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Life Sciences

  • A guide to biotechnology commercialisation
    A guide to biotechnology commercialisation
    Pete Hotten Recorded: Aug 20 2019 43 mins
    Over the past century, life sciences has exploded with innovation and it continues to promise excellent commercial opportunities for those with scientific and academic research in this area. However, research on its own is not enough for these discoveries and inventions to reach their commercial potential. With over thirty years' experience in the biotechnology sector, expert Pete Hotten provides a framework for commercialisation, what to look out for in market research and how evaluating the competition can help determine next best steps.
  • Mixed mode Chromatography in Purifying biologics - Overview
    Mixed mode Chromatography in Purifying biologics - Overview
    Vivek Halan Zumutor Biologics Pvt Ltd, Bangalore, India Recorded: Aug 20 2019 41 mins
    This Webinar will discuss MMC in purifying biologics which includes monoclonal antibodies (mAbs), Bispecific antibodies (BsAbs), antibody fragments (Scfv,Fab) and other recombinant proåteins. My discussion is intended for audience from biopharmaceutical industry as well as active collaborators from academic institutes.
  • Cell Culture Fundamentals
    Cell Culture Fundamentals
    Kyung-A (Katie) Song, Ph.D. Recorded: Aug 15 2019 44 mins
    Cell culture is a fundamental technique for a variety of applications. Cells are cultured in controlled conditions including temperature, gas exchange, pH, and culture media (energy and nutrients). This webinar will introduce basic concepts of cell culture and provide tips on how to succeed in culturing mammalian cells.

    In this webinar, we will review:
    •Introduction to cell culture
    •Critical factors for successful cell culture
    •Cell culture tips and techniques

    Presenter Bio:

    Dr. Kyung-A Song graduated from Sungkyunkwan University with a Ph.D. in molecular biology and cancer immunology. She completed her postdoctoral fellowship in pharmaceutical research and drug discovery at Virginia Commonwealth University. She has extensive experience in a variety of cell culture techniques including isolation and culture of primary patient cells. She has worked with xenograft models and many cancer cell lines, and she has expertise in in vitro cell based functional assays and in vivo experiments. She is currently a Scientific Support Specialist for Corning Life Sciences where she answers customer inquiries about all products in the extensive Corning Life Sciences product portfolio.
  • Today’s State of S&OE
    Today’s State of S&OE
    Hear from Victoria Chen, who has been helping F500 companies achieve supply chain operational excellence for over a decade Recorded: Aug 14 2019 33 mins
    Time is running out, so register today to save your spot.
  • Determinación de macro y micronutrientes
    Determinación de macro y micronutrientes
    Omar Ruiz Sotelo,Field Marketing Specialist, Merck KGaaA Darmstadt Germany Recorded: Aug 13 2019 44 mins
    Aplicaciones para agricultura, acuacultura y agua de mar a través del Método fotométrico.
  • Mapping Future Technology Needs For Real Time Release Testing
    Mapping Future Technology Needs For Real Time Release Testing
    Dr Udayanath Aich, Associate Director at Bristol-Myers Squibb Recorded: Aug 9 2019 52 mins
    Real time monitoring and in-time release of products create a demand to move testing from QC release (off-line) analysis to the manufacturing shop floor (in-line, on-line or at-line monitoring), in order to address Biopharmaceutical manufacturing goals of reducing speed, cost and maximizing quality of product. BioPhorum Operations Group (BPOG) published a Biomanufacturing Technology Roadmap in July 2017 with the active collaboration of Biopharma industry representatives and supply partners. As part of implementation of roadmap strategy, BPOG’s ILM-RTR technical forum team is developing User Requirement Specifications (URS) for prioritized CQA’s and CPP focusing on the critical control points and future requirements of real time release (RTR). The URS documents will promote effective development of desired Short, Mid and Long term technologies by the innovators and supply partners.

