Agenda

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Before the Event
Sat, 14 Oct
  • 0800 - 1700
    2023 ISPE International Emerging Leader Hackathon Day 1
    Students and recent graduates will be tasked with analyzing a problem statement, acting as a consultant group to help the company solve an issue, to pitch it to a panel of expert judges at the culmination of the Hackathon. At the end of the two days, each team will present to a group of judges and industry leaders. The judges will evaluate the presentations, provide feedback to the teams, and identify the best solution. The winning team will be announced during the ISPE Membership Meeting & Awards Lunch on Monday afternoon.
  • 1500 - 1800
    Registration Open
Day 1
Sun, 15 Oct
  • 0700 - 1800
    Registration Open
  • 0800 - 1300
    2023 ISPE International Emerging Leader Hackathon Day 2
    On Sunday, each hackathon team will present to the panel of Hackathon judges and industry leaders. The judges will evaluate the presentations, provide feedback to the teams, and identify the best-proposed solution. The winning team will be announced during the ISPE Membership Meeting & Awards Lunch on Monday afternoon.
  • 0900 - 1200
    Workshop: Holistic Digital Pharma 4.0 Maturity Assessment
    The pharmaceutical industry is highly regulated due to its involvement with products that are essential to human health. The Holistic Pharma 4.0 Digital Maturity Assessment is a key step for pharmaceutical companies aiming to implement digital transformation initiatives in the framework of Industry 4.0 or Pharma 4.0. The objective of this workshop is to enable participants to apply and conduct the Holistic Pharma 4.0 Digital Maturity Assessment, evaluate the organization's status and readiness for digital transformation, identify areas for improvement and comprehend the major obstacles they may encounter the path to achieving a higher maturity level. Participants will also learn how to interpret the results of the assessment through a heatmap, which will highlight the organization's strong and weak areas of structural capability. The goal is also to get feedback from the audience of the maturity assessment for content and structure. The workshop is designed for all managers involved in a digital transformation journey like Chief Digital Officers (CDOs), Quality leads, Engineering, IT, Operations and Supply Chain of all kinds of life sciences manufacturing organizations and Service, Equipment and Software providers to assess the organization’s maturity in regard to readiness for a digital transformation. 

    0900 – 0915: Welcome, Announcements, Introductions by Christian Wölbeling
    0915 – 0945: Presentation of Pharma 4.0 Maturity Assessment model by Daniele Iacovelli, Vincent Gerber, and Philipp Klaesle
    0945 – 1015: Six Pharma 4.0 Industry Surveys – Maturity Lessons Learned by Daniele Iacovelli and Laura Kuger
    1015 – 1115: Execution of assessment with participants by Vincent Gerber and Philipp Klaesle
    1115 – 1145: Discussing the maturity assessment results by Vincent Gerber and Philipp Klaesle
    1145 – 1200: Feedback round for the Pharma 4.0 maturity model approach with all participants 

    Participants are encouraged to bring their personal devices/laptops to this workshop.
    Speakers

    Laura Kuger

    PhD Candidate
    Karlsruhe Institute of Technology (KIT)

    Daniele Iacovelli

    CDO/Global Head of Digital, Analytics & Operational Excellence
    F. Hoffmann-La Roche
  • 0900 - 1200
    Workshop: ICH Q9(R1) and Quality Risk Management
    This 3-hour workshop consists of 3 plenary presentations and two breakout sessions. ICH Q9 (R1) Topic Leader, Kevin O'Donnell from EMA will summarize the rationale for and changes to the recently issued ICH Q9, Quality Risk Management revision. There will be two industry presentations summarizing ISPE activity to support the ICH Q9 Implementation Working Group with provision of case studies covering the topics of formality, subjectivity, decision-making and product availability. These will be followed by two breakout discussion sessions, each session covering two of the above topics in parallel. A participant could, therefore, attend and contribute to two out of the four breakout topic discussions. The Workshop will conclude with feedback from the breakout groups, a Q&A and closing remarks.
    Speakers
  • 0900 - 1200
    Workshop: Development of a Contamination Control Strategy
    According to Annex 1, Contamination Control Strategy (CCS) is referred to as a family of documents that unite, evaluate, and record the adequacy of tools used to assure the purity and quality of drug products. The heightened focus on the CCS is centered around not only physical mechanisms to control contamination but now also emphasizes how the mechanisms work together and how they are managed as a group. This workshop will engage attendees in the development of a CCS using a case study and supporting documentation from an existing cGMP facility. Attendees will be exposed to a methodology to develop a CCS that was performed for the actual facility that is used for the case study. Attendees will interact with different procedures and design documents and see how the documents support each other and work together to ensure that the facility operates in a way to prevent contamination of drug products. Attendees will be exposed to the use of Layers of Protection Analysis (LOPA) for the CCS. Lastly, attendees will experience realistic challenges during the creation of the CCS and gain valuable lessons learned from the actual team that executed the same CCS methodology.
    Speakers

    Jose A. Caraballo

    VP Quality Systems, Compliance, and Quality Engineering
    Kite Pharma, Inc.
  • 1300 - 1600
    Workshop: Designing & Operations of a Flexible Mfg Facility
    Designing and Operations of a Flexible Manufacturing Facility Workshop. The first presentation will focus on the importance of facility programming to develop a thorough conceptual design that sets the project on the right path of an efficient design that meets schedule and cost targets. The programming approach will walk-through the development of a layout and challenges of defining criteria for a flexible facility.
    •Identifying facility requirements and prioritizing needs vs. wants
    •Progression of a conceptual layout
    •Defining flexibility to provide a basis for the design

    The second presentation will be a case study of a CTDMO that will discuss the overall facility and it’s approach to the facility designed for Multi-products, Multi- clients, and muliti-manufacturing and testing areas to provide a facility that provides end to end capabilities for ATMP drug products. The presentation will demonstrate the approach and key drivers for the facility design focused on a flexible suite for multiple products, multiple clients and accommodation of all levels of therapy life cycle including clinical and commercial production considerations.
    •Room layout for flexibility in current and future process operations
    •Suites designed for ease of change-over and reconfiguration
    •Multiple floors with differing room arrangement options
    •Understanding challenges of facility retrofit and renovation
    Speakers
  • 1300 - 1600
    Workshop: OEE and ML for Process Optimization Using Seeq
    Outline:
    • ML (Machine Learning) Presentation
    • ML Hands On Exercise
    • OEE (Overall Equipment Effectiveness) Presentation
    • OEE Hands on Exercise
    Description:
    When a plant or unit operation is not performing at its optimal efficiency, it is useful to track downtime and quantify the gap between equipment operation and perfect production. Opportunities to improve production can be understood using the Overall Equipment Effectiveness (OEE) metric.

    When out of specification material is produced, organizations can spend precious time and money trying to identify the root cause. Machine learning allows users to compare process data to known periods of good and/or bad production to identify aberrant periods and key contributors.

    In this workshop, we will walk through OEE and ML for pharmaceutical processes. We will use example process data to
    1. Demonstrate techniques to identify downtime and build out OEE metrics to identify production opportunity&nbsp
    2. Use machine learning to compare process data to a predefined baseline to isolate the key contributor to process upsets.

    Note: This is a hands-on workshop; participants are encouraged to bring their own laptops to be able to walk through OEE and ML practice examples led by the workshop instructors.
    Speakers
  • 1300 - 1600
    Workshop: Essentials for Leadership Development
    Join us for an enlightening exploration of leadership in the Pharmaceutical Industry with ISPE's "Leadership 101" program. Designed to provide you with key insights into what it takes to succeed in a leadership role within this sector, this program is an essential asset for your career progression.
    Welcome to our informative and engaging workshop, "The Essentials for Leadership Development." This session serves as an introduction to the ISPE's Leadership 101 program. Over a 3-hour span, this workshop promotes self-reflection and fosters both individual and group interactions.
    This workshop aims to develop proficiency in three essential aspects of leadership within the pharmaceutical industry:
         
    1. Leading Yourself: The first part of the workshop is centered on personal leadership. It focuses on aligning your mindset with your actions, while adhering to a set of core values that influence your decisions and interactions with others. A successful leadership journey begins with mastering self-guidance.    This workshop offers a valuable opportunity to enhance your leadership skills and better understand the unique dynamics of the pharmaceutical industry. Take the next step in your career journey by expanding your leadership acumen with us.
      2.    
    2. Leading the Business: The second part of the workshop gives you a basic understanding of how KPIs, revenue, and expenses influence your team's operations. We'll discuss how you can take a more proactive approach to these aspects of your operations and provide practical strategies to help you plan more effectively.
      3.    
    3. Leading Others: The final part emphasizes the importance of effective communication, particularly in conveying Key Process Indicators (KPIs) and their significance to diverse levels within your team and organization. As technical skills can vary in their application across different companies and teams, we'll explore how to recognize these differences and how to incorporate this understanding into effective communication of team goals and objectives.
    Please note that this is an interactive session, so participants are advised to come prepared with a mobile device for full participation in various activities. Attendees should have the free ISPE mobile app downloaded on their device and should already be logged-in to ask questions and maximize engagement.
    Speakers

    Martin Orcoyen

    President | ISPE Argentina Affiliate (2021-2025) ||| Director De Operaciones
    Qualipharma
  • 1300 - 1600
    Workshop: Innovation & sustainable development of biopharma
    This conference workshop provides comprehensive insights into the emerging trends, regulatory differences, and technological advancements in the Chinese pharmaceutical and healthcare sector.

