.
  • Engineering First Principles: Applications to Pharmaceutical Manufacturing
    Engineering First Principles: Applications to Pharmaceutical Manufacturing
    Bernard McGarvey, PhD Chemical Engineering Nov 5 2019 3:00 pm UTC 90 mins
    Within the pharmaceutical industry, creating a robust Operational Control Strategy (OCS) is a key step to accomplishing the goals of Quality by Design (QbD). Along the way to developing this robust Operational Control Strategy many problems will be encountered that need to be solved. The use of a First Principles based approach provides value because it improves the effectiveness and efficiency of our problem solving, thereby leading to solutions that are more likely to work without unintended consequences and were created in a faster and more cost effective manner. Based on the author’s experience, a clear definition of what First Principles are will be given (and what they are not!). Areas of opportunity where the application of First Principles is likely to be successful will be described. An outline of a high-level process for implementing a First Principles based approach will be presented. Finally an example of the application of First Principles in the pharmaceutical industry will be briefly described.
  • Pharmaceutical Forensics for Safe Manufacturing and Supply
    Pharmaceutical Forensics for Safe Manufacturing and Supply
    Ravi Kalyanaraman and Jeremy Peters of BMS and Robert Heintz of Thermo Fisher Scientific Nov 6 2019 6:00 am UTC 76 mins
    Why Use Raman Microscopy for Pharmaceutical Forensics?
    by Dr. Robert Heintz, Senior Applications Specialist at Thermo Fisher Scientific

    Raman microscopy is uniquely suited for providing essential information for pharmaceutical forensic applications. The use of visible lasers allows for analysis of very small samples with spatial resolutions down to a micron or better. Materials can be analyzed in glass containers and through transparent packaging. Mapping and imaging provides information on the spatial distribution of components as well as particle sizes and shapes. Confocal operation allows for probing inside transparent materials and analyze different layers or inclusions without the need to cut or cross-section the sample. Raman microscopy is non-destructive and preserves the sample for further analysis. Raman spectra can be used not only for the conformation of expected components but also the identification of unknown contaminants or impurities. Spectral features are very sensitive to molecular structure and can be used to distinguish polymorphs and other very chemically similar materials.

    Followed by Pharmaceutical Forensics for Safe Manufacturing and Supply
    by Ravi Kalyanaraman, Director at BMS

    Pharmaceutical Investigations and Technology (PIT) is a group within Global Analytical Technology (GAT) department in the commercial Quality organization within Bristol-Myers Squibb. The PIT group has been a key part in BMS for 30 + years in providing analytical support for commercial manufacturing and in pharmaceutical forensics. This include particulate and foreign matter characterization in pharmaceutical products and screening counterfeit drugs. Several analytical tools and techniques are used by PIT to support the pharmaceutical forensics.This talk will feature all the analytical techniques used by PIT and how the results are used in resolving manufacturing issues and to protect patients from counterfeit drugs.
  • 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 Nov 11 2019 2:00 am UTC 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.
  • 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 Nov 11 2019 3:00 pm UTC 90 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 a presentation presented by Lori Daane, Pharma Microbiology Scientific Director at bioMérieux
  • 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 Nov 15 2019 3:00 pm UTC 90 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
  • Biopharmaceutical process development – Trends/ Challenges/Opportunities
    Biopharmaceutical process development – Trends/ Challenges/Opportunities
    Kumar Gaurav, AGM (Regulatory Affairs) at Panacea Biotec Ltd Nov 20 2019 9:30 am UTC 90 mins
    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
  • 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 Nov 21 2019 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
  • Monitoring Impurities in Biologics
    Monitoring Impurities in Biologics
    Diane McCarthy, PhD, Senior Scientific Liaison, Global Biologics, US Pharmacopeia  Nov 26 2019 3:00 pm UTC 90 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.
  • From Homegrown to Commercial PIM: Transition Strategies for Success
    From Homegrown to Commercial PIM: Transition Strategies for Success
    Alison Tran, Client Partner, EIS; Chantal Schweizer, Principal Consultant, EIS Dec 4 2019 6:00 pm UTC 53 mins
    As your business and product data complexity grows, so too may your need for an enhanced PIM system that accounts for numerous operating units, separate companies, global operations, and more.

    How do you judge whether you are ready to jump from your homegrown solution? And if you’re ready to make the jump, what is the best path to ensure that you transition from one system to another successfully?

    In this session you will learn:

    * The milestones that signal your readiness to take on a commercial PIM
    * Best practices when making the transition to a commercial PIM
    * How to align your PIM strategy to a logical data model

    SPEAKERS
    Alison Tran, EIS, Client Partner, brings over 14 years of business and technology consulting experience in technology adoption, software implementation, organizational redesign, change management and process reengineering.
    Chantal Schweizer, EIS, Principal Consultant, a senior information organization professional with over 10 years experience in product information and taxonomy design.
  • 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 Dec 11 2019 4:00 pm UTC 75 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.
  • 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.
  • Utility of Generating  Data: Drug Manufacture’s Perspective: Will USP...
    Utility of Generating Data: Drug Manufacture’s Perspective: Will USP...
    Ken Wong, Deputy Director at Sanofi Pasteur and Desmond G. Hunt, Principal Liaison at United States Pharmacopeia Jun 23 2020 2:00 pm UTC 90 mins
    Full Title:Utility of Generating Data: Drug Manufacture’s Perspective: Will USP permit such format?

    Presented by Ken Wong, Deputy Director at Sanofi Pasteur

    This talk will focus on an overall application of USP starting from risk assessment to qualification of disposable manufacturing systems based on USP data set. All the key principles with examples where these principles need to be satisfied before one can apply the USP data for disposable manufacturing system qualification will be discussed and illustrated. Lastly, different qualification approaches will also be presented to provide broader understanding.

    Followed by a presentation by Desmond G. Hunt, Principal Liaison at United States Pharmacopeia

    Dr. Desmond G. Hunt has been with USP since 2005 and holds the position of Principle Scientific Liaison in the Compendial Science Group-General Chapters. He is the scientific liaison to the Packaging and Distribution and Dosage Forms Expert Committees, where he works to develop and revise USP Standards. He has authored many publications and peer-reviewed articles and is a frequent speaker and instructor on topics related to pharmaceutical packaging, particulate matter in parenteral and ophthalmic dosage forms and good storage and transportation practices. He participates on several industry Working Groups and Technical Committees related to his areas of expertise. Dr. Hunt obtained his M.S. and Ph.D. from the University of Texas at Austin and prior to joining USP, was a Research Fellow at the National Institutes of Health, Bethesda, MD, USA
  • 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
  • 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 Feb 18 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.
  • 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.
  • 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