Agenda

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Technical PresentationLive-streamed education sessions.

Day 1
Tuesday, 1 February 2022
  • 0830 - 0845
    Welcome and Opening Remarks
    Speakers
    Presentation Information
    [ISPE Foundation Update]
    Speaker: Lou Kennedy
    || [Welcome and Opening Remarks]
    Speaker: Thomas B. Hartman
    || [Conference Overview]
    Speaker: Jeff Biskup
  • 0845 - 1015
    COVID's Impact on Pharma Facilities of the Future
    The opening session will take a high-level look ahead at global pharmaceutical manufacturing and related regulatory systems. We will discuss how COVID has impacted our business and the applications of future manufacturing operations and the facilities required to adequately produce product that is safe, cost effective and meets the needs of the patients we serve. Key industry leaders will share their perspectives and their insights into how they see the industry changing as we move forward from COVID.
    Session Leaders
    Speakers
    Presentation Information
    [An Introduction to ISPE Facilities of the Future Conference from the Beginning: A Visionary’s Perspective]
    Speaker: Lou Schmukler
  • 1015 - 1100
    Break - Exhibits and Poster Display
  • 1015 - 1100
    Professional Posters
    Speakers

    Kaitlyn Vap

    Lead Product Application Specialist, Life Sciences
    Suez WTS
    Presentation Information
    [Equipment Monitoring and Predictive Maintenance in Pharma 4.0 Operations]
    Presenter: Massimo Consolaro
    The presentation provides a general definition of the fourth industrial revolution by using 4 pillars of Industry 4.0 as reference: Things, Connectivity, Data and Analytics. Modern system architecture transition from complex parallel wiring to digital solutions is described, and advantages of such improvement are shown in details. Secure measures to enable machine remote connections and ensure data integrity and redundancy are highlighted. Advanced data analytics procedures with real case example are shown, including a description of the advantages related to improved machine performance and maintenance. A new tool for retrospective process analysis is also presented. As a result of this presentation, attendees will understand how digitalization of a machine can enable GMP relevant advantages; improve data integrity; and enhance operators training procedures.
    || [Transforming Life Sciences Construction Management Through Digitized Benchmarking and Predictive Estimating]
    Presenter: Jason D'Orlando
    All too often, pharmaceutical capital investments are benchmarked against initial concept baselines that are rooted in immature assumptions, data not truly comparable, or not using best practices to develop a solid baseline range. Turner & Townsend Taurus has decades of pharmaceutical program experience ranging from troubled projects to successful ones, with a deep library worth of digitized benchmarking data. In this presentation we will demonstrate, through our proven early planning approach combining technology, people, and past market data, how effective early concept planning and estimating allows your capital program to baseline to ensure a proper roadmap to managing risk throughout your program. We will take you through our TIC (TARGET, IMPROVE, CONTROL) methodology to developing data driven conceptual estimates and schedules that integrate the whole program from concept through regulatory submission. We will provide a detailed review of how we utilize our state-of-the-art benchmarking tool, the HIVE, and bring our industry experts to show how our experience intersects with real world tools and capability to deliver world class up front program planning. The participants will come away with an understanding of the needed steps to utilize technology, industry data and a proven plan to develop a solid up-front baseline.
    || [Integration of Online TOC and Conductivity Analysis with a CIP Skid for Real-Time Cleaning Validation/Verification]
    Speaker: Kaitlyn Vap
    Current pressures to meet today’s production demands are motivating companies to embrace Process Analytical Technology (PAT) to realize efficiency gains. The capability of integrating online analysis with cleaning validation (CV) enables lean processes. CV programs must demonstrate comprehensive cleanliness by testing for defined quality attributes. Total organic carbon (TOC) and conductivity analysis are commonly used in CV applications because of the accuracy and precision in assessing the cleanliness of equipment and processes. The data they yield is incredibly useful in scale-up, optimization, or root cause analysis, functionality that can accelerate equipment release time from days to minutes. This presentation will address solutions that invite innovation, automation, and optimization into cleaning validation programs.
    || [Driving Business Performance at Facility Hand Over]
    Presenter: Allison A. Cacciatore
    When bringing a new drug product to market, drug sponsors are faced with whether to build a new facility or partner with a CDMO. Drug discovery speed coupled with new advances in regulatory approval strategies are decreasing time to market and leading to CDMO backlogs. Drug sponsors are now considering building their own facilities that are CDMO-like ballroom designs. Once a drug sponsor decides to build its own facility then the primary decision becomes: are you designing a nimble facility or are you designing a quick facility? This presentation will discuss common pitfalls encountered during project execution and how to make sure when delivering the project that there are no surprises.
  • 1100 - 1300
    Pharma 4.0
    Historically, industrial manufacturing has advanced from mechanization to mass production and then to automation/computerization. The next phase of manufacturing (referred to as Industry 4.0) involves integration of equipment and communication systems. The pharmaceutical industry is undergoing these same transformations (with the most recent phase referred to as Pharma 4.0). This session will explore aspects of Pharma 4.0 including IoT based technology and analytics, robotics in pharma manufacturing, a data mindset. This will include: The vision to integrate data and to easily visualize and analyze data providing insights across sites The future of pharmaceutical manufacturing with robots and cobots. The fundamental mindset shift to achieve a data driven decision.
    Session Leaders
    Speakers