    1300 – 1310: Welcome by Ping ZHANG & Sophie PANG
    1310 – 1330: Development of ISPE China in recent 3 years by Hongyang LI
    1300 – 1400: Comparative Analysis of NMPA/FDA Regulations-Pathway to Entry Chinese Market Successfully by Ping ZHANG
    1400 – 1430: Gene and Cell Therapy in China – landscape and regulatory update by Frank GAO
    1430 – 1445: Break 1445 – 1515: Manufacturing Excellence on Biologics Products with Single Use Technology and Robust Quality Operations by Sherry GU
    1515 – 1530: High performance and Cost-effective Bioprocess Solutions by Peter FU
    1530 – 1600: QA/Closing
    Speakers
    Placeholder Person Graphic

    Yang Gao

    CSO @ BRL; Board Member @ ISPE Shanghai & Chairman of GCT Committee
    BRL Medicine

    Ping Zhang

    Senior Vice President
    Shenzhen Hepalink Pharmaceutical Co., Ltd.
  • 1500 - 1600
    ISPE Student/Recent Graduate Orientation
    ISPE & the ISPE Foundation invite students and recent graduates to join us for an interactive session to get the most out of your experience at ISPE’s Annual Meeting & Expo.  You’ll gain career advice, learn about the benefits of your ISPE membership and participate in a fun networking activity.
    Session Leaders

    Tori JOHNSON

    Director, Development and Foundation Operations
    ISPE Foundation
    Speakers
  • 1600 - 1800
    Sunday Social Sponsored in Part by ISPE Southwest Chapter
    Check-in, un-wind and enjoy yourself at the ISPE Sunday Social! Conveniently located on-property, come join us for cocktails, hors d'oeuvres, prizes and a chance to meet with your peers. Whether you attend the Sunday workshops or are arriving after a long day of travel, be sure to start the 2023 ISPE Annual Meeting & Expo off right!

    Attendees of the Sunday Social (up to 150) will receive an exclusive swag bag of ISPE items when visiting the Membership table during the event. These free swag bags are available on a first come first serve basis and are limited to 150.
  • 1900 - 2200
    Facility of the Year Awards Celebratory Reception & Banquet
    Join ISPE to celebrate the 2023 Facility of the Year Awards Celebratory Reception and Banquet where we will formally recognize and celebrate the 2023 Category winners' achievements at ISPE’s premier award presentation ceremony and dinner. Livestream access is ONLY included in the In-Person All Access Pass and the Virtual All-Access Pass. To attend this event in person, attendees MUST register separately and pay. Attire is formal, black-tie.
Day 2
Mon, 16 Oct
  • 0600 - 0730
    14th Annual ISPE 5K Run/Walk
    Join us for ISPE 14th Annual ISPE 5K Run/Walk held during the ISPE Annual Meeting & Expo. Your participation in this year’s 5K event will again support ISPE Foundation’s mission fueling global health equity by fostering access to knowledge and nurturing diverse talent. Additional registration and a donation fee of $25 is required to participate.
  • 0700 - 0800
    Continental Breakfast in Foyer
  • 0700 - 1800
    Registration Open
  • 0800 - 0810
    Welcome and Opening Remarks
    Speakers

    Joydeep Ganguly

    Senior Vice President, Corporate Operations
    Gilead Sciences, Inc.
  • 0810 - 0835
    Keynote Session with Dr. Robert Califf
    We are thrilled to announce that Robert M. Califf, MD, Commissioner of Food and Drugs at the FDA will be joining ISPE during the 2023 ISPE Annual Meeting & Expo. Commissioner Califf's unique insights and extensive experience in the pharmaceutical and regulatory space promise to shed light on the ongoing challenges and opportunities facing the industry. Don't miss this opportunity to hear firsthand from one of the leading voices in healthcare regulation
    Speakers
  • 0835 - 0855
    Navigating Uncertainty: The Power of Resilient Supply Chains
    In an ever-increasing VUCA world, supply chains are facing unprecedented challenges and uncertainties - demanding greater resiliency than ever before.  But amidst the chaos, there lies an opportunity to build resilience and emerge stronger.  In this keynote, Pam Cheng, EVP Global Operations & IT and Chief Sustainability Officer will reflect on a post-pandemic world, taking stock of how the Pharma industry and supply chains navigated COVID-19 - and how well our best laid continuity plans worked. 

    At AstraZeneca, our supply chain delivers life-saving medicines to patients around the world, and we believe in the strong connection between healthy planet and healthy people.   There is a clear synergy between resiliency and sustainability.  However, with growing complexity on the horizon, an increase in geopolitical tensions and natural ‘disasters’ growing more frequent and more severe, it’s imperative we understand how climate-conscious decisions we make today, are critical to greater supply chain resilience in the future.
    Speakers

    Pam Cheng

    Executive VP of Global Operations & IT, Chief Sustainability Officer
    AstraZeneca
  • 0855 - 0920
    Science, Patient & the Role Engineering Plays as a Catalyst
    Scientific innovation is moving faster than ever before. In this environment, top scientific leaders and pharma organizations are driven by the needs of the researchers working across a myriad of scientific platforms, therapeutic areas and methods. Moving beyond the historical imperatives of delivering cost-efficient assets on time, engineering and operations teams must partner with CSOs and other scientific leaders to add exponential value to research settings. Gilead’s Foster City campus is recognized as one of the most sustainable biotech campuses in the world, as evidenced by its use of renewable energy, large-scale solar installations and eco-friendly infrastructure. As Gilead maps out its next decade, including plans for a new Research Center in Foster City, hear from Gilead EVP of Research Flavius Martin, M.D. about the strong partnership between Research and Corporate Operations as the company expands Gilead’s Research footprint to ensure a distinct home that is socially responsible for the company’s community of scientists. The new Research Center will build on Gilead’s history of success in this space, redefine sustainability standards for research buildings and allow the company to attract and retain top scientific talent.
    Speakers
  • 0920 - 0940
    The Pursuit of Excellence in Novel Therapeutic Development
    In an era where the need for groundbreaking treatments to address unmet medical needs has never been more pressing, it is crucial for us in the pharmaceutical engineering community to develop and enable technologies in a timely manner. In this keynote, Judy Chou, Ph.D., President and Chief Executive Officer of AltruBio will address the successful introduction of novel therapies, especially Advanced Therapeutic Medical Products (ATMPs), as a testament to the fruitful partnership between engineers and biological scientists. To accelerate the development of novel therapeutics further, significant opportunities for enhancement remain, particularly in the realms of operational excellence in manufacturing and addressing sustainability challenges related to supply chains and energy consumption. Embracing ongoing disruptive technologies is imperative and inevitable in achieving these goals.
    Speakers
  • 0940 - 0945
    Conference Highlights
    Speakers
  • 0945 - 1000
    Coffee Break
  • 1000 - 1130
    CSA - Opportunities for GAMP 5 2nd Edition & 21 CFR Part 11
    In this session you will hear about how GAMP 5 Second Edition has had an impact on the pharmaceutical industry, the current FDA position on Computer Software Assurance (CSA) including how organizations are adapting to a CSA environment, the significant areas of progress and, conversely the remaining challenges and understanding how a Maturity model approach may provide a framework to enable innovation and plan future progress.
    Since the release of the FDA Draft Guidance titled "Computer Software Assurance for Production and Quality System Software" on 13th September 2022, many questions and concerns have been raised regarding the impact of the guidance on 21 CFR Part 11.  The session will focus on the implications and opportunities of CSA draft guidance and GAMP 5 Second Edition on 21 CFR Part 11 through presentations delivered by members of the GAMP Global Steering Committee and a panel discussion, including leading industry experts along with representatives from the FDA.
    Please join us for what should be a very engaging and informative session.

