Agenda

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Technical PresentationLive-streamed education sessions.

Before the Event - Day 4
28 October - 29 October 2022
Before the Event - Day 3
29 October - 30 October 2022
  • 0800 - 1300
    2022 ISPE International Emerging Leaders & Student Hackathon
    2022 International Emerging Leader & Student Hackathon The ISPE International Hackathons are events organized by, and for the ISPE Emerging Leaders and Students. The main objective of the Hackathon is to divulge knowledge, in an innovative situation, on the trending topics of the pharmaceutical sector, and to provide and promote networking opportunities between Emerging Leaders, Students, and Senior Industry Experts. The International ISPE Annual Meeting Hackathon will be held the weekend before the ISPE Annual Meeting & Expo in Orlando, FL, USA at the Gaylord Palms Resort & Convention Center. The Emerging Leaders and Students will be divided into multidisciplinary teams. Each team will be tasked with analyzing the problem statement, developing a project charter, and assessing the financial implications of their proposed solutions, with the ultimate goal of pitching to a panel of expert judges at the culmination of the Hackathon. All teams will be assigned a dedicated coach and given access to resources including Pharmaceutical Engineering Magazine and the ISPE Communities of Practice. At the end of the two days, each team will present to a group of judges and industry leaders. The judges will evaluate the presentations, provide feedback to the teams, and identify the best solution. The winners will be announced during the Membership Meeting and Awards Lunch. Registration is ONLY for Emerging Leaders, Students, and Recent Graduates.
Day 1
Sunday, 30 October 2022
  • 0700 - 1800
    Registration Open
  • 0800 - 1200
    Workshop: CSA - The Next Steps for Better Compliance
    In this workshop attendees will brainstorm efficiencies and improvements that can be gained through the application of CSA and critical thinking within computerized system lifecycles.  

    In an industry first collaboration between Society of Quality Assurance Computer Validation & Information technology Compliance Specialty Section (SQA CVIC-SS) and ISPE GAMP, this workshop builds upon the SQA’s Quality College on 22-23 September 2022 in Raleigh, NC.  The outputs and ideas of the Quality College will provide the foundation for the attendees of the ISPE GAMP workshop to explore the CSA concepts and benefits in more practical detail.  

    The workshop activities will examine:
    • What improvements can CSA and critical thinking bring to computerized system lifecycles and what fundamentals will remain unchanged? 
    • How critical thinking can become inherent organizationally?
    • How to engage leadership, including the quality function, with CSA concepts?
    • What metrics and knowledge management practices can quantify and optimize the benefits of CSA in achieving and maintaining computerized systems as fit for intended use? 
    • How supplier assessments and internal auditing practices need to evolve to maximize leveraging of prior activities? 
    • What are the barriers to progress and how can they be overcome?

    This workshop will contribute to industry understanding of critical thinking and CSA.
    Session Leaders
    Speakers
  • 0900 - 1200
    Workshop: Process Validation - Emerging Challenges and Hot Topics
    This workshop session will address selected hot topics within focused workgroups giving attendees the opportunity to participate in facilitated small group discussions. This format will allow attendees to share experiences or challenges and discuss tools and learnings with colleagues outside of their organization, but with similar interest/experience, bringing a wider understanding of these issues.  

    Topics/Issues/Challenges for discussion will include PV for products under accelerated development/breakthrough designation; PV for continuous manufacturing; PV applied to emerging/new technology and product platforms; as well as discussions of PV in regions other than US/EU.  Drawing from the ISPE PV team, volunteer SMEs will lead the groups and facilitate sharing experiences and thoughts, providing an environment to discuss ideas and strategies to address particular challenges based on experience and knowledge.
    Session Leaders
    Speakers
  • 1300 - 1600
    Workshop: Aseptic Compliance Health Check
    In this hands-on workshop, attendees will be provided an example tool to use while the instructors lead them through analyzing examples of aseptic processes and facilities to demonstrate the use of the tool.

    The examples are generally drawn from real-life experiences and are chosen to highlight three areas:
    1. Do legacy processes meet cGMP requirements – for example, are you performing sterile filtration at the filling line?
    2. Upcoming Annex 1 Requirements – For example, smoke visualization is becoming increasingly used not just for airflow dynamics for clearance rates, etc. but as an integral tool for defining best practices when looking at environmental controls and operator activities. Determine the locations for EM monitoring program (item 4.16 in draft annex 1) and using smoke visualizations as an interactive tool in an aseptic operators training armory (item 7.19 in draft annex 1).
    3. Hot Topics and Recent Inspection Trends – What recently has come up in the latest inspections?
    Session Leaders
    Speakers

    Ian Kevin Owen

    Global Aseptic Fill Finish Subject Matter Expert
    Exyte Central Europe GmbH
  • 1300 - 1600
    Workshop: Career Connections - Developing Your Personal Brand
    Presented by Women in Pharma® 
    Do you have a personal brand? Is it on purpose? Whether you like it or not, hiring managers and HR professionals are judging you based on what they find - and don’t find - from you online. Want it to stand out from your peers and your competition so you can get hired for the job of your dreams?  In the first half of this workshop, you will learn how to evolve as a leader-professional and develop your personal brand.  This immersive hands-on workshop is designed to elevate your personal LinkedIn Profile to take it to the next level.  Whether you are looking to build meaningful connections, expand your network, or stand out from the best, this workshop will show you tactics to level up your LinkedIn profile.

    In the second half of the workshop, you’ll discover how to create psychological safety allowing you to pursue your leadership potential, expand your confidence, and hone communication skills.  We will explore the key components of psychological safety to establish authenticity, allowing for inclusivity to drive a more powerful work experience.

    Phil Gerbyshak is a LinkedIn Sales Trainer, Sr. Sales Enablement Program Manager at BambooHR and talk show host of ‘The Sales and Leadership Show’ on sales, leadership and digital strategies.  He has been doing custom LinkedIn training since 2010.  Bring your electronic device to this hands-on workshop to level up your LinkedIn profile.  Phil will take you step by step to help your profile stand out. You will learn tactics to leverage your LinkedIn profile to build connections and grow your network, tips to grow your career, and sell yourself with your personal brand.

    Kara Kirby is a leadership consultant and CEO of Insights Leadership group and podcast host of Pop! On Leadership. She works with companies all over the world to guide their pursuit of being the best places to work. In this session, Kara will be onsite with us to guide our conversations and solve for elements in our organization that hold people back from stepping into their leadership potential. We will look at how to create psychological safety so that the best ideas rise and flourish, honing authenticity, leadership reluctance, and the power of creating a not just diverse but inclusive workforce.
    Session Leaders
  • 1900 - 2200
    Facility of the Year (FOYA) Dinner and Awards
    Join ISPE to celebrate the 2022 Facility of the Year Awards Celebratory Reception and Banquet where we will formally recognize and celebrate the 2022 Category winners' achievements at ISPE’s premier award presentation ceremony and dinner.
Day 2
Monday, 31 October 2022
  • 0600 - 0730
    13th Annual ISPE 5K Charity Run/Walk
    Start your day with the 13th Annual ISPE 5K Run/Walk. Join in the competition or enjoy a morning walk watching the sunrise in Orlando, FL. This year’s 5K event will benefit the ISPE Foundation supporting education, training, and research for the advancement of innovative technologies benefiting patients around the world.  Includes T-Shirt and race bib.
  • 0700 - 1800
    Registration Open
  • 0730 - 0845
    Breakfast
  • 0830 - 0845
    Welcome and Opening Remarks
    Speakers

