2020 ISPE Biopharmaceutical Manufacturing Virtual Conference Sessions

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2020 ISPE Biopharmaceutical Manufacturing Virtual Conference Sessions

Biovc20

The 2020 ISPE Biopharmaceutical Manufacturing Virtual Conference focused on innovation in facilities, production methods, and technologies that enable a competitive and sustainable biopharmaceutical product supply for the future. This conference brought together experts that are developing, implementing, and operating advanced supply chains providing high quality medicines to global markets.

If you missed the conference, this is your opportunity to gain access to all of the educational content from the conference and view it on your own schedule. Get the biggest bang for your buck by purchasing the entire conference in one package or review the list of sessions to purchase individual.

2020 ISPE Biopharmaceutical Manufacturing
Virtual Conference Sessions

All purchases include access to the plenary sessions

  Per Session Package
Member $199   $1,295  
Nonmember   $249    $1,850
Government/Academia* N/A $500  
Student* N/A $90  

Conference Sessions

  • Cell & Gene Therapy Sessions

    Cell and Gene Therapy CMC and Manufacturing

    Cell and Gene Therapy CMC and Manufacturing: Ensuring the Analysis, Production and Quality Robust and cost-effective characterization and manufacturing presents a core challenge in the commercialization of gene and cell therapies with pressure mounting on CMC, analytical and manufacturing teams to keep up with accelerated development times and cost pressures. Gene and Cell Therapy CMC and Manufacturing examines the critical challenges facing the production, characterization and quality control of gene and cell therapies, with dedicated presentations on rapid CMC development, product and process characterization, upstream and downstream bioprocessing and considerations for personalized and large-scale manufacturing.

    • Transformation from R&D to Manufacturing
      James Warren, PhD, Vice President Pharmaceutical Development
      Ultragenyx
    • Re-thinking Comparability Assessments for Individualized Therapeutics?
      Kathy Francissen, PhD, Senior Director, Pharma Technical Regulatory
      Genentech, A Member of the Roche Group
    • Virtual Inspections: Navigating the New Paradigm
      Monica M. Commerford, PhD, Manager of Regulatory Affairs
      Brammer Bio

    Planning, Building and Operating Cell and Gene Therapy

    Planning, Building and Operating Cell and Gene Therapy Facilities (Part I) Many cell and gene therapy facilities are in different phases of planning, construction, and expansion.  Learn from experts in engineering and manufacturing about how these facilities are progressing. This two-session track will explore various designs as we move from lab scale to higher volume production; control for single use to allow for multiple manufacturing trains. These sessions will examine going from manual to automated processing to meet the demand and the various technologies and layouts being utilized to supply patient needs and meet regulatory GMP requirements.  

    • Building Flexibility for Multiple Cell Therapy Processes
      Daniel Swanson, Senior Project Engineer Biopharmaceutical Pilot Plant
      GlaxoSmithKline  
    • Leveraging Operational Simulations for Gene Therapy Facilities
      Niranjan Kulkarni, PhD, Director, Operations Improvement
      CRB

    Planning, Building and Operating Cell and Gene Therapy

    Planning, Building and Operating Cell and Gene Therapy Facilities (Part II) Many cell and gene therapy facilities are in different phases of planning, construction, and expansion.  Learn from experts in engineering and manufacturing about how these facilities are progressing.   This two-session track will explore various designs as we move from lab scale to higher volume production; control for single use to allow for multiple manufacturing trains. These sessions will examine going from manual to automated processing to meet the demand and the various technologies and layouts being utilized to supply patient needs and meet regulatory GMP requirements.  

    • ATMP Facility Scale-up to Production using Isolator Technology
      Michael Hennessy Head of Global Sales
      ProSys Group  
    • The Impact of Innovation on Building the Facilities of the Future
      John Khoury, Principal Engineer
      ProjectFarma
      Alexis Melendez, Director of Engineering and Facilities Kite
      Pharma, Inc.

    Practical Challenges With Quality System Management

    Practical Challenges with Quality System Management in Cell and Gene Therapies This session will focus on the challenges with the establishment of quality oversight and systems from the initial patient interface through manufacturing and supply for cell and gene therapies.  Experience with the application of cGMPs in the hospital setting will be discussed as well as the conflicting priorities when multiple companies are imposing different demands on the same institutions, notably as these controls are part of the approved applications. The efforts to harmonize standards globally, as well as the regulator experience in determining true compliance risks will be addressed.  

    • FDA Perspective on GMPs for Cell & Gene Therapies
      Ekaterina Allen, PhD, RAC, Regulatory Project Manager & CMC Facilities Reviewer,
      FDA/CBER  
    • Quality Considerations for Cell & Gene Therapy
      Luciana Mansolelli, Head Quality Strategic Planning, Cell & Gene Technical Development & Manufacturing
      Novartis
    • Challenges for GMPs for ATMPs: European Perspective
      Lina Ertle, Head of External Relations EMEA &
      Japan, Roche
  • Digitalization Sessions

    Increased Automation and Digitalization in Manufacturing

    Increased Automation and Digitalization in Manufacturing Computer systems have continued to help manage complexity involved in biopharmaceutical manufacturing.  Such systems have evolved in ways previously not anticipated.  This session will explore some of the evolving uses of computer systems to allow a greater focus on product quality.  