    10:00 – 10:15: GAMP 5 Second Edition – A Year On by Heather Watson
    10:15 – 10:40: GAMP 5 Second Edition - Maximizing Value by Sion Wyn
    10:40 – 11:00: GAMP 5 Second Edition and Future Guidance by Chris Clark
    11:00 – 11:30: Implications and Opportunities of CSA on GAMP 5 Second Edition and 21 CFR Part 11 by Francisco Vicenty, Daniel Walter, Ken Shitamoto, Jason Spiegler, Sion Wyn, Chris Clark and Heather Watson, moderated by Khaled Moussally
    Speakers

    Ken Shitamoto

    Executive Director, IT - Quality and Compliance
    Gilead Sciences

    Khaled Moussally

    Executive Vice President Clients & Regulatory Relations
    Compliance Group Inc
  • 1000 - 1130
    Environmental Sustainability - Operations and Products
    In order to address environmental sustainability in the pharmaceutical industry, a holistic approach is needed to address environmental footprint from both operations and products.
    In this session, seven sustainability experts and senior leaders from Roche/Genentech, GSK, and Takeda will share how they have advanced tools to identify opportunities to minimize their environmental footprint, developed operations and product sustainability roadmaps, and have implemented innovative technologies to decarbonize their operations and reduce their environmental footprints.

    1000 – 1025: Roche's 10-year Ambition to Halve Total Environmental Impact of its Operations by Behzad Torabifar and Kenneth Hamilton
    1025 – 1045: Steam-generating Heat Pumps; Water Reduction by Utilizing Recovered Reverse Osmosis (RO) Concentrate by Harald Erös and Gregory Groberman
    1045 – 1105: GSK Approach to Ecodesign for Development of More Sustainable Products, Processes, Packaging and Devices by Daniel D'Aquila
    1105 – 1130: Question and Answer/Panel Discussion moderated by Behzad Torabifar
     
    Speakers

    Harald Erös

    Lead of Refrigeration, Cooling and Heat-Pump Technologies
    Takeda

    Babak Haghiri

    Vice President of Manufacturing - Site Head Los Angeles
    Takeda Pharmaceutical
  • 1000 - 1130
    Global Drug Shortage Prevention and Future Directions
    As the world attempts to emerge from the pandemic and return to activity reminiscent of pre-pandemic times, there are still uncertainties remaining related to supply chain stability. Many valuable lessons can be learned from the pandemic and applied to planning for the possibility of another pandemic, or even a tripledemic. Some global Health Authorities have been active in developing guidance and recommendations to mitigate disruption in the supply chain and secure patient access to critical medicines based on these recent learnings in an effort to improve planning and preventative measures. Additionally, some governments have imposed legislative measures to encouraging onshoring as a protective measure to insulate domestic supply chains from disruption. In parallel, to appreciate and align with regulatory efforts to address shortages and supply chain instability, the ISPE Drug Shortages Initiative team has developed expanded guidance on the quality, technical, and regulatory aspects of drug shortage prevention. Regulators and experts will present experiences related to securing supply chain, mitigating drug shortages, and efforts to proactively be prepared for the possibility of a future pandemic.

    As a result of this session participants will gain:
         
    • Insights from experiences endured during the SARS-CoV-2 pandemic and potentially longer-lasting impacts on the global supply chain, from both regulatory and industry perspectives.
      •    
    • Overviews of regulatory and industry initiatives which aim to achieve further transparency across the supply chain.
      •    
    • An understanding of HA perspectives related to regulatory expectations to mitigate drug shortages and supply chain strain (e.g., FDA, EU).
      •    
    • Opportunities to interact with global regulators (including FDA and European Commission) and industry in a Q&A session and informally at the conference.

    10:00 – 10:25: Updates on Drug Shortages and Supply Chain Challenge by Emily Thakur
    10:25 – 10:40: The ISPE Drug Shortages Prevention Model (ISPE DSPM) – Guidance for Drug Shortage Prevention Excellence by Diane Hustead
    10:40 – 10:55: Updates Regarding European Commission Drug Shortage Prevention and Mitigation by Wolfgang Philipp
    10:55 – 11:10: EMA Extended Mandate in the Management of Medicine Shortages by Monica Dias
    11:10 – 11:30: Question and Answer/Panel Discussion
    Session Leaders

    Lynne Ensor

    SVP, Head of Global Strategic Compliance Consulting
    PAREXEL International
    Speakers

    Monica Dias, PhD

    Head of Supply and Availability of Medicines and Medical Devices
    EMA
  • 1000 - 1130
    Therapy Development and Facility Design for Market Readiness
    Building for Success! The journey of introducing a new therapy to the market involves more than just its development. Join our upcoming session to explore the critical role of facility design and construction in the success of a therapy. Our esteemed speakers will share their experiences through compelling case studies, providing invaluable insights into the entire process, from the initial stages of therapy development to the later phases of facility design and construction. Don't miss this opportunity to gain a comprehensive understanding of how to navigate the path to market for a successful therapy.

    1000 – 1030: FOYA Operations: Resilient Project Execution, Design-Assist Model Success by Gene Russell and Brendan McGrath
    1030 – 1100: Vertex Pharmaceuticals: Pioneering Cell Therapies for the Next Generation by Emily Heffernan and Mark Melilli
    1100 – 1130: Building cGMP Facilities in Challenging Times by Laura Whelan, Sal Ceja, Nima Payan, and Nino Adamo
    Session Leaders
    Speakers

    Sal Ceja

    Principal, Architect, AIA, LEED AP
    EwingCole

    Brendan McGrath

    Site Head & Vice President Manufacturing
    WuXi Biologics (Shanghai) Co., Ltd.

    Gene Russell

    Senior Director, Head of Engineering
    WuXi Biologics

    Nino Adamo

    Vice President and General Manager
    Turner Construction Co

    Nima Payan

    Chief Operating Officer
    SPIN Biotech Consulting LLC

    Laura Whelan

    Executive Vice President, Project Management Services
    Savills North America
    Placeholder Person Graphic

    Mark R. Melilli

    Cell & Gene Therapy Advanced Manufacturing Lead
    Vertex Pharmaceuticals
  • 1000 - 1130
    Combination Products: Success in Advanced Therapies
    Breakthrough innovations in medicinal based therapies as well as technological device developments have led to the rapid rise in the use of combination products. Risk management is important as it underpins the success of development, manufacturing, post market surveillance, and lifecycle management of advanced therapies. Alignment with regulators for efficient regulatory pathways is critical for predictable outcomes. In this session, we review:
         
    • Integration of Medicinal and Medical Device Quality Risk Management approaches for successful combination product development and lifecycle management.
    • Insights and best practices for combination products in the EU, discussing both clinical trial applications and Notified Body experience.
    • Evolving innovations in the combination product space.
    • The evolving FDA regulatory landscape supporting innovative new combination products.

    10:00 – 10:25: Combination Products Risk Management: Integration of ICH Q9(R1) and ISO 14971:2019 by Susan Neadle
    10:25 – 10:45: Lifecycle Management of Notified Body Opinions- A Streamlined Approach by Lori-Anne Boville
    10:45 – 11:00: Disruptive Medicine Innovations- Next Generation Combination Products by James (Jim) Wabby
    11:00 – 11:20: Combination Products through the Eyes of the FDA by Steven Hertz
    11:20 – 11:30: Question and Answer/Panel Discussion moderated by Susan Neadle
    Speakers

    Lori-Anne Boville

    Group Director, Pharma Technical Regulatory, Device and Combination Products
    Genentech Inc.
  • 1130 - 1345
    Membership Meeting and Awards Lunch - Open to All Attendees
    The ISPE Membership Meeting and Awards Lunch is open to all In-Person All Access Attendees. Meet the ISPE leadership and colleagues while learning about significant achievements made by the industry in the past year. Celebrate with your peers as the ISPE International Honor Awards are presented and learn about the 2023 Facility of the Year Awards (FOYA) Category Winners & Overall Winner.
  • 1345 - 1515
    The Holistic Digital Transformation: The Pharma 4.0 Journey
    The holistic digital transformational approach is the mission of the ISPE CoP Pharma 4.0. The ISPE Baseline Guide Pharma 4.0 created by the CoP Pharma 4.0 is educating on the basic principles of this transformational journey! One of the key prerequisites for a digital transformation is the vertical and horizontal integration. From the beginning the concept of the integration is based on a holistic “Plug & Produce” concept to build an environment which is based on an interoperable architecture to turn data into knowledge for accurate data-based decision making. Getting out of the Lighthouse trap and building interoperable “Manufacturing X” environments!