    Presented by Dr. Udayanath Aich Associate Director at Bristol-Myers Squibb

    Dr. Udayanath Aich has an extensive experience and management skills in analytical chemistry, and CMC analytical strategies for early, late and commercial biologics products. He then decided to move to M.I.T to gain extensive skills in the area of Biopharmaceutical characterization and drug development. Dr. Aich joined at Thermo Fisher Scientific in the chromatographic and mass spectrometric division to broaden his extensive analytical skills. Then Dr. Aich worked as Investigator at GlaxoSmithKline in the area of protein and glycans characterization, process analytics, CMC analytical strategies as ATL and structure-function study. Finally, before joining at Bristol Myers Squibb, Uday was working at Sanofi related to high throughput technologies, process analytical technologies (PAT), Analytical method harmonization, multi-attribute method Dev, analytical method dev, robustness, qualification and transfer for early and late stage product including 2nd generation commercial product as part of life-cycle analytics.
  • The Secret to Successful Marketing to the Technical B2B Buyer
    The Secret to Successful Marketing to the Technical B2B Buyer
    EarleyInfoSci, Mouser Electronics, Brock White Recorded: Aug 7 2019 59 mins
    The B2B technical buyer is a unique persona with specialized needs. In order to get and keep this valuable customer on your site you must speak directly to their needs. So, how are the needs of technical buyers defined and translated into an engaging experience? The B2B and B2C ecommerce experiences have many similarities. Some lessons learned from B2C can be valuable to B2B. However, the two markets also have important differences, and the customer journey needs to reflect them.

    In this panel you will learn specifics about:

    --The archetypes of B2B buyer
    --Motivators and demotivators for making purchases
    --How to identify, structure and present content and assets that move the sale forward
    --The critical role of personalization
    --How merchandizing, cross-sell and up-sell leverage organizational knowledge about customer challenges

    This roundtable delivers valuable insights for CMOs, VPs of Digital, and Senior Marketing executives in organizations that operate as manufacturers, suppliers, and/or distributors in the industrial, high-tech, aerospace, life-sciences, and MRO spaces.
  • Cloud Done Right! 9 Critical Elements for Success
    Cloud Done Right! 9 Critical Elements for Success
    Unisys - Raj Raman, Lakshmi Ashok, Allen McMichael, Lori Pierson, Lisa McLaine, Brenda Celeste Recorded: Aug 7 2019 63 mins
    Enterprises need to modernize their operations to grow and stay competitive. But changes to IT infrastructure can quickly get out of hand. This involves moving workloads from on-premises data centers to public-cloud, private-cloud and hybrid-cloud solutions. The process is challenging and time consuming, leaving many organizations struggling to meet their business initiatives. In this webinar we’ll describe the nine key attributes that enterprises must master to be successful.

    Please join us on July 24th to learn how Unisys CloudForte™ helps our clients accelerate their migration to the cloud, while mitigating their risk and managing their costs.


    Presenters
    •Lisa McLaine - Global Director - Cloud and Infrastructure Services
    •Raj R. Ramen - Chief Technology Officer - Cloud
    •Lori Pierson - Portfolio Head - Global Cloud, Infrastructure and Application Services
    •Lakshmi Ashok - Chief Technology Officer - Homeland Security and Critical Infrastructure
    •Allen McMichael - Head - Global Cloud Managed Service Operations
    •Brenda Celeste - Director - Analyst Relations, North America
  • Bioburden Control within Continuous Manufacturing
    Bioburden Control within Continuous Manufacturing
    Britta Manser, Manager EU SLS Continuous Bioprocessing for Pall Corporation Recorded: Aug 7 2019 4 mins
    Bioburden control within continuous manufacturing

    Bioburden control within continuous manufacturing is a key area of concern in the biotech industry. In this short video from Pall Biotech, Britta Manser outlines how existing technologies can help mitigate potential risks linked to bioburden control among new technologies.

    Do you like the idea of producing 100 g of your mAb product every day? This is now possible using a continuous processing platform. Download a brochure to discover how.

    http://go.pall.com/brochure-continuousbioprocessing.html?utm_source=biopharma-asia&utm_medium=link&utm_campaign=19-03-121-ISCON&utm_content=brochure
  • Designing production facilities of the future
    Designing production facilities of the future
    Geoffrey Hodge, Chief Technical Officer at Unum Therapeutics and Gary Pigeau, Ph.D., Director at GE Healthcare Recorded: Jul 30 2019 87 mins
    Engineered autologous T cell products have proven to be an extremely promising new therapeutic modality, but they are currently time-consuming and costly to manufacture. This presentation will review the history of biotherapeutics development to look for lessons we can learn that may accelerate advances in autologous cell therapy manufacturing. It will also highlight the differences between traditional biotherapeutics manufacture and autologous cell manufacture to identify areas which may require us to look to other industries for inspiration. Finally, it will present an integrated vision for an autologous cell therapy manufacturing facility of the future which incorporates current initiatives, lessons from the past, and ideas from other industries to improve the robustness, cost, and time of autologous cell therapy manufacture.

    Followed by Enterprise solutions for cell and gene therapy

    The cell and gene therapy industry is growing at a rapid pace, with more and more attention on manufacturing rigor and scalability. Solutions are needed to achieve these outcomes while providing the speed and agility to succeed in this dynamic space. To tackle these issues and make life-saving therapies more accessible, the industry needs a new way of thinking. This presentation will discuss approaches that can be applied in modular fashion to create a customized production facility with the flexibility to evolve over time.