    Julien Janda

    Head of Process & Technology, GMS Global Engineering
    Takeda Pharmaceutical International AG

    Richard Denk

    Senior Consultant Aseptic Processing & Containment
    SKAN AG
    Presentation Information
    [The Future of Robotics for Pharma Manufacturing]
    Speakers: Julien Janda and Richard Denk
    The ISPE DACH founded in 2019 the Special Interest Group for Future Robotics in Oral Solid Dosage and Aseptic Processing. The SIG Future Robotics is working on different new application Robotics could be used. The presentation would introduce new field on Robotics for the pharmaceutical manufacturing as well as what regulatory and safety requirements are needed.
    || [Accelerate Pharmaceutical Product Development and Achieve 'right the first-time' Quality with Advanced Manufacturing Technologies and Cloud]
    Speaker: Yury Gomez
    With the dynamic changes in both the pharma regulatory landscape and government policies, many leading pharma organizations are now more than ever under increased pressure to reimagine their internal operations to deliver consistent quality outcomes, minimize operational costs and accelerate scientific innovation for existing and unmet medical conditions. Intelligent automation delivers on the possibilities to truly reimagine process design and quality control through advanced manufacturing solutions leveraging cutting edge technology including IOT, digital twins, control towers, and AI/ML enabled cloud while empowering pharma companies and operators with real time data and insights to make better decisions & drive competitive advantage. This presentation will discuss insights on how to develop a multi-horizon roadmap to capture the full value that data, analytics and simulations can unlock to address pharma manufacturing most pressing challenges.
    || [Data for Everyone - Building the future with a data mindset]
    Speaker: Shanshan Liu
    The fundamental mindset shift to achieve a data driven decision. The presentation will follow the data flow and demonstrate the pharma application of data collection, data analysis, data presentation, use of data and data integrity. The demonstration will be supported with industry case studies which will cover the product lifecycle from development, validation, production, maintenance to distribution. Also develop a new perspective of the existing data and the valuable database; learn how the data could be utilised to drive the decision making; be encouraged to initiate an organisation wide discussion on how to enable the transformation into a data era.
  • 1100 - 1300
    Bio Manufacturing of the Future
    Bio Manufacturing of the Future requires cost effective, scalable solutions that can be implemented quicker than the traditional stainless steel facilities of yesterday. This session explores aspects of bio manufacturing that challenge the status quo and push the boundaries of bio manufacturing as we know it. From continuous methodologies to disposable technologies, we explore the industries response to the bio manufacturing capacity challenge.
    Session Leaders