    Jörg Zimmermann

    Vice President, Vetter Development Service, External Affairs
    Vetter Pharma-Fertigung GmbH & Co.
  • 0845 - 1015
    Opening Keynote
    Session Leaders
    Speakers
    Presentation Information
    [Future-proofing a Global TechOps Organization: The transformation of Global Manufacturing & Supply at Takeda]
    Speaker: Thomas Wozniewski, Ph.D.
    Spanning more than 30 manufacturing sites across the globe, the manufacturing network of Takeda is not only geographically complex but also from a technology perspective: It comprises manufacturing sites for small molecules, biologics, plasma-derived therapies, cell & gene therapies and vaccines. This diverse network is undergoing a constant transformation, following not only the general pharmaceutical industry trend towards a higher degree of digitalization and automation but also to be ready for Takeda's modality agnostic pipeline. At the same time, the manufacturing network needs to address rising expectations towards the reduction of environmental impact and demographic challenges. Thomas Wozniewski, Global Manufacturing & Supply Officer and member of the Takeda Executive Team, explains how the global TechOps organization is managing this complex transformation.
    || [A Cancer Veteran’s Remarkable Journey]
    Speaker: Robert Weker
    Every patient is unique. Every cancer journey is unique. As a three-time cancer ‘sur-thrivor,’ Rob and his family have faced the many challenges of this disease. Rob provides his insights on his journey(s) - including participation in a clinical trial? Finding the best medical team? Work and financial implications? – and his ongoing efforts to amplify the patient voice to enable patients to make informed decisions throughout.
  • 1000 - 1900
    Expo Hall Open
  • 1015 - 1100
    Break in Expo Hall
  • 1100 - 1230
    Concurrent Session: Pharma 4.0 - Industry Status & Methodologies
    Digitalization opens new horizons to achieve new levels of connectivity, transparency, agility and productivity through the application of faster and more accurate information to (automated) decision-making. The fundamentals of the digitalization process lie in in the structure underneath the data being created, used, reported, stored, and destroyed.  Currently, in the Pharma 3.0 environment the approach for automation is in a process-centric environment. However, moving to pharma 4.0, a different approach in which the data life cycle is centralized, will lead to a data-centric approach. Each data life cycle needs to be completed and aligned to be considered a data set. In current production processes different data sets are created for each process. Visualizing the data sets amongst different process steps will automatically trigger missing data, misaligned data or duplicate data. Moving to Pharma 4.0, each data set will need to be assessable at any time in any business layer. Therefore, a system needs to be in place to show the data architecture and how it interacts with various processes. This session will discuss the status and examples of practical methodologies to transition to a digitalized Phara 4.0 Operating Model-based organization.
    Session Leaders
    Speakers
  • 1100 - 1230
    Concurrent Session: Recent Developments in Advanced Manufacturing
    Today’s manufacturing platforms and associated analytics are smaller, lighter, and significantly more modular versus their predecessors. These technological advances are enabling much smaller factory footprints, allowing a transportable manufacturing platform and facilities paradigm to gain considerable traction as a viable alternative to more traditional equipment train and facilities constructs. Flexible, transportable units have the potential to address variable demand through scale-out, take advantage of off-site fabrication principles, and may be installed more quickly than for traditional construction practices. Consequently, when business needs change, as they so often do, manufacturing units can be relocated.   The potential financial, technical, quality, and regulatory challenges vs. opportunities associated with the movability of the manufacturing environment will be addressed and case studies will be presented to illustrate the challenges vs. benefits of mobility and operating a mobile facility. Presentations will provide perspectives on advanced biopharmaceutical manufacturing trends drawn from the work of ISPE's Product Quality Lifecycle Implementation (PQLI)® team and subteam, ISPE PQLI Transportable/Point of Care Manufacturing Technology team.
    Session Leaders
  • 1100 - 1230
    Concurrent Session: Building a Quality Organization
    While pharmaceutical GMPs and their associated guidelines recommend a quality unit that is independent of the manufacturing unit, they give little or no information on its organizational construct. This session will explore how to build a pharmaceutical quality system to meet ICH Q10 expectations to “assure the desired product quality is routinely met, suitable process performance is achieved, the set of controls are appropriate, improvement opportunities are identified and evaluated, and the body of knowledge is continually expanded.” Additionally, the speakers will address how to build an organization with a sustainable quality culture and meet all necessary compliance requirements internationally. Senior leaders from a start-up company (Phlow), a spin-off company (Organon), and a rapidly growing company (Moderna) will discuss how to balance addressing compliance needs and planning for expanding roles, commensurate with evolving company capabilities and capacity.
    Session Leaders
    Speakers

    Wayne Motsek

    Manager, Validation/Technical Svcs
    Barr Laboratories Inc
  • 1100 - 1230
    Concurrent Session: GPG Good Engineering Practices at Operation Warp Speed
    The COVID pandemic, and more specifically, Operation Warp Speed driven projects, rocked the global supply chain and taught the industry that the paradigm of typical project durations could be shattered.  The success of a number of these projects has driven the industry to expect an unprecedented level of speed on future projects.  Good Engineering Practices are critical to the delivery of compliant biopharmaceutical projects; however, their application is absolutely crucial as design, procurement and verification activities are conducted throughout fast-tracked projects. This session will describe the concepts of the guide, the principles and drivers behind its revision, and the practical application of the guide for customers’ use. In addition, speakers will provide a case study of a BARDA funded Operation Warp Speed BSL-2 Aseptic / Isolated Formulation and Filling Facility with a project duration of 11 months from concept to aseptic process simulation readiness, which completely challenged the paradigm and basic understanding of how fast a project would be delivered from concept through CQV.
    Session Leaders
    Speakers

    Paul F. Valerio

    Director of Process Technology / Senior Associate
    IPS - Integrated Project Services, LLC
  • 1100 - 1230
    Concurrent Session: Patient Centric Specifications
    Session Leaders
    Speakers

    Simon Linke

    Associate Director - Pharmaceutical Development
    AstraZeneca
    Presentation Information
    [Applications of Patient Centric Specifications]
    Speakers: Simon Linke
    Ann Subashi
    Regulatory Speaker is TBA
    The development of patient centric specifications builds on existing industry guidance and utilizes the science and knowledge generated through the development and life-cycle of a pharmaceutical product. By taking this understanding and applying it to establish specifications that focus on the patient, rather than simply the batch data available at time of clinical/marketing application, significant benefits can be gained for both regulatory agencies and industry.

    In this session, industry experts will cover the application of patient centric specifications for a range of critical quality attributes; from chemical impurities to dissolution profiles. The session will include case studies from across industry and include discussion on both small molecule and the latest considerations for biologicals.