    Modern facilities include integrated technologies that close and automate processing, delivering the scalability and control lacking in typical manual workflows. An integrated platform can be housed inside a prefabricated structure – a cleanroom or a larger manufacturing facility. Both options allow for quick addition of GMP manufacturing capacity without interrupting existing work. A manufacturing execution system can be added to bring facilities together with cloud-based oversight of what is happening in real time.
  • How pharma marketing can stay ahead of the evolving customer journey
    How pharma marketing can stay ahead of the evolving customer journey
    Robb DeFilippis, Managing Director, Life Sciences, Tag, Steve Pitts, Business Director, Tag, Dominic Tyer, pharmaphorum Recorded: Jul 23 2019 64 mins
    Overview
    Join our live webinar taking place on Tuesday 23rd July at 16:00 BST / 11:00 EST / 08:00 PST.

    Customer journeys in pharma are changing, with important implications for the marketing supply chain. How can pharmaceutical marketers capitalise on this trend and free up budget to invest in additional marketing channels?

    Focus
    New developments in data and digital are changing traditional customer journeys and forcing pharmaceutical companies to evolve in order to keep up.

    Companies like Apple and Amazon have elevated customer expectations for personalised content and interactions across multiple channels, in the process setting new standards for marketing. But, as they push the envelope, what are the implications for pharma’s work in customer engagement?

    This pharmaphorum webinar, in association with Tag, will examine the challenges that pharma marketing faces to stay ahead of the evolving customer journey and offer expert insight from both the pharma and FMCG sectors on how to convert these challenges into opportunities .

    The expert panel will consider exclusive research carried out by Tag and pharmaphorum across the US, Europe and Asia-Pacific among senior decision-makers in pharma and FMCG marketing.

    The webinar, which takes place on Tuesday 23rd July at 16:00 BST / 11:00 EST / 08:00 PST will also look at:
    •How pharma currently allocates its marketing budgets
    •Where marketers would like to have more money to invest
    •How much time is spent directing creative ideation and managing marketing production

    For more information, please visit:
    https://pharmaphorum.com/digital/how-pharma-marketing-can-stay-ahead-of-the-evolving-customer-journey/
  • Innovation Strategy: How to start a start-up
    Innovation Strategy: How to start a start-up
    Joe Sekhon Recorded: Jul 17 2019 46 mins
    In this webinar, senior IP lecturer and distinguished start-up mentor, Joe Sekhon, will take us through his proven framework for giving ideas the best chance of success.
  • Use of Computational Modelling in Specification Setting and Establishing Control
    Use of Computational Modelling in Specification Setting and Establishing Control
    Thomas O'Connor, Scientist at FDA and Sean Bermingham, Head of Formulated Products at PSE Ltd Recorded: Jul 15 2019 77 mins
    Full Title: Use of Computational Modelling in Specification Setting and Establishing Control Strategy

    The proportion of scientific evidence supporting medical product regulatory applications derived from modeling and simulation studies is expected to continue to grow into the future. In the Quality by Design framework, mathematical models can and have be utilized at every stage of product development and manufacturing. Thus, the regulatory assessment of product quality models is not unprecedented but the frequency, types of models, and applications are evolving. This evolution is being driven in part by the adoption of advanced manufacturing such as continuous pharmaceutical manufacturing.

    The ICH Quality Implementation Working Group points to consider document categorizes models based on the model’s contribution in assuring the quality of the product. Models utilized as part of the control strategy are typically categorized as either high or medium impact depending on the role of the model. Minimal guidance though is provided on model validation. A recent standard (ASME V&V 40) outlines a process for making risk-informed determinations as to whether a model is credible for decision-making for a specified context of use. The presentation will discuss how the framework could be used to develop model validation plans and support regulatory assessment using case studies from both drug substance and drug product manufacturing.
  • Data Governance: Achieving Sustainability Among Whiners
    Data Governance: Achieving Sustainability Among Whiners
    Seth Maislin, Principal Consultant, Earley Information Science & Seth Earley, CEO, Earley Information Science Recorded: Jul 10 2019 60 mins
    Let’s face it - no one likes the ‘G’ word. It’s too often a sour antidote to excitement and nimbleness: Triple checks, security barriers, privacy forms, council reviews. It’s as awful as pulling teeth and paying taxes, right?

    Thankfully it doesn’t have to be, and many organizations have found an effective rhythm for long-term, sustainable data stewardship.

