Before the Event
November 03, 2018
Day 1
November 04, 2018
  • 0700 - 1800
    Registration Open
  • 1100 - 1245
    Young Professionals Brunch and Orientation
    A highlight for Young Professionals! Network with your colleagues and peers during a tour of Yards Brewery’s newest facility. Yards has been brewing in the City of Brotherly Love since 1994. The tour will take you through the Brewery’s canning and bottling lines, where you will see how beer is brewed and sample some of Yards’ 20 different beers. Once back at the bar, you can share drinks, food, ideas, and conversation while playing games at the famous Philadelphia brewery. You don’t have to be a young professional or over 21 to attend! Includes: Food, One drink voucher, Nonalcoholic beverages, and Brewery tour with tasting - Hosted by ISPE’s Young Professional Committee. (Cash bar).
  • 1300 - 1500
    WORKSHOP: Building a Framework for Success: A Tale of Two Site Master Plans
    As production expands, new product lines are introduced, quality standards evolve, and process improvements are made it seems like many manufacturing sites are in a constant state of renovation. Onsite management and engineering teams are continually challenged with how to make changes to their facility in the quickest and most cost-effective manner, while causing the least amount of disruption to current operations. This can be particularly challenging in older facilities that have been in operation for several decades and have experienced several cycles of growth and decline. During cycles of growth, a site's flows, storage, and office capacity are often compromised to expand production capacity in a timely, cost effective manner. This session will discuss the day-to-day challenges that site management and engineering teams face and show how a site master plan can be used to create a framework for growth that can maximize the use of space and lead to a more efficient work flow. Attendees will leave with a better understanding of the master plan process, how to use a master plan and the potential benefits.
    Session Leaders
    Architect/planner
    Flad Architects
    Speakers
    Architect/planner
    Flad Architects
    Director of Operations
    Johnson & Johnson
  • 1300 - 1500
    WORKSHOP: Lifecycle Process Validation: How are we still getting this wrong?
    Regulatory authorities have issued revised guidelines on Process Validation to align process validation with a product lifecycle concept and with ICH Q8, Q9, Q10, Q11. These revised guidelines link product/process development, qualification of the commercial manufacturing process, and continued monitoring/verification that the process remains in a state of control. Lifecycle process validation continues to generate confusion within the pharmaceutical industry as evidenced by the recurrence of several items on FDA 483s. In this session, real-life examples where the PV guidance document was either misunderstood, inappropriately interpreted, or simply ignored will be highlighted. Clarification for some of the most commonly confused points in the guidance as well as suggestions on how to prevent and / or remediate these compliance gaps will be provided. The need for enhanced sampling during PPQ and Stage 3a is broadly recognized in the industry. In this session, the role of statistical uncertainty in making inferences based on samples, and the implications for designing sampling plans in the context of the goals of lifecycle PV, particularly in the transition from PPQ to routine manufacturing will be discussed. Common pitfalls in the use of statistics and sampling plans in PPQ and Stage 3a will be presented through real-life examples. In this session, attendees will get a first look at ISPE’s newest guide, “The Good Practice Guide for Practical Implementation of the Lifecycle Approach to Process Validation”. This guide provides step by step implementation approaches, standardized platforms and fundamental PQLI process understanding to establish accepted process validation standards as well as provide overviews on case studies.
    Session Leaders
    Director, Compliance
    Johnson & Johnson
    [The Goldilocks of Enhanced Sampling: Not Too Much and Not Too Little ]
    Speaker: Katherine Giacoletti
    || [An Overview: Practical Implementation of the Lifecycle Approach to Process Validation ]
    Speaker: Robert Beal, PMP
    || [An overview of ISPE’s Good Practice Guide for Practical Implementation of the Lifecycle Approach to Process Validation]
    Speaker: Robert Beall, PMP
    The Good Practice Guide for Practical Implementation of the lifecycle approach to process validation (as described, for example, by FDA’s Process Validation: General Principles and Practices, EU Annex 15, WHO Process Validation Guide and China FDA Validation Guide. and concepts presented in ICHQ8 – 11) prescribe that quality be designed into pharmaceutical manufacturing processes and that the control strategy implemented to ensure such quality is robust, is confirmed at the commercial scale and prior to product registration for biologic products. The control strategy is maintained throughout the commercial lifecycle of a product. This guide provides step by step implementation approaches, standardized platforms and fundamental PQLI process understanding to establish accepted process validation standards.
