Agenda

Session times are listed in Eastern Time (ET). Find your personal viewing time on the World Clock.


Before the Event
Saturday, 30 October 2021
Day 1
Sunday, 31 October 2021
  • 0700 - 1800
    Registration Open
  • 0800 - 1800
    FOYA Category Winner Displays
  • 1300 - 1600
    FOYA Category Winner Presentations

    Get an in-depth look at the latest, state-of-the-art developments being implemented, the winning projects, and see how excellence was delivered through agility, collaboration, and innovative thinking. Featured presentations include the 2021 Facility of the Year Awards Program Winners.

      Facility Integration - Takeda Pharmaceuticals International AG
      Project: NINLARO The Grange Castle Factory P2 Facility

      Operational Excellence - ElevateBio
      Project: ElevateBio BaseCamp

      Project Execution - Janssen Sciences Ireland
      Project: BioCork2 – Large Scale Fed Batch Facility

      Process Intelligence and Innovation - Takeda Pharmaceuticals International AG
      Project: Packaging Building and Automatic Line Clearance

      Social Impact - Government Pharmaceutical Organization
      Project: Thailand Self Sufficient for Pandemic Vaccines; Influenza and COVID-19

      Operational Agility: COVID-19 Impact - Gilead Sciences, Inc.
      Project: Gilead Sciences, Inc., Center for Innovative Drug Research (CIDR)

      Operational Agility: COVID-19 Impact - Grand River Aseptic Manufacturing
      Project: Grand River Aseptic Manufacturing Large-Scale Fill-Finish Facility

      Honorable Mention - Biocon Biologics Limited
      Project: Biocon Biologics Manufacturing (B3) Project

      Honorable Mention - Locus Biosciences
      Project: Commercial Phage Production Facility Upfit

      Honorable Mention - Raymond G. Perelman Center for Cellular and Molecular Therapeutics
      Project:  Raymond G. Perelman Center for Cellular and Molecular Therapeutics

    Session Leaders
    Speakers

    Wendy Summers

    Vice President, Pharmaceutical Operations and Technology
    Locus Biosciences, Inc.

    Mario Miele

    Vice President Facilities and Engineering
    ElevateBio

    John Wichelt

    Vice President Client Pharmaceutical Services
    Grand River Aseptic Manufacturing
    Presentation Information
    [Build of Innovative MAbs Drug Substance Facility Providing Positive Societal Impact]
    Honorable Mention - Biocon Biologics Limited
    Project: Biocon Biologics Manufacturing (B3) Project
    Speaker: Maneesh Ghildyal
    This presentation will focus on successful completion of this fast-track project with more than 3 Million hours without a Lost Time Incident, with optimized and reduced production cost per unit translating to positive societal impact on patient population with focus on environment and sustainability throughout every aspect of the design.
    || [Thailand Self Sufficient for Pandemic Vaccines]
    Social Impact - Government Pharmaceutical Organization
    Project: Thailand Self Sufficient for Pandemic Vaccines; Influenza and COVID-19
    Speaker: Withoon Danwiboon
    This presentation is a brief summary of GPO’s self-sufficiency and sustainability for vaccine production in Thailand. The presentation covers a success story of an establishment of an egg-based vaccine production process along with the manufacturing facility construction, and vaccine distribution in Thailand.
    || [Innovative Design to Deliver Viral Vector Manufacturing]
    Honorable Mention - Locus Biosciences
    Project: Commercial Phage Production Facility Upfit
    Speaker: Wendy Summers
    A discussion on the build of the Locus Biosciences viral vector manufacturing facility and the rationale that went into the design. The presentation will focus down on the use of novel approaches used to contain viral vectors, prevent contamination, and ensure the safety of associates working in the facility.
    || [New Packaging Building and Automatic Line Clearance (ALC)]
    Process Intelligence and Innovation - Takeda Pharmaceuticals International AG
    Project: Packaging Building and Automatic Line Clearance
    Speaker: Masahiro Kondo
    Takeda is accelerating automation and digital innovation to deliver high quality pharmaceutical products to patients. We will introduce our highly automated end-to-end packaging system and also several cutting edges of digital technologies used at this new packaging building, including automatic line clearance which Takeda implemented as the first pharmaceutical company in a commercial packaging facility.
    || [ElevateBio BaseCamp – Enabling the Next Generation of Cell and Gene Therapies]
    Operational Excellence - ElevateBio
    Project: ElevateBio BaseCamp
    Speaker: Mario Miele
    ElevateBio’s BaseCamp Facility is our Center of Innovation and enables our unique business model that provides integrated research and process development expertise, with flexible manufacturing capacity, thereby reducing time and cost required to take new therapies to market. Integration of ElevateBio’s founding vision into the facility design, building a team of industry experts, incorporation of digital platforms and a drive to deliver life changing therapies to patients in need all contributed to successful project execution.
    || [On Track to Defeat a Pandemic]
    Operational Agility: COVID-19 Impact - Grand River Aseptic Manufacturing
    Project: Grand River Aseptic Manufacturing Large-Scale Fill-Finish Facility
    Speaker: John Wichelt
    Grand River Aseptic Manufacturing set about on an ambitious new large-scale fill-finish facility with no idea that a global health crisis was coming down the tracks. Strategic site selection and flexible equipment choices prepared the CDMO to respond to the COVID-19 pandemic under the federal government’s Operation Warp Speed. To support the goal of increasing domestic fill-finish capacity, GRAM partnered with Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to support the manufacture of its SARS-CoV-2 vaccine.
  • 1900 - 2200
    FOYA Reception and Banquet
    Join ISPE to celebrate the 2021 Facility of the Year Awards Celebratory Reception and Banquet where we will formally recognize and celebrate the 2021 Category winners achievements at ISPE’s premier award presentation ceremony and dinner.  Separate ticketed event can be purchased through the registration of ISPE Annual Meeting.
Day 2
Monday, 1 November 2021
  • 0545 - 0800
    12th Annual ISPE 5K Run/Walk
  • 0700 - 0830
    Grab-n-Go Breakfast
  • 0700 - 1730
    Registration Open
  • 0800 - 1800
    FOYA Category Winner Displays
  • 0830 - 0845
    Welcome and Opening Remarks
    Speakers
    Presentation Information
    [Welcome and Opening Remarks]
    Speakers: Joanne Barrick and Thomas Hartman
  • 0845 - 1115
    Opening Plenary Session
    Session Leaders
    Speakers

    Robin Kumoluyi

    VP & Chief Quality Officer
    Janssen Pharmaceuticals
    Johnson & Johnson Corporation

    Deusdedit Mubangizi

    Unit Head Prequalification Unit (PQT) Regulation & Prequalification Department
    World Health Organization
    Presentation Information
    [Leading with Agility: How the COVID-19 Pandemic was a catalyst for new collaboration and innovation at Johnson & Johnson]
    Speaker: Robin Kumoluyi
    From the early days of the COVID-19 pandemic, Johnson & Johnson, as the world’s largest and most broadly-based healthcare company, has played a pivotal role on a global stage. J&J has adapted new ways of working and forged a unique path to continue to transform as a leader during this unprecedented time. In this keynote address, we will explore reflections, lessons-learned and examples of how the COVID-19 pandemic was a catalyst for new collaboration and innovation at J&J to enable continued success today and for the future.
    || [Regulatory Resiliency in Challenging Times]
    Speaker: Elizabeth Miller
    Regulators quickly adapted business operations for inspections, investigations, and sampling work to provide the necessary oversight of regulated industry. This presentation will describe how agility, collaboration and innovation were key to conducting regulatory work and enabling market access.
    || [Our Journey with SMA: Navigating Uncharted Waters Towards a Port of Calm]
    Speaker: Kristen Farrell
    || [WHO: Agility, Innovation and Collaboration during the Covid-19 Pandemic]
    Speaker: Deusdedit Mubangizi
    The global number of confirmed COVID-19 cases and deaths reported to WHO has passed over 220 million cases and 4.5 million deaths. Getting vaccinated, maintaining physical distancing, cleaning hands, avoiding crowded and closed spaces, and wearing a mask are ‘anti-lockdown measures’. However, without the unpresidential embracement by world leaders, pharma industry, regulators and society to seek tools to assist in mitigating transmission and save lifes these numbers could have been higher. During the past 18 months while the world was fighting the pandemic, national medicines regulators have enabled manufacturing capacity by adopting regulatory flexibility to ensure continuous sustainability of product delivery, not to mention the significant acceleration to normal development timelines of product through clinical trials until product roll out. The world saw agility and the ability of pharma, together with regulators, working tiredly to identify and approve new candidates for treatment and prevention of the disease, while collaborating on a platform of sharing, talking, consulting and discussing best practices, best treatment and best collaborating tools to detect, respond and treat the covid-19 disease.
  • 1000 - 1830
    Expo Hall Open
  • 1115 - 1300
    ISPE Foundation Virtual Golf Experience
  • 1115 - 1300
    Networking Lunch in Expo Hall
  • 1115 - 1300
    Poster Displays in Expo Hall
    Speakers