    Join us on Tuesday, August 28th, at 11:00 AM ET as we discuss ‘Data Governance: Achieving Sustainability Among Whiners,’ where we’ll explore how you can implement this necessary rhythm, even if you’re surrounded by governance resistors.

    You will learn:

    1.Good governance is empowering, not (only) a “necessarily evil”
    2.The Effective As: Automation, Assignment, Attitude
    3.Analytics for achieving fast failure (and recovery)

    Speakers:
    Seth Maislin is a Principal Consultant with Earley Information Science. For more than 20 years he has demonstrated strengths in classification and taxonomy, indexing and content modeling, information architecture, search, and usability. He has dedicated the last 10+ years to providing sustaining information management solutions to clients facing real and complex findability challenges.

    Seth Earley is the Founder and CEO of Earley Information Science. An expert with 20+ years experience in Knowledge Strategy, Data and Information Architecture, Search-based Applications and Information Findability solutions. Seth has worked with a diverse roster of Fortune 1000 companies helping them to achieve higher levels of operating performance by making information more findable, usable and valuable through integrated enterprise architectures supporting analytics, e-commerce and customer experience applications.
  • IP Strategy: Tackling Open Source Software
    IP Strategy: Tackling Open Source Software
    Martin Callinan, Source Code Control Recorded: Jul 10 2019 42 mins
    In this webinar, we'll dive into the latest developments in managing Open Source Software as part of your IP strategy. The webinar will review recent changes in the world of Open Source Software, including highlights of the 2019 Open Source Security and Risk Survey. There will be an assessment of the changing dynamic, using the example of Soundview. The webinar will cover advice on how to manage Openchain, which is on track to be a ISO Standard within 12 months. Additionally, this webinar will investigate the new PCI software lifecycle with an example of how to manage this on an ongoing basis – the process and the tools.
  • Chemical and Physical Transformation Monitoring by Raman and IR Spectroscopies
    Chemical and Physical Transformation Monitoring by Raman and IR Spectroscopies
    John Wasylyk, Sr Principal Scientist at BMS and Karen Esmonde-White, Senior Marcom Specialist at Kaiser Optical Systems Inc Recorded: Jul 1 2019 63 mins
    During the lengthy process of pharmaceutical development, an Active Pharmaceutical Ingredient (API) or its intermediates can go through many physical and chemical changes. These changes are needed to produce the API with the correct chemical structure and physical property. Monitoring the progress of these transformations is important for the process understanding as well as serving as a tool for in-process control (IPC) to ensure the completeness of the transformation. IR and Raman Spectroscopies are sensitive to both chemical and physical changes of a compound and have evolved into useful tools in our lab for monitoring both chemical and physical transformations. They can be used to monitor the progress of the chemical reaction leading to the desired product, the slurry-to-slurry form transformation leading to the desired crystalline form, and the instability of API leading to undesired degradant. When used in-line, they can also be used to study the kinetics of a chemical reaction as well as the rate of crystalline form conversion...

    Followed by Utility of Raman spectroscopy in continuous processing of liquids and solids

    An important consideration in successful continuous manufacturing is integrating analytical tools into the flow. In batch reaction monitoring, on-line and at-line analyses enable Quality by Design (QbD) and ensure stable operations. Intense reaction conditions, non-traditional chemistries, high throughput and speeds, and miniaturized reactors are challenging environments for analytical tools originally developed for batch reaction monitoring. We present process Raman technologies adapted for continuous manufacturing processes in liquids and solids. Over the last 20 years, Raman spectroscopy has become an established technique for process monitoring and control, with applications in continuous manufacturing of liquids and solids...
  • Collaborating for Successful Open Access Publishing
    Collaborating for Successful Open Access Publishing
    Yvonne Desmond and Kevin Griffin, Technological University Dublin Recorded: Jun 28 2019 56 mins
    Technological University Dublin is a first-of-its-kind university in Ireland, thanks in part to a first-of-its-kind open access journal publishing program that supports and amplifies the culture of research at the university.

    On May 21st at 11:00 a.m. Greenwich Mean Time, Yvonne Desmond, Digital Services and Research Librarian at Technological University Dublin, and Kevin Griffin, Kevin Griffin, Lecturer in the School of Hospitality Management and Tourism and editor of the International Journal of Religious Tourism and Pilgrimage, shared the history and lessons learned from the publishing program's role at the university.