    It will highlight the challenges the industry is faced with by a discordant regulatory environment, across both a clinical and commercial space and the benefits from adopting patient centric specifications will be discussed. The hope being that wider adoption of these principles could form the cornerstone to achieving global regulatory harmonization, reducing the complexity of managing a product through its life-cycle, reducing environmental impact from our pharmaceutical processes, improving supply chain robustness and potentially minimizing drug shortage and disruption of supply of medicines to patients.
    || [Patient Centricity as Part of a Drug Development Program]
    Speaker: Bikash Chatterjee
    A patient centric strategy goes beyond simply engaging with patients as clinical subjects or partnering with patient advocacy organizations. Patient centricity cannot be outsourced. Patient centricity as it relates to pharma/biotech means stepping out of the status quo to gather and analyze patient data in a way that is transparent to the patient and can be integrated into the drug development process and thinking. This presentation will describe an approach to drug development which integrates patient centric considerations at the drug development level as well as where patient centric and health equity considerations can be integrated as part of a clinical trial strategy that will actually shrink the recruitment time for clinical studies.
  • 1230 - 1345
    Lunch in Expo Hall
  • 1345 - 1515
    Concurrent Session: **NEW** GAMP 5 Second Edition - An Overview
    The "GAMP 5 Guide – A Risk-Based Approach to Compliant GxP Computerized Systems" was published in 2008 and is widely recognized as the leading practical guidance for the implementation, management and operation of computerized GxP systems.  Since the original publication date, technology has advanced and even though the principles and framework are as applicable today as they ever have been, the elapse of time since publication may give the impression that the content may not be current. This session will describe how, while maintaining the principles and framework of the First Edition, the publication of the GAMP 5 Second Edition updates their application in the modern world. It highlights the use of Critical Thinking by knowledgeable and experienced SMEs to define appropriate approaches. Presentations delivered in this session will provide a foundation for the "New GAMP 5 2nd Edition roundtable" session to follow which will allow for a deeper dive into the revisions applied to the Second Edition.
    Session Leaders
    Speakers
  • 1345 - 1515
    Concurrent Session: Increasing Assurance in H2O2 Cycle Efficacy with EIs
    Aseptic manufacturing processes are inherently lengthy and time consuming due to the many process steps that are required, not only for the manufacturing processes themselves, but also the preparation of facilities, consumables and equipment for use. Manufacturing process that utilize Hydrogen Peroxide (H2O2) for decontamination have traditionally relied on initial validation and periodic revalidation to check the efficacy of the process with biological indicators (BIs). The BIs require incubation that determines a binary pass/fail result which effects the speed at which the process can be deemed as fit for use but also potentially, as a result of a BI failure, lead to investigations into product quality of any batches manufactured between qualification. Enzyme Indicators (EIs) are an innovative rapid tool for providing instant and quantitative feedback, of H202 efficacy by providing real time quantifiable data when applied to cycle optimization, qualification, continuous process monitoring and trouble-shooting.

    This session will provide an overview of the technology and showcase case studies from various pharmaceutical companies and their collective suggestions on applications and future usage of EIs. Presentations will demonstrate the EIs ability to aid, clarify and provide additional confidence of H202 cycle. This, in turn ensures that these critical processes are optimized to sustain the industry demands of aseptic manufacturing continuity.
    Session Leaders
    Speakers

    Terrence Hollis

    Senior Manager - Sterile Injectables Process Engineering - Global Technology
    Pfizer
  • 1345 - 1515
    Concurrent Session: Quality and Regulatory Challenges in ATMPs
    This session aims to provide a diverse set of perspectives on quality/regulatory topics as it pertains to late stage/commercial ATMPs (primarily autologous cell therapy).  The goal is to bring industry and regulators together to discuss shared challenges and highlight learning opportunities for both as this field evolves.  In particular, the presenters will provide a good view of what areas of opportunity exist  - focus areas on capacity expansions/needs, aseptic processing challenges, raw material challenges, and inspection aspects are examples of the topics that would be mutually beneficial as well as of great interest to attendees. While technical challenges are at the forefront of this complex manufacturing environment, the regulatory and quality considerations associated with these need to be factored in so that health authority expectations can continue to be met.  Further industry-regulator collaboration will aid in this effort.
    Session Leaders
    Speakers
  • 1345 - 1515
    Concurrent Session: Drug Shortages - Progress in a Challenging Year
    As we enter a transitional period within the pandemic, some uncertainties remain. The need to continually improve supply chain resiliency remains certain, as demonstrated by the challenges with Single Use Systems. Health Authorities (HA) globally demonstrate continued interest in adopting measures targeted towards drug shortage prevention activities, particularly in regard to risk assessment and business continuity planning. In parallel over this past year, the ISPE Drug Shortages Initiative has modernized the drug shortages prevention plan and prepared an example of how to apply risk management concepts to drug availability. Experts from the front line will present their experiences and learnings.
    Session Leaders

    Jessica Lee Hale

    Associate Director, Devices & Digital Health, US-Global Product Strategy
    Organon LLC
    Speakers

    Dharti Pancholi

    Executive Vice President and Managing Director
    PharmEng Technology
  • 1345 - 1515
    Concurrent Session: Combination Products - Evolving State of the Art
    State of the art expectations and practices in the combination product space continue to evolve across jurisdictions around the world.  Shifts in regulatory frameworks, guidance, control strategies and technical product solutions are making substantive impacts on the delivery of new medicinal therapies. Efforts to drive convergence are in their infancy. This session will discuss a range of key shifts in state-of-the-art expectations, practices and technology solutions, including the QSR Amendment proposed rule, the Genus v. FDA court decision, Essential Performance Requirements, Combination Products Human Factors and Risk Management, EU MDR, and Harmonization Efforts underway.  Case studies will be presented, reflecting the impacts of these evolving expectations on combination products.
    Session Leaders
  • 1515 - 1530
    Break
  • 1530 - 1700
    Concurrent Session: **NEW** GAMP 5 Second Edition Roundtable
    In this session, the panelists will provide brief presentations on key topic areas of the GAMP 5 revision, including Critical Thinking; Applicability of iterative and incremental software development methods; IT infrastructure; Blockchain; Artificial intelligence and machine learning; and Computer Software Assurance.  In addition, attendees will have the opportunity to engage in direct discussion with the primary authors of the material covering these topics.
    Session Leaders
  • 1530 - 1700
    Concurrent Session: Legacy Facilities: How to get the most bang for your buck
    There are countless aging pharma manufacturing facilities that continue to operate on the edge of regulatory failure. They limp along for years, squeezing though audits based on data reviews and procedural controls. While the need to upgrade these facilities may be clear to those that operate them, teams often find it difficult to receive the capital approval to bring the facility up to today’s regulatory standards. If you are responsible for, or work in such a facility, and are looking for some tools and guidance to make facility or equipment improvements, this session is for you. This is the next installation of the “Is Your Facility on Borrowed Time” series brought to you by the ISPE Sterile Products Processing Community of Practice. In this interactive session, you will learn how to assess options for upgrading a legacy sterile manufacturing facility (e.g., transfer to alternative asset, retrofit in place, build adjacent, build greenfield), and determine how to get the most “Bang for your buck” given fixed capital allocation. We will discuss decision points and implications of each option, and will include an evaluation of the options against a business case framework to make a robust recommendation to leadership.
    Session Leaders
    Speakers
  • 1530 - 1700
    Concurrent Session: Robust APQ and FDA Quality Management Maturity
    FDA introduced interest in quality management system maturity and a rating system of maturity of manufacturing facilities in their 2019 Drug Shortages report. In 2020, FDA initiated a limited pilot program, the purpose of which is to gain insight from third-party assessments of a manufacturer's quality management system to inform future development of an FDA rating system. This session will provide content on industry's approach toward assessing, aspiring, acting, and advancing quality system maturity, as well as FDA's latest thinking on assessing and rating quality system maturity and its quality metric feedback program. Through discussion and Q&A, attendees will have the opportunity to interact with FDA, industry, and academic experts on these topics.
    Session Leaders

    Tami J. Frederick

    Senior Director, Corporate Quality Systems & Cultural Excellence
    Perrigo
    Speakers
  • 1530 - 1700
    Concurrent Session: Supply Chain Optimization
    Session description coming soon.
    Session Leaders
    Speakers
    Placeholder Person Graphic

    Alan G. Kelly

    Head of Alofisel Manufacturing and Supply
    Takeda Pharmaceuticals Intern
    Presentation Information
    [2022 FOYA Winner: Takeda Pharmaceuticals International AG, Alofisel Global Program]
    Speaker: Alan Kelly
    Category: Supply Chain

    Takeda Pharmaceuticals International AG, founded in 1781, is a patient-driven, R&D-focused pharmaceutical company with headquarters in Tokyo, Japan. Its mission is to strive toward better health for people and a brighter future for the world through leading innovation in medicine.