    Jeremy Freeman

    Pharmaceutical Sector Business Development Director
    PM Group
    Presentation Information
    [Justifying Investment in Manufacturing Execution Systems]
    Presenter: Dirk Sweigart
    Guidance for life sciences companies considering investment in MES applications, including how to measure MES-related cash flow and reasonably evaluate an investment in MES versus other alternatives. As a result of this presentation, participants will: learn how to express a potential project in realistic financial terms for presentation to executives; what types and sources (and losses) of value can be found in MES projects and expressed in ROI; consider how to manage project risks by considering upside and downside cases.
    || [Cable and Pipe Penetration Seals for Cleanrooms and Laboratories]
    Presenter: Sarah Mueller
    This session addresses the importance of sealing cable and pipe penetrations for effective management of fire, water, gas, EMI and sound in laboratories, cleanrooms and other advanced facilities. As a result of this presentation, participants will learn about penetration sealing methods through walls/floors/equipment, acoustics and laboratory architecture, and sealing in classified and explosive locations. References will be made to UL, NEMA, EX, STC, FM and how the approvals relate to sealing barriers for fire, water, gas, and EMI.
    || [Digital Asset Management to Re-imagine Project Delivery]
    Presenter: Jeremy Freeman
    Reimaging Capital Project Delivery - using Digital Asset Lifecycle Information Management - supporting Modularization and Digital Custody Transfer to Opex. This topic addresses the opportunity to influence the project schedule by supporting modularization and off site fabrication using digital execution techniques. Facilitate efficient on site assembly and commissioning using virtual construction techniques and promote early start up by digital handover to operating systems. Content shall address: the digital asset information lifecycle; information governance to support modularized project execution; project life cycle information requirements; supply chain on boarding; document data collection and model federation; Virtual Digital Construction (VDC) Principals and Opportunities; digital handover to operations; the role of the program integrator.
    || [Validation in the Pharma 4.0 World]
    Presenters: Michelle Vuolo and Chip Bennett
    There are so many promises of the 4.0 world. Why has the adoption in the pharmaceutical industry been so slow relative to other industries? Is it regulations? Is it processes? Is it mindset? This session is intended to dive into some aspects related to quality and, in particular, validation. We will explore efficient, more focused ways to approach validation in a world where digital is the focus and data is fundamental. How can we demonstrate fitness for intended use in this data driven world? We will present a high level approach with some examples of how they can/have been successfully applied in real world scenarios: Learning Objectives. Shift the mindset from static document formats to digital data as the focal point for demonstrating control. Apply existing topics such as Quality by Design, Risk Management and Process Validation to the 4.0 world. Understand some of the needed paradigm shifts as discussed in "Validation 4.0 - Shifting Paradigms, Pharmaceutical Engineering, ISPE, November-December 2020, Volume 40, Number 6."
    || [T&ID, the Single Use Facility P&ID]
    Presenter: Carl Carlson
    The benefits of applying a proactive method of documenting the Single Use facility Equipment, Connections and Connectors as a next step in Single Use Technology process documentation. Much like P&IDs document a stainless steel facility process train for the correct design as well as the production capacities and designed for purpose. The use of a T&ID will facilitate definition of the process as well as serve as a training tool. Single Use facilities have the distinguishing fact that the process train is assembled every time a production lot is produced. The T&ID can document the process and be used for Technology transfer, GMP documentation, Training, SAP tracking, and a tool for Risk Assessment.
  • 1300 - 1430
    Concurrent Session: New Approaches to Process Agility and Reliability
    Over the past decade the adoption of Pharma 4.0 technologies and the challenges of accelerating new therapies while meeting  regulatory and business expectations for process robustness and reliability have driven new approaches in the industry. The sector’s accelerated response to the COVID pandemic was both enabled and sped up by these foundational innovations. This session will look at some of these responses and share the broader use of agile automation and data analytics to deliver more capable and reliable operations. The session includes a novel parenteral PAT case study that illustrates how the convergence of analytical and process technologies is delivering real value and ensuring a reliable supply of medicines to patients.
    Session Leaders
    Speakers
    Presentation Information
    [How Pharma 4.0 Helped Life Sciences Thrive During the Pandemic]
    Speaker: Frank Maggiore
    Unlike traditional systems, intelligent, Pharma 4.0-driven platforms are flexible, ergonomic and easy to deploy. These dynamic platforms leverage artificial intelligence, machine learning, augmented reality to connect people, processes and environments to help organizations connect the dots between what they have, how they use it and what they will need soon. As a result, procedures are streamlined, better predictions can be made, and automated processes are triggered. For these reasons, we saw rapid adoption of intelligent, Pharma 4.0 systems within the life sciences industry during the COVID pandemic. This presentation will discuss the significance of this trend and how it allowed organizations to improve reliability, scale faster and increase their speed to market.
    || [From Defect Detection to Contaminant Characterization]
    Speaker: Andrea Sardella
    From defect detection to contaminant characterization to improve the detection rate and reduce false rejects in lyophilized products inspection. Recent developments of led light sources in the mid-infrared in conjunction with new higher sensitivity NIR sensors have allowed developing a multispectral imaging system suited to the inspection of lyophilized products without the drawback of previous systems, based on halogen lamps and highly light-demanding dispersive optics systems. We will present a new approach based on solid-state lighting devices and high throughput optical systems that operate at production rate. The high dimensionality data output has been elaborated using multivariate analysis to demonstrate the advantages in terms of detection accuracy, even in the case of few examples. Contaminants are characterized based on their spectral fingerprint providing relevant information as PAT tool and inherently reducing the false reject due to the product’s texture and topography variability.
    || [Achieving GxP Agility with Islands of Automation]
    Speakers: John Spohn and John Parraga
    The speed with which vaccines for COVID were developed, tested, produced, and delivered is a stunning achievement fueled by unprecedented collaboration within industry and with regulators. It has also brought into stark relief a new challenge: Manufacturing activities must meet or exceed the nimbleness evidenced by these recent development and regulatory activities. Truly agile GxP manufacturing is no longer an aspiration but an urgent need. This presentation will focus on several hurdles for agile GxP manufacturing that stem from the growing dependence on single-use systems: mobile, self-controlled ‘islands of automation’. We will address key stakeholder concerns about making the integration or reconfiguration of unit operations more systematic, efficient, and predictable as well as restoring comprehensive EBRs and real time release. Attendees will also hear how to relieve operators of repetitive manual data entry and to mitigate the need for staff to train, utilize, and administer the user interfaces and platforms of each island. The presentation will also discuss potential relief from certain routine commissioning tasks. Surmounting these hurdles are keys to the faster and more confident stand-ups, scale-ups and tech transfers vital to providing therapies for urgent needs.
  • 1300 - 1430
    Concurrent Session: Fill Finish
    This session will focus on technologies associated with the future state of Fill-Finish manufacturing. The presentations in this session cover a wide variety of technologies such as innovative processes using modern technologies and intelligent modular concepts, the development of an innovative cGMP-compliant and flexible production cell based on isolator technology and technological highlights to cover major challenges for the aseptic handling of viral vaccines under BSL2. Three different projects pushing the boundaries of Fill-Finish to show Agility, industry Collaboration and successful Innovation in new technologies.
    Session Leaders
    Speakers
    Presentation Information
    [Vaccines for the World - Insights into a BSL2 fill-finish Facility]
    Speakers: Thom O’Sullivan and Laura Moody
    The design and implementation of a state-of-the art fill finish facility for viral vaccines faces numerous challenges. Besides the right facility design with focus on BSL2 aspects, this project had the challenge of a very short timeline (fast-track project) combined with facility space limitations. One major goal was to combine the flexibility to handle liquid and lyo products with fully-isolated equipment, to guarantee the highest degree of operator safety . Besides that, the presentation covers also insights into the background for handling of viral vaccines as well as the major hurdles from a project execution perspective.
    || [Next Steps: New Industry Standard for fill/finish Technology]
    Speakers: Klaus Ullherr and Ute Schleyer
    In the case of small commercial quantities, batch sizes vary between 500-3,000 units. The technical and economic challenge for high value drugs in smaller batch sizes is to maximize API-yield, flexibility and time-to-market. A new industry standard for fill/ finish technology is currently in the realization process. Its development started by linking Vetter’s know-how in process development for aseptic filling and clean room technology with the expertise of Syntegon Technology GmbH in system and plant technology. The objective is the development of an innovative, cGMP-compliant and flexible production cell based on isolator technology. This presentation will show the outline of the cooperation and the status quo of this newly developed fill/finish equipment with insights into the detailed design and technical innovations.
  • 1300 - 1430
    Concurrent Session: Digital Innovation - Ensuring Quality and Regulatory Compliant Solutions
    This digital innovation session allows attendees to discover how to cost effectively/efficiently validate and ensure the quality of their machine learning (ML) and software automation projects, while collecting and establishing the necessary evidence to withstand regulatory scrutiny. From a newly formed GAMP5 framework to computer systems/software assurance for automation, this session provides easily understandable and practical approaches behind the “mystery” of compliance for such novel digital technologies. Not only does the session give you tangible information to use in your next project, but it also breaks it down into the details you need. This includes ML as a sub-component of your overarching system(s), recommended risk-based life cycle deliverables, and right-sized scalable efforts to put your time and money where it matters most.
    Session Leaders

    Eric J. Staib

    Vice President of Compliance & Quality Management
    Signant Health
    Speakers

    Eric J. Staib

    Vice President of Compliance & Quality Management
    Signant Health
    Presentation Information
    [Computer Software Assurance & Automation (Paperless)]
    Speakers: Meher Muttanapalli
    Adoption of the novel Computer Software Assurance (CSA) instead of traditional & heavily documented focused Computer System Validation resolves many challenges. CSA focuses on critical thinking and testing/assurance instead of documentation by streamlining the validation efforts based on the integral risks to the product quality, patient safety and data integrity. CSA allows for taking credit of the work/testing performed by software provider and puts the least burden on the manufacturer. Use of Limited Scripted/Unscripted Ad-Hoc testing approaches focuses on Testing and not scripting addressing the high critical risks and help mitigate the controls for a computerized system used in production and QMS.
    || [Documenting the Machine Learning Life Cycle]
    Speaker: Robert Robinson
    There is an uncertainty in industry as to what documentation and/or deliverables that need to be created as part of the "machine learning life cycle". This presentation shall examine each phase of the AI/ML implementation process and provide recommendations, based upon recent regulatory guidance and the presenters own experience, as to what is required in terms of evidence, data, and deliverables to support an inspection and/or client audit.
    || [Applying a GAMP® 5 Framework to AI/ML]
    Speaker: Eric Staib
    This presentation will describe a life cycle framework for Machine Learning (ML) for use within life sciences in a GxP regulated environment. The life cycle of an ML sub-system or component to be embedded in a wider computerized system life cycle, and for most systems using these technologies many aspects of the traditional computerized system life cycle and the compliance and validation approach are still fully applicable (e.g. those related to specification and verification of user interface, reporting, security, access control, data integrity controls and data life cycle management).
  • 1300 - 1430
    Concurrent Session: QRM/CQV - Best Practices and Lessons Learned
    This session will address the development of standardized templates, application of risk-based concepts, and examples of implementation by Bayer and Amgen.  In addition, the session will provide case studies demonstrating design with qualification in mind.  Join the discussion and hear more about best practices, industry use-cases, and utilizing a system of lean integrated CQV.
    Session Leaders
    Speakers

    Midhu Varghese

    Associate Director, Commissioning & Qualification
    AbbVie, Inc.
    Presentation Information
    [To Catch a Template - Best Practices Supporting QRM the C&Q process]
    Speakers: Midhu Varghese and Steven Wisniewski
    With the recent release of the Commissioning and Qualification, Baseline Guide 5 v2, ISPE C&Q Steering team has shed light on the mystery of “how" by developing standardized templates across several process deliverable examples. Part 1 of this presentation will show User Requirements Specifications (URS), System Risk Assessments (SRA), Design Qualification (DQ), Acceptance and Release Summary Reports developed by the cross-company Task Team and explain the philosophy and concepts behind the content. The presentation will demonstrate application of the risk-based concepts and how scaling, based on complexity, impacts documentation activities. Example deliverables will be presented related to production equipment, packaging equipment and critical utilities.
    || [Lean Integrated CQV - Case Studies and Lesson Learned from CGT]
    Speaker: David Macdonald
    2020-21 has demonstrated the importance of delivering new production capacity on an expedited timeline. Too often in the past, CQV testing has been the last dragging item on the critical path preventing the start of GMP manufacturing. The principals of ASTM E2500 have been with us for 15 years but rarely fully utilized. Using a system of lean integrated CQV based on the principals of E2500 and the revision of the C&Q baseline guide allows the reduction of testing, especially on site testing, and the removal of some CQV activities from the projects critical path. This is design with qualification in mind, with quality and validation integrated into the early phases of the project. This approach will be described and two case studies will be discussed - a large GT project and a smaller flexible CGT project. From these case studies participants will see the advantage of integrating QA and Validation into the project early allowing for the rational design of testing - once and in the best phase for the expedited delivery of the facility.
    || [To Catch a Template – Example Company Best Practices of the QRM C&Q]
    Speaker: Joerg Block
    In part two of this presentation, Dr. Block will present examples showing application of C&Q Process deliverables to System Risk Assessment approaches being applied at his organization. Insight will be presented on how Bayer AG is moving forward with the establishment of QRM best practices with multiple risk assessment tools supporting the application of QRM in C&Q..
  • 1300 - 1430
    Concurrent Session: Drug Shortages and Meeting Supply Chain Challenges
    During the pandemic, supply chain issues and drug shortages were discovered across many industries, including biopharmaceuticals.  Drug shortages have the potential to be one of the most impactful supply chain challenges to the health of people throughout the world and are a topic of significant interest to manufacturers, regulators, policymakers, health care professionals, and, most importantly, patients.  The slow pace of post-approval changes can also impact the supply chain and has the potential to create drug shortages. While the purpose of post-approval changes is typically to improve the quality of the product by incorporating a new understanding of the drug or process, approval of these changes can take months or years. Using a Digitalization Toolbox beginning with Process Development and throughout the pharmaceutical lifecycle enables a flexible change management of the product through a robust Control Strategy.  The optimal toolbox includes software and analytical tools to address knowledge management, holistic process understanding and the process monitoring and quality control across the development steps; a Holistic Control Strategy approach. This session will cover these topics and discuss how experiences with the COVID-19 pandemic provided an opportunity to further reduce drug shortages and improve the time it takes for post-approval changes to be implemented.  Additionally, analytical models can help to maintain and manage complex supply chains from the start of development in order to shorten the time to patient.  Finally, the session will open the topic of Holistic Control Strategy approach to increase processing efficiency and control across drug development.
    Session Leaders
    Speakers

    Drishya Nair

    Manager, Life Sciences Consulting
    Ernst & Young US LLP

    Jay Welsh

    Partner & Supply Chain Leader
    Ernst & Young US LLP
    Presentation Information
    [ISPE Drug and Device Shortages: Business Continuity Planning]
    Speakers: Stephanie Garth, Jay Welsh, and Drishya Nair
    Following the issuance of the FDA Drug Shortages: Root Causes and Potential Solutions, there has been renewed activity by HAs globally as well as ISPE to the drug shortages issue, particularly with the need to respond to the COVID 19 pandemic. Access to critical medicines has been primary focus for Life Sciences companies especially since the pandemic and many solutions are being developed to solve the Supply Chain challenges during such global health emergency situations. Experts from the front line will present experiences and the steps involved in planning ahead including: a Business Continuity plan, summarizing actions for senior management to prepare proactively for potential drug shortages. Prioritization, risk assessment, mitigation options. Experiences and learnings from the COVID 19 pandemic supply chain pressures.
    || [Improving Supply of Medicines Through SCIENCE & RELIANCE 1VQPAC]
    Speaker: Anders Vinther
    Post-approval changes are inevitable and necessary throughout the life of a drug product—to implement new knowledge, maintain a state of control, and drive continual improvement. Many of these post-approval changes require regulatory agency approval by individual countries before implementation. Because of the global regulatory complexity, individual post-approval changes usually take years for full worldwide approval even when they reduce patient risk, improve compliance, or enhance the manufacturing process or test methods. This global complexity slows down continual improvement and innovation and can cause drug shortages and current good manufacturing practices compliance issues. A global problem needs a global solution. Chief Quality Officers from the largest pharma companies are speaking with “One Voice of Quality” and have defined how companies can demonstrate an effective Quality System for managing PACs both at a system and individual level. The solutions are based on ICH Q9, Q10, Q12 and driven by SCIENCE.
    || [ISPE Pharma 4.0™ - Managing the Development Supply Chain]
    Speaker: Christian Wölbeling
    Digitalization enables the continuous design, execution and lifecycle management of the ICH Control Strategy. Using the Digitalization Toolbox starting in Process Development and using it along the pharmaceutical lifecycle enables a flexible change management of the product but more importantly of the Control Strategy. Challenges are still in the knowledge management, holistic process understanding and the process monitoring and quality control across the development steps, calling this the Holistic Control Strategy approach. Analytical models will help to maintain and manage complex supply chains which are already starting in Process Development to shorten the time to patient. The ISPE Pharma 4.0™ Operating Model offers holistic concepts for digitalized Control Strategies.
  • 1300 - 1430
    Concurrent Session: Path to a Global Quality Dossier - Part 1
    Industry has observed vastly different and region-specific CMC submission requirements and quality standards which can cause delays in approval of new medicines to patients worldwide.  A related challenge is the differing global Post Approval Change requirements that can risk continuity of supply of medicines.  The ideal state is a global quality dossier that can be assessed by multiple regulators and provides for a single, approved dossier that is globally maintained.  This would allow faster access of medicines to patients around the world, reduce the risk of supply shortages, help resource constrained regulators to rely on each other’s expertise and provide less regulatory burden to industry.  ICH Quality guidelines provide a firm foundation, and ICH Q8-Q12 outline key principles that cover product development by incorporating principles of risk assessments, pharmaceutical quality systems, and lifecycle management. In this two-part session, key aspects of a potential path to a global quality dossier will be presented.  In part 1, presentations will focus on control strategy, a globally harmonized, risk-based quality overall summary and an update on Accumulus.
    Session Leaders