    What you’ll learn from the presenters:

    • How innovative thinking and technology can transform global reach
    • Tips for successful collaborations
    • Practical insights to start or improve your own journal publishing program
  • From Telephone to Telepathy – The Evolution of Digital Support
    From Telephone to Telepathy – The Evolution of Digital Support
    Weston Morris, Global Leader for Unisys Digital Workplace Services Recorded: Jun 26 2019 61 mins
    Today’s enterprises need capabilities that go beyond the “Service Desk” and “Desktop Support.” Enterprises need capabilities that:

    •Start with how users devices are provisioned and configured so they are ready to ‘phone home’ when a problem is detected.
    •Include Artificial Intelligence and machine learning as inherent components of the digital workplace ecosystem.
    •Go beyond the visualization of device data to proactive resolution response.
    •Use intelligent analytics to infer how the end-users feel about their service without the hassle of a formal survey.

    Please join us as we profile seven clients’ use of our Digital Support innovations to accelerate digital transformation.
  • Addressing Consumer Safety Concerns with Zero Trust Security
    Addressing Consumer Safety Concerns with Zero Trust Security
    Christopher Kloes, VP of Security, Unisys Recorded: Jun 24 2019 27 mins
    In this webinar, you’ll learn:

    •The leading security concerns for consumers worldwide
    •The benefits of a Zero Trust security model to protect critical customer information
    •Five steps for implementing Zero Trust
  • Embase for drug analytics
    Embase for drug analytics
    Dr. Erin van Buel Recorded: Jun 20 2019 52 mins
    Biomedical literature has a critical role in post-market surveillance and vigilance to ensure the safety and effectiveness of drugs and medical devices. In the meantime, data extracted from the literature is being more used in different stages of drug discovery and development to achieve different goals. Understanding the relationship between drug-disease, drug-drug, device-disease and device-device can provide important insights for drug development and re-positioning.

    In this webinar, Quality Control Scientist Dr. Erin van Buel will discuss
    •Indexing principles and relationships identified with in-depth indexing in Embase
    •How to use advanced search filters and features to identify semantic relationships between drugs and diseases, such as drugs used to treat a disease, drug-drug combination, drug-drug interaction, etc.
    •How the semantic relationships identified with in-depth indexing can be used to inform drug development, re-positioning and safety

    Date: Jun 20, 2019
    Time: 16:00 CET
  • Innovation in Biomanufacturing Plants
    Innovation in Biomanufacturing Plants
    Chris Chen PhD, CEO of WuXi Biologics and Dr. Sébastien Ribault, Senior Director for Global Delivery and Sales at Merck Recorded: Jun 20 2019 72 mins
    Biopharmaceutical plants will look different in the future. Agility and flexibility for rapidly changing product portfolios, single-use technologies, continuous manufacturing, small batch manufacturing, personalised medicine manufacturing will not only change the face of a plant but will also require other logistics models. Chris will explain WuXi Biologics' approach to biological facilities of the future.
  • 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 Recorded: Jun 14 2019 74 mins
    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.

    Followed by 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. All of these aspects of Raman microscopy make it an indispensable tool for pharmaceutical forensics.
  • S&OE: When Bad Things Happen to Good Plans
    S&OE: When Bad Things Happen to Good Plans
    Hear from Katherine Ross, Former Worldwide Vice President, Customer and Logistics Services for Johnson & Johnson Recorded: Jun 13 2019 45 mins
  • Orphan medicines launch excellence: sustaining launch success
    Orphan medicines launch excellence: sustaining launch success
    Peter Meeus, European Orphan Medicines, Sarah Rickwood, IQVIA, Angela McFarlane, IQVIA, Paul Tunnah, pharmaphorum Recorded: Jun 13 2019 72 mins
    Launching orphan medicines excellently will become even more important over the next five years as more patients with rare diseases have pharmacotherapies available.

    There are also a growing number of disease-focussed registries, increasing public and policy maker awareness, and significant R&D investment in orphan drugs, as well as in digital technologies to support trials and treatment.

    But a new frontier of challenge faces orphan medicines companies as the gap between orphan medicines and mainstream specialty products narrows.

    To understand how to succeed in launching an orphan medicine in the coming years, companies must learn from past launches and apply an orphan medicines-focused launch excellence framework for success.

    This internationally relevant webinar will provide US and European examples to illustrate the ways in which the pharmaceutical market for orphan medicines is changing and how, consequently, launch strategies must evolve.