    1345 – 1405: Digital Transformation – Scotty, Beam Me Up... – The Pharma 4.0 Baseline Guide by Christian Wölbeling
    1405 – 1425: Unlocking Efficiency and Innovation: Harnessing Process Events in the Life Science Industry by using OPC UA by Rod Hoffman
    1425 – 1445: Unlocking Efficiency through Digital Twins by Rene Pascal Fischer
    1445 – 1515: Panel Discussion: The Future of Integration – A Never Ending Story?
     
    Speakers

    Rod Hoffman

    IT/OT Connected Factory Business Partner
    AstraZeneca
  • 1345 - 1515
    Design & Implementation of Systems & Facilities
    This session will be focused on different types of facility designs and installed critical systems that support/enable manufacturing excellence and stability. In the first talk, attendees will learn about Restricted Access Barrier Systems (RABS) that are regularly utilized in sterile manufacturing clean rooms.  Each facility typically has its own needs and requirements, and requires careful evaluation before new RABS systems are installed on-site.  A case study will demonstrate how analysis of the facility and the manufacturing process before RABS installation is a critical first step to ensure sterility assurance. Next, attendees will learn about time-to-market deployment of a new manufacturing facility through use of a hybrid modular delivery method.  The case study discussion surrounding the hybrid modular (“box-in-box”) project will demonstrate time savings, execution efficiency and reduction of site congestion at the site as well as how the design and manufacturing processes impact the environmental impact of the facility as it is built and will be operated. Third, there will be two FOYA Introductions of winners announced during the ISPE Europe Annual Conference. Each presentation will conclude with a brief Q&A and discussion where everybody is encouraged to ask questions and discuss with the speakers.

    13:45 – 13:55: Welcome and Introductions by Pär Almhem
    13:55 – 14:20: RABS Retrofit - Solutions for Compliance and Performance by Leslie M. Edwards, Brian K. Smith & Paul Valerio
    14:20 – 14:45: Hybrid Modular (Box-in-Box) Sterile Facility Case Study by Pär Almhem, Bob A. Brady, and Richard Sanderson
    14:45 – 15:00: FOYA Winner 1 - FJ2 Breaking new ground - beyond the “Wall of 0.05µg/m3”: Containment Facility Construction Concept and Verification by Daisuke Hirasawa
    15:00 – 15:15: FOYA Winner 2 - American-Made: The Homegrown Solution to the Domestic Drug Shortage by Omair Ahmed
    Speakers

    Omair Ahmed

    Chief Operating Officer
    Nexus Pharmaceuticals LLC

    Paul F. Valerio

    Director of Process Technology / Senior Associate
    IPS - Integrated Project Services, LLC
  • 1345 - 1515
    Supply Chain Resilience and Transformational Change
    Join us for an insightful session that encompasses three key areas crucial to the success of pharmaceutical companies: supply chain operations, lifecycle management, and lab transformation.  First, Vertex will share their best practices on supply chain operations and shipping validation for regulatory filing, bridging the knowledge gap by utilizing transport simulation testing and cold chain engineering tools and ensure positive regulatory feedback. They will explore their supply chain flexibility and resilience, enabling multiple pathways for safe and efficacious product delivery.  Second, Baxter and DPS Group will explore the challenges of pharmaceutical product lifecycle management, including supply chain disruption, cost pressures, and regulatory expectations, offering valuable lessons from industry experts. They will explore strategies to maintain continuity of supply and profitability amidst competition and diverse patient population needs. Lastly, Cognizant will dive into lab transformation, focusing on digitalization and its impact on performance and compliance, with a spotlight on workforce transformation, lab quality control, data integrity, and sustainable practices. By attending this comprehensive session, you will gain valuable insights, practical strategies, and actionable knowledge to thrive in the pharmaceutical industry.

    1345 – 1410: How Vertex Created a Resilient CGT Supply Chain by Robert Battista and Luis Hernandez
    1410 – 1430: Transformational Change to Maintain Product Continuity by John Wass, Philip Lyman and Andy Wilkinson
    1430 – 1450: Connected Labs – Competitive Edge to Drive Patient Safety by Henal Shah
    1450 – 1515: Question and Answer/Panel Discussion moderated by Chelsea Coffey
     
    Session Leaders
    Speakers

    Henal Shah

    Head of the European Lab Centre of Excellence (CoE) Practice
    Cognizant Technology Solutions
  • 1345 - 1515
    Technology Advancement
    We are living in a time where both industries and regulatory bodies are actively advocating for the integration of advanced technologies more than ever before. Join us in this session as we showcase various examples of these technologies that are readily available to help you reduce costs, improve efficiency, and enhance overall quality. Don't miss out on this opportunity to discover cutting-edge solutions that can take your business to the next level.

    1350 – 1415: An Innovative Approach for a Faster Small Batch Release by Dominic Baca and Giacomo Girotto
    1415 – 1440: Development of an Aseptic Filling Platform Technology by Austin Lock
    1440 – 1505: Recent Advances in Membrane based WFI Generation by Nissan Cohen, Rod Freeman and Anders Widov
    1505 – 1515: Question and Answer/Panel Discussion moderated by Pierre Winnepenninckx
     
    Session Leaders
    Speakers

    Dominic Baca

    Manager, Global Manufacturing Science & Technology
    Genetech
  • 1345 - 1515
    Modernizing Regulatory CMC Submissions: Enabling Change
    The session will discuss the current challenges of static and unstructured PDF-based CMC regulatory submissions for drug applications and the modernization efforts of utilizing structured data for regulatory CMC submissions. The session will address actionable steps companies can take to enable digital transformation to streamline and improve the current process of preparing regulatory CMC submissions. Specifically, the session will provide insights on how industry can incorporate advanced technologies to prepare for emerging global regulatory requirements that will change the CMC regulatory submission and review paradigm. Ultimately, companies will need to modify their internal processes to ensure compliance with new regulatory requirements, but there is less clarity across industry on the roadmap for implementation and how to best navigate a stepwise approach towards modernization. The session will also include a Regulator’s perspective to the challenges of PDF-based submissions and the need of digitization, digitalization and automation to readily capture information and effectively utilize modern knowledge management tools. Recently, FDA’s Office of Digital Transformation (ODT) has rolled out a series of action plans for technology and data modernization. The session will give an overview of FDA’s digital transformation history including some CMC-specific initiatives such as the Knowledge-Aided Assessment and Structured Application (KASA) and Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (PQ/CMC) initiatives to modernize the CMC submission and review process. Together, industry and regulators can leverage technology to collaboratively build towards a future vision of enhanced efficiency, reduced filing timelines, and improved speed  to market for critical therapeutics.

    13:45 – 14:10: Unleashing the Power of Data Standardization for Optimized CMC Regulatory Information Management and Submissions by Marquerita Algorri and Sheetal Gaiki
    14:10 – 14:25: Balancing Data and Narrative with the Use of the Overall Control Strategy by Ciby Abraham, Ph.D.
    14:25 – 14:40: Regulatory Consideration on Digital Transformation of the CMC Submission and Review Process by Maotang Zhou, Ph.D.
    14:40 – 15:15: Question and Answer/Panel Discussion moderated by Nina Cauchon
     
    Session Leaders
    Speakers

    Ciby Abraham, PhD

    Senior Director and Group Manager, Project and Product Leadership
    AstraZeneca
  • 1515 - 1530
    Coffee Break
  • 1530 - 1700
    Application of PAT for Real-World GMP Operations
    The first part of the Process Analytical Technology session discusses best practices in the design, implementation, and operation of PAT for actual GMP operations. The design and implementation drive the digital transformation. This includes the IT infrasructure requirements to facilitate the data management under GMP standards, the application of 'classical' PAT based on spectroscopic equipment through to soft sensors i.e., data-driven analytics, and process insights revealed by PAT back to the control strategy as a holistic instrument.
    The second part of the session is a case study from Takeda's Neuchatel site, tying the strategic vision of digitalization in manufacturing to the real-time benefits of PAT. The Digital Twin Model allows monitoring, investigation and prediction of critical quality attributes (outputs) by varying the process parameters (inputs). Predictive modeling is a key attribute to ensure operational excellence and a robust manufacturing process. This promises to be a great session showing how far PAT techniques and technologies have moved pharmaceutical manufacturing from feedback, reactive approaches to predictive modelling for maximum efficiency and yield.