    Gregory Rullo

    Senior Director, Regulatory Affairs-CMC
    AstraZeneca Pharmaceuticals
    Speakers

    Rodrigo Palacios

    Associate Director, Global Regulatory Policy
    F. Hoffmann-La Roche AG
    Presentation Information
    [Risk Based Quality Overall Summary]
    Speaker: Ciby Abraham
    Currently there are varying CMC submission requirements and quality standards for ICH and non-ICH countries that cause global delays to approval of new medicines to patients even though the quality of the product supplied is the same. Perhaps a greater challenge are differing global Post Approval Change requirements where supply of medicines can be interrupted. The quality of a drug should ensure safety, efficacy and consider patient risk-benefit. The Quality Overall Summary (QOS) provides an ideal opportunity to provide a comprehensive view of the control strategy and discuss patient risk-benefit. Unfortunately the QOS is not harmonized in the ICH regions and no Module 3 document provides a logical spot to discuss either the overall control strategy or patient risk-benefit.
    || [Cloud-Based Submissions and Structured Data Accumulus Summary]
    Speaker: Rodrigo Palacios
    The current approach to how sponsors and health authorities exchange data is inefficient and ripe for transformation. Existing regulatory filing processes are inconsistent across geographies, require significant manual effort, and use outdated technology that ultimately leads to delays in patient access to medications and higher drug development costs. A radical transformation is needed from a static transactional exchange between sponsors and regulators to a dynamic approach capable of exploiting the full range of data sources and digital tools. This presentation will explore how Accumulus Synergy is taking this aspiration from theory to practice via execution of use cases in partnership with regulators. Accumulus Synergy is working with the FDA’s Oncology Center of Excellence (OCE) and other global health authorities to design, develop, and deploy, a full-scale, cloud-based solution enabling collaborative review of structured data submissions by regulators. In addition, we will also discuss the long-term aspirations and regulatory design considerations and show how tangible progress is being made in the near term via use cases with regulators for parallel review and CMC Stability Data Automation, Usage and Exchange. These use cases intend to provide a proof of concept that can be scaled to all aspects of regulatory filings.
    || [Control Strategy Harmonization Metrics and Importance of ICHQ12]
    Speaker: Tim Watson
    ICH guidelines introduced risk-based approaches and enhanced scientific understanding as an opportunity to encourage continuous process improvement for pharmaceutical manufacturing. Conceptually, Quality by Design (QbD) promised to improve confidence in quality through the lifecycle of pharmaceutical products. A primary incentive for industry is the prospect of global regulatory concordance for new applications and post approval changes. Unfortunately, during the last decade, the industry has experienced a proliferation of regulatory divergence regarding the interpretation of ICH guidelines (and control strategies) across geographic regions. Rather than truly harmonized regulatory expectations, localized interpretations of ICH guidance have resulted in different technical requirements and/ or control strategies posing significant challenges for a global industry. As a result, the increased complexity of manufacturing supply chains and the regulatory burden associated with maintaining compliance with these diverse regulatory expectations serves as a barrier to continual improvement and innovation. Divergence has become one of the newest risks to continued improvements (disincentive) and risks temporary drug shortages in some markets.
  • 1430 - 1500
    Networking Break in Expo Hall
  • 1430 - 1500
    ISPE Foundation Virtual Golf Experience
  • 1430 - 1500
    Poster Presentations in Expo Hall
    Speakers

    Jeremy Freeman

    Pharmaceutical Sector Business Development Director
    PM Group
    Presentation Information
    [Cable and Pipe Penetration Seals for Cleanrooms and Laboratories]
    Presenter: Sarah Mueller
    This session addresses the importance of sealing cable and pipe penetrations for effective management of fire, water, gas, EMI and sound in laboratories, cleanrooms and other advanced facilities. As a result of this presentation, participants will learn about penetration sealing methods through walls/floors/equipment, acoustics and laboratory architecture, and sealing in classified and explosive locations. References will be made to UL, NEMA, EX, STC, FM and how the approvals relate to sealing barriers for fire, water, gas, and EMI.
    || [Digital Asset Management to Re-imagine Project Delivery]
    Presenter: Jeremy Freeman
    Reimaging Capital Project Delivery - using Digital Asset Lifecycle Information Management - supporting Modularization and Digital Custody Transfer to Opex.This topic addresses the opportunity to influence the project schedule by supporting modularization and off site fabrication using digital execution techniques. Facilitate efficient on site assembly and commissioning using virtual construction techniques and promote early start up by digital handover to operating systems. Content shall address: the digital asset information lifecycle; information governance to support modularized project execution; project life cycle information requirements; supply chain on boarding; document data collection and model federation; Virtual Digital Construction (VDC) Principals and Opportunities; digital handover to operations; the role of the program integrator.
    || [Validation in the Pharma 4.0 World]
    Presenters: Michelle Vuolo and Chip Bennett
    There are so many promises of the 4.0 world. Why has the adoption in the pharmaceutical industry been so slow relative to other industries? Is it regulations? Is it processes? Is it mindset? This session is intended to dive into some aspects related to quality and, in particular, validation. We will explore efficient, more focused ways to approach validation in a world where digital is the focus and data is fundamental. How can we demonstrate fitness for intended use in this data driven world? We will present a high level approach with some examples of how they can/have been successfully applied in real world scenarios: Learning Objectives. Shift the mindset from static document formats to digital data as the focal point for demonstrating control. Apply existing topics such as Quality by Design, Risk Management and Process Validation to the 4.0 world. Understand some of the needed paradigm shifts as discussed in "Validation 4.0 - Shifting Paradigms, Pharmaceutical Engineering, ISPE, November-December 2020, Volume 40, Number 6."
    || [T&ID, the Single Use Facility P&ID]
    Presenter: Carl Carlson
    The benefits of applying a proactive method of documenting the Single Use facility Equipment, Connections and Connectors as a next step in Single Use Technology process documentation. Much like P&IDs document a stainless steel facility process train for the correct design as well as the production capacities and designed for purpose. The use of a T&ID will facilitate definition of the process as well as serve as a training tool. Single Use facilities have the distinguishing fact that the process train is assembled every time a production lot is produced. The T&ID can document the process and be used for Technology transfer, GMP documentation, Training, SAP tracking, and a tool for Risk Assessment.
  • 1500 - 1630
    Concurrent Session: Increasing Facility Flexibility through Improving Turnarounds and New Product Introduction
    The timelines involved in the introduction of new therapies often requires the creation of additional capacity while avoiding significant new capital investments.  Maximising the productivity of existing assets is key to that response and the ability to reduce the time taken to complete cleaning and turnarounds can add real value.  Similarly  faster product introduction can be enabled through standardisation of quickly adaptable and adoptable single use process components and their associated automation systems.  The three presentations in this session will share real world examples of companies delivering on those objectives and realising significant value.
    Session Leaders
    Speakers
    Presentation Information
    [Single-Use Standardisation in Pandemic Times]
    Speakers: Javier Lozano and Juerg Brechbuehler
    It is widely accepted that standardisation of Single Use (SU) designs would be beneficial to the industry, providing simpler, faster and lower cost solutions. However, as SU technology become more widely adopted, suppliers may struggle to keep up with demand. A widely adopted SU Standardisation approach is needed to alleviate SU supply issues. This would not only benefit the biopharma industry by helping to ensure production but ultimately, it would help patients as well. This presentation will consider current practices in designing Single Use processes and facilities, and will examine where standardisation may be appropriate. It will present an analysis of the benefits an industry wide standardisation will bring to both end users and SU vendors, and highlight the advantages and challenges that standardisation may bring. Focusing on the areas where standardisation has the greatest potential impact, the speakers will look to a potential future scenario where vendors compete on product attributes rather than dimensions and end users enjoy greater supply-chain security, and shorter leadtimes.
    || [Agile Turnaround & Cleaning: Supporting Sustainable Drug Supply]
    Speakers: Kenneth Pierce and Geraldine Murray
    Manufacturing paradigms continually change and supply stability and sustainability have become significant issues during the Covid-19 crisis. How can we support supply without increasing demand on finite resources, or increasing our ecological resource footprint? What if you are at 90+% of the designed manufacturing capacity? Can you demonstrate continuing viability without capital investment? Are your utility systems running at capacity? This co-presentation with Astellas, Dublin, Ireland will look at aging/established facilities environmental responsibility and efficiency. Their best version of Pharm4.0 is delivered by people, SME knowledge, and their empowerment to challenge the norms of operation. We showcase a methodology for dismantling and rebuilding cleaning programmes without requiring engineering support that can release your production capacity. We examine two different drivers; one supply maintenance (API), and one supply increase (Biotech), both with an environmental twist. We show how human intuition, experience and knowledge was empowered to leverage continually generated, but inadequately utilised, data.
    || [Plug and Play Automation for Single Use Biopharma Equipment]
    Speaker: Clay Schaeffer
    As the biopharma industry moves towards more agile production environments, process equipment automation systems will require tools that align with the inherent flexibility of single-use technology (SUT). SUT enhances a manufacturer’s ability to modify operations to meet the needs of today’s dynamic industry, however, integrating flexible platforms into the plant infrastructure requires extended timelines and increased costs due to custom development and validation of data interfaces. The BioPhorum Plug and Play workgroup has been working since 2017 to leverage established and emerging communications standards to move from the current state of unique and custom software interfaces to a configurable, standardized approach that enables rapid integration of intelligent process skids into a facility’s existing manufacturing system. This seminar will discuss the fundamentals of Plug and Play technology, how Plug and Play is being developed by BioPhorum in collaboration with other industry groups, and the progress made to date.
  • 1500 - 1630
    Concurrent Session: Tech Transfer
    This session will focus on three critical areas for successful tech transfer. The first presentation will provide insight to working with and establishing the right team for positive collaboration with a CDMO. The second presentation dives into a specific process and walks through steps to avoid common pitfalls in designing and transferring a cleaning process for manufacturing. The final presentation unlocks the concerns around continuous product and data flow from discovery through manufacturing exposing potential savings in time and costs. Concurrent Session: Tech Transfer|Concurrent Session: Tech Transfer|Concurrent Session: Tech Transfer| The valuable information will help ensure successful tech transfer and can lead to accelerated project timelines, waste reduction, and improve profitability.
    Session Leaders
    Speakers