    Alofisel is a first-in-class stem cell therapy product and the first allogeneic mesenchymal stem cell therapy to receive approval by the European Medicines Agency. The project was designed with a product shelf life of only 48 hours and requires seamless cold chain transportation. Takeda had to completely rethink the supply chain to get the product from the plant to the hospital to be administered to the patient within a very short time frame.

    The program is recognized in this year’s awards for its novel and innovative approach to end-to-end supply chain management as well as the program’s innovative design in expanding the Alofisel manufacturing network from its initial plant in Madrid, Spain, to other regions across the globe with new facilities in the US, Japan, and Ireland.

    The program’s implementation included the introduction of a bespoke world-class end-to-end supply chain introducing a made-to-order process under one IoT solution. This included the implementation of a cloud-based control tower function, the first of its kind at Takeda. It provides the interfaces to coordinate between clinic, manufacturing, and logistic providers who specialize in the cold chain transport of living organs for transplant surgeries. This dynamic approach enables hospitals to book a manufacturing slot via an SAP Leonardo web portal, which includes order status monitoring, on-time delivery tracking by GPS, and end-to-end coordination from “plant to patient”. This innovative supply chain ensures that the product is available to the patient in less than 48 hours from the manufacturing plant.

    With the planned launches, Takeda Global Manufacturing and Supply function undertook the challenge to expand the Alofisel manufacturing network to support the supply to other geographies. In doing so, the individual project teams were empowered to introduce innovative manufacturing designs to new facilities across the globe. Running these projects under one program enabled the rapid transfer of processes and technologies from site to site. The highest standards of facility design ensured a highly efficient and right-first-time manufacturing process. The introduction of rapid testing methods enabling the real-time batch release of the product to the patient further supported the seamless end-to-end supply chain.
  • 1530 - 1700
    Concurrent Session: 3 in 1 - Assets, Sustainability & Social Impact
    Session leader and description coming soon.
    Speakers

    Shannon Craft

    Delivery Systems (eCMMS), Sr. Manager
    Johnson & Johnson
    Presentation Information
    [2022 FOYA Winner: Catalent, Inc. Project Mercury ]
    Speaker: John Machulski
    Category: Social Impact

    Catalent is the leading global provider of development sciences and manufacturing platforms for medicines, including biotherapeutics, cell and gene therapies, and consumer health products. With almost 90 years of serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance, and ensuring reliable global clinical and commercial product supply. Catalent’s workforce exceeds 17,000 people, including more than 2,500 scientists and technicians, at more than 50 facilities on four continents, and in the fiscal year 2021, it generated $4 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey.

    Catalent’s Project Mercury was delivered in the face of the global pandemic. With an unknown manufacturing process for a vaccine candidate under development, the team pivoted on existing projects to ensure success, adding 40% more scope including secondary packaging and inspection. The project added 40,000 sq ft to cover the most stringent of the unknown needs of the process, reducing the risk to supply. The project team also cut six months off their schedule. The team beat the clock while managing the complexities of execution within the COVID-19 restricted environment and delivered the needed capacity to meet important pandemic demands.

    From March 2020 onwards, the constant threat of the COVID-19 virus hung over the entire project. Therefore, Catalent knew they needed to go beyond masks, hand sanitizer, and mobile hand washing stations to keep staff safe. As soon as COVID-19 made itself known as a threat, they brought in a consultant to advise them on infection control measures.
    || [Assets, Technology, and ME2 - Johnson & Johnson]
    Speaker: Shannon Craft
    Assets experience infancy. Assets experience adolescence. Assets experience mid-life (crisis). Assets experience maturity. And, in all cases, assets will experience end-of-life. At Johnson & Johnson (JNJ), assets experience the full lifecycle of performing in an FDA regulated environment under the watchful eye of Manufacturing Equipment Excellence (ME2). For 20+ years, the ME2 program at J&J has driven excellence into everything related to manufacturing assets, including advanced technologies. Today, the technological elements of Asset Performance Management (APM) are ever present in JNJ's ongoing ME2 efforts to continuously improve and re-invent what's considered "good". Tried and true processes including Reliability Centered Maintenance (RCM), Total Productive Maintenance (TPM) are put to the test, year in and year out, plus technologies like Asset Lifecycle Information Management (ALIM) and Enterprise Asset Management (EAM) continue to converge and analyze asset data in more meaningful ways. Today, ME2 is considered the global milestone of manufacturing asset management within the life sciences.
    || [Sustainability in a Biomanufacturing Facility]
    Speaker: Jim Fisher
    Amgen’s biomanufacturing facility located in New Albany, Ohio, will be a state-of-the-art facility having the latest available in digital and robotic technology. The site will focus on the three pillars of sustainability: innovation, efficiency, and renewable energy with a focus on our planet, our people, and our purpose. This presentation will address how Amgen is working to meet sustainability goals through emerging technologies and practices. Lessons learned and real-life examples will be shared throughout the presentation as the Amgen team works through the process of building the facility with their company goals in sustainability at the forefront of their focus.
  • 1700 - 1845
    Welcome Reception in Expo Hall
  • 1900 - 2100
    ISPE Women in Pharma Networking Event
    Join us for an evening of networking, food, and fun at one of the Gaylord Palms most popular restaurant!  Sponsored by ISPE’s Women in Pharma.
Day 3
Tuesday, 1 November 2022
  • 0700 - 0800
    Morning Yoga
    Start your day on the beautiful greens of the Gaylord Palms with the Florida sunshine!   Take the stress away with low-impact yoga while connecting with new and old friends.  You’ll feel refreshed and ready to start your day. Registration is included for In-Person All Access Attendees. Sponsored by Women in Pharma
  • 0700 - 1800
    Registration Open
  • 0730 - 0845
    Breakfast
  • 0830 - 1000
    Keynote Session
    Session Leaders
  • 1000 - 1045
    Break in Expo Hall
  • 1000 - 1600
    Expo Hall Open
  • 1045 - 1215
    Concurrent Session: New Paradigm for Analytical Methods - ICH Q2(R2) & Q14
    In the first quarter of 2022 drafts of ICH Q2(R2) and Q14 were released for public comment. This is the first time there have been significant changes to the guidance for analytical methods since the release of Q2 in the 1990's. Stop and think for a moment how much change there has been in the past several decades. The speed of development has increased, the diversity of therapeutic products has changed, and the technology employed (including use of multivariate methods) to test these materials has continued to evolve. This session will bring together the opinions of thought leaders in this area (EWG industry, EWG regulatory, and the practitioner) to share their perspectives and lead a discussion on the new operating system that is possible given the new draft ICH guidelines. Presentations will be followed by a roundtable/panel discussion to address questions and obtain feedback on the guidance documents (including implementation and case studies) and/or solicit input on any available feedback from the EWG.
    Session Leaders
    Speakers
  • 1045 - 1215
    Concurrent Session: Moving from Pharma 3.0 to 4.0 and Harnessing the Power of the Pharma 4.0 Vision
    Speakers
    Presentation Information
    [How Data-centric mapping leads towards Pharma 4.0]
    Speakers: Emmie Heeren and Arend Jan Wassink
    One of the principal tenets of Pharma 4.0 states that “Digitalization will open new horizons to achieve new levels of connectivity, transparency, agility and productivity through the application of faster and more accurate information for decision-making.”

    The main question is: how to start the transition from Pharma 3.0 towards Pharma 4.0?