    Tara Tibbs

    Sr Director Engineering API/DP
    Eli Lilly & Co
    Speakers

    Robert K. Allen

    Executive Technical Director |Advanced Technologies & Life Sciences
    Fluor Life Sciences
    Presentation Information
    [Leveraging Single Use Technologies to Scale-Out Globally]
    Speakers: Scott Keetch and Bob Allen
    This presentation will address the ability to leverage single use technology for the rapid deployment of launch facilities independent of modality by the implementation of common platforms for process equipment, automation, instrumentation, modular cleanrooms and supporting utilities. Topics to be covered include construction strategies and design concepts for worldwide use; validation approaches allowing for optimized value; automation and data handling approaches for repeat use; and the incorporation of Cytiva formally GEHC FlexFactory(TM). Attendees will understand the importance of standardization and the value of being able to repeat a design that can be used globally; construct validation programs that address planned duplication of process and utility systems globally; understand how to reduce the time to market by utilizing standardized, modular design versus traditional stick-built construction; and the facility accommodating a wide range of SUT equipment types and sizes to maximize process flexibility to support multi-product modality.
    || [Bio Manufacturing Facilities of the Future]
    Speaker: Jim Weidner
    Building new facilities can take years. We want to run the plants for decades. Supply plans changes after completing the facilities’ designs result in changes for processes to be run in the facilities. Flexibility to address potential future company needs requires facility reconfigurability. In this presentation, reconfigurable design options will cover how facilities might have capabilities for a combination of: high titer monoclonal antibody production with perfusion cell culture, low titer monoclonal antibody production with fed batch cell culture, mRNA processing, semi-continuous purification, and batch purification. We will also discuss best practice to advance Digital 4.0 with lessons learned, as many companies are advancing digital strategies for new and existing facilities. Finally, environmentally sustainable designs and designs for Employee Wellness are key to make the world a better place and attract talent: Sometimes there is synergy in the programs. In a few instances the two scorings compete against each other a little. We will discuss some recent lessons.
  • 1300 - 1400
    Lunch - Exhibits and Poster Display
  • 1400 - 1530
    Cell & Gene Therapy
    New facilities for the GMP manufacture of cell and gene therapies are starting to come online. This session includes presentations on two recently constructed facilities that represent the latest industry best practices in design, construction, and flexible, sustainable operation. Speed of construction is a common thread, along with innovative facility designs intended to accommodate future conditions. Join us for an informative session and the opportunity to interact with industry leaders in this segment.
    Session Leaders
    Speakers
    Presentation Information
    [Cell Forge 1: Creating a Next Generation Allogeneic Cell Therapy GMP Manufacturing Facility]
    Speaker: Benjamin Beneski
    This presentation will describe the facility design, construction, and startup of Cell Forge 1, Allogene Therapeutics’ state-of-the-art manufacturing facility in Newark, CA. Cell Forge 1 was designed to be scalable and flexible to produce our allogeneic, off-the-shelf, CART cell therapies faster, more reliably, and at greater scale. In addition to process-driven design criteria, significant effort went towards sustainability in design, resulting in a facility that reduces energy usage and integrates renewable energy sources. We’ll share experiences from our facility construction process, including site selection and the challenges of managing facility construction and startup during the global pandemic.
  • 1400 - 1530
    Emerging Technologies I
    Awareness of the pharmaceutical industry has increased significantly in the last 12 months due to the global pandemic. The timely production and delivery of vaccines at capacity has been a major issue across the world, and the way the industry has responded to meet that challenge has undoubtedly driven knowledge and lessons learnt which should be captured to continually improve the industry. Additionally, it can be argued that the pharmaceutical industry is changing at its fastest rate in decades, driven in part by the requirement to manufacture new process modalities, as well as the need to deliver new facilities in a quicker and more cost effective manner. Furthermore, growing demand for more flexible and sustainable facilities, together with the advancement of new processing and Pharma 4.0 technologies, such as digitization and robotics, requires that Site Master Planning needs to advance accordingly. This session will hear about the new Vaccines Manufacturing and Innovation facility in the UK and how it responded to the pandemic challenge, and also, how its design basis changed to become platform and technology agnostic with the ability to ramp capacity 20 fold with a 6 month timeframe. Additionally, the session will look at Site Master Planning the Future and how it should adjust to accommodate new process modalities, delivery methods, and Pharma 4.0 technologies.
    Session Leaders
    Speakers

    Jordaan Kemp

    Director of Architecture and Process Architect SME
    PM Group
    Presentation Information
    [Masterplanning the Future]
    Speakers: Jordaan Kemp and Jessica Hays
    Will be a comprehensive outlook on some of the most relevant Pharmaceutical developments in the world that are configuring a new understanding on the role of master plans. In a time of faster project delivery, evolution of process modalities, products and production processes, growing demands for more flexible processes and facilities and a shift in company objectives, the traditional modernist planning model might be transitioning to a new stage and this is the hypothesis and starting point of the presentation. We will look at the following key areas that affects how we plan and arrange our site masterplans for clients: modular design solutions; flexibility; adaptable modules; the drivers for pre-investments to assist speed to market; impact of the various modalities on support functions and designing for adaptability; impact of robotics and the integration of cobots • digitization and next generation technological developments; designing a sustainable future ; well building design and creating great working environment. Our new generation of masterplanning methodology is testing renewed strategies to understand and plan sites, and by also using the intersection of the digital and physical, to display information and communicate within client organizations to help plan their futures.
  • 1530 - 1615
    Break - Exhibits and Poster Display
  • 1615 - 1745
    Pharma Collaborations in the COVID Era
    The Pandemic brought significant challenges to industries around the world.  The Pharma Industry rose to the challenge and quickly engaged, collaborated and responded at an unprecedented speed.  This session explores a few examples of these collaborations, lessons learned and how COVID has changed Pharma relationships forevermore.
    Session Leaders