    Sachin Misra

    Pharmaceuticals & Biotech Industry Principal
    Kalypso
    Presentation Information
    [The Ultimate Friend Request: Global CDMO Tech Transfer]
    Speakers: Mohamed Shaker and Amanda Culliton
    A successful technology transfer to a CDMO is far more than just sending over your data and documents and hoping for the best – it’s “friending” another team that is going to help you achieve your goals and bring your product to market faster. In these days of international biomanufacturing at warp speeds, getting this relationship right from the beginning is more important than ever. Much like with your online friends, you’ll gain the most benefit by establishing a positive collaboration with your CDMO, ultimately resulting in accelerated timelines and process improvements. Join us for real-world examples of what to do, and what not to do, for a positive and successful tech transfer to a CDMO. After this presentation, you’ll know what to do to foster open communication and maintain a productive relationship between the two teams.
    || [Digital Tech Transfer / Scale-UpBiophorum – BPIT CMO Integration]
    Speakers: Daniel UpDyke and Sachin Misra
    The Pharmaceutical industry sells a variety of products and therapeutic packages that include diagnostic tests, drugs, monitoring devices and mechanisms, as well as a wide range of services to support patients. In addition, due to constant merger and acquisition activity, companies often struggle with a cumbersome patchwork of system and tools. Extended value chains in the Pharmaceutical industry are becoming more global and complex in nature, making visibility of information and structured data across the value chain a vital issue for efficient tech transfer and rapid scale-up. With all of these challenges, there has been a major shift away from national to "regional" or "global" manufacturing & value chain structures with emerging economies, providing further opportunities for manufacturing and sourcing for the Pharmaceuticals industry. A continuous product and process data flow from Discovery to Internal or External Manufacturing can enable efficient and effective Tech Transfer and Scale-Up – unlocking significant timeline, cost and profitability improvements.
    || [Cleaning Considerations: Design, Start-up, and Commissioning]
    Speaker: Paul Lopolito
    Equipment cleaning concerns are often over-looked during design, startup, and commissioning of pharmaceutical facilities. This is often the case with newer technologies such as mRNA vaccines and cannabis derived products. Failures to link the manufacturing process to cleaning agent selection, physical properties of cleaning chemicals, storage and handling requirements, waste discharge restrictions, dispensing requirements, and material compatibility can lead to costly delays. Technical transfer teams and regulatory agencies expect laboratory testing to support cleaning agent selection, cycle development, critical parameter selection, and a continuous monitoring strategy. Current industry trends also demand a sustainable cleaning approach which considers water consumption, energy requirements, carry-over concerns of active ingredients, and personnel safety. The presentation will focus on some steps to avoid common pitfalls in designing a new cleaning process through laboratory testing as well as leveraging a master soil to take full advantage of factory acceptance testing and commissioning events of new equipment. This valuable insight enables engineering and commissioning teams to dedicate resources on their manufacturing process.
  • 1500 - 1630
    Concurrent Session: GAMP® 5 - Critical Thinking, Agile Methods, and IT Infrastructure Control
    This session will focus on how the GAMP® 5 model is evolving to adapt to the current changes in digitalization.  The topics in this session include: Understanding the flexibility of GAMP® 5, that Agile does demonstrate control and how records or tools can be used in place of documentation. Critical Thinking is a mindset that must be applied when implementing GAMP® 5 to ensure that a risk-based approach to quality and compliance takes account of the multiple layers of assurance that may exist upstream or downstream of the system within the business process it supports. The use of Good IT Practices, electronic IT Service Management Tools and Automation as an effective means of achieving continuous compliance of the IT infrastructure environment including cloud and on premise.
    Session Leaders
    Speakers
    Presentation Information
    [Critical Thinking]
    Speakers: Lorrie Vuolo-Schussler and Guy Wingate
    Lifecycle management of computerized systems in the pharmaceutical industry must assure reliable operation, data integrity and regulatory compliance while responding to the realities of cost control. While GAMP 5 presents a risk-based approach to determine the most suitable approach to the validation of computerized systems, sub-optimal approaches often waste resources on non-value-added activities, leading to insufficient or excessive work, budget overspend and delays. Critical Thinking is a mindset that must be applied when implementing GAMP 5 to ensure that a risk-based approach to quality and compliance takes account of the multiple layers of assurance that may exist upstream or downstream of the system within the business process it supports. This presentation will explore how critical thinking can be applied holistically to assure the overall computerized system is fit for use in support of the business process, and will safeguard patient safety, product quality and data integrity.
    || [GAMP® - Agile Software Methods and GXP]
    Speaker: Elizabeth McLellan
    Some pharmaceutical organizations and suppliers are hesitant to adopt Agile software development and support practices as they are concerned about how this methodology aligns with GxP requirements. This presentation will cover the discussions and conclusions from the GAMP Agile Special Interest Group and present how Agile can be used in a GxP environment and show alignment with GAMP5 principles. Areas covered will be the shift in mindset required (from certainty to discovery), requirements management, the use of tools (in place of documentation). As a result participants should understand the flexibility of GAMP5, that Agile does demonstrate control and how records/tools can be used in place of documentation.
    || [GAMP GPG – Enabling Innovation Critical Thinking, Agile, IT Service Management]
    Speaker: Randy Perez
    This presentation focuses on pragmatic quality and risk-based approaches to IT infrastructure. It covers recommendations made by a US FDA/industry team linked to the US FDA Center for Devices and Radiological Health (CDRH) Case for Quality initiative which is promoting a risk-based, product quality, and patient-centric approach to computerized systems assurance—as well as the GAMP® reexamination of approaches to IT infrastructure control and compliance. The session examines the use of Good IT Practices, electronic IT Service Management Tools and Automation as an effective means of achieving continuous compliance of the IT infratructure environment including cloud and on premise. Current approaches to IT Infrastructure compliance are point in time solutions that do not truly address the continuous threats to the performance and integrity of the IT Infrastructure environment. This approach is endorsed by the GAMP leadership. IT services models (cloud), quality practices (e.g. ITIL), electronic tools (e.g. service management tools) and automation have significantly advanced over the past decade and provide a more assured and repeatable means of governing IT Infrascture environments. Relationships between regulated companies and IT Service providers will be clarified to ensxure that all organisations engaged in the provision and governance of IT sxervices understand their respective accountabilities.
  • 1500 - 1630
    Concurrent Session: CAR-T and the Future
    The future of gene therapy to most effectively meet the needs of our global population requires focused agility for development and manufacturing. Speed and flexibility are at the forefront and & innovations like adaptive facilities and ethical supply chains are integral for success. This session represents a collection of case studies focused on how facility design is changing to keep up with this rapidly evolving field. Please join us for a discussion around various design solutions and best practices that can support how to make these facilities work both technically and financially.
    Session Leaders
    Speakers

    Tom Bannon

    Biopharma & Advanced Therapies SME
    PM Group
    Presentation Information
    [Looking Beyond Autologous – Transitioning to Allogeneic]
    Speakers: Arantxa Lera and Tom Bannon
    Significant capital is being invested globally to design and construct autologous cell therapy facilities. These first generation personalised cell therapies scale out to cater for high patient population. This results in space intensive facilities. Many autologous cell therapy manufacturers are investigating next generation allogeneic replacements for their existing therapies. This presentation will focus on transitioning existing facilities from autologous to allogeneic operations. It will also demonstrate how existing buildings can adapt from their autologous to allogeneic operations. This presentation will highlight the attributes of autologous and allogeneic cell therapy facilities, and outline the manufacturing challenges in transitioning between these. The presentation will outline how existing facilities will face challenges in transitioning to allogeneic and will outline how new facilities can be designed to be adaptable and/or flexible to facilitate this development in a compliant manner that does not affect therapy quality.
    || [A Scalable and Flexible Future for Gene Therapy Production]
    Speakers: Carissa Marak and Branden Salinas
    The future of gene therapy and defending our global population from disease—those we know and those to come—requires new nimbleness for development and manufacturing. Speed and flexibility are at the forefront of current life sciences trends. Innovations like adaptive facilities and ethical supply chains enable advances in targeted treatments like precision medicine, as well as help shorten the research life cycle. All of this is progressing with the health and well-being of the global population in mind. The more we can implement solutions to benefit people—quickly and effectively—the better. This presentation will discuss the science and technology behind Umoja Biopharma’s emerging approach that leverages a range of synergistic innovative technologies to develop scalable, next-generation cancer immunotherapies. Additionally, we will discuss how facility design is changing to keep up with this field that is evolving rapidly. We will discuss practical tips and design solutions that can support how to make these facilities work both financially and in terms of GMP standards.
    || [Flexible Universal CAR-T Manufacturing in Isolators]
    Speakers: Steven Doares and Leslie Edwards
    Traditional cell and gene therapy processes have utilized biosafety cabinets in conventional cleanrooms which can lead to costly facility, less process control with a risk of contamination and operator safety. Through a novel CAR-T process integrated with a multi-chamber, modular isolator system, the traditional aseptic process environment can now be better controlled to improve sterility assurance, maintaining process efficiency for the quality of the product and safety of the operator and patient. The case study will discuss upstream, downstream and aseptic filling steps to be performed in a closed isolator that can have better aseptic control environment as well as safety for the operator in similar system using viral vector or ADCs.
  • 1500 - 1630
    Concurrent Session: Innovations in Supply Chain and CGT Operations
    Cell and Gene Therapies (CGTs) are a growing field with its own set of challenges. The science of these innovative therapies is incredible, but so are the logistics and costs around supply chain and process efficiency.  The sheer number of systems in these facilities requires a great deal of material that can create material/process/personnel/waste flows that can lead to inefficiency and increase the Cost of Goods (COG).  In addition, supply disruptions during the COVID-19 pandemic have exposed many vulnerabilities across our supply chains for drugs and medical devices.  Implementing an efficient and flexible supply chain, is critical.  In this session, the presenters will use their design, operational and technology experience to lay out some of these challenges specific to CGT and demonstrate how proper design, materials planning and decentralized supply chain management can, increase flexibility, lower the cost of goods and improve the efficiency of getting medicine into the right hands at the right time.
    Session Leaders
    Speakers
    Placeholder Person Graphic

    Marcia Steger

    Senior Manager of External Manufacturing, Drug Product
    Moderna
    Presentation Information
    [Decentralized Supply/Demand Signaling System]
    Speaker: James Canterbury
    Supply disruptions during the COVID-19 pandemic have exposed many vulnerabilities across our supply chains for drugs and medical devices. Derived from a white paper written by ISPE in December 2020 a better system for communication across the ecosystem of manufacturers, distributors, and dispensers was designed. The Distributed Supply/Demand Signaling (DS2) System is a decentralized approach to capturing trusted and timely information about the availability and distribution of medicines and medical countermeasures. This presentation will walk through the design and share progress made against these challenging goals.
    || [Disruptive Innovations: Key to CGT’s Growth & Maturity]
    Speakers: Komal Hatti and Marcia Steger
    CGT has the potential to cure untreatable diseases and dramatically alter global human health and longevity. Unfortunately, high costs make it accessible only to a handful in the wealthy nations. Global C-19 vaccine administration disparity is a sobering reminder that transformative innovations must be affordable to reach masses. The presentation will cover: 1. Analysis of the current COGs and operational challenges leading to high costs, from a CGT owner's perspective. Significant efficiency conflicts across process design, facility, supply chain, infrastructure, talent and systems exist that must be resolved. 2. Disruptive innovations are needed to complete the CGT revolution. Many such innovations are already underway. They need to be discussed, understood and adopted by the industry. We will explore innovations such as facility design to support the dynamic nature of the industry; lab automation; closed process; and facility and process optimization through predictive simulation technologies, based on the concept of digital twinning.
  • 1500 - 1630
    Concurrent Session: Path to a Global Quality Dossier - Part 2
    Industry has observed vastly different and region-specific CMC submission requirements and quality standards which can cause delays in approval of new medicines to patients worldwide.  A related challenge is the differing global Post Approval Change requirements that can risk continuity of supply of medicines.  The ideal state is a global quality dossier that can be assessed by multiple regulators and provides for a single, approved dossier that is globally maintained.  This would allow faster access of medicines to patients around the world, reduce the risk of supply shortages, help resource constrained regulators to rely on each other’s expertise and provide less regulatory burden to industry.  ICH Quality guidelines provide a firm foundation, and ICH Q8-Q12 outline key principles that cover product development by incorporating principles of risk assessments, pharmaceutical quality systems, and lifecycle management. In this two-part session, key aspects of a potential path to a global quality dossier will be presented.  Part 2 presentations will explore patient centric approach to post approval changes and how structured quality data combined with analytics can facilitate consistent and faster regulator assessment.  Part 2 will also include a panel discussion and Q&A with all of the presenters from both Part 1 & Part 2.
    Session Leaders

    Gregory Rullo

    Senior Director, Regulatory Affairs-CMC
    AstraZeneca Pharmaceuticals
    Speakers

    Rodrigo Palacios

    Associate Director, Global Regulatory Policy
    F. Hoffmann-La Roche AG
    Presentation Information
    [Patient Centricity in the Post Approval Space Balancing the Data with the Story]
    Speakers: Sarah Pope Miksinski and Angela Currie
    Due to the overall complexity of the global market and combined with recent learnings from the COVID 19 pandemic, significant efforts remain focused on the challenge of efficient product launch and continued supply following approval. Many factors play into this focus including post-approval efficiency (Q12), global-based post-approval opportunities, mutual reliance, risk based inspections and benefit/risk in the post-approval space. This presentation will identify various post-approval opportunities, with a primary focus on patient centric approaches and potential translation of some key pre-approval initiatives into the post-approval arena.
    || [ICH M4Q Revision: An Opportunity for a Global Quality Dossier]
    Speaker: Lawrence Yu
    The current ICH M4Q(R1), introduced in 2002, provides a harmonized structure and format for presenting quality information of drug submissions. It offers benefits and improvements over the local and paper submissions. Opportunities, however, exist to achieve a greater harmonization worldwide. Recently, ICH formed an informal Working Group to develop the Concept Paper and Business Plan for ICH M4Q revision. This presentation will describe status of ICH’s effort and present the future state of regulatory submission and review for human drugs and biologics. It will also discuss the path to get there, including cloud-computing, M4Q revision, structured data standard, and FDA’s regulatory review digitalization effort.
    || []
    Additional Panelists:
    Blanka Hirschlerová
    Ciby Abraham
    Rodrigo Palacios
    Timothy Watson
  • 1630 - 1730
    Meet & Greet with Women in Pharma at the ISPE Annual Meeting
    Stop by the ISPE Booth to meet Women in Pharma leaders and learn more about Women in Pharma and how you can become a Women in Pharma Ambassador.
  • 1630 - 1830
    Poster Presentations in Expo Hall
  • 1630 - 1830
    Welcome Reception in Expo Hall
Day 3
Tuesday, 2 November 2021
  • 0700 - 0800
    Brighten Your Day with Women in Pharma
    Start your day with us. This will be a time for connection and reflection as we share insight from 2021 and move ahead to 2022! This will be a chance to learn more about our programs, take pictures and network with other WIP members. We will provide refreshments and a special gratitude journal for everyone that joins to take home!  Included with all Annual Meeting Registration Types!
  • 0700 - 1730
    Registration Open
  • 0800 - 1000
    Membership and Awards Breakfast
    Meet ISPE leadership and colleagues while learning about significant achievements made by industry in the past year. Be among the first group to recognize the Overall Winner of the 2021 Facility of the Year Awards (FOYA), and celebrate with your peers as the ISPE International Honor Award and the International Student Poster Competition Award winners are presented.
  • 1000 - 1400
    Expo Hall Open
  • 1030 - 1200
    Concurrent Session: Learnings from COVID - Innovations for Parenteral Productivity/Capacity
    The COVID pandemic has led to a spotlight focus on parenteral operations capabilities and capacity as the industry responded in an unprecedented manner to the need to innoculate billions of people.  Leveraging and scaling technologies and adapting at speed to the emerging therapeutic and vaccine needs has driven a ‘barrier breaking’ mentality within companies and as illustrated by these three case studies the results were spectacular. The presentations will enable attendees learn about approaches to agile and innovative execution that are hopefully also applicable to other technology platforms.
    Session Leaders
    Speakers