    We start with well know process mapping, which is called process-centered process mapping, followed by the concept of data-oriented process mapping, which will lead to full understanding of your data flow, ready for the digital world. The data-oriented process maps, are placed in the RAMI architecture, specifically designed for the industry 4.0 environment, resulting in an analysis of the current situation. The analysis provides input for the working plan describing how to reach the desired data integrated level, needed for the transformation towards Pharma 4.0.

    The presentation provides insights into process maps and data flows in the pharmaceutical industry with a focus on data integrity issues using the context of the RAMI model. Using ICH Q10 as a reference, it underlines the fundamentals to the main objectives of the guideline; product realization, establish, and maintain a state of control and risk management, and continual improvement.
    || [Quality 4.0- Revolutionizing the Role of Quality]
    Speaker: Scott Deckebach
    The pharmaceutical industry, like all industries, is being swept inextricably forward on the digital tidal wave - where the flood of data will continue to transform and underpin the future of the industry. Successful companies will be the masters of these seas – where technologies to collect large volumes of data and automate practically every segment of the pharmaceutical value chain are now mature and quickly becoming common. And where newer data analytics and artificial intelligence technologies are quickly becoming realistic tools to revolutionize how the industry distills new value out of the rising sea of available data. Data integrity, like clean water, will be paramount to survive. Quality organizations will need to make strategic shifts in process and approach and skills and mindset, and redefine how data is used to sustainably and efficiently achieve the quality mission. New paradigms will be required to sustainably achieve data integrity, demonstrate compliance and assure product quality.
    || [Accelerating Quality 4.0 through Connected Life Sciences]
    Speaker: Oxana Pickeral, Ph.D, MBA
    With ever-increasing process complexity and demand for personalized therapies, how can companies deliver products faster while keeping patient safety a top priority? Harnessing the power of quality data at every stage of the pharmaceutical product lifecycle is crucial to accelerating product release. Leading pharmaceutical companies are creating a digital ecosystem and aggressively adopting 4.0 technologies like Cloud, AI, machine learning and automation to gain the speed and scale they need to compete in today’s environment. This presentation will support this topic by addressing how digital transformation breaks down data silos, securely connecting remote teams and suppliers with the quality intelligence needed for rapid decisions.
  • 1045 - 1215
    Session title description coming soon.
    Session Leaders
    Speakers
    Presentation Information
    [Decarbonization in the Pharmaceutical Industry]
    Speaker: Lindsay Smart
    The pharmaceutical industry is subject to numerous standards, laws and guidelines. Process plants and other operational infrastructure form a functional whole. An understanding of these parameters is necessary in order to develop, and implement, an overarching, tailored decarbonization concept. For the pharmaceutical industry, production is the essential core element. Therefore, following a process-focused project management approach, in which the production process is at the center of consideration, allows a company to scrutinize existing standards and define potentials for energy optimization. There are numerous possibilities to achieve the goal of optimizing energy consumption of bioprocessing plants and such control models can often be created with little physical effort. The decisive factor is that the corresponding requirements are already defined in the preliminary planning of a project. Finding a strategic and structured approach to energy optimization and decarbonization is a major challenge for companies - it needs to be ambitious, but, at the same time, realistic. The goal is to align an external perspective with an internal perspective of the company. The result is a structured cost-benefit analysis showing how much CO2 is saved by each measure and the incumbent costs. This provides a clear picture of which reduction potentials are possible.
    || [Machine Learning to Sustainable Production: A Case Study]
    Speaker: Michele Schio
    The presentation describes a case-study showing machine-learning capabilities in reducing environmental impacts and costs, with a very limited investment in instrumentation and software.VTU Engineering has designed the expansion of a cooling towers system for an API plant in Northern Italy (~1200 MWh/year, OPEX>100 000 €/year): targets are to maintain the T-range of the cooling water, reduce pressure fluctuations in the distribution network. Six 6 induced draft cooling towers, two pumps (without VSD), and little instrumentation resulted in a plant with little controllability, available 24/7, not energy efficient.The proposed (and simulated) solution installs a weather station, few temperature and pressure sensors, and will equip the motors with VSD to manage the power absorption. The whole system will be connected to an AI unit which follows the L.I.C.O. approach:Learn: the AI unit monitors the system.Integrate: the algorithm is tested against different scenarios (off-line), identifies variables correlation, defines control strategies (data-analysis, machine training).Control: AI unit is put on-line as a surrogate model for the plant and is used in an optimal control scheme with a tailored objective function (energy saving). New set-points are proposed to the DCSOptimize: the control strategy is continuously improved.
    || [2022 FOYA Winner: Janssen Biologics B.V., VLF Expansion]
    Speaker: James Shovlin
    Category: Social Impact

    Janssen Biologics BV in Leiden, the Netherlands, is a J&J biopharmaceutical production and laboratory testing facility that produces clinical and commercial bulk active pharmaceutical ingredients and provides analytical testing services for J&J’s global portfolio of vaccines.

    The site also houses J&J’s Vaccine Launch Facility (VLF), an innovative manufacturing facility that supports large-scale production of vaccines for late-stage clinical trials as well as the launch of new vaccines on a large scale for global public use.

    The existing VLF represented an opportunity to enable large-scale COVID-19 vaccine drug substance manufacturing by building a new, 25,000-square-foot sterile manufacturing facility adjacent to the existing VLF.

    The Johnson and Johnson vaccine was critical to resolving an unmet medical need during the COVID-19 pandemic by providing the world with a single shot COVID-19 vaccine available on a not-for-profit basis for emergency pandemic use. To provide the world with single-shot COVID vaccines, the J&J production capacity needed to be increased. The constrained timeline for the construction of the VLF expansion was one of the requisites for J&J to meet its COVID-19 vaccine supply commitment. An integrated and collaborative project execution approach involving various internal and external stakeholders was required to meet these challenging deadlines.

    Janssen was granted regulatory approval (Emergency Use Authorization) of the drug substance batch 12 months after the first pile for the new downstream processing facility. The project team invested the equivalent of 300-man years in realizing the facility and rapidly hired and onboarded more than 250 new employees at their Leiden facility.

    The construction activities were executed during an increased level of positive COVID cases in the Netherlands. J&J kept the personal safety of all project team members as its top priority. J&J implemented various safety measures to reduce the risk of contractors being exposed to the COVID virus.
  • 1045 - 1215
    Concurrent Session: Navigating the Supply Chain for ATMPs
    The supply chain for cellular therapies has a unique aspect of starting with a patient undergoing a procedure and ending with another procedure. This session will provide case studies and best practices around the demarcation of clinical practice with GMP for cellular therapies, orchestration of patient procedures, defining chain of identify information, and clarifying the differences between chain of identity and lot genealogy. These are major issues that are unique to the cellular ATMP supply chain. Our presentations will address these aspects by providing both a basis level of understanding of the topics and best practices. These points will be supported with real life experiences. By presenting the why (basis understanding), the how (best practices), and the what (experiences), we aim to provide attendee with the tools to navigate these unique aspects of the supply chain for ATMPs.
    Session Leaders
    Speakers
  • 1045 - 1215
    Concurrent Session: Coping with Data Integrity & Digitalization in Supply
    Session leader and description coming soon.
    Speakers

    Danilo Neri, Ph.D.