    • BioPhorum Plug and Play: Developing and Utilizing Standards to Enable Reduced Project Delivery Time
      Bruce Kane, P.E. Global Life Science Technical Consultant
      Rockwell  
    • Automation How Digital is Transforming Quality Assurance Operations: A Focus on Real and Right Time Release
      Michael Shanno, Head of Digital and IT Biologics Quality
      Sanofi
    • The Digital Twin: Integrated Engineering the Key to Cost-Effective Digitalization
      Martin Mayer, Business Development
      ZETA
  • Drug Products Sessions

    Technology Advancements for Drug Product Manufacturing

    Technology Advancements for Drug Product ManufacturingThis session will discuss technology advances related to the manufacturing of biologic drug products of different dosage forms.  Technologies and case studies to be discussed include low temperature sealing of container closures and continuous aseptic spray freeze-drying. 

    • Dynamic Challenge Sealing Performance for Biologic Container Systems at Low Temperature
      Qingyu Zeng, PhD, Fellow, Technical Director
      West Pharmaceutical Services, Inc.  
    • Single-Use Technology for Final Fill: An Overview
      Laura Moody, PhD, Product Manager – Primary Packaging Pharma Liquid Packaging, North America,
      Syntegon Pharma Technology LLC
    • Vial Visualization Using AI
      Joshua Stauffer, Staff Engineer
      Merck & Co., Inc.
  • Pharma 4.0 Sessions

    Pharma 4.0: What it is, What it isn’t

    Pharma 4.0: What it is, What it isn’t and How to Implement itTrying to figure out what Pharma 4.0 is and what it means to your business? This session will clarify what Pharma 4.0 is and offer practical aspects of how it has been implemented in the plant and what it means to your workforce.

    • Why Pharma 4.0? Did We Advance?
      Christian Woelbeling, Senior Director Global Accounts
      Werum IT Solutions  
    • Enabling Automation and Pharma 4.0 in Cell Therapy
      Laura Moody, PhD, Product Manager – Primary Packaging
      Shin Kawamata, Director of R&D Centre for Cell Therapy
      Foundation for Biomedical Research and Innovation (FBRI)
      David Margetts, CEO
      Factorytalk, Co. Ltd.
    • Pharma 4.0 Meets Operator 4.0: Facing Knowledge Challenges of Manufacturing in the 4.0
      Era Patrick Boyle, President
      SkillPad Canada Inc.
  • Plenary Sessions - Bonus Content Included

    Innovation in Technological Platforms in Biopharmaceutical

    Plenary Session - Innovation in Technological Platforms in Biopharmaceutical Manufacturing As described in the morning session, regulatory expectations continue to evolve given the complexities associated with new products and innovation. This session will provide an opportunity to hear more about this topic in the context of an innovative vaccine facility and related sterile manufacturing requirements.

    • Process and Facility Innovation using PODs in Vaccine Manufacturing – Benefits and Challenges
      Maria Hoffman, Executive Director, Supply Chain Management
      Merck  
    • Innovations in Sterile Manufacturing – Regulatory Considerations
      Patricia Hughes, PhD, Branch Chief, Division of Microbiology Assessment
      CDER, FDA

    Opening Plenary

    Opening Plenary - Challenges and Opportunities in the Manufacturing of New Treatment Modalities This year, the 2020 ISPE Biopharmaceutical Manufacturing Conference will focus on advances in manufacturing, facilities, and analytics important to bring new therapies to patients. Now more than ever, manufacturing is on the critical path as many new treatments in the area of personalized medicines and individualized batch production present the challenge to bring these medicines through rapid development, reliable manufacturing, and availability to patients a pace with the advances clinical research is bringing to address unmet needs. At the same time, biosimilars are advancing with the opportunity to provide more access to medicines.  In this opening session, we will hear an important regulatory perspective from FDA on gene therapy drug development and a reflection from industry on 10 years of Biosimilars.


    Regulatory and Industry Insights & Lessons Learned

    Closing Plenary Session & Fireside Chat - Regulatory and Industry Insights & Lessons Learned Wrapping up the conference it is important to hear from regulatory leaders to help frame the strategy for the era ahead.  Lessons learned from organizations around the world will give individuals the most current insights for those difficult discussion back at your home base. 