    Matt Hall, PhD

    Principal Technical Affairs Manager
    Corning Pharmaceutical Technologies

    Mevluet Yilmaz

    Director of Sales – Pharma North America
    OPTIMA Machinery Corporation

    Lane Hapke

    Vice President of Manufacturing Operations
    Ampio Pharmaceuticals Inc
    Presentation Information
    [Adaptive and Agile Pharmaceutical Manufacturing through Cognitive Cyber-Physical Eco-system]
    Speaker: Ramy Harik
    The unforeseeable COVID outbreak is demanding drastic capacity from the US pharmaceutical industry, where severe drug shortages and large-scale vaccine (and eventually booster) production are unprecedentedly challenging the agility of the global supply chain, resource planning, decisionmakers, and production facilities. Empowering facilities to autonomously discover, plan and control dynamic production schedules driven by governmental drug shortage listings and emergent surgery priorities, will inject the current pharmaceutical manufacturers with new vitality to undertake life-saving responsibilities. This talk discusses a complete cognitive eco-system of digital twins, PharmaNext, which will capture, analyze, understand, and adapt pharmaceutical production facility status, perform edge analytics, identify anomalies, and elevate enterprise intelligence to prescriptive analytics level through an innovative autonomous semantic integration philosophy.
    || [Glass Packaging & Equipment Technologies Augments Manufacturing Capacity]
    Speakers: Matt Hall and Mevluet Yilmaz
    High-speed liquid pharmaceutical fill/finish is essential for the production of high-volume drugs. Maximum filling speeds in the industry can be limited by several non-mechanical factors, including manual container loading, micro stops and commodity quality. Recent innovations in primary glass packaging technology offer solutions to several of these historical limitations. These limitations include damage resistance that decreases glass particulate generation and cosmetic defects, reduced friction on the line that improves operational efficiency, and inherently increased strength that limits breakage and reduces line interventions. An overview of the science that enables these innovations will be provided, followed by a case study from a commercial filling line trials along with aggregate throughput data that quantifies the operational benefits that can be realized with innovative glass packaging. In the latter section, we will provide a look into how a leading equipment manufacturer is exploring methods to augment filling line technologies that can utilize these innovations in glass packaging to increase the overall capacity and output of fill-finish operations. These technologies coupled together can accelerate the delivery of vaccines and help alleviate the drug shortages caused by production bottlenecks.
    || [Pivoting From One to Multiple Production Platforms to Treat COVID]
    Speaker: Lane Hapke
    During the COVID-19 health emergency, the pharmaceutical industry has been challenged to rapidly introduce new medications and/or delivery methods for existing and emerging medications. Ampio Pharmaceuticals has a lead immunomodulatory drug candidate in late-stage development for osteoarthritis of the knee as a 5cc intra-articular injection from sterile single-use vials. This product, Ampion, has demonstrated anti-inflammatory effects, which, when delivered directly to COVID-19 patients may reduce the viral induced cytokine storm and improve clinical outcomes. Ampion development for drug delivery directly to COVID-19 patients via inhalation using sterile vials and via IV systemic application was needed quickly from the existing manufacturing facility. The manufacturing challenge presents itself in the need for new delivery methods of Ampion. This presentation will describe the changes that were made in the manufacturing process, redesigning single-use line sets to accommodate semi-continuously producing drug substance at double the batch size, modifications to the filling process to fill both 10cc vials to support inhalation therapy and 250cc IV bags for direct patient application. The manufacturing facility is now able to support multiple configurations of Ampion drug delivery (injection, IV, inhalation) using modular cleanrooms, minimal fixed equipment, and flexible manufacturing arrangements using single-use closed systems in the original design.
  • 1030 - 1200
    Concurrent Session: Demystifying the Control Strategy
    The Control Strategy becomes more and more important and many different control strategies must be effectively designed, developed, and implemented to secure robust manufacturing and product quality throughout the products lifetime. The label ‘Control Strategy’ is used widely and for different purposes: The control strategy (as defined by ICH Q10), the product control strategy (ICH Q8, Q11), the manufacturing control strategy (the executed product control strategy), the performance-based control strategy (ICH Q12), the cross-contamination control strategy (EU GMP, Vol 4, Annex 1), the lifecycle control strategy including the recently created maturity model by the PAT & LCS CoP and even the holistic control strategy (Pharma 4.0).  Why so many different control strategies? How to they relate? What are the similarities and differences? How to use modern Design of Experiments (DoE) to ensure effective control strategies based on proper process understanding? How are they managed throughout the product lifecycle and the lifecycle of the control strategies? The difference between these control strategies will be demystified, and through case studies we will understand the impact of modern DoE and how the maturity of the control strategies supports fast, robust, and seamless batch and continuous product manufacture in a connected and digital world.
    Speakers
    Presentation Information
    [Modern vs Classical DOE- Reduce Runs and Expand Modelling]
    Speaker: Tara Scherder
    The advantages of designed experiments (DOE) are well recognized, gaining significant popularity in both discovery and process characterization over the past decade. Although many scientists are familiar with classical DOE such as factorial or response surface designs to, they may not be leveraging an optimal approach. So, what's new? Computational advancements have led to new classes of designs having statistical properties that allow: Reduction in the number of experiments, flexibility to assign varying focus to factors, adequate model precision, evaluation of more terms. This can translate to faster experimental decisions, accelerated development, more accurate modelling, and less resources. Characteristics of these new designs will be described, along with examples of the advantages of these methods compared to classical designs.
  • 1030 - 1200
    Concurrent Session: Lifecycle Management and Modernization
    The focus of this session will be on the implementation of modern computerized systems in the pharmaceutical industry.  The presentations in this session will provide insight on how to approach implementing your own specific computerized system strategies through critical thinking and risk analysis.  After participating in this session you will have a better understanding of how to practically modernize software compliance methods for computerized systems in the future.
    Session Leaders
    Speakers

    Khaled Moussally

    Executive Vice President Quality - Clients & Regulatory Relations
    Compliance Group
    Presentation Information
    [Modernization – Lessons Learned Collaborating with GAMP® and CSA]
    Speakers: Ken Shitamoto and Khaled Moussally
    A retrospective journey on navigating change, building credibility, and influence. This presentation describes the journey from observer to thought leadership in the Computer Systems Assurance space. How we achieved success and earned the credibility on the FDA-Industry Computer Systems Assurance Team; how we partnered with GAMP® to co-author the CSA Appendix in the GAMP GPG Data Integrity by Design; a discussion of the key obstacles we faced, lessons learned from the obstacles, and how these lessons apply to both work and life. As a result of this presentation participants will: 1. have pragmatic guidance on how to implement Computer Systems Assurance; 2. understand critical thinking and organizational change management in the context of modernization with resistance from tradition and rituals; 3. have a case study on influence and credibility that can be applied to other topics of interest. Sometimes you just need one entertaining story to realize you can make a difference.
    || [Discovery Mindset: Benefit Patients Through Fast Time to Market]
    Speakers: Mario Moreira and Elizabeth McLellan
    Change is the only constant, and in the pharmaceutical industry, change is required to improve delivery—which benefits both patients and revenue generation through faster time to market. This presentation will address how applying Agile methods—including a discovery mindset—to digitalization of the pharmaceutical industry can help reduce time to market for drug development, which in turn benefits patients.
    || [AI Maturity Model for GxP Application]
    Speakers: Rolf Blumenthal and Nico Erdmann
    Artificial Intelligence (AI) becomes increasingly important to the GxP-regulated areas of the pharmaceutical industry, while the validation of these systems remains uncertain. The classical method of selecting a GAMP category to identify the appropriate computerized system validation (CSV) approach can only be applied to validate the AI infrastructure. However, it does not provide guidance for validating a software system applying trained AI-algorithms . We herein propose a maturity model to fill this gap. The maturity model considers autonomy as well as control design. Autonomy to learn represents the feasibility to automatically perform improvement of the AI system by training. The Control Design determines the capability of the system to monitor and execute the pharmaceutical process automatically. The combination of both determines the generic risk categories of the AI application and builds the basis for a validation strategy. As a result of this presentation participants will understand the limitations regarding the validation of AI applications, can follow the proposed maturity model concept and benefit from the recommendations for the implementation / use of the maturity concept. Our maturity model will act as one of the corner stones to make Artificial Intelligence widely applicable in the GxP area.
  • 1030 - 1200
    Concurrent Session: Pharma and the Environment - How Will We Meet the Needs?
    This session will take a good look into how the pharma industry is committing to reducing or eliminating their impact on the environment.  As the industry looks into environmental controls, sustainability programs and reducing the carbon footprint how are companies evaluating existing buildings, new capital project requirements and other options for renewable energy.  These presentations will take a look into options while the case study review will show how the outcomes can be paramount.  Overall environmental programs from design to construction through operation are key for minimizing impact and obtaining some of our LEED and other awards.  Please join us for the next generation of environmental discussions.
    Session Leaders
    Speakers

    Bailey Forrest

    Senior Director, Project Management & HSE Operations
    Fluor Enterprises, Inc.
    Presentation Information
    [Net Zero Carbon: How will Pharma Meet the Challenge?]
    Speakers: Christopher Lee; Mike Dieterich and Keith Beattie
    Several leading pharmaceutical companies have committed to reducing or eliminating their carbon impacts. For any organization with this goal, how you use your existing facilities and how you continue to grow your business will need to evolve. Understanding where your company needs to make change will require evaluation of existing buildings, capital project requirements, and options for renewable energy. This presentation will review the need for the industry to transition to more sustainable practices across their operations and will highlights decarbonization strategies for existing buildings/renovations and new buildings. It will also provide an overview of certifications that can help you benchmark a project or building’s performance. To provide an owner’s perspective on strategies with carbon goals we will be joined by an owner representative from AstraZeneca.
    || [Delivering a Novel Large Scale API Facility AND Sustainable Goals]
    Speaker: Bailey Forrest
    Upcoming large scale biotechnical manufacturing EPCQ projects will be challenged to meet production scale targets, aggressive timelines AND modern sustainable goals. At the Novo Nordisk DAPI-US Project in Clayton, North Carolina, Sustainable and EHS (Environmental, Health, Safety) outcomes were paramount. The goal was to complete a modern large scale API manufacturing campus (80 acres, 800k SF; three API facilities, $2Bill) that was also efficient and supportive to Novo Nordisk’s sustainable goals. These goals shaped development of the program, and resulted in positive outcomes which have established a lasting legacy for a safe and sustainable culture as the project moves into operations. In relation to these priorities, the project successfully achieved Gold LEED recognition for all 6 buildings, supported Novo Nordisk’s successful commitment to be carbon neutral in 2020, and achieved best-in-class community partnership recognition. This presentation will examine key aspects of the Sustainability/EHS program through the design, the construction and the beginning of operation phases. Successful strategies, and learnings from less successful strategies will be reviewed.
    || [Environmental Control and Sustainability - Challenging the Norm]
    Speaker: Norman Goldschmidt
    The industry has been changing, with new equipment, new technologies and new expectations challenging traditional facility design and operations. Have Environmental Control or Sustainability Questions keeping you up at night? “Is there any way to save energy and reduce carbon emissions in Life Science Cleanrooms?” “Are our manufacturing facilities safe from COVID-19 or similar viruses?” “What do investigators expect in Smoke Studies?” “How do I use CFD to help design more efficient cleanrooms?"" “Do I need high air change rates for my operations?” The Sustainability Facilities, HVAC and Controlled Environments COP can help! In this presentation we will: 1. Review the latest practices and standards for energy efficient cleanroom design. 2. Get insight into the HVAC implications of the upcoming Annex 1 revision. 3. Demystify the Environmental Control challenges of ATMP production. 4. Outline how system configuration significantly impacts energy. 5. And more… Is your concern not on this list? Don’t worry, this is your chance to “Challenge OUR Norm”. Norm Goldschmidt and Nick Haycocks will provide insight and answers to your questions about Design, Operation, Qualification and Regulation… No Holds Barred, ask your toughest questions to challenge COP experts..."
  • 1030 - 1200
    Concurrent Session: SCOPE Response To Pandemic Challenges
    Welcome to our session titled ‘Response to Pandemic Challenges’! This aptly named session features two presentations – 1. Resilient Manufacturing for Handling Disruptions, and 2. Pandemic-inspired supply chain solutions. Even before the COVID-19 pandemic challenged the life sciences industry, demand in the life sciences construction sector was outpacing supply. But with the pandemic, Project Warp Speed and COVID-19 vaccines fueling new demand, the supply chain is struggling to keep up with demands and supply for key ingredients and finished products. This session will examine some key aspects, including but not restricted to: Designing digital and agile manufacturing process to mitigate the effects of disruption Plan how to make manufacturing more agile Understand how the life sciences industry can adapt to supply chain delays Share lessons learned to strengthen domestic supply chains through improved manufacturing and construction techniques Come join our dynamic presenters – Jeff Peragallo (Director and VP of Operations at Linesight), Brian A. Curran (Sr. VP at MasterControl) and Regina Fullin (VP of Regulatory Affairs and Quality Assurance at Compliance Team).
    Session Leaders
    Speakers