    1530 – 1600: Digital Evolution Strategies in MSAT by Veronika Nindl
    1600 – 1700: Application of PAT for Real-World GMP Operations by Dr. Hubertus Rehbaum, Line Lundsberg-Nielsen and Andrew Palm
    Session Leaders
    Speakers
  • 1530 - 1700
    Quality Risk Management Application to Pre-PV Decision Making, Equipment Qualification and Cleaning Processes
    This session will highlight the importance of commissioning and qualification throughout the biopharmaceutical facility with a focus on manufacturing operations.
    First, the audience will learn about the importance of harmonized decision-making framework and risk-based evaluation of the need for manufacturing a pre-PV (process validation) demonstration batch.  Included are decision flow chart, previously manufactured batch assessment tools and case study application examples. Next, the speakers will provide an overview on of the current state of the industry in regard to adoption rate of Quality Risk Management (QRM) Based Integrated C&Q, C&Q best practices, benchmarking and key performance indicators.
    To conclude this session, the last presentation of the session will discuss relevant topics necessary to develop a comprehensive assessment to characterize cleaning program practices, typical observations from assessments, and sustainability opportunities identified in reduced water usage, optimized chemistries, cleaning cycle duration reduction, potential energy reductions, and developmental studies to support identified solutions.
    Each presentation will conclude with a brief Q&A and discussion where everybody is encouraged to ask questions and discuss with the speakers.

    15:30 –16:05: Risk Based Decision Process for Pre-PV Demo Batch by Joanne R. Barrick
    16:05 – 16:30: Adoption of Integrated C&Q – Benchmarking & Survey Results by Nathan W. Temple
    16:30 – 17:00: Sustainability Through Cleaning Program Standardization by Keith Bader and Andy Brewer
     
    Session Leaders
    Speakers

    Keith E. Bader

    Vice President, Cleaning Science & Laboratory Services
    Hyde Engineering + Consulting Inc
  • 1530 - 1700
    Innovations & Best Practices in Sustainable Development
    Sustainability plays a vital role in building resilient and efficient sustainable pharmaceutical supply chains. This session will showcase innovations and best practices in sustainable development and governance. Attendees will gain valuable insights into environmental stewardship, energy efficiency, waste reduction, and responsible manufacturing practices. Integrating sustainability into pharmaceutical operations will be emphasized, highlighting the positive impact it can have on the industry's bottom line and public perception. This session aims to equip attendees with practical strategies to promote sustainability and foster responsible pharmaceutical manufacturing.

    1530 – 1600: Sustainability Strategy & Governance: Integrated Change by Patricia (Trish) Melton, Guy Wingate and Ylva Ek
    1600 – 1625: Enabling Technologies in Sustainable Development by Jie Chen
    1625 – 1645:  Project "NISHWAS" The Breath of Relief by Kedar Gokhale
    1645 – 1700:  Question and Answer/Panel Discussion
    Session Leaders

    Aaron Weinstein

    Senior Director, Compliance Consulting
    IPS – Integrated Project Services, LLC
    Speakers

    Ylva Ek

    Founder
    Robur Life Science Advisory AB
  • 1530 - 1700
    Transformation into ATMP
    It's remarkable how rapidly the field of ATMP development is advancing, with more and more organizations entering this space. In this session, we'll take a closer look at how a conventional biologics manufacturing facility was transformed into a modern, multi-modal facility for ATMP products. Although ATMP products, processes, and facilities have unique characteristics, they are still built on fundamental pillars that we will explore during this session. Join us to gain insights into the latest advancements in the field of ATMPs and how they can be implemented in your own manufacturing facility.

    1530 – 1615: A Multi-Modal Transformation of a Campus by Andrew Slusser, Jim Green, and Drew Johnston
    1615 – 1700: Conquering the Four Pillars of Biopharma Manufacturing, a panel discussion led by Chad Salisbury
    Session Leaders
    Speakers
    Placeholder Person Graphic

    Stephen Marr

    Vice President, Head of Capital
    Spark Therapeutics, Inc.

    Gregory R. Gara

    Vice President of Pharmaceutical Engineering
    Sarepta Therapeutics

    Andrew Slusser

    Senior Director of Architecture/ Process Architecture SME
    PM Group
  • 1530 - 1700
    Global Harmonization to Advance Innovation
    This session will focus on global regulator harmonization Initiatives that advance global application approvals of innovative products, technologies, and modalities. Decisions to pursue and implement pharmaceutical innovations are frequently based on receptivity from global regulatory authorities. Lack of regulatory convergence can hinder innovation and continual improvement and increase the risk of drug shortages. In recent years, several opportunities have emerged to address some of the regulatory challenges that have been a barrier to manufacturing innovation, including:
         
    • Improvements in risk-based regulatory assessments of applications
      •    
    • Increased opportunities for direct engagement with regulatory authorities to align on application expectations and standards for new technologies
      •    
    • Expanded mechanisms for collaborative regulatory review/assessment of applications between regulatory authorities
      •    
    • Application of relevant learnings from the response to the COVID-19 pandemic toward increased adoption of mutual reliance/mutual recognition between regulatory authorities
      •    
    • New technologies to improve product reliability, local access, and sustainability
    The culmination of circumstances has led several regulator-only organizations to initiate forward-looking programs toward harmonization of product quality reviews and inspections. This session will describe the existing hurdles to be reconciled to improve global regulatory harmonization for innovative technologies and the programs established to build trust and alignment between regulators. The content from presentations from key regulatory authorities and industry leaders will serve as the basis of an integrated panel discussion.

    1530 – 1600: Barriers to Innovation:  Preliminary Results from ISPE Survey by Roger Nosal
    1600 – 1620: ICMRA Collaborative Pilots: Vision and Achievements Leading to Regulatory Alignment and Efficiencies in Global CMC Assessment and Inspection Activities by Susan Polifko
    1620 – 1640: PIC/S Perspective: Considerations on Harmonization and Innovation by Paul Gustafson
    1640 – 1700: Question and Answer/Panel Discussion moderated by Christine Moore (with Bob Iser to join)
    Session Leaders
    Speakers

    Paul A. Gustafson

    2022-2023 PIC/S Chair, Sr. Corporate Regulatory Compliance & Enforcement Advisor
    Regulatory Operations and Enforcement Branch (ROEB), Health Canada

    Roger Nosal

    Head of Global Regulatory Strategy and Submissions
    NGT Biopharma

    Robert L. Iser, M.S.

    Vice President, Quality Policy and Advocacy (VP)
    Pharma Technical Quality & Compliance (PTQ), Genentech/Roche
  • 1700 - 1900
    ISPE Career Center in the EXPO Hall
    The ISPE Career Center is a one-stop shop for professional development, career advancement and personal branding resources. Join us at the Career Center featuring a networking lounge, a headshot booth, on-site resume reviews, raffle prizes, and more.
  • 1700 - 1900
    Welcome Reception in EXPO Hall
  • 1930 - 2130
    ISPE Women in Pharma and Emerging Leaders Event
    Women in Pharma's Allure of the Ally, Presented by AstraZeneca! Let’s travel back in time for a swanky night with some of the most impressive broads and fellas in the industry. The Women in Pharma and Emerging Leaders Monday Night Event - Allure of the Ally - is open to all conference attendees, but capacity is limited to keep the sent off. Only those with a secret password will be allowed into the speakeasy, so reserve your spot today, old sport, to enjoy a night of music, drinks and networking with the best in the biz. Conveniently located on-property at the 1923 Prohibition Bar. In addition, by making a minimum donation to the ISPE Foundation of $50 during this event there is a chance to win a $200 Disney gift card. Those who donate will be entered into a raffle. The winner must be registered for the event and present to redeem the prize. This event is sold out.
Day 3
Tue, 17 Oct
  • 0700 - 0800
    Continental Breakfast in Foyer
  • 0700 - 0800
    ISPE Self Defense Class Powered and Led by Women in Pharma
    Kick-off your Tuesday morning with an extra dose of power and confidence this Annual Meeting with a ISPE Self-Defense Class, Powered and Led by Women in Pharma. Join us on Tuesday, 17 October, at 7 am for a class consisting of traditional boxing methods and combinations to help you defend yourself with confidence. This instructor-led class will provide you with guidance and feedback on forms to ensure a safe and enjoyable experience.
  • 0700 - 1800
    Registration Open
  • 0800 - 0805
    Opening Remarks
    Speakers
  • 0805 - 0810
    ISPE Southwest Chapter President's Welcome
    Speakers
  • 0810 - 0815
    ISPE Foundation Greeting
    Speakers
  • 0815 - 0845
    Be the White Crayon: A Patient Perspective
    Matthew Pearl’s life story, and all the lessons he has learned along the way. Matt’s inspiring journey includes life’s ups and downs with a rare disease called, Fanconi Anemia (FA), enduring a lifesaving bone marrow transplant, and encouraging an older sister who also has FA. FA life lesson #6: Research is the key. We can make a difference together.
    Speakers