    • Facilitating Development of Advanced Therapies
      Raj K. Puri, MD, Director, Division of Cellular & Gene Therapies
      CBER, FDA  
    • Industry and Regulatory Fireside Chat
      Raj K. Puri, MD, PhD, Director, Division of Cellular & Gene Therapies
      CBER, FDA
      Patricia Hughes, PhD, Branch Chief, Division of Microbiology Assessment
      CDER, FDA
      John Balchunas, Workforce Director National Institute for
      Innovation in Manufacturing Biopharmaceuticals (NIIMBL)
      Lawrence Hill, CEO & VP Global Clinical Development
      Gan & Lee USA
      Maria Hoffman, Executive Director, Supply Chain Management
      Merck
    • Closing Remarks & Adjourn
      Joseph Famulare, Conference Chair, VP Global Compliance & External Collaboration
      Genentech

    Regulatory Updates on Biotechnological & Biological Products

    Regulatory Updates on Biotechnological and Biologic Products Regulatory expectations related to biotechnology and biological products are continually evolving both within mature and emerging regulatory agencies. This session will provide a snapshot of recent regulatory changes across the global landscape. Invited speakers will provide a sampling of some of the recent regulatory responses related to the ongoing COVID-19 pandemic, discuss the rapidly evolving regulatory landscape in China, and highlight some of the recent trends related to sterile products in the United States.

    • COVID-19 Pandemic Regulatory Responses
      Joseph Famulare, Vice President, Global Quality Compliance and External Relations Genentech, A Member of the
      Roche Group  
    • Update on Sterile Products and Change Management
      Richard Friedman, Deputy Director, Science & Regulatory Policy
      CDER, FDA  
    • Regulatory Requirement Differences Between China and US for Biologics & Biosimilars
      Lawrence A. Hill, PharmD, RPh, MBA, CEO
      Gan &Lee Pharmaceuticals USA
  • Quality Control Sessions

    Automation, Robotics and Digitalization in QC Labs

    Automation, Robotics and Digitalization in Biopharmaceutical QC Labs The goal of this session is to engage laboratory leaders, automation and informatics experts, regulators, and instrument/equipment/software vendors in rich discussions regarding the use of automation, robotics, and digital solutions to advance multiple dimensions of operational excellence in the pharma quality control laboratories.

    • Technology Solutions & Business Drivers for Moving from Manual to Automated Solutions in the Pharmaceutical QC Lab
      Jacqueline Larew, Senior Advisor-Global Quality
      Eli Lilly and Company
      Mark G. Schweitzer, Global AS&T and Scientific Initiatives
      Novartis  
    • QC Today and QC in the Future
      Vinny Browning III, Executive Director Commercial Attributes Sciences
      Amgen  
    • Case Study: Automation of Stability Data Reporting and Trend Analysis
      Janine Kuratli, Manager Data Analytics
      CSL Behring  
    • Case Study: Automated Technology Platform for Real-Time PCR-based Adventitious Agent Detection
      Sven M. Deutschmann, PhD, Head of Global ASAT
      Adventitious Agents    
    • Testing & Alternative Microbiological Methods, Global QC
      Sven M. Deutschmann, PhD, Head of Global ASAT
      Roche Diagnostics GmbH

    Single Use Technology Strategies

    Single Use Technology Strategies The approach to manufacture is never simple and now more and more hybridized. In this session experts share their latest findings and recommendations in SUT.  Given the movement toward personalized medicine even if you are not a single use proponent, getting ready for the future is important to your business.

    • Going from N-1 to Purified Product in a Closed and Connected Single-use Solution
      Pietro Perrone, PE Cytiva, Formerly GE Healthcare Life Hande Özgen, PhD,
      Scientist Cytiva, Formerly GE Healthcare Life  
    • Single-use Versus Stainless Steel Biomanufacturing Facilities: Are Hybrid Facilities the Best of Both Worlds?
      Lindsay Smart
      ZETA
  • Regulatory Harmonization Sessions

    Application of ICH Q12 Principles in Modern CMC Submissions

    Application of ICH Q12 Principles in Modern CMC Submissions This session brings together industry and regulatory agency representatives to discuss case studies involving the implementation of ICH Q12 principles in regulatory submissions to facilitate post-approval CMC changes in an efficient and predictable manner.

    • FDA Perspective on the Implementation of ICH Q12
      Pietro Perrone, PE Terrance Ocheltree, PhD, President
      PharmTree Consultants  
    • ICH Q12 and Beyond: The Journey Towards Regulatory Convergence in Product Life Cycle Management
      Nina Cauchon, PhD, Director, Regulatory Affairs – CMC
      Amgen Inc.
    • Application of ICH Q12, Established Conditions, and a Product Life Cycle Management Document to the Analytical Aspects of the 2019 FDA Q12 Pilot Program
      Michael Cohen, PhD, Research Fellow – Global CMC
      Pfizer  
    • Extended Panel Q&A/Discussion
      Nina Cauchon, PhD, Director, Regulatory Affairs – CMC
      Amgen Inc.
      Michael Cohen, PhD, Research Fellow – Global CMC
      Pfizer
      Andrew Chang, PhD, Vice President, Quality and Regulatory Compliance, Product Supply Quality
      Novo Nordisk

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*ISPE Membership is required for these rates.