    Executive Vice President & Partner, CSV/CSA & Data Integrity Advisor
    PQE Group

    Dave Leitham

    SVP, Pharma General Manager
    Aspen Technology, Inc.
    Presentation Information
    [Data Integrity Surveillance Program for GxP Suppliers]
    Speaker: Danilo Neri, Ph.D.
    Worldwide Regulatory Authorities have become more and more focused on Data Integrity as the Regulated Companies are required to strictly ensure the reliability of records, which are ultimately determined by the Computerized Systems managing these records and determined to have a potential impact on Patient Safety and Product Quality. This regulatory expectation is required to be met in the globalized industry, which has increased the complexity of the supply chain network for all the business spaces, including the pharmaceutical products which result in higher efforts and costs from regulated companies are required to ensure integrity of data (and ultimately the quality of products and safety of patients), provided or enabled by the different GxP supplier across the whole supply chain.
    The presentation will show a business case with a practical model that allows establishing a cost-effective Data Integrity Surveillance process, keeping in mind the reshoring effect cause by the pandemic phenomena since 2020.
    || [Using Digitalization to Speed Time to Market]
    Speaker: Dave Leitham
    Co-Speaker: Andrew Jenkins
    Supple chain disruptions remain a challenge across industries, while at the same time, speed to market and greater accessibility to quality medicines has become an even greater business imperative. Digital technologies are widely available for pharma manufacturing and are key to the industry overcoming these hurdles and progressing the Pharma 4.0 vision. The need for continuous improvement comes with the territory and reinforces the reality that digital transformation is never truly complete. By adopting a range of technologies that address what might seem like discrete challenges (unplanned downtime, cumbersome batch review, reactive instead of proactive planning and scheduling) a company can build its resiliency across the value chain network. The whole is then greater than the sum of its parts.
  • 1215 - 1345
    Lunch in Expo Hall
    If you do not plan to attend the Membership Meeting and Awards Lunch, please enjoy lunch provided in the Expo Hall.
  • 1215 - 1345
    Membership Meeting and Awards Lunch
    The Membership Meeting and Awards Lunch is open to all In-Person All Access Attendees.
  • 1345 - 1515
    Concurrent Session: Digital Transformation
    Session title and description coming soon.
    Session Leaders
    Speakers

    Susan Cleary

    Director of Product Development
    Novatek International
    Presentation Information
    [Advanced Data Analytics in Biologics Manufacturing]
    Speaker: Yiming Peng, Ph.D.
    In recent years, many pharmaceutical companies have been piloting advanced data analytics techniques to discover insights on the manufacturing processes. In this talk we will discuss a commercial biologics product case study in which we have consolidated disparate data sources that were previously not accessible in aggregate, including raw material specifications, manufacturing equipment, manufacturing process information, etc. and applied advanced data analytics including statistical modeling and machine learning. The goal is to unearth and understand the key drivers of an intractable cell growth challenge, and be able to predict when the yield will be low during the manufacturing process. We will discuss the findings, share lessons learned, and continue building advanced data analytics capability to enable more efficient and reliable production of our critical medicines for the patients.
    || [Data Analysis and Trending for Aseptic Processing]
    Speaker: Susan Cleary
    This presentation will include a brief review of key regulations as they relate to the need to use the data collected for trending, process control, investigation and root cause analysis. The digitization is still in process, pharma industry due to the regulatory scrutiny are sometimes late adopters but the need to digitize is ever more important based on the evolution of the regulations encouraging trending and using data.

    The discussion will cover the key contamination control processes including pharmaceutical water, HVAC, and gas monitoring, as well as environmental and personnel monitoring, also touching on cleaning validation and cleaning process monitoring. The talk will relate to the different trending tools, when they should be used, and what they mean. Examples of trends will be included in the presentation.
    || [Maximize Your Data with Innovative Modelling]
    Speaker: Tara Scherder
    As we gather more information from our processes, we need mathematical models that provide flexibility and accuracy for complex systems. Classical statistical modelling and prediction often fall short in these situations. Bayesian statistical methods, however, are fundamentally flexible and can address these shortcomings. They can be leveraged to improve outcomes from complex systems/relationships made possible with digital transformation.

    These advanced methods are not part of typical statistical training received by engineers and scientists. However, it is critical that engineers are aware of these options, so that the data they collect can be leveraged for maximum value. This presentation will cover common situations (e.g., hierarchical models, risk-based stability modelling, staged testing) where innovative modelling provides answers when classic approaches fail.
  • 1345 - 1515
    Session title and description coming soon.
    Session Leaders
    Speakers
    Placeholder Person Graphic

    Alan G. Kelly

    Head of Alofisel Manufacturing and Supply
    Takeda Pharmaceuticals Intern
    Presentation Information
    [Digitization of Workflows in Cleanrooms]
    Speaker: Jørgen Rübner
    Description coming soon!
    || [Development of Technology: Finance Tool for Reducing Manual Operations in Pharmaceutical Production]
    Speaker: Peter Luke
    Often, new technology implementation is driven by early adapters in a project/production team, with limited business case foundation or broad stakeholder sponsorship. As a result, the implementation outcome varies widely and traceability from early decisions to proven productivity gains are lacking. Recognizing this challenge, the project management team, responsible for delivering a 2.8 Billion USD API manufacturing facility, developed a decision-tool for linking manual operations to relevant technologies to reduce the combined manning requirements. The result has been a process that clearly links a business case to each technology candidate and established full traceability for the decision process. This paper will present the process developed, the stakeholder mapping process and the roadmap for ultimately securing success of the initiative.
    || [2022 FOYA Winner: Takeda Pharmaceuticals International AG, Project TaSiVa]
    Speaker: Alan Kelly
    Category: Pharma 4.0

    Takeda Pharmaceuticals International AG is a global, patient-centric, and science-driven biopharmaceutical company with headquarters in Tokyo, Japan. Its purpose is to strive toward better health for people and a brighter future for the world. We are guided by our values of Integrity, Fairness, Honesty, and Perseverance. Takeda operates over 30 manufacturing sites around the world.

    Vaccines represent one of Takeda’s core therapeutic areas. The TaSiVa facility is located in Singen, Germany. The innovative approach to the project, implementing pharma 4.0 technologies as part of the overall project delivery, also complemented the companywide digital transformation. It included several key collaborations with suppliers and academia to develop pharma 4.0 solutions.

    The facility was built with state-of-the-art process equipment and then layered with advanced digital technologies in several key areas. A complete IT infrastructure upgrade was completed at the site during the early phase of the project thus providing the platform to utilize advanced information technology (IT)/ operational technology (OT) solutions as part of the project delivery.

    Real-time performance tracking and management are achieved through the implementation of an embedded warehouse management system (eWM) coupled with the use of electronic batch records. Interfacing these systems enabled a “no-touch” transport concept to be implemented using autonomous mobile robots to transport materials to and from manufacturing and logistics. This also includes an automated Kardex storage and robot system for automated transport of small goods to operations. The electronic batch records (EBR) system is interfaced with other OT solutions in quality control LIMS and is used for environmental monitoring which is a paper-free process at the plant.

    Robotics are used in packaging alongside operators to increase safety and improve ergonomics at the syringe and vial loading stations on the lines. A single centralized palletizer is employed to simultaneously pack pallets from the facility’s 2 packaging lines.

    A solution to significantly reduce material waste was developed using an advanced algorithm based to optimize drug substance selection. An automated dosing solution ensures precision dosing of the drug substance during processing. In the lab, a highly manual process of counting immune-stained foci was converted to an automated system that was initially trained using thousands of pictures and is targeted for fully automated counting in routine operations.
    || [2022 FOYA Winner: CRISPR Therapeutics]
    Speaker: Brad Ebel
    Category: Innovation

    The CRISPR manufacturing facility was designed thoughtfully and innovatively, and the ability of the facility to catalyze the promise of the technology impressed the judges. The facility is unique in utilizing a compact design with multiple independent production suites, each capable of producing a different product at a different stage of development while maintaining strict product segregation. FOYA judges were particularly impressed with the use of a fully integrated digital stack that enables a small on-site warehouse to be continuously supplied from external sources yet still maintain uninterrupted production and testing operations.