    Brian Curran

    Senior Vice President of Manufacturing Customer Success
    MasterControl

    Regina Maria Fullin

    Vice President of Regulatory Affairs and Quality Assurance Consulting
    Compliance Team, LLC
    Presentation Information
    [Pandemic-inspired Supply Chain Solutions]
    Speaker: Jeff Peragallo
    Even before the COVID-19 pandemic challenged the life sciences industry, demand in the life sciences construction sector was outpacing supply. But with the pandemic, Project Warp Speed and COVID-19 vaccines fueling new demand, the supply chain is struggling to keep up with demand for vaccines and therapies. With 30 percent of all U.S. building products being imported from China and some American construction firms relying on China for up to 80 percent of their materials, border closures and increased demand created the perfect storm of supply chain and project delays for vital projects. A year after the pandemic, the life sciences construction industry has learned new lessons in managing supply chain delays and improving project timelines. This presentation will examine: 1. How Biden’s Buy American plan will change the life sciences construction industry 2. Lessons learned to strengthen domestic supply chains through improved manufacturing and construction techniques 3. How the life sciences industry can adapt to supply chain delays 4. The role of clients and construction consultants in supply chain management 5. What’s ahead for the life sciences construction industry.
    || [Resilient Manufacturing for Handling Disruptions]
    Speakers: Brian Curran and Regina Fullin
    The COVID-19 pandemic was a rude awakening for manufacturers. Firms that felt adequately prepared soon discovered there were gaps in their preparation. The pandemic might be on its way out, but disruption can and does happen in other forms. Pharma companies can’t avoid this, but they can avoid dramatic repercussions. By designing a digital and agile manufacturing process, pharma manufacturers can decrease the effect of disruption to their processes. A prime example of this agility is digitized batch records. Pharma companies that were using paper batch records had no visibility into the process at a time when so many were working from home. Firms that had adopted digitized batch records before the pandemic were able to scale and pivot, quickly adjusting to changes in their supply chains and demand. Bringing automation to the manufacturing line also simplified compliance and significantly decreased the time needed for batch review.
  • 1030 - 1200
    Concurrent Session: Advancing Pharmaceutical Quality - Quality Management Maturity
    This session focuses on Advancing Pharmaceutical Quality (APQ) and specifically the APQ Quality Maturity Framework that has been developed by ISPE over the past 3 years evolving from ISPE’s research in response to FDA Quality Metrics draft guidance and ISPE’s Cultural Excellence report.  This industry-for-industry quality maturity framework provides an Assess, Aspire, Act and Advance model for quality management maturity.  In this session, industry experts will provide the APQ Quality Management Maturity Framework and will provide their learnings from the Quality Metrics Feedback Program.  FDA will present its journey toward assessing quality management maturity as well as their learnings from the FDA Quality Metrics Feedback Program.  Further, FDA will provide an update on the Quality Management Maturity Pilot.
    Session Leaders

    Tami J. Frederick

    Senior Director, Corporate Quality Systems & Cultural Excellence
    Perrigo
    Speakers

    Tami J. Frederick

    Senior Director, Corporate Quality Systems & Cultural Excellence
    Perrigo
    Presentation Information
    [Advancing Pharmaceutical Quality: Management Responsibilities and Management Review Practical Guide]
    Speaker: Michael Grischeau
    This important presentation will dive into the details of the Advancing Pharmaceutical Quality Program to emphasize the Management Responsibilities and Management Review (MRR) aspects of ICH Q10. The APQ team will share the Assess, Aspire, Act and Advance model for MRR and will show a practical example of it’s use in industry. Quality Management Maturity through the APQ program will demonstrate how an organization can understand their current state of maturity, advance their maturity, and how this improvement results in value to the business beyond compliance.
    || [An Update on CDER’s Pilot Programs: Quality Metrics (QM) and Quality Management Maturity (QMM)]
    Speaker: Nandini Rakala
    FDA will provide updates on the FDA Metrics programs as well as the Quality Management Maturity Pilot program and share insights on the same.
    || [Advancing Pharmaceutical Quality:Quality Management Maturity Program]
    Speaker: Tami Frederick
    This presentation will cover ISPE’s Advancing Pharmaceutical Quality Program developed by industry to advance the current state of pharmaceutical quality by providing practical tools and approaches to enhance the effectiveness of the Pharmaceutical Quality System. The Model will provide a means to Assess, Aspire, Act and Advance the state of the Pharmaceutical Quality System. The APQ team have incorporated Cultural Excellence as a foundation for the overall Quality Management Maturity Program and will share the importance the six dimensions of Cultural Excellence enhanced with a Robust Rewards and Recognition Model.
  • 1200 - 1400
    ISPE Foundation Virtual Golf Experience
  • 1200 - 1400
    Networking Lunch in Expo Hall
  • 1200 - 1400
    Poster Presentations in Expo Hall
  • 1400 - 1530
    Concurrent Session: ATMP - New Modality Processing Approaches
    Innovative ATMP treatments for patients have come a long way since the first insertion gene therapy clinical trial in 1990. Since then over 3,000 clinical trials have been initiated with a growing number of therapeutics, addressing many complex and unmet needs, approved by regulators around the world. The technology platform is coming of age and this session shares some of the opportunities and challenges of bringing such processing to the next level.  From the challenges of developing and designing facilities and processes for personalised, single patient treatments to the development of uniquely agile quality management systems the presentations in this session will focus on how the industry is responding while remaining aligned with the emerging regulatory guidance on such processing.
    Session Leaders
    Speakers

    Parikshit Sanghavi

    Supply Chain & Manufacturing Leader for North America
    Cognizant Life Science Manufacturing
    Presentation Information
    [Impact of New Drug Therapies on Manufacturing]
    Speaker: Parikshit Sanghavi
    Next generation therapeutic modalities such as Cell & Gene Therapy promise to bring significant advances in medicine with the halting or reversal of the damage caused by some of the world’s most complex diseases. This brings with it transformational change to the manufacturing supply chain to deliver these therapies to the end patient. Within these modalities, manufacturing is adapting from the historic quite centralised large volume one recipe fits all manufacturing push model to a far more decentralised and prolific lab scale pull manufacturing network providing unique personalised care localised to the patient with manufacturing taking place in within hours & days from collection to transfusion back to the patient. The presentation will explore what does this mean for current S95 manufacturing automation systems and technologies in order to enable this tectonic shift and what are the emerging automation needs for these new manufacturing methods.
    || [Car-T Facility Design - Autologous vs. Allogeneic]
    Speakers: Michael Lennon and Christian Estes
    Chimeric antigen receptor T cell (CAR-T) therapy clinical and commercial scale manufacturing has exploded as its own sector within the Cell and Gene industry. Emerging manufacturers are looking for the limits on their ability to plan for scaling their production. Many are now understanding the specific facility requirements for producing both Autologous and Allogeneic products and what scaling methods can be applied, whether it be scaling up, scaling out, or a combination of both, Scaling Squared (S2). We will compare these two facilities types, which have similarities and differences that are important to understand in order to determine how production can be scaled. We will describe the difference between Autologous and Allogeneic CAR-T product requirements, examples of clinical and commercial scale manufacturing facilities, and highlight their specific differences. These requirements directly drive initial capital investments for young or transitioning manufacturing companies, and therefore become a hurdle toward getting from R&D to Clinical/Commercialization. Participants will better understand: How Autologous and Allogeneic Car-T products are manufactured. See examples of each facility type highlighting their differences and how to expand each. Better understand what it takes to move from one product type to another, even in a single facility (multi-product).
    || [Cell and Gene Therapy Regulatory and Commercial Challenges]
    Speaker: Peter Millili
    In 2021, the ISPE Regulatory and Quality Harmonization Committee's (RQHC) North American Focus group is exploring the regulatory and commercial challenges associated with cell and gene therapy. Taking into consideration the evolution of this field in recent years, with rapid expansion of facilities around the world and the first commercial approvals of cell therapy molecules in particular, key technical challenges in the commercialization and lifecycle management of these molecules are presenting, which intersect with the quality and regulatory environment. Furthermore, as commercialization progresses and industry experience is gained, specific areas of opportunity for alignment are becoming clear. From managing capacity constraints, to navigating rapid cycle times required by the nature of this type of therapy, to prioritizing key process improvements that enable a step-change in the field, it is important for cross-industry learning so that the dialogue can begin on how to take this growing field into the future. To that end, a sub-team of the RQHC North American Focus group will explore these topics from the perspective of a cross-industry team, summarizing areas of focus/learnings to date, while also identifying areas of future engagement with health authorities.
  • 1400 - 1530
    Concurrent Session: Aseptic Facilities and Technologies
    Focused on aseptic facilities and technologies, this session will take attendees through relevant and cutting edge topics currently affecting the production of parenteral products. Attendees will dive into the challenges which are often found in aging facilities and learn about strategies for the justification and execution of modernization projects. They will also uncover recent learnings from the practical application of Single Use Systems and find out whether this trend will continue as a viable option over stainless steel (or, is there another option…?) Finally, with the need for more vaccine and biological facilities, product safety and operator exposure are at the forefront of facility design requirements. This session will conclude with strategies for effective and repeatable Bio-decontamination cycles based on the analysis of available technologies.
    Session Leaders
    Speakers

    Justin Walsh

    Application & Business Development Engineer
    Vaisala Inc
    Presentation Information
    [Single-Use Vs Stainless Steel: Are Hybrid Facilities the Best of Both Worlds?]
    Speaker: Lindsay Smart
    The pharmaceutical industry is constantly facing severe time and cost pressures. In order to react to new developments quickly the focus is ever increasingly centered on time-to-market as well as modular, highly flexible production concepts for new products. During the planning phase for so-called fast-track projects, single-use technologies (SUT) are becoming increasingly more important. However, it is suggested the optimal industry solution should rely on a hybrid of customized single-use and stainless steel solutions. State-of-the-art hybrid solutions are based on well-designed engineering concepts, combining SUT with high-tech stainless steel components. Therefore, benefits of both system types can be realized: low investment costs, high flexibility and shorter set-up times of SUT along with durability, optimized automation and process safety, integrity and reproducibility of stainless steel components. Case studies will illustrate the differing levels of SUT integration in biomanufacturing facilities and: 1. how customized dancefloor concepts improve process functionality, ergonomics, operator safety, simplify maintenance and minimize the design footprint of such facilities. 2. how supplier agnostic concepts can utilize a plug-and-play stainless steel “backbone” to integrate SUT and automation platforms from any provider. 3. how customized assemblies can be interconnected with highly sophisticated mechanical and automation cross-functionality to optimize facility layout.
    || [Measurement & Control of Hydrogen Peroxide Bio-Decontamination Cycles]
    Speaker: Justin Walsh
    This presentation will discuss how to measure and control a vaporized hydrogen peroxide bio-decontamination process effectively and repeatedly. It will begin with the basics of hydrogen peroxide use in bio-decontamination processes, the different applications it benefits, and what advantages it has over other methods. We will cover the bio-decontamination cycle phases and the importance of real-time measurements to control each cycle. We recognize the importance of these measurements to ensure the conditions of the validated cycle are reproduced accurately and repeatedly. One of the ways to ensure conditions are being met consistently is to understand the different variables and parameters available, so the difference between relative humidity and relative saturation will be highlighted. We promote the use of the parameter to make control decisions, as this unit more accurately represents the risk of unwanted condensation in the process. We will evaluate different measurement technologies, their benefits, and challenges, as well as the measurement ranges that they are capable of. In the fourth section, we will give you some tips about mounting and positioning of sensors, discuss how temperature mapping can further aid in condensation prevention, and conclude with an analysis of H202 sensor calibration to maintain stable process measurements.
    || [Is Your Facility on Borrowed Time? Part 1]
    Speakers: Jason Collins and Chris Schwartz
    In the opening plenary session at the 2021 ISPE Aseptic Conference, Rick Friedman addressed the continuum of legacy facilities stating: “Older facilities typically include processing lines and facility layouts that are less effective at mitigating the various operational variables that pose risk to product sterility.” There are countless aging sterile injectable facilities around the world that continue to operate on the edge of regulatory failure. They continue limping along for years, squeezing though audits based on extensive data reviews and the application of increased procedural controls. 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 learning series is for you. This presentation will address how to identify the regulatory risks and potential consequences of not reinvesting and making facility or equipment improvements that meet today’s sterile injectable manufacturing standards. It will also cover the principles of putting together a business case to clearly communicate the justification for the facility or equipment upgrades. Lastly, this talk will also examine potential solutions and strategies for retrofitting a facility with minimal impact to ongoing operations.
  • 1400 - 1530
    Concurrent Session: Elements of Digitalization in the Pharma 4.0 Journey
    The session will examine the components required as the industry progresses towards an implementation of the Pharma 4.0 concept where manufacturing is driven by the digitization of processes and methodologies.  The speakers will explore various aspects required in the realization of a Pharma 4.0 enabled facility including the building of digital solutions in a GMP environment, the digitization of SOPs, the elimination of paper and data capture to produce a digital batch record.  We will hear a case study that provides insight into the delivery of data as a validation package and the benefits that will transform the validation efforts moving forward.  Within the context of Pharma 4.0 we will also review the function of the operator in this new environment and how their role will change from one of system monitoring to the role of contributor and collaborator and the tools required to achieve this paradigm shift.
    Session Leaders
    Speakers
    Presentation Information
    [Validation is gone – a case study in data to tell the story]
    Speaker: Levi Schenk
    A case study on how IT validation deliverables can be captured fully electronically and viewed in a data analytics form (Power BI). More details are in the attached information sheet, this would stitch the themes of Pharma 4.0, CSA, and Data Integrity together showing how we can display fitness-for-intended use through our daily work and make validation an exercise in data analytics not documents.
    || [eBR in Pharma 4.0 - Instrumenting the Manufacturing Processes]
    Speakers: Gilad Langer and Patrick Heytt
    Our industry is arguably still stuck in the Pharma 2.0 paradigm where processes are paper based, rigid and constraint. In addition the digital technology that we consider best of breed are really relics of Pharma 3.0, monolithic systems that take an immense effort to implement and yield nothing more than an electronic version of the paper we so much are reliant on. The presentation will exemplify digital tools to rapidly digitize batch information by the people who develop and use the batch records. We call this democratizing the history record and is a core principle driving digital transformation. This interesting method has been adopted by GSK and J&J and is already yielding some positive results. In this session you can learn how digital technology is used for rapid development of solutions to instrument the manufacturing processes and capture batch information.
    || [4.0 & Digital Quality Transformation Journey: The eQMS Project]
    Speaker: Teresa Minero
  • 1400 - 1530
    Concurrent Session: Project Management in a Warp Speed Environment
    This session will look at and assess how Project Warp Speed has changed how projects are developed, assessed and executed.  Everything from how much risk the project contains to how much can be tolerated has given the industry a new definition of “fast”.  The session will discuss the efforts and overall project timeline as well how to maintain safety and improve supply chain.  The case study will provide specific examples of areas for awareness and potential pitfalls.  Leverage in the single use market to how decision makers and planners can use the technology to improve execution and production flow from APIs to vaccines.  This session will be vital to  how we as an industry can respond in the future.
    Session Leaders
    Speakers