    Matthew Pearl

    Patient Advocate & Inspirational Speaker
    Fanconi Anemia Research Fund & EveryLife Foundation
  • 0845 - 0910
    Reinventing Partnerships and Medicine for a Healthier World
    For decades, biopharmaceutical companies have developed new therapies using a cookie cutter approach to development and manufacturing. While there have been tremendous advances in science, patients still struggle with adherence and are challenged with medication access. In addition, daily pills do not optimize pharmacology in their delivery, such that patients suffer from the peaks and troughs in drug levels, which may impact safety and efficacy. Some of these challenges have even greater impact when considering global health issues like malaria eradication, safe contraception and HIV prevention and treatment. In the case of malaria, an oral treatment delivering drug for 2 weeks could lead to dramatically reduced disease transmission and potential eradication. Working in partnerships with organizations like the Gates Foundation and the NIH, an emerging new delivery platform representing one of the most significant advances in oral drug delivery may change all that. Replacing daily oral medications is possible through the development of an innovative drug delivery platform that delivers long-acting oral therapies that last for a week or as long as a month for a wide array of therapeutic areas. From the development of new technology that enables clinical work to be conducted in a lab setting, to state-of-the art continuous manufacturing that allows for flexible and efficient production, new science is changing the way therapies are developed and delivered by changing the pill and not the patient. The ability to optimize the way medicine is delivered has the potential to improve adherence and health outcomes while simplifying people’s lives around the world.
    Speakers
  • 0910 - 0915
    Closing Announcements
    Speakers
  • 0915 - 1015
    Networking Break in the EXPO Hall
  • 0915 - 1615
    ISPE Career Center in the EXPO Hall
    The ISPE Career Center is a one-stop shop for professional development, career advancement and personal branding resources. Join us at the Career Center featuring a networking lounge, a headshot booth, on-site resume reviews, raffle prizes, and more.
  • 0915 - 1615
    EXPO Hall Open
  • 1015 - 1145
    Leveraging ML for Process, Efficiency, and Compliance
    Artificial Intelligence (AI) and Machine Learning (ML) are changing the manner in which we manufacture product, analyze data, and improve processes. It is through this digital innovation that we are better able to reduce cost, gain efficiencies, and do so in an ever more compliant manner than ever before. However, such optimizations must be done with an increased focus on data, process controls, and risk-based decision making. Explore two such examples related to batch record data and product development, while discussing one of the newest appendices in GAMP5 2nd Edition.

    1015 – 1020: Welcome, Announcements, Introductions by Eric Staib
    1020 – 1045: GAMP5 Appendix D11 Overview and AI/ML Discussion by Eric Staib and Brandi Stockton
    1045 – 1115: Accelerate Batch Insights with Machine Learning by Tatum O'Kennedy
    1115 – 1135: Using AI to Facilitate and Streamline C&Q by Bruce Klopfenstein and Mehron “Ron” Mirian
    1135 – 1145: Question and Answer/Panel Discussion
    Speakers
  • 1015 - 1145
    Advancements in Drug Development and Equipment Design

    The main needs for pharmaceutical companies have been described extensively, such as: Bringing NDEs faster to the market and gaining a higher supply chain agility. Applying advanced manufacturing technologies is one answer by which those needs can be addressed. Close collaboration between all departments and external stakeholders such as the regulators is another opportunity. Whether in the development or manufacturing, every activity is focused on getting critical treatments as fast, safe, and agile as possible to the patient.
    This session will provide key principles for accelerating product development, adapting advanced manufacturing technologies and automation solutions supported by best-case examples, and answering the following key question: What is still missing today, and how will this be addressed in the future?

    1015 – 1040: API Attributes: LOS to Commercial Drug Product Process by Steve Crowley
    1040 – 1100: The Only Thing Certain is Change: Planning Automation Design to Meet Future Flexibility by Rachelle Howard
    1100 – 1120: Continuous Tableting Control Strategies: When and How to Apply Them by Anthony Tantuccio
    1120 – 1140: CMC Acceleration Levers for Product Development by Shermeen Abbas
    1140 – 1145: Question and Answer/Panel Discussion moderated by Richard Steiner.

    Session Supporter: Pharmatech Associates

    Session Leaders
    Speakers

    Rachelle Howard, PhD

    Director of Manufacturing Automation and Digital Strategy
    Vertex Pharmaceuticals, Inc.

    Stephen Crowley

    Associate Principal Scientist, Oral Formulation Sciences
    Merck
  • 1015 - 1145
    Supply Chain Fragility and the Impact on Patient Care
    Although COVID-19 brought increased awareness of the importance of supply chain resiliency, the criticality of consistent availability of high-quality pharmaceuticals has been understood by pharmacists and pharmacy providers for several decades given the enduring crisis of drug shortages. For the last 20 years, the supply of pharmaceuticals, particularly older legacy (i.e. generic) medications has been repeatedly interrupted creating urgent patient care challenges and increasing health care costs. The situation has progressed to the point that having almost 300 ongoing active shortages of medications is considered “normal.” The status quo cannot continue when patient care is being negatively impacted by the absence of medications and when the U.S. health system is spending an estimated $359 million annually to manage shortages. In this session, we will discuss the current state of shortages (where things are improving and where they are not), the novel strategies and collaborations being implemented to alter the existing landscape, and the work that remains to define the value of quality and reliability in pharmaceutical manufacturing particularly as it relates to older molecules.

    1015 – 1020: A Brief History of the Shortage Era by Steven Lucio
    1020 - 1110: The Clinical Consequences of Drug Shortages on Patient Care by Carina Dolan
    1110 – 1135: Chartering a New Path to Supply Resilience Through Collaboration and Shared Insights by Mittal Sutaria
    1135 – 1145: Question and Answer/Panel Discussion moderated by Steven Lucio
     
    Speakers
  • 1015 - 1145
    ATMP Lifecycle
    As with other medicinal products, the success rate of ATMP products reaching commercialization is often lower than desired, if not worse. One critical factor for improving success is having a deep understanding of product critical quality attributes (CQAs) and critical process parameters (CPPs). Join us in this session as we take a deep dive into the discovery and development of advanced therapy medicinal products (ATMPs), sharing experiences and insights to improve the success rate of ATMP product commercialization. We'll also delve into the specific topic of lifecycle management and comparability of AAV gene therapy, using real-world examples to illustrate best practices. Don't miss out on this valuable opportunity to enhance your understanding of ATMPs and their commercialization potential.

    1015 – 1115: Improving Manufacturability ATMP Discovery to Commercial by Erich Bozenhardt, Zhimei Du, and George Todorov
    1115 – 1145: Bringing Processing Home by Mao-shih Liang & John Easson
     
    Session Leaders
    Speakers

    John Easson

    MS&T Process Science Leader
    Spark Therapeutics, Inc.

    Erich H. Bozenhardt

    Associate Director Process Engineering, Regenerative Medicine
    United Therapeutics
  • 1015 - 1145
    Quality Management Maturity in Action
    ISPE APQ Case Study and FDA QMM Program Learnings. The ISPE Advancing Pharmaceutical Quality (APQ) Program has been developed by industry expert representatives, for industry use, to advance the current state of pharmaceutical quality by providing practical tools and approaches to enhance the effectiveness of the Pharmaceutical Quality System (PQS). The APQ program recognizes that the ability to advance the maturity of quality management lies within the industry itself to provide a range of sustainable and practical quality management improvement strategies.
    This ISPE Advancing Pharmaceutical Quality Program is a practical framework that an organization can use to first assess the maturity and then advance the state of quality within their organization. It is a quality management maturity program that aims to identify good practices and good behaviors which support the continual improvement of quality management effectiveness. It has been developed to support organizations to Assess, Aspire, Act and Advance the maturity and effectiveness of their quality management. It provides specific guidance on how to assess and improve each element of the Pharmaceutical Quality System.
    Further, FDA will share learnings from FDA QMM Pilot studies and risk management model studies in partnership with St. Gallen University.
    ISPE enables industry to proactively demonstrate the value of quality management maturity which benefits regulators, industry, and patients. The ISPE APQ program is a voluntary, industry led program for QMM whereby industry can assess, aspire, act, and advance their level of quality management maturity and share it independently with their patients, consumers, customers, and health authorities globally, based upon international ICH Q10 standards. The APQ QMM program entails quality system assessment, performance measures, improvement tools for advancement, and case studies for robust application.
    Training for the ISPE APQ program will begin in 2023 where our expert team will share practical examples and case studies of the five guides in action.