    Digital tools were embedded into the facility design so that multiple production suites and multiple products at different stages of development can be managed simultaneously. CRISPR’s commitment to implement a fully digital control system, manifesting in a 6-layer digital landscape that not just monitors and/or controls shop floor and laboratory equipment, but makes the data available through a secure network to a variety of display devices throughout the facility. The system is fully redundant and provides traceability to the Quality Management System (QMS).

    While the facility design was grounded in fundamental good engineering practices, there was intentionality in the flexibility of the facility that the committee found very innovative. CRISPR Therapeutics has been a leader in applying CRISPR/Cas9 technology to drug development. More recently they have begun to manufacture cellular therapies at scale, to test their clinical utility. The manufacturing technology has been applied to autologous products as well as allogeneic products. Future success in this area is dependent on the flexibility of the facility as defined by the ability to produce different products within the same footprint to support clinical trial requirements.
  • 1345 - 1515
    Concurrent Session: ICH Q12 Implementation Progress and Future Opportunities
    ICH Q12 is a truly transformational guideline that has a wide scope of applicability across the pharmaceutical development lifecycle and can help streamline the post-approval change management process by promoting the adoption of flexible science- and risk-based approaches. While in some markets full ICH Q12 implementation is well underway, in other markets ICH Q12 adoption has been partial or lagging. Further, potential lack of global convergence and alignment on ICH Q12 implementation approaches creates a risk of divergent implementation strategies among health authorities, placing an additional burden on the applicants and making the overall process less efficient. This session will summarize progress made to date on the global implementation of ICH Q12 and reflect on the remaining challenges and future opportunities to accelerate its adoption across the different regions. Featuring both industry and regulatory presenters, the session will help foster the open industry-regulator dialogue on the path forward to the global ICH Q12 adoption and help draw attention to the remaining implementation challenges and roadblocks.
    Session Leaders
  • 1345 - 1515
    Blockchain applications in pharma and biopharma are becoming more mainstream; for the past 4 years we have held a blockchain session at the annual meeting where we seek to educate and inform our members about the most significant applications of the technology. In this session we will hear from three speakers, each covering a component of industry trends - pragmatic use case of how blockchain is improving operations; industry consortia and foundations, guidance on utilizing blockchain in regulated environments. These different points of view will combine to help the audience understand what is actually happening with the technology and will prepare listeners as their organizations continue (or begin) to leverage decentralized ledger technology.
    Session Leaders
    Speakers

    Tanya Sharma

    Partner At Assurea, Steering Committee Women in Pharma
    Assurea, LLC

    James Gannon

    Director - Digital Quality Compliance
    Novartis Pharma AG
  • 1345 - 1515
    Concurrent Session: OSD - Business Considerations & CM Challenges
    Over 50% of the NDA's approved by the FDA over the last five years have been OSD products.  OSD is the workhorse of the pharma industry. Manufacturing technologies are evolving each year including increasing use of PAT, new granulation technologies, and a slow but steady use of continuous manufacturing.  Continuous manufacturing has been the dominate OSD industry buzz for years, yet its infiltration into the business has been less than expected. This session will discuss business considerations, new technologies, equipment trends, and continuous manufacturing - the impact, advantages, and challenges.
  • 1515 - 1600
    Break in Expo Hall
  • 1600 - 1730
    Concurrent Session: Keeping up in the Digital World - A Dive into Validation
    The terms “4.0” and “digital transformation” are generally understood to be technology focused. There are much deeper changes that must be made both in the tangible and intangible arenas, from documented processes such as validation to deeply rooted cultural shifts. This session will dive into how we need to shift our thinking when it comes to the approaches taken with validation. We will also discuss the more important shift in our thinking: all these changes are not just to support an initiative with a finite beginning and end, but rather they should be part of a continuous modernization that supports getting regulated industries closer to where we are in our personal and consumer lives.
    Session Leaders
    Speakers
  • 1600 - 1730
    Concurrent Session: Product Lifecycle, Lifecycle Maturity Model and Real Time Release Testing for BioTech Products
    Session Leaders
    Speakers
    Presentation Information
    [The Control Strategy Maturity Model]
    Speaker: Line Lundsberg-Nielsen, Ph.D.
    Many illustrations and maturity models are available that describes different aspects of Control Strategy maturity and digitalisation maturity. The pharmaceutical industry is undergoing a digital transformation which is one necessary prerequisite to achieving higher levels of Control Strategy maturity. The ISPE PAT&LCS Control Strategy maturity model attempts to translate and harmonise terms and define the key capabilities to achieve advanced manufacturing Control Strategies. The model can be used in many ways. One is as a self-assess tool where the current level of the manufacturing Control Strategy is assessed for a given product or site; and gaps and actions proposed that are required to achieve the desired state for product manufacture and release; or to support any further investment in platforms or technologies, just to mention a few.
    || [Digital Twin for Efficient Product Life Cycling]
    Speaker: Christoph Herwig, PhD
    Digital twins are key elements in the field of capturing and deploying knowledge and are recognize as a power knowledge management tool. But how can those twins be easibily generated and maintained? And moreover, where can digital twins be deployed during the product life cycle? This contirbution aims at showing industrial examples of how to deploy digital twins for very efficient experimental design, outperforming classical exporative Design of Experiments approaches. Even more, deploying the twin in real time, they can be used to ensure process robustness and also increase productivivty signifcantly. We will show how the digital twin can directly, and not indirectyl via othe process variables, optimize productivity. Hence digital twins are an essential tool inside of the digital transformation of biopharmaceutical industry.
    || [First steps towards RTRT for a BioTech Process]
    Speaker: Lorenz Liesum, Ph.D.
    Within the manufacturing world of solid dosage forms, many applications have been implemented in recent years using advanced analytical technologies and digital tools for supporting an enhanced control strategy. This presentation will discuss a pilot project related to sterile manufacturing with the objective to implement a control system using real time elements and making use of predictive multivariate models for process monitoring of different aseptic unit operations.

    The presentation will elaborate on how to take the first steps towards Real Time Release Testing for a drug product biotech process introducing new analytical technologies covering physicochemical assays as well as rapid microbiological assessments. Furthermore the difference of multivariate statistical process control applied to a DP process in comparison with a drug substance process will be illustrated. The goal of this initiative is primarily to simplify the release process and reduce the overall release lead times. An outlook on how to extend this concept to a drug substance process will be given.
  • 1600 - 1730
    Concurrent Session: Regulatory Considerations to Boost Innovation and Supply Chain Resilience
    The pace of innovation in the pharmaceutical field is accelerating and the development of a global, flexible and harmonized regulatory framework will be a key enabler to bring medicines to patients faster. Since its inception, ICH has been concerned with establishing global convergence and alignment on technical criteria with the intent to harmonize regulatory expectations.  This session is intended to provide a status update of regulatory changes that will boost innovation. The presentations will set the stage of the current barriers to harmonization and to implementation of innovative technologies such as API continuous manufacturing, and will offer a proposal for a more comprehensive QOS document that provides a mechanism for industry to convey a holistic view of their control strategy.  The session will highlight examples of how to overcome technical and regulatory challenges and enable supply chain resilience.
    Session Leaders
    Speakers
    Presentation Information
    [Addressing Divergent Global QOS Requirements]
    Speaker: Connie Langer
    ICH M4Q(R1) provides a harmonized structure and format for presenting detailed CMC information in Module 3 and a summary of the CMC information in Module 2. Although several countries have implemented this ICH CTD format, many have adopted quality documentation expectations that exceed ICH guidance and in effect create divergent expectations for CMC content that presents a considerable barrier to harmonized global applications and approvals. This presentation will describe the rationale and purpose for a multitude of CMC summary documents, and will offer a proposal for a more comprehensive QOS document which leverages alternative tools outlined in ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management to potentially fulfill the requirements of regulatory authorities world-wide. A single global QOS format would enable expeditious and simultaneous submission of applications globally to improve patient access to medicines and improve the efficiency and economy of regulatory review and risk assessment of an application while providing a mechanism for industry to convey a holistic view of their control strategy and present established conditions which facilitate life cycle management and continuous supply.
    || [The Virtuous Framework ]
    Speaker: Alessandra Leone
    The presentation is intended to provide a status update of regulatory framework changes that will boost innovation and supply chain resilience.