    Thomas Page, PhD

    Vice President, Engineering and Asset Development
    Fujifilm Diosynth Biotechnologies

    Leigh Formanek

    Director of Construction & Project Services; US Lean Leader
    DPS Group Global
    Presentation Information
    [Applying Warp Speed Lessons to Your Next Manufacturing Facility]
    Speakers: JP Bornholdt and Thomas Page
    Many of the life sciences trends that are driving innovation today were here pre-COVID, but the pandemic was an accelerant. This is true of the vaccine research that is moving at rapid speed to curb this acute global crisis, but it doesn’t stop there. The same tide is lifting all areas of the life sciences industry. This is particularly true for advanced therapy medicinal products. The pandemic is pushing the envelope on speed-to-market to the point that facility design and construction may be experiencing a paradigm shift. The tried-and-true approach needs to be revisited as Operation Warp Speed is demanding the biopharmaceutical industry to navigate uncharted territory. During this presentation, we will highlight lessons learned from a Warp Speed project and provide advice and new approaches on how to apply these lessons to the future of ATMP manufacturing.
    || [Project Management in a Warp Speed Environment]
    Speakers: Leigh Formanek, Bruce Klopfenstein
    Operation Warp Speed has led to a new meaning of “fast” in the life sciences industry as companies accelerate the development, manufacturing and distribution of vaccines, therapeutics and diagnostics (known as counter measures) in response to the COVID-19 pandemic. In order to meet Warp Speed demands while maintaining standards for safety and efficacy, companies must closely coordinate their efforts across the product timeline. Architecture, Engineering and Construction (A/E/C) companies like DPS play a vital role in these Warp Speed pursuits to expedite the engineering, procurement, construction management and validation (EPCMV) of licensed facilities more quickly than ever before. Presentation regarding how to strategize and execute projects at warp speed.
  • 1400 - 1530
    Concurrent Session: Packaging and Supply Chain Improvement
    Packaging Excellence is a critical aspect of drug manufacturing. A container closure system refers to the sum of packaging components that together contain and protect the dosage form. In this session, Container Closure Integrity (CCI) will be addressed, emphasizing balance and optimization of the critical variables using strong process information.  In a related topic, business continuity management (BCM) will be discussed.  BCM is critical to ensure that the necessary infrastructure and procedures are in place and personnel are prepared to appropriately respond when disruptive incidents do occur.
    Session Leaders
    Speakers
    Presentation Information
    [Systematically Safeguarding Container Closure Integrity]
    Speaker: Qingyu Zeng
    Any systematical pharmaceutical manufacturing approach for ensuring container closure system (CCS) performance must include choosing qualified CCS components and proper manufacturing process setup as well as applicable testing methods. Systematic considerations are required to ensure container closure integrity (CCI) performance through entire product shelf life. In order to minimize risks, the practical strategy must balance and optimize some critical variables through a data-driven approach for informed decision-making for the best CCS performance. This presentation is to address the systematic considerations for Safeguarding Container Closure Integrity Through A Systematic Approach.
    || [Supply Chain Business Continuity in Drug Development]
    Speaker: Bikash Chatterjee
    Business continuity refers to the ability of a company to continue to perform critical business functions in the case of disruptions such as natural disasters, fires, computer system crashes and geopolitical events. Business continuity management (BCM) involves the development and implementation of a management strategy to ensure that the necessary infrastructure and procedures are in place and personnel are prepared to appropriately respond when incidents do occur. This presentation will discuss a framework for analyzing your supply chian as part of a BC exercise and its implications from a regulatory and CMC perspective.
  • 1400 - 1530
    Concurrent Session: Lessons Learned on Virtual Inspections and What to Take Forward Post-Pandemic
    This session will explore how both industry and regulatory authorities have adapted to manage our governance responsibilities during the COVID-19 pandemic when travel was restricted, and resources of many types were scarce.  We will discuss the Lessons we have Learned – what worked, what didn’t work so well, and what we feel is valuable to take forward as we move into the “new normal” with more remote work.  Speakers will represent a global perspective including the cross-industry collaboration on the IFPMA paper on Virtual Inspections, results from the EFPIA Survey on Inspection Practices, as well as insights from both MHRA and WHO.
    Session Leaders
    Speakers

    Ian Jackson

    Unit Manager, Inspection Risk, Control and Governance
    MHRA

    Joey Gouws, PhD

    Team Lead, Inspection Services, Prequalification Team
    World Health Organization
    Presentation Information
    [Alternative GMP/GDP Inspection Practices]
    Speaker: Sarah Barkow
    In the early days of the 2020 COVID-19 pandemic many GMP and GDP inspections were postponed due to travel restrictions. In order to maintain the supply of medical products it quickly became necessary for both industry and health authorities to explore alternative or supplemental approaches to on-site inspections. The IFPMA GMP Task Force developed a paper based on the biopharmaceutical research-based industry’s experience related to conducting and receiving remote inspections. This paper was shared broadly across industry and health authorities to establish common understanding and definitions for using technology to enable virtual assessments. The presentation will discuss the content of the paper as well as learnings from companies having had virtual inspections over the last months.
    || [Pandemic Lessons Learned: The Regulatory Inspections Toolbox]
    Speaker: Stephan Rönninger
    Complying with regulatory processes and ensuring continuous supply can be a challenge especially during crises such as the COVID-19 pandemic. Practicable experience will be presented on alternative approaches to on-site inspections based on learnings from EFPIA member companies. This presentation will demonstrate the pros and cons using paper-based or e-technology enabled inspections. Reality demonstrated that reliance and recognition is possible while utilizing expertise and opportunities from local inspectorates. Added value is demonstrated in retaining these practices beyond the pandemic situation e.g., based on data from the annual inspection survey among EFPIA member companies and guidance available from the Pharmaceutical Inspection Corporation Scheme (PIC/S). Lessons learned for both pre-approval and routine inspections could be permanently implemented, in compliance with existing legislation.
  • 1530 - 1600
    Break
  • 1600 - 1730
    Concurrent Session: Continuous Drug Substance Manufacturing - Coming of Age
    Continuous processing (CP) has long been heralded as a breakthrough innovation for pharmaceutical processing.  The approach has been actively encouraged as a route to ‘cleaner, flexible and more efficient’ processing (Dr. Janet Woodcock, FDA, AAPS Meeting, 2011). While significant progress has been made in realising this objective in drug product manufacturing, progress on its application at a large scale in drug substance / API processing has lagged expectations. This session presents the experiences of two pharmaceutical companies who have made significant investments in this area for both small and large molecule therapies. Their insights into the challenges of such processing and especially as to how the digital technologies inherent in Pharma 4.0 can enable the CP vision will form an interesting and hopefully educational final session in the 2021 Annual Meeting Agile Innovation stream.
    Session Leaders
    Speakers

    Kevin Seibert, PhD

    Engineering Fellow, Synthetic Molecule Design and Development
    Eli Lilly and Co
    Presentation Information
    [Perspectives on a Hybrid Continuous Peptide Manufacturing Scale-up]
    Speaker: Kevin Seibert
    Eli Lilly and Company have utilized continuous processing technology in development and manufacturing environments for over a decade. In 2017, a Small Volume Continuous (SVC) facility was built to further expand the use of continuous processing technology. The facility was awarded the ISPE Process Innovation Award in 2019. Recently a new synthetic approach to a peptide production process for the treatment of diabetes using traditional solid phase peptide synthesis along with liquid phase peptide synthesis incorporating continuous processing technology has been developed. To meet projected product demands, a new peptide manufacturing facility, IE2b, is due to come online in 2022. This presentation will provide an overview of the drivers to develop a manufacturing platform using continuous synthesis methodologies for commercial peptide manufacturing and insights into the novel design concepts incorporated into the new IE2b peptide manufacturing building. We will discuss some of the significant manufacturing challenges and considerations associated with using continuous synthesis technology and with scaling from development to the SVC facility to a new commercial peptide manufacturing facility. The presentation will also cover an overview of some of the digital plant initiatives adopted to support the scale up and enable efficient long term commercial supply from the IE2b peptide manufacturing facility.
    || [Implementation of Continuous Manufacturing for Monoclonal Antibodies]
    Speaker: Tom Ransohoff
    Significant progress has been made at demonstrating the feasibility and value of intensified and continuous manufacturing of monoclonal antibodies (mAbs) and other biologics at pilot scale. Furthermore, regulatory guidance and standards for continuous manufacturing are emerging. An overview of strategies for overcoming the challenges in GMP implementation of continuous biomanufacturing will be presented. Approaches for batch definition, microbiological control, process development and other topics will be reviewed. These strategies are based on a review of broad industry applications along with specific experiences related to development of a continuous manufacturing platform at Resilience.
  • 1600 - 1730
    Concurrent Session: Data Analytics and AI
    At the forefront of digital transformation in the pharmaceutical industry, Data Analytics and AI are among some of the key technologies involved. What makes AI a foundational element for advanced process control in biomanufacturing? How does predictive maintenance become a reality in process intensive aseptic operations? What are some regulatory challenges involved? And how can risks associated with a Big Data infrastructure be mitigated to drive Operational Excellence? These are the questions being addressed in this session. Three broad presentations will dive into the application challenges in a pharmaceutical manufacturing environment while highlighting some of the immense benefits and promises offered by Data Analytics and AI.
    Session Leaders
    Speakers

    Rick Jarrell

    Business Development – Life Science – Americas
    Eurotherm by Schneider Electric