    Speakers
    Partner
    SynoloStats LLC
    Director, Product Lifecycle Managment
    ProPharma Group
  • 1300 - 1500
    WORKSHOP: The Use of Descriptive Statistics in the Pharma Industry
    Process capability indices and other descriptive statistical tools have been used successfully in a number of process industries (chemicals, electronics) and discussed at length in numerous textbooks. More often than not, those textbook examples do not readily apply to the pharmaceutical and biotech industry. We will present and discuss several such case studies, which include learning how to deal with non-normal data sets or data sets that are very limited. We will also present and discuss the pros and cons of various process capability indices. They are not all created equal. Some are better suited than others in certain situations. We will also discuss how those tools can be used in a CMO setting and how different pharmaceutical and biotech companies go about it. Typically. those tools are not used in isolation and are part of a broader program (i.e. CPV, tech transfer approach, APRs...). We will provide insight into how various companies have gone about integrating those tools. Lastly, we will review and discuss the ISPE Process Capability Maturity Model as it provides insight into 9 areas that an organization needs to focus on to maximize the value derived from such tools.
    Session Leaders
    Group Vice President
    Tunnell Consulting, Inc.
  • 1300 - 1500
    WORKSHOP: Data Integrity Strategy and Implementation
    Data Integrity continues to be a major focus of both regulatory agencies and regulated companies. This series of workshops and exercises will focus on identifying and implementing appropriate controls and culture at a strategic level. A basic understanding of data integrity principles is needed to identify and implement effective controls, including identifying regulated data and understanding the data life cycle within which the data is created, processed, stored and retrieved, as laid out in the FDA, MHRA and other data integrity guidances. Workshops and exercises will provide a fundamental understanding of the application of the guidances into manufacturing processes and laboratory audits. The workshop will empower participants to develop a roadmap around the identification and implementation of controls at the corporate management level to assure a risk-managed, efficient corporate-wide level of controls.
    Session Leaders
    Regional Informatics CSV Consultant
    Waters Corporation
    [Preparing your Laboratory for a Data Integrity Audit ]
    Speaker: Miguel Pagan
    || [Data Integrity controls in Manufacturing ]
    Speaker: Sam Brooks
    || [Defining, Implementing & Monitoring Data Integrity Controls ]
    Speaker: Doug Shaw, CISA
    || [Data Integrity controls in Manufacturing ]
    Speaker: George Bass, BS, MBA
    Speakers
    Principal Consultant, Director
    Brooks Information Integrity Innovations
    Director, CSV & IT Consulting
    Azzur Group
    CSV and Data Integrity Consultant
    GGB SERVICES
  • 1300 - 1500
    WORKSHOP: Equipment Reliability and Preserving Functional Requirements
    Physical Assets are purchased, commissioned, operated, and maintained to produce a specific, high quality product reliability, consistently, and economically. This session focuses on the success of applying ISO 55000, ASSET MANAGEMENT, to preserve the design functions of an asset throughout its useful life. The latest facilities to become certified under ISO 55000 will serve as Case Studies for the audience to discuss and apply their successes as a road map for improving Asset Management Strategies. Steps to become certified under ISO 55000 will be reviewed as well as the benefits of this certification. In this session, participants will review the latest case studies, compare them to their processes, and with the assistance of the presenters, develop a road map to apply ISO 55000 across their organization.
    Session Leaders
    Asset Management & Reliability Specialist
    Commissioning Agents
    [The ISO-55000 “Shall” Statements ]
    Speaker: Robert Smith
    || [What is Asset Management? ]
    Speaker: John Hughes, CAMA, CMRP
    || [Writing an Effective Asset Management Plan]
    Speaker: John Hughes, CAMA, CMRP
    || [The ISO-55000 “Shall” Statements ]
    Speaker: Richard Tree
    Speakers
    Radiopharmaceutical Production Manager
    International Isotopes Inc - Idaho Falls, Idaho
    Asset Management & Reliability Specialist
    Commissioning Agents
    Asset Management & Reliability Specialist
    Commissioning Agents
    Vice President, North America
    Commissioning Agents, Inc.
  • 1300 - 1515
    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 via innovative thinking. Featured presentations include the 2018 Facility of the Year Awards Program Winners.
    Speakers
    Vice President, Project Management
    Vetter Pharma-Fertigung GmbH & Co.
    VP, GM and Site Head - Bayview
    Emergent Bio-Solutions
    Global Engineering
    Pfizer
    Deputy Managing Director
    GPO Thailand
    Vice President Engineering
    Vetter Pharma-Fertigung GmbH & Co.
    Associate Director, Engineering
    Shire
    Engineering Director
    Shire
    Director Capital Project
    CRB
  • 1500 - 1530
    Networking Break
  • 1530 - 1730
    OPENING PLENARY SESSION
    The Opening Plenary Session will set the tone for the entire conference, laying a foundation for innovative thinking around next generation therapies. Hear from Novo Nordisk and Pfizer executives on how their organizations have defined and implemented innovative products and processes. The closing speaker provides unique insight and inspiration from a patient's perspective on how the work of