    The pace of innovation in the pharmaceutical field is accelerating and the development of a global, flexible and harmonized regulatory framework will be a key enabler to bring medicines to patients faster.

    The presentation will set the stage of the current barriers to implementation of innovative technologies and then cover recent learnings and virtuous examples of how challenges can be overcome. This presentation can be considered for inclusion into a wider session possibly involving regulators and a panel discussion on the matter.
  • 1600 - 1730
    Concurrent Session: Managing ATMP Data Interactions with Blockchain
    This panel discussion session will guide the audience through an exploration of distributed ledger (blockchain) technology and data interactions that are needed in the ATMP supply chain. Real life experiences related to ATMP data management with be discussed to support the topic. The panel will convey perspectives on the limits of applications of this technology and debate the use cases to provide a balanced view to attendees. This will inform attendees of possible considerations for implementation of distributed ledger technology. Following a brief introduction of distributed ledger technology, participants will hear from industry leaders about current use cases, the challenges, limits, and solutions to utilizing this technology for ATMPs.
    Session Leaders
    Speakers
  • 1600 - 1730
    Concurrent Session: Innovations and emerging technologies in projects, ramp-up & production
    Session leader and description coming soon.
    Speakers

    Sumit Verma

    Senior Vice President, Commercial Manufacturing
    Iovance Biotherapeutics, Inc.
    Presentation Information
    [2022 FOYA Winner: Iovance Biotherapeutics Inc., iCTC Project]
    Speaker: Sumit Verma
    Category: Honorable Mention

    Iovance is a late-stage oncology company focused on developing, manufacturing, and commercializing novel cancer immunotherapies based on Tumor-Infiltrating Lymphocytes (TIL). These are a naturally occurring immune response to a cancerous tumor but, for patients with cancer, their natural TIL response is reduced. At the iCTC, billions of a patient’s TILs are generated and sent back to be infused as a one-time cancer treatment when the patient has few remaining options.

    This critical and personalized treatment requires a facility that eliminates all errors, cross-contamination, failure, or shutdown. It must also work according to other people’s schedules – surgeons, transport, air travel – and quickly get the treatment back to the patient.

    Unlike a typical manufacturing facility that is designed to produce millions of identical products, at the iCTC each product is made from the starting material of an individual patient and is unique. A mistake or production failure can leave a patient without potentially life-saving treatment.

    This autologous therapy approach is not unusual and there are a growing number of these new facilities. Iovance has a goal to "be the first company in the world to commercially produce a personalized therapy for solid tumors" and as a relatively small company, their progress toward achieving that first with iCTC, as well as having an excellent facility was recognized by the judges.

    With only one chance of success and a production timeline of 22 days, there is no room for error when developing these therapies and the facility was designed with significant redundancies to support its operation 24 hours a day, 365 days of the year.

    The facility treats the tumor specimen as a “patient” moving through the facility and process. To achieve that, Pharma 4.0 principles were applied and the Iovance team developed a proprietary chain of custody (COC) software. This tracks the patient sample from the hospital to iCTC, throughout the production process at iCTC, and then back to the hospital and patient.

    A fully electronic batch record and continuous and centralized monitoring of every piece of equipment were also part of the design from the beginning.
    || [A Paradigm Change in Fill Finish via Collaboration]
    Speaker: Austin Lock
    Major issues affecting the drug product industry include long lead times, high equipment costs, and a reliance on modified legacy technologies that introduce operational compromises. To meet the unprecedented demand for pharmaceuticals, the industry needs to adopt a more responsive, modular, technology approach that overcomes the major issues affecting the industry.

    This presentation introduces a paradigm shift in Fill Finish technology (to be made public in Q2 2022). Using the backdrop of a collaboration case study between three international companies, each offering something very different, it describes the innovation journey from vision to solution. By starting with first principles and adopting a range of technologies such as robotics, smart manufacturing, modular design and construction, the presentation will describe how the companies combined their knowledge and skill sets, and modified existing product offerings, to design and build a flexible equipment offering that is unique within the industry. This pre-engineered, pre-qualified, and cost effective solution, offers the industry a scale-out, in-country solution that will enable wider filling opportunities.

    Similar to Operation Warp Speed where industry demonstrated how collaboration resulted in delivering unimaginable results, this presentation reinforces the notion that collaboration between companies, can deliver enhanced outcomes for the benefit of the industry.
  • 1900 - 2200
    Tuesday Night Celebration: Hawaiian Luau at Discovery Cove
Day 4
Wednesday, 2 November 2022
After the Event
Thursday, 3 November 2022
  • 0830 - 1400
    1st Annual ISPE Foundation Golf Tournament
    Tee time 8:30 a.m. at Celebration Golf Club (www.celebrationgolf.com). Additional details coming soon. Separate registration and fee required.
  • 0830 - 1630
    Training Course: GAMP® 5, Annex 11/Part 11 Basic Principles
    Day 1 of a two day course. Separate registration required.

    This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP® guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements.
  • 0830 - 1630
    Training Course: GAMP® Data Integrity 21
    Day 1 of a two day course. Separate registration required.

    This GAMP Data Integrity 21 CFR Part 11 Training Course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems to provide the tools and techniques to implement proper controls for data.
  • 0830 - 1630
    Training Course: Science and Risk-based C&Q
    Day 1 of a two day course. Separate registration required.

    Worldwide Regulatory expectations and guidance as led by FDA and the EU have stated that all Pharmaceutical Quality Systems should apply a QRM (Quality Risk Management) approach. Through interactive workshops, this course will explain and apply the science and risk-based approach to integrated lifecycle Commissioning & Qualification by conducting verification of systems, equipment and facilities in accordance with the recently issued 2nd Edition Guide, ICH documents Q8 (R2), Q9, and Q10, current Regulatory Guidance, industry best practices, and ASTM E2500.
After the Event
Friday, 4 November 2022
  • 0830 - 1630
    Training Course: GAMP® 5, Annex 11/Part 11 Basic Principles (cont.)
    Day 2 of a two day course.

    This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP® guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements.
  • 0830 - 1630
    Training Course: GAMP® Data Integrity 21 CFR Part 11 (cont.)
    Day 2 of a two day course.

    This GAMP Data Integrity 21 CFR Part 11 Training Course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems to provide the tools and techniques to implement proper controls for data.
  • 0830 - 1630
    Training Course: Science and Risk-based C&Q (cont.)
    Day 2 of a two day course.

    Worldwide Regulatory expectations and guidance as led by FDA and the EU have stated that all Pharmaceutical Quality Systems should apply a QRM (Quality Risk Management) approach. Through interactive workshops, this course will explain and apply the science and risk-based approach to integrated lifecycle Commissioning & Qualification by conducting verification of systems, equipment and facilities in accordance with the recently issued 2nd Edition Guide, ICH documents Q8 (R2), Q9, and Q10, current Regulatory Guidance, industry best practices, and ASTM E2500.