    Andy Alasso

    Senior Vice President, Product Management
    Aizon
    Presentation Information
    [A Data Analytics & AI Driven Approach to Inform Aseptic Processing]
    Speaker: Vaibhav Kshirsagar
    A time consuming, energy-intensive and expensive operation such as Freeze Drying requires constant monitoring of all system components -the product, process & equipment. An average freeze dryer logs data from over 200 sensor and equipment tags amounting to about 5 billion data points per year. Moreover, the impact of process deviations or equipment failures on product valued in the millions of dollars could be catastrophic. The current state of monitoring equipment performance relies on a reactionary approach, where any failure or unplanned event is followed by a corrective action. This causes frequent production rescheduling and increased equipment downtime. By performing a thorough analysis of failure modes seen in different subsystems, a necessary set of sensors was identified. Process and equipment specific models were deployed on this sensor data. Training regions that captured predefined failures determined through a root cause analysis were established and semi-supervised models were developed. A system architecture to enable secure data transfer from equipment to the cloud suitable for pharmaceutical environments has been put together.
    || [Risk Mitigation for Higher Levels of Data Integrity]
    Speaker: Rick Jarrell
    Never before have Life Science companies been able to collect and analyze such large amounts of data. Big Data is here for this industry, as is the ability to analyze that data. However, how do businesses work to increase assurances that the data collected is of the highest integrity possible? This is of even a higher concern when data is collected from a regulated GMP process or environment. What guidance is available from the market and regulatory agencies that will help deliver solutions for high data integrity? What risk mitigation strategies can be employed to make certain that systems and processes support high levels data integrity? In the end, high data integrity is of paramount concern for those needing to address both product quality and product safety issues.
    || [AI: The Core Foundation to Control of Biomanufacturing Processes]
    Speaker: Andy Alasso
    Biomanufacturing processes continue to grow in complexity and Pharma 4.0 technologies promise to propel the industry into a new modern era of efficient manufacturing and higher quality. The foundational element to achieve the promises of this new era lie in the adoption of artificial intelligence (AI). AI enables the management of multi-parametric reality from other statistical dimensions and human knowledge as the specific ingredient that leads to the augmented control into the batch. AI principles will be described, including its place in regulated industries, and case studies cases will be used to demonstrate that AI is a reality in pharma manufacturing.
  • 1600 - 1730
    The application of blockchain technology to help the medical supply chain become more secure and resilient is increasingly gaining more traction in our industry.  During this session we will hear from three speakers exploring actual use cases of the technology and the benefits, and learnings, in their experience.
    Session Leaders
    Speakers
    Presentation Information
    [Blockchain for Medical Research]
    Speaker: Sean Manion
    It takes 17 years on average to bring new medical treatments ideas into evidence-based clinical practice. The growing replicability crisis in science further delays these "new miracles." Blockchain can improve science and accelerate medical research while bringing a new layer of trust to healthcare. The presenter will share his experience and insights on helping to innovate medical research using emerging technology. The application of real-world-evidence has become center stage following the COVID-19 pandemic and the need for a common governance to performing scientific research has never been greater.
    || [Application of Blockchain for Verification of Saleable Returns]
    Speaker: Gregg Gorniak
    Enacted in 2013, the Drug Supply Chain Security Act (DSCSA) is a ten year journey to ensure a safe and secure supply chain in the US through an electronic, interoperable system to verify, authenticate, and trace prescription drugs. This presentation will take the audience through the major milestones that have been achieved thus far and describe how blockchain is being used to facilitate the verification of saleable returns. Blockchain usage for Verification of Saleable returns is one of the largest production use cases of blockchain in pharma. The presenter will discuss how GSK used the technology to meet the DSCSA regulatory requirements.
    || [Takeda’s Plasma Derived Therapies Business Unit]
    Speaker: Nathaniel Arlander
    The demand for plasma derived therapies is steadily growing and our ability to source plasma continues to be a constraint on the industry. As Takeda strives to optimize the use of each and every drop of this precious resource we need to innovate in order to make our current processes more efficient. As we think about the future of the plasma industry it becomes even more important that we have an industry level utility that can trust and share information across the entire ecosystem. Using a distributed system to capture the providence and data generated from each plasma donation, from the time it is collected to the time a finished therapy is dispensed brings a level of trust and transparency to our regulators. We believe this will raise the bar for how plasma is collected and distributed allowing for the industry to create new products and open new markets. This presentation is a case study of our efforts to date and the lessons we have learned (both internal and external) as we have stood up our MVP.
  • 1600 - 1730
    Concurrent Session: Steps to Success in a Pharma Facility
    There are emerging requirements for the safe and effective manufacturing of such new entity types as ATMPs and 3D cellular constructs. Factory-in-a box advances including prefabricated design, and process simplifications are providing flexible and future-proofed facilities. 4.0 developments in pharma now include digital twin modeling, vision guided robotics and packaging automation. This session will explore evolving approaches to facility design and scale-up planning, as well as automation in process trains that support such emerging entities as cell therapies and printed organoids.
    Session Leaders
    Speakers

    Trevor Stenzel

    Operations Manager - Advanced Manufacturing Services (AMS)
    Jacobs

    Tim W. Lisle

    Director of Process Architecture
    Precis Engineering, Inc.
    Presentation Information
    [Steps to Success: Planning the First Manufacturing Space]
    Speakers: Kristina Pumphrey and Tim Lisle
    Over the past decade the landscape of the pharmaceutical industry has changed with the innovations of new technologies, like ATMPs. There are more start-up companies that are looking for their first manufacturing space. This presentation will look at the challenges a companies faces at the start of their manufacturing journey. Understanding initial needs and how to get through the early stages of growth is the first key to long-term company success. This presentation will address newly evolving scale-up and manufacturing needs related to ATMP processes, associated equipment, and facilities supporting these operations. We will look at challenges and lessons learned in designing the first manufacturing facilities often on a limited budget. With proper planning and assistance the client can navigate the regulatory and quality requirements within specific budget and schedule constraints.
    || [3D Bioprinting Suite and Facility Design Considerations]
    Speaker: William Whitford
    Co-author: Toni Manzano, CSO and Co-founder, Aizon / Professor, Universitat Autònoma de Barcelona
    Both 3D bioprinting technologies and applications are developing at an extremely fast pace. Diverse analytical and diagnostic products made using bioprinting technologies include microfluidic devices, organ-on-a-chip systems, and 3D in vitro tissue models for both drug research and clinical diagnostics. Therapeutic products are also beginning to be developed and include bioprinted patches, tissues, and even organs. For the regulation of these products, the US FDA has spoken on the issue of the certification of 3D printed medical devices. However, 3D bioprinting technology is so new and dynamic that basic questions remain regarding practical requirements for the manufacturing of diagnostic and therapeutic materials, devices and cell therapies. Facility and work-flow solutions are dependent upon many process design and compliance factors. As technological and regulatory obstacles are being removed, the development of biomanufacturing operations raises new considerations. These considerations include whether the product is indication-specific, patient-specific or customizable- as well as hospital-made or mass produced. We will present current thoughts on facilities and workflows for the regulated manufacturing of 3D bioprinted products.
    || [Robots and Pharma]
    Speakers: Andrew Baird and Trevor Sterzel
    This presentation describes the potential benefits provided by the further use of robotics and automation in the pharmaceuticals industry. Through a plethora of legacy and emerging robotic technologies, there are endless areas for automation to exist within a pharma facility. This presentation describes a few of those cases as well as the process in which we go about implementing these automated solutions. Topics include, but are not limited to: 3D Simulation, Digital Twin, Robots versus Cobots, Adaptive Gripper Technology, Vision-Guided Robots, AGVs, and the current state of Robots and the Pharma industry. This presentation includes multiple case studies. Specifically, a case study involving a Festo Pharmaceutical Additives Packaging Line that has been completely automated. Presenters will also begin to dig in to the process that we are currently going through in order to fully-automate a Pharma facility that handles Plasma Bottles.
  • 1600 - 1730
    Concurrent Session: Improving Operations Through Efficiency
    Digital work instructions are a tool that is becoming more and more prevalent. Digital work instructions can help personnel be more efficient while capturing critical data can allow manufacturing, QC, and warehouse managers to more quickly improve the way task steps are executed.   In this session, Improving Operations Through Efficiency, presenters from the manufacturing and software sides will discuss the IT challenges and the impact to business and regulatory to consider when implementing this exciting technology.  As quality and Digital Transformation become more important, Testing and SQA teams must adapt, changing compliance and documentation practices to adopt modern tools and methodologies. Many organizations struggle with how to make this transformation possible.  Utilizing a case study, one part of this session will discuss how to modernize software compliance to support digital transformation and the strategic adoption of a CSA model to improve efficiency while remaining compliant with regulatory bodies and your own Quality Organization. Additionally, GMP industry has been scrutinizing vendors/suppliers with more rigorous qualification programs to determine if they can provide the necessary goods or services to the standards that the GMP company requires. The Quality System approach calls for periodic auditing of suppliers based on risk assessment either by paper, on-site, or both even for processing aids such as cleaners, disinfectants and other Life Sciences consumables.  As part of this session, risk-based evaluations of process aids and how these may impact the process, assigning requirements based on risk level and industry trends for compliance for vendors of processing aids, will be discussed.
    Session Leaders
    Speakers
    Presentation Information
    [Case Study: GxP Digital Work Instructions - Pharma Manufacturing]
    Speakers: Padraig Culbert and Philip Gammell
    Many companies are exploring digitalisation and the key challenges they face, include trying to predict how these new technologies and methods will integrate into their businesses and deliver important benefits. Regulatory compliance is also a key consideration. This presentation will cover an important case study into these issues. Astellas implemented digital work instructions in the GxP operation of a pharmaceutical packaging line as part of a pilot aimed at examining the value of the new technology and methods for the business. The digital work instruction solution was implemented by Connect Academy. The study examines the results of the pilot to date across four strands: human factors, technology, regulatory and business.
    || [Digital Compliance: Practical Considerations to Modernize CSV and Adopt CSA]
    Speaker: Dori Gonzalez-Acevedo
    Burdensome documents have become the focus of Computer Systems Validation and the testing of regulated systems. As actual quality and Digital Transformation become more important, Testing and SQA teams must adapt, changing compliance and documentation practices to adopt modern tools and methodologies. Many organizations struggle with how to make this transformation possible. Through a case study analysis, Tx3 will discuss how to practically modernize software compliance to support digital transformation and the strategic adoption of a CSA model. This presentation will cover: Enable Digital Validation – more than just applying electronic signatures; Support Digital Transformation while complying to regulations; How to apply the CSA model to a modern CSV program; and Best practices – considering your people, processes, and technology.
    || [Supplier Qualification for Non-GMP Regulated Materials]
    Speaker: Elizabeth Rivera
    Since the launch of FDA Guidance on Quality Systems (QS), the GMP industry has been scrutinizing vendors/suppliers with more rigorous qualification programs to determine if they can provide the necessary goods or services to the standards that the GMP company requires. The QS approach calls for periodic auditing of suppliers based on risk assessment either by paper, on-site, or both even for processing aids. The supplier approval process may include proof or completion of some (or all) of the following: Certified quality system such as ISO, supplier/quality questionnaire, product specifications, change notification policy, contingency planning policy, among others. This presentation will help understand a vendor/supplier’s position on QS compliance to meet GMP needs. Examples will be provided using processing aids such as cleaners, disinfectants and other Life Sciences consumables.
  • 1600 - 1730
    Concurrent Session: What's New from ICH?
    This session features industry members from active ICH working groups providing insights on four important documents.  Three of these documents will be available for Step 2 Public Comment in the fall of 2021.  Don’t miss the opportunity to get insights from the industry experts who developed the text in the documents as you prepare to review and provide comments on ICH Q2(R2) Analytical Method Validation, ICH Q14 Analytical Method Development, and ICH Q9(R1) Quality Risk Management.  You will also hear about implementation progress on ICH Q12 Lifecycle Management including tools and enablers.
    Session Leaders
    Speakers

    Stephen Mahoney

    Executive Director, Global Quality & Compliance
    Genentech, A Member of the Roche Group
    Presentation Information
    [ICH Q9 (R1) Quality Risk Management Revision – Why Now?]
    Speaker: Stephen Mahoney
    Members of the ICH Expert Working Group (EWG) will provide an overview of the ongoing work to update the current ICH Q9 Guideline on Quality Risk Management (QRM). In particular, the Q9(R1) EWG will discuss the following harmonization activities: (1) making limited and specific adjustments to chapters and annexes of current ICH Q9 Guideline; and (2) developing specific training materials (with examples) to supplement the existing ICH briefing pack on ICH Q9, as well as to explain and facilitate the implementation and application of the proposed revisions.
    || [Concepts and Perspectives on Analytical Procedures (ICH Q2(R2)/Q14)]
    Speaker: Nina Cauchon
    A new Quality guideline, ICH Q14 (Analytical Procedure Development) is being proposed in order to facilitate more efficient, sound scientific and risk-based approval as well as post-approval change management of analytical procedures, improve regulatory communication between industry and regulators. ICH Q2(R1) Guideline on Validation of Analytical Procedures is also being revised. Together, these two guidelines will provide harmonized and streamlined concepts for a diverse variety of analytical procedures, including examples. The use of an enhanced approach for analytical procedure development using concepts such as the Analytical Target Profile (ATP) and the application of prior knowledge and risk management principles will be described. Regulatory recommendations for reporting analytical procedure development activities in submissions will be discussed, along with opportunities to present a scientific basis for flexible regulatory approaches to post-approval Analytical Procedure changes.
    || [Progress on the Global Adoption and Implementation of ICH Q12]
    Speaker: Andrew Chang
    ICH Q12 is a transformational guideline that was endorsed in November 2019 at the ICH biannual meeting in Singapore. It has a wide scope of applicability and builds on the framework laid down in ICH Q8, Q9, Q10 and Q11 guidelines and aims to address key remaining technical and regulatory hurdles that prevented the full adoption and implementation of flexible science- and risk-based approaches to post-approval chemistry, manufacturing and controls (CMC) change management during commercial manufacturing. Currently, both the industry and regulators are actively working to develop ICH Q12 adoption and implementation plans. This presentation will include insight of ICH Q12 IWG workplan and activities, current implementation status within specific countries, e.g., USA, Japan, Canada, and China, and personal remarks on opportunity and challenges of global implementation of ICH Q12 to enhance efficient and effective product lifecycle management.
  • 1830 - 2130
    "A Night to Unite" Celebration
Day 4
Wednesday, 3 November 2021