    1015 – 1040: FDA Quality Management Maturity Program Learnings by Marcus Yambot
    1040 – 1055: Robust Advancing Pharmaceutical Quality Program- QMM through Assess, Aspire, Act, Advance by Tami Frederick
    1055 – 1145: ISPE Advancing Pharmaceutical Quality Program (QMM) Sets Up Your Organization for Success! by Maria Amaya, Michael Grischeau, Andrew Denny, Christine Moore
    Speakers

    Andrew Denny

    Senior Director, Governance & Performance Management
    Bristol-Myers Squibb

    Maria Amaya

    Lead External Advocacy North America (Quality Policy)
    Genentech, A Member of the Roche Group

    Tami J. Frederick

    Senior Director, Corporate Quality Systems & Cultural Excellence
    Perrigo
  • 1145 - 1345
    Lunch in the EXPO Hall
  • 1345 - 1415
    the potential of modular production with zenon and MTP*
    *SPONSORED SESSION*
                     
    • ESG and Scope 1-2-3 emissions – how we can help reach your sustainability goals
      •                            
    • Incubator decontamination in 3-hours, saves 30% in energy costs, and does not use filters
      •                            
    • Cryogenic storage without LN2
      •                            
    • New ULT freezer tools to correct behavior, help safeguard samples, and improve energy efficiency
      •                            
    • Calculating CO2 sequestration equivalencies – the savings in dollars and to the planet
  • 1345 - 1515
    The Digital Journey
    In this interactive session we will engage and challenge the audience’s perception of the industry’s digital predicament. The session presents some diverse digital transformation case studies from across our industry. Three different presentations will focus on the challenges and opportunities across the whole product lifecycle of integrating technology, data, culture, processes to drive innovation, sustainability, and speed to market. The session will explore approaches to creating a holistic roadmap to digitalization, driving cultural change and organizational development, and designing sustainable facilities for accelerated launch of new molecules. The overall theme emphasizes the need to unify data to impact the role of change management in influencing digital maturity. Attending this session will provide attendees some industry best practices on how companies are navigating the digital transformation journey.

    1345 - 1415: Vision, Ambition, Reality of AstraZeneca's Digitalization Journey by Chad Kellner, Kevin Hynes and Matthew Beu
    1415 - 1445: Cultural Change During Digital Transformation by Heike Monika Roeder and Paige Kane
    1445 - 1500: Connected by Intent by David Staunton
    1500 – 1515: Question and Answer/Panel Discussion moderated by Mark O'Connor
     
    Session Leaders

    Mark O'Connor

    Technical Lead and Production Start-up Manager
    AstraZeneca
    Speakers

    Kevin Hynes

    Head: Business Intelligence & Digitalization
    AstraZeneca
  • 1345 - 1515
    Achieving Net Zero in Pharma Manufacturing
    This session, Achieving Net Zero in Pharma Manufacturing: Case Study, Challenges and Pathways, will explore how Takeda will achieve their NetZero goals by 2035 and AstraZeneca's 'Ambition Zero Carbon' strategy to eliminate emissions by 2025 and be carbon negative across the entire value chain by 2030. The speakers will discuss the current issues and challenges, including the impact of regulatory compliance and quality control on sustainable design practices. They will also delve into the pathways towards achieving NetZero, the impacts of introducing new products, and the constraints on existing facility systems infrastructure operations and monitoring. Additionally, our expert speakers will share their experiences, learnings, and best practices for achieving NetZero in pharmaceutical manufacturing.

    1345 – 1415: AstraZeneca Carbon Zero Strategy by Hamid Teimourian & Justin McGarvey
    1415 – 1450: Sustainable Manufacturing of Plasma-Derived Therapies: From an Idea to Reality by Geoffrey Pot
    1450 – 1515: Question and Answer/Panel Discussion moderated by Amanat Kaur
     
    Session Leaders

    Amanat Kaur

    Bioprocess Engineer
    Hyde Engineering & Consulting
    Speakers
  • 1345 - 1515
    Product Development, Supply Chain Security, & MFG Excellence
    For this session, the first segment will examine market dynamics that companies must navigate to successfully launch products in these regions. Attendees will be equipped with insights on how a knowledgeable manufacturing operating unit and optimized supply chain is vital to ensure acceleration and flawless execution and that leveraging historical data, lessons learned, and technology can enable predictive planning. The second segment will explore the critical link between supply chain security and product quality with a special focus on how risk is factored into best practices for remote GMP auditing and the challenges to overcome. The third segment, FOYA 2023 Pharma 4.0 Awardee, Genentech, invested $240 million in a state-of-the-art biologics facility that integrates advanced technologies to support the clinical supply chain. The presentation focuses on executing the project innovatively, establishing a culture of curiosity and boldness. Topics include leadership, team engagement, qualification approaches, and future operations organization.
    By participating in this session, attendees will gain a comprehensive understanding of the key considerations and strategies for introducing new products into emerging markets, gain insights into the risks and vulnerabilities that exist in supply chains and the strategies and technologies that companies can implement to mitigate those risks.

    1345 – 1410: New Product Introduction – China and Brazil by Erica Torres and Lindsey Daniel
    1410 – 1430: The Link Between Supply Chain Security and Quality by Jim Fries
    1430 – 1450: FOYA Pharma 4.0: Factory of the Future: A look into innovation in the South San Francisco Clinical Supply Center by Jeff Davis and Michael Greening
    1450 – 1515: Question and Answer/Panel Discussion moderated by Chelsea Coffey
    Session Leaders
    Speakers
  • 1345 - 1515
    Advances in ATMP
    To wrap up the ATMP and Advanced Technologies Track, what could be more fitting than a discussion on the latest advancements in ATMPs? Since the first CAR-T therapy was approved in 2017, the industry, regulators, and even the general public's understanding of ATMPs has grown significantly. With the need for multi-modal facilities and the development of next-generation manufacturing processes and equipment, we face new challenges as well as exciting opportunities. Join us in this session to gain insights into current trends in facility design, process equipment, and emerging platform technologies. Discover how the latest advancements in ATMPs can help you take your business to the next level.

    1345 – 1430: Advancing ATMP Platforms by Erich Bozenhardt, Aaron Allen and Charles Heffernan
    1430 – 1515: Advances in Multimodal ATMP Facilities by Julie Vickers, Francesca McBride, Peter Cramer and Todd Rumsey
     
    Session Leaders
    Speakers

    Erich H. Bozenhardt

    Associate Director Process Engineering, Regenerative Medicine
    United Therapeutics

    Julie Vickers

    Process Subject Matter Expert
    Jacobs Engineering Group Inc
  • 1345 - 1515
    Updates on ICH Quality Topics: ICH Q12, Q14 and M4Q
    ICH delivers guidance on science- and risk-based strategies and is an enabler of greater harmonization worldwide to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner.
    The ICH Q12 Lifecycle Management guideline provides a framework for managing post-approval changes. Global adoption and implementation of ICH Q12 continues to present challenges both for industry and regulators. Attendees will learn about the worldwide status of the implementation ICH Q12, with a particular focus on the benefits and challenges of putting into practice PACMPs and established conditions. The draft version of ICH Q14, the Analytical Procedure Development guideline, was released for public consultation in March 2022.  Attendees will learn by example how statistical methods can be leveraged to most efficiently and effectively meet several fundamental aspects of analytical procedure lifecycle management described in this guideline.
    Introduction of the Quality - M4Q(R1) guideline on the Common Technical Document (CTD) in 2002 harmonized the format of quality information for registration of pharmaceuticals. Attendees will learn about important revisions to M4Q(R1) including improvements in registration and lifecycle management efficiency, leveraging digital technologies, and accelerating patient and consumer access to pharmaceuticals.
    This session will explore recent updates on ICH Q12, Q14 and M4Q through a series of five lightening talks followed by an interactive panel discussion that includes industry and regulatory agency subject matter experts.