    This pharmaphorum debate, held in partnership with IQIVA, will also look at how pharmaceutical companies can optimise all the activities needed to take orphan medicines from clinical development to commercialisation, including:

    •Identifying the three fundamental challenges for orphan medicine launch excellence
    •Discussing the ways in which companies launching orphan medicines can learn from excellence in mainstream launches
    •Examining, in-depth, the specific areas of focus which are crucial for orphan medicines excellence.
  • BRC v8 et ISO 22000 : 2018, du Système de management de la qualité au process de
    BRC v8 et ISO 22000 : 2018, du Système de management de la qualité au process de
    Alexia Lafarge and Adele Gisselman Recorded: Jun 13 2019 51 mins
    Evolutions des référentiels qualité et crises sanitaires, comment le nettoyage et la désinfection apportent des réponses aux changements majeurs.
    Nous présenterons les solutions de contrôle rapide du nettoyage allant des méthodes conventionnelles microbiologiques aux méthodes rapides en passant par le contrôle de l’air.
  • Famous Cancers
    Famous Cancers
    Nicole Lewis Aug 27 2019 3:00 pm UTC 75 mins
    It’s no secret that we live in a celebrity centric culture hungry for the latest news about our favorite famous faces. This lecture will employ the fascinating world of celebrities to introduce the immunohistochemical grid approach to cancer disease states. We will specifically use cancer stories from past and present entertainers, athletes, and politicians to examine the histological characteristics and statistics that define various tumor types. These cases will also be our launching pad as we take a deep dive into the intricate world of tumor immunophenotyping by highlighting recent antibody additions and their impact on modern detection. Attendees will learn the utility of these new antibodies and gain a better overall understating of how diagnostic grids are used by pathologists to provide thorough and accurate patient care.
  • Creating a Copyright Policy for your IR
    Creating a Copyright Policy for your IR
    Shawn Martin, Dartmouth College Aug 27 2019 3:00 pm UTC 60 mins
    The world of copyright is vast, and there are some basics that every institutional repository administrator needs to know. Whether you're launching your new repository or looking to strengthen your copyright outreach on campus, join Shawn Martin, Head of Scholarly Communication, Copyright, and Publishing at Dartmouth College, as he presents "Creating a Copyright Policy for your IR" on August 27, 2019. Topics include:
    - What is an isn't under the umbrella of the University's rights to post
    - The ins and outs of licenses
    - Rights checking workflows that won't consume all your time
    - Including copyright in your outreach strategies
  • Beyond Purely Data-Driven Approaches for Efficient Knowledge Management in Proce
    Beyond Purely Data-Driven Approaches for Efficient Knowledge Management in Proce
    Moritz von Stosch of GlaxoSmithKline Vaccines Followed by Klaus Mauch and Shilpa Nargund of Insilico Biotechnology AG Sep 2 2019 8:00 am UTC 90 mins
    Title: Beyond Purely Data-Driven Approaches for Efficient Knowledge Management in Process Development

    Knowledge from first principles is freely available and generally valid, and when integrated along with Artificial Intelligence (data-driven) methods, it can greatly improve the understanding and applicability. The applications of such an approach, referred to as hybrid modelling, to a fermentation and controlled drug release case are presented and the learnings from the development of these models are shared.
  • Innovative contracting in Europe – a Trojan horse?
    Innovative contracting in Europe – a Trojan horse?
    Smita Sealey and Barry Farimond, ZS Associates, Malcolm Qualie, NHS England, Alain Boulanger, Filippo Drago Sep 2 2019 2:00 pm UTC 75 mins
    Overview

    With pricing of drugs at the centre of political and social debate, the market access and pricing environment in Europe has become increasingly challenging over the years. Innovative contracting has since become a common route to overcome these challenges and ensure timely access for patients.


    Focus

    Join us on Monday 2nd September from 15:00-16:00 BST as we discuss the future of innovative contracting with our panel of European payers. Key topics to be covered include:

    To what extent and how contracting helps improve patient access?
    What prior successes and failures can teach us about designing contracts that deliver true value to the health systems?
    Can we avoid contracting and what would be the alternative?

    In the past decade, we have moved from simple discounting and traditional volume-based agreements to more complex value-based models involving measurement of health outcomes, risk-sharing and cost containment guarantees. The feasibility of these contracts tends to vary by EU market, dependent mainly on the available healthcare system infrastructure to collect and process data as well as other regulatory and philosophical differences.