    Tara Tibbs

    Sr Director Engineering API/DP
    Eli Lilly & Co
    Speakers

    Matt Edwards

    Vice President, Indianapolis Parenteral Manufacturing
    Eli Lilly And Company
  • 1745 - 1845
    Welcome Reception - Exhibits and Poster Display
  • 1845 - 2030
    Executive Forum Dinner
    Presentation & Panel Discussion
    Session Leaders
    Speakers

    Patrick J. Poisson

    Executive Vice President, Technical Operations
    United Therapeutics Corporation
    Presentation Information
    [Lessons Learned from Operation Warp Speed for Rapid Vaccine Development]
    Speaker: Matthew Hepburn

    Panelists:
    Matthew Hepburn
    Patrick Poisson
    Oliver Hennig
    Additional Panelists TBD
Day 2
Wednesday, 2 February 2022
  • 0700 - 0830
    Women in Pharma® Breakfast: Navigating the Burnout
    Trying to navigate in this busy world is challenging with our current work schedules.  Taking time for yourself is hard, especially as a working professional.  Join us for a discussion on mindfulness, taking time for yourself, and how this will help you become a better employee, family member, or colleague. Our panel will share their stories and answer questions on how you can sustain working in our post pandemic world and control the burnout.
    Session Leaders
    Speakers
  • 0845 - 1015
    Benefiting from Emerging Technologies
    This session provides insights from industry experts in meeting the extraordinary challenges of pharmaceutical production and development in the COVID age.  Hear about their experiences implementing new and emerging technologies and how these lessons learned can benefit future opportunities.
    Session Leaders
    Speakers
    Presentation Information
    [mRNA Technology. Beyond COVID-19 Vaccine]
    Speakers: Oliver Hening and David Estapé
    mRNA is not just the basis of new COVID-19 vaccines. mRNA is also a versatile technology for the development and manufacturing of new medicinal product candidates such as cancer. As cancer is also a global health threat, BioNTech aspires to develop individualized cancer treatments. The manufacturing process behind mRNA-based cancer vaccine candidates is equivalent to mRNA-based the company’s COVID-19 vaccine. The vaccine manufacturing approaches mainly differs in the required quantity, e.g. a few microgram of mRNA for the individualized vaccine candidates compared to hundreds of kilograms for a pandemic supply. The new technology allowed not only developing a new COVID-19 vaccine in a record time but also to quickly ramp-up the manufacturing facilities to supply billions of doses. The presentation will reveal key elements that make mRNA such a powerful technology and that define the facility set-up of tomorrow already today, for both: individualized medicines as well as for large volume medical products such as vaccines against infectious diseases.
  • 1015 - 1100
    Break - Exhibits and Poster Display
  • 1100 - 1230
    Modular Facility
    This session will explore novel ways to reduce project time lines and demonstrate how PODular manufacturing will increase facility flexibility to meet potential future changing business needs. The presentation is directly applicable to flexible manufacturing facilities and responsiveness of drug supply.  It will address key lead time challenges in traditional manufacturing and offer an option for manufacturing closer to the customer.
    Session Leaders
    Speakers