    1345-1350: Welcome, Announcements, Introductions by Connie Langer
    1350-1402: Revision of ICH M4Q by Sarah Pope Miksinski
    1402-1414: Analytical Procedure Lifecycle Statistical Practices by Tara Scherder
    1414-1426: ICH Q12 Current Status, Challenges, and Opportunities by Eli Zavialov
    1426-1438: Benefits of Worldwide Acceptance of PACMPs by Ben Stevens
    1438-1450: ICH Q12, Q14 and M4Q – US FDA Perspective by Mahesh Ramanadham
    1450-1515: Question and Answer/Panel Discussion
    Speakers
  • 1515 - 1615
    Networking Break in the EXPO Hall
  • 1615 - 1635
    2023 ISPE Hackathon Winning Team
    The winning team of the 2023 ISPE International Emerging Leader Hackathon will showcase their presentation, identifying the best solution to a problem statement.

    On Saturday and Sunday during the 2023 ISPE Annual Meeting & Expo, students and recent graduates will be tasked with analyzing a problem statement, acting as a consultant group to help the company solve an issue, to pitch it to a panel of expert judges at the culmination of the Hackathon. At the end of the two days, each team will present to a group of judges and industry leaders. The judges will evaluate the presentations, provide feedback to the teams, and identify the best solution. The winning team will be announced during the ISPE Membership Meeting & Awards Lunch on Monday afternoon and showcase their presentation on Tuesday afternoon.
  • 1635 - 1700
    Unveiling Las Vegas: A Frontier of Innovation
    Join us for an immersive exploration of Las Vegas as a hub of innovation. Discover how this iconic city has evolved beyond its entertainment roots to become a thriving center for technological advancements, urban sustainability, and creative problem-solving. Explore the dynamic blend of cutting-edge startups, smart city initiatives, and inventive collaborations that are shaping the future of Las Vegas and inspiring innovation worldwide.
    Speakers
  • 1900 - 2200
    Tuesday Night Celebration: Classic Vegas at the Mob Museum
    Included in your In-Person All Access Pass! For all other registrants, the add-on fee for the Tuesday Night Celebration is $225. Join us to experience the best of classic Las Vegas at The Mob Museum. Round trip transportation buses are provided and scheduled to start loading outside the Shark Reef Entrance at 1800, and will begin departing at 1830. There will be food, refreshments, activities, and great networking opportunities with friends and colleagues. You won't want to miss the chance to celebrate the pharmaceutical industry! The celebration starts at approximately 1900.
Day 4
Wed, 18 Oct
  • 0700 - 1330
    Registration Open
  • 0800 - 0900
    Continental Breakfast in Foyer
  • 0900 - 0930
    Key ICH guidelines harmonizing advanced manufacturing approaches such as ICH Q12 and ICH Q13, along with greater international collaboration and other trends supporting more efficient access to medicines for patients, will continue to evolve.  The COVID-19 pandemic allowed regulatory authorities to test some innovative tools while also demonstrating a great need for enhanced global collaboration among regulators.  Challenges across the supply chain, leading to shortages, and other pressures such as the need for increased access to personalized medicines made at the point of care, require increased agilities and innovation in manufacturing.  Other trends with increased focus on underserved populations to support greater inclusion of diverse patient populations during product development and in the post-market add to the complexity of the life-cycle management of products.  Improved efficiencies in product development, clinical trials, manufacturing, and post-market surveillance, including leveraging data systems, AI, and real world evidence for product management, will be required to launch global product development and regulation to the next level.
    Speakers
  • 0900 - 1300
    ISPE Career Center in the EXPO Hall
    The ISPE Career Center is a one-stop shop for professional development, career advancement and personal branding resources. The Career Center booth features a networking lounge, a headshot booth, on-site resume reviews, raffle prizes, and more.
  • 0900 - 1300
    EXPO Hall Open
  • 0930 - 1045
    Global Regulatory Town Hall
    The Global Regulatory Town Hall will bring together regulators from around the world to provide their insights on current issues such as harmonization of the practical application of standards and regulations at the interface between regulatory inspections and assessments (e.g., adoption of harmonized standards from ICH, PIC/S, etc.). Panelists will also discuss the impact of coordination efforts such as ORBIS and ACCESS on the assessment and approval process.

    This year you will have a unique opportunity to participate and have your questions answered SUBMIT NOW
    Speakers

    Paul A. Gustafson

    2022-2023 PIC/S Chair, Sr. Corporate Regulatory Compliance & Enforcement Advisor
    Regulatory Operations and Enforcement Branch (ROEB), Health Canada

    Vimal Sachdeva

    GMP Inspector (Technical Officer)
    World Health Organization

    David Churchward

    Global Head Sterility Assurance, Cell and Gene Technologies
    Lonza Biologics
  • 1045 - 1105
    Developing a Workforce for the Future
    As the pharmaceutical sector rapidly evolves with new treatment modalities, advanced technology and digitalization, it's imperative we harness the potential of innovation. This promises enhanced patient care and operational benefits but also brings forth challenges tied to organizational change and developing workforce capabilities. This session delves into the skills future pharmaceutical professionals need to thrive in this transforming landscape. With a clear call to action - Adapt, Learn, and Lead - we'll discuss strategies to ensure professionals are not only ready to adopt new technology but also drive innovative change. By understanding and navigating these shifts, we can ensure that our industry isn't merely reacting, but leading the way forward.
    Speakers

    David Churchward

    Global Head Sterility Assurance, Cell and Gene Technologies
    Lonza Biologics
  • 1105 - 1115
    Closing Words and Adjournment
    Speakers
  • 1115 - 1300
    Reception: What Happens in the EXPO, Stays in the EXPO
    Let's join together to celebrate the knowledge shared, connections built, and memories made as we wrap-up ISPE's largest event of the year! You won't want to miss this event where you can enjoy food, beverages, exclusive giveaways, last chance opportunities and lots of surprises as we say farewell to the attendees, exhibitors and staff who participated in the 2023 ISPE Annual Meeting & Expo. We hope to see you next year! Attendees must be present to win and accept any giveaway prizes. All prize announcements will be held around 12:30 PM.
After the Event
Thu, 19 Oct
  • 0800 - 1400
    2nd Annual ISPE Foundation Golf Tournament
    The ISPE Foundation is excited to announce its second annual golf tournament. Hosted at the Wildhorse Golf Club in Henderson, NV, the Foundation invites you to join us for this event on 19 October 2023. Tee time is 0800 - buses will arrive outside the Mandalay Bay Tour Lobby at 0615 and depart at 0630.
     
     Additional registration is required to participate. Please visit ISPE Foundation’s website for more information at https://ispefoundation.org/2nd-annual-ispe-foundation-golf-tournament   
     
     Proceeds benefit ISPE Foundation. Learn more about registering or sponsoring contact Tori Johnson, at tjohnson@ispe.org or Barbara Bender at bbender@ispe.org
  • 0800 - 1630
    Commissioning & Qualification Training Course
    Worldwide Regulatory expectations and guidance as led by FDA and the EU have stated that all Pharmaceutical Quality Systems should apply a QRM (Quality Risk Management) approach. Through interactive workshops, this course will explain and apply the science and risk-based approach to integrated lifecycle Commissioning & Qualification by conducting verification of systems, equipment and facilities in accordance with the recently issued 2nd Edition Guide, ICH documents Q8 (R2), Q9, and Q10, current Regulatory Guidance, industry best practices, and ASTM E2500.

    Separate registration required.
    To learn more and register, follow this link: https://ispe.org/training/course/commissioning-qualification
  • 0800 - 1630
    GAMP® Data Integrity 21 CFR Part 11 Training Course
    The importance and amount of data being generated to ensure product quality and patient safety continues to grow, and proper controls around that data continue to be a subject of regulatory scrutiny. Regulatory agencies across the world are repeatedly citing data integrity issues. As a result, industry guidance and enforcement strategies are evolving. Regulatory concerns and warning letters have extended to all areas of the pharmaceutical, biotech, and medical device business, including manufacturing, development, clinical, pharmacovigilance and other areas of the product lifecycle. This course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems to provide the tools and techniques to implement proper controls for data to ensure the integrity and validity of the information throughout the data lifecycle.

    Separate registration required.
    To learn more and register, follow this link: https://ispe.org/training/course/gamp-data-integrity-2-day-training
  • 0800 - 1630
    GAMP® Basic Principles Training Course
    This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical, biotech, or medical device industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements, by building upon existing industry good practice in an efficient and effective manner. This classroom course has been updated to include the new revised GAMP® 5 Second Edition.

    Separate registration required.
    To learn more and register, follow this link: https://ispe.org/training/course/gamp-basic-principles-2-day-training-course
After the Event
Fri, 20 Oct