    Ultimately, the question remains as to whether these agreements are a move towards better healthcare provision and more connected healthcare infrastructures, or are they slowing down access and creating administrative burden due to their complexity?
  • Corningシングルユース技術による細胞培養アプリケーションセミナー
    Corningシングルユース技術による細胞培養アプリケーションセミナー
    コーニングインターナショナル株式会社ライフサイエンス事業部 石渡孝至 Sep 3 2019 6:00 am UTC 60 mins
    製品プロトコールを基に細胞培養事例の紹介と周辺装置を含めたプロセスソリューションについて概説します。
  • CAR-T and other immunotherapies
    CAR-T and other immunotherapies
    Iain Armstrong (Partner, HGF), Sarah Morgan (Senior Writer, LSIPR) Sep 3 2019 2:00 pm UTC 75 mins
    Immunotherapies, such as CAR-T cells, are a hugely promising therapeutic area, both in terms of clinical benefits and potential market size.
    While the treatments are complicated and expensive, they have proven remarkably effective in achieving positive outcomes in forms of cancer that are otherwise difficult to treat. As a result, their clinical use has recently been approved in both the US and Europe.
    The webinar will consider how commercial and technological developments have also impacted patent filings in this area. As the field becomes increasingly crowded, the likelihood of obtaining very broad patent protection decreases. However, the number of patent filings continues to grow dramatically.
  • 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 Sep 4 2019 8:00 am UTC 75 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.
  • PharmaPendium August release: Unlocking and sharing critical safety insights
    PharmaPendium August release: Unlocking and sharing critical safety insights
    Marnix Wieffer Sep 5 2019 2:00 pm UTC 45 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
  • 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 Sep 5 2019 3:00 pm UTC 60 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
  • 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 Sep 10 2019 5:00 am UTC 75 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.
  • 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 Sep 10 2019 2:00 pm UTC 90 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.
  • 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 Sep 12 2019 2:00 pm UTC 75 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.
  • Biopharmaceutical process development – Trends/ Challenges/Opportunities
    Biopharmaceutical process development – Trends/ Challenges/Opportunities
    Kumar Gaurav, AGM (Regulatory Affairs) at Panacea Biotec Ltd Sep 13 2019 9:30 am UTC 75 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
  • 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 Sep 17 2019 2:00 pm UTC 75 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.
  • 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 Sep 18 2019 7:00 am UTC 75 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 somewhat unique challenge of transitioning from clinical manufacturing to commercial manufacturing and maintaining both clinical and commercial manufacturing in the same facility.

    Followed by a presentation by Kevin Mullen, Sr. Product Manager, Single-Use Systems at Thermo Fisher Scientific
  • 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 Sep 19 2019 2:00 pm UTC 75 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.
  • Full-Line Integrated Continuous Process from Upstream to Downstream
    Full-Line Integrated Continuous Process from Upstream to Downstream
    Jackal Tsou, Supervisor at Mycenax Biotech Inc.and Gerben Zijlstra, Global Technology Consultant at Sartorius Stedim Biotech Sep 24 2019 8:00 am UTC 75 mins
    As the development process of monoclonal antibodies has come to a steady, it is assumed the automatic flow can be adopted and it is the beginning test ground for continuous manufacturing, to link the upstream cultivation to downstream purification in a continuous mode. We will show some preliminary results for this new era, Biomanufacturing 4.0.

    Presented by Jackal Tsou, Team Supervisor of Downstream Process Development at Mycenax Biotech Inc.

    Pearl has worked over 15 years in the biotechnology industries to serve both operating and consulting roles for more than 30 biomedical projects. As Director of Project development, she operates in CMC, project management, project oversight, regulatory consulting and business development fields. Pearl’s educational credentials include a Bachelor of Nutrition and Health Science and a Master in Molecular Biology and Biotechnology. She has brought the very first biological medicinal product from preclinical to NDA approval in Taiwan.

    Followed by Gerben Zijlstra, Global Technology Consultant at Sartorius Stedim Biotech

    Gerben is a regular speaker on process intensification and continuous biomanufacturing. He received his Ph.D. from the University of Wageningen, NL, in the field of process integration in cell culture.
    He has worked for more than 20 years at CMO DSM Biologics and has been involved in the development of several Bio-therapeutics. He was one of the early adopters of single-use bioreactors and is the first inventor of the Concentrated Fed-Batch – XD® technology. Gerben was deeply involved in the tech transfer of XD® technology to the Brisbane, AU site, which received the 2014 ISPE facility of the year award for process innovations. As a consultant at Xendo, Gerben has been working on Continuous BioManufacturing and Gene Therapy projects. Since 2016 he has joined the Sartorius Team, where he currently holds a position as Global Tech Expert for Intensified BioManufacturing.
  • Characterization of Biotherapeutics
    Characterization of Biotherapeutics
    Diane McCarthy, PhD, Senior Scientific Liaison, US Pharmacopeia and Kai Scheffler Product Manager at Thermo Fisher Scientific Sep 24 2019 2:00 pm UTC 75 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.
  • Fast GC - Background, Theory and implementation in the lab
    Fast GC - Background, Theory and implementation in the lab
    Dr. Frank Michel, Analytical & Chromatography Scientific Advisor, Merck KGaA Darmstadt, Germany Sep 25 2019 6:00 am UTC 75 mins
    The approach of Fast GC is becoming more and more popular, because it can vastly increase sample throughput and improve laboratory efficiency in routine analytical laboratories. This webinar will address the theoretical background, practical aspects and considerations to implement this technique in any GC lab.
  • Implementation Of An Affordable & Scalable Manufacturing Strategy
    Implementation Of An Affordable & Scalable Manufacturing Strategy
    Bastiaan Leewis of MeiraGTx and Ankita Desai of Eppendorf Sep 25 2019 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.
  • Cerebral Organoids as a 3D Model for Glioma
    Cerebral Organoids as a 3D Model for Glioma
    Amanda Linkous, Ph.D. Sep 26 2019 4:00 pm UTC 45 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, we have established a unique model system whereby we can retro-engineer patient-specific GBMs using patient-derived glioma stem cells (GSCs) and human embryonic stem cell (hESC)-derived cerebral organoids. Our 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. Our 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)
  • Cost Considerations for the Application of Continuous Processing
    Cost Considerations for the Application of Continuous Processing
    Narasimha Rao Nedunuri, CEO of CLONZ Biotech and José Castillo, PhD, CTo and co-founder of Univercells Oct 2 2019 9:30 am UTC 75 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.
  • 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 Oct 2 2019 5:00 pm UTC 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
  • Qualification of Raw Materials Used in the Manufacturing of Cellular Therapies
    Qualification of Raw Materials Used in the Manufacturing of Cellular Therapies
    Fouad Atouf, Ph.D., Director at USP and Horst Ruppach, Ph.D. Scientific Director at Charles River Oct 7 2019 2:00 pm UTC 75 mins
    Qualification of raw materials used in the manufacturing of cellular therapies requires the use of risk assessment strategies to categorize the critical components of a manufacturing process. In addition to cell culture supplements, excipients and other formulation’s components must meet the required quality to ensure consistency in manufacturing and subsequently the quality and safety of finished cell therapy products. This presentation will discuss the critical challenges facing the development of cell therapies, and the type of qualification programs to help ensure consistency in the manufacturing of cell and gene therapies.

    Presented by Fouad Atouf, Ph.D., Director at US Pharmacopeia

    Fouad Atouf is Vice President, Science—Global Biologics, for USP. He leads all scientific activities related to the development and maintenance of documentary and reference standards for biologics and antibiotics, and oversees the biologics laboratories in USP–U.S. and USP–India. His department supports the work of the associated USP Expert Committees. Dr. Atouf has been at USP for over 10 years and served in a variety of scientific leadership roles including being the regional champion for the Middle East and North Africa Region, where he helped facilitate programs designed to enhance the understanding of the role of regulations and standards in the registration of medicinal products. Dr. Atouf has strong background and experience in the development and regulation of cellular and tissue-based products. Prior to joining USP in 2006, his research at the U.S. National Institutes of Health focused on developing methods for the in vitro generation of cell-based therapies for diabetes. Dr. Atouf is the author of numerous publications in peer-reviewed journals and a frequent speaker at national and international scientific conferences. Dr. Atouf earned his Master’s degree in Biochemistry and his Ph.D. in Cell Biology from the Pierre & Marie Curie University, Paris, France.
  • FDA Perspective on Aseptic Process Simulation for Cell Therapy Product Manufa...
    FDA Perspective on Aseptic Process Simulation for Cell Therapy Product Manufa...
    Lily Koo, Consumer Safety Officer at Food and Drug Administration Oct 16 2019 2:00 pm UTC 75 mins
    Full Title: FDA Perspective on Aseptic Process Simulation for Cell Therapy Product Manufacturing

    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. Case studies will be presented and discussed.

    Presented by Lily Koo, CBER at Food and Drug Administration

    Lily Koo is a Consumer Safety Officer in the Division of Manufacturing and Product Quality (DMPQ) in the Office of Compliance and Biologics Quality (OCBQ), at FDA’s Center for Biologics Evaluation and Research (CBER). Her primary responsibilities include review of facility and equipment information in license applications and supplements for viral vaccines, blood fractionation products, cell and gene therapy products, and in vitro diagnostic kits. Lily also conducts pre-license and pre-approval inspections of biological manufacturing facilities. Prior to joining CBER, she worked two and half years at the Center for Device and Radiological Health and ten years at the National Institutes of Health. Lily received her B.S. in bioengineering from the University of Pennsylvania and her Ph.D. in chemical engineering from Massachusetts Institute of Technology.