    Dennis Powers

    Vice President of Business Development & Design Consulting
    Sartorius-Stedim Corp
    Presentation Information
    [Genentech's New Clinical Supply Center: A manufacturing template for future commercial facilities]
    Speaker: Doug Deveny
    The presentation will explore many of the methodologies utilized and resulting design characteristics intended to achieve these goals over the lifecycle of the facility. A modular design approach, involving the creation and deployment of standard unit operation work cells, will be highlighted throughout the discussion, illustrating its impact on the facility configuration, construction techniques and project timelines, as well as the potential options and benefits expected to be realized on similar future next generation projects. In addition, progressive regulatory strategies, leveraging functionally-closed systems, have been integrated to reduce spatial segregations and area classifications, while minimizing the need for modifications to accommodate future process changes and technologies.
    || [Transportable Manufacturing]
    Speakers: Michael O'Brien and Dennis Powers
    Supply chain end-to-end lead times are typically long, triggering decision-making prior to the actual customer demand signals. Demand can be highly variable and unpredictable, while the industry is often challenged with drug shortages. As political, regulatory, and market demand requirements evolve, one’s ability to respond appropriately and in a timely fashion is therefore undermined. Today’s manufacturing platforms and associated analytics are smaller, lighter, and significantly more modular versus their predecessors, enabling much smaller factory footprints, allowing for the realization of a transportable manufacturing platform and facilities concept. These flexible, transportable units can address variable demand through scale out (running the continuous process longer, or replication of the unit), and may be installed more quickly than traditional manufacturing site expansion. Consequently, when business needs change down the road, the manufacturing unit can be moved to another location. The potential financial, technical, and regulatory obstacles for the movability of a manufacturing environment will be addressed. Case studies will be presented that illustrate the benefits of mobility and the opportunities and challenges of operating a mobile facility.
  • 1100 - 1230
    Emerging Technologies II
    The second of the Emerging Technology sessions focuses on concepts promoting rapidly advancing manufacturing technologies enabling improvement in quality and process robustness, supply chain agility, and reduced costs. The session will address emerging practices for applying and taking advantage of the rapidly accumulating data, and illustrate examples of beneficial uses of that data.  Digitization is a key to enabling our industry to capitalize on many of the emerging technologies as they become available.   While these few examples are the “tip of the iceberg” of potential operational enhancements, hopefully they will ultimately lead to improved patient outcomes by mining and applying the right useful data.  Examples are great ways to help us better understand and recognize what further improvements might be most impactful and what data is pertinent to enabling those advances to be realized.
    Session Leaders
    Speakers
    Presentation Information
    [Enabling Accelerated Development through a Digital Design Appproach]
    Speaker: Jon-Paul Sherlock
    Whilst Pharmaceutical companies have long been data rich, the means to translate these data to knowledge, understanding, predictive intelligence, and subsequently value, has been lacking. Digital design of pharmaceutical manufacturing processes will be critical as it will not only enable faster process development, but also create foundations that will extend into commercial operations. AstraZeneca recognises the value of integrating a Smart Factory vision with Innovative Manufacturing Platforms and an integrated digital and data strategy. Examples of early application will be shared including the use of AI to automate and accelerate experimentation and the development of digital twins to support continuous process development.
    || []
    Speaker: Arlene Joyner
  • 1230 - 1315
    Lunch - Exhibits and Poster Display
  • 1315 - 1445
    Reducing the Cost of Vaccine Delivery
    This Session will look at new technological advancements and innovations to accelerate the development and commercialization of vaccines to address the threat of future epidemics. Speakers from the Bill & Melinda Gates Foundation and Apiject will provide an overview of how each working to provide low cost, high reliability vaccine manufacturing.
    Session Leaders
    Speakers

    Rachel Lee

    Program Manager, Vaccine Development & Surveillance
    Bill & Melinda Gates Foundation
    Presentation Information
    [Innovative Delivery Approaches Reducing the Cost of Goods]
    Speaker: Rachel Lee
  • 1500 - 1640
    Solving World Problems through Modernization and Lifesaving Drugs
    The world has experienced a dramatic year and the pharmaceutical industry and regulators have been at the forefront of improving the lives of people impacted by the pandemic. The response to the pandemic by the industry and its regulators has been tremendous. Helping solve the world’s problems together has changed the role of the industry and has driven value for the world. In our closing plenary session, we will hear from Joydeep Ganguly, SVP of Gilead, regarding how 2020 redefined the role and the value drivers of their efforts. We will also have Rick Friedman, Deputy Director, Science & Regulatory Policy, Office of Manufacturing Quality, CDER/FDA speak about the advantages of modern manufacturing. The session will conclude with a panel discussion including industry and regulatory leaders.
    Session Leaders
    Speakers

    Joydeep Ganguly

    Senior Vice President, Corporate Operations
    Gilead Sciences Inc

    Rick Friedman

    Deputy Director, Office of Manufacturing Quality
    CDER/FDA
    Presentation Information
    [Value Creation, Operational Agility, and Social Impact - How 2020 redefined our role and value drivers]
    Speaker: Joydeep Ganguly
    || [Advantages of Modern Manufacturing for Patients, Industry and Regulators]
    Speaker: Rick Friedman

    Panelists:
    Joydeep Ganguly
    Rick Friedman
    Oliver Hennig
    Regulatory Representative, invited
    Additional panelists: TBD
  • 1640 - 1645
    Closing Remarks & Adjourn
    Speakers
    Presentation Information
    [Closing Remarks]
    Speaker: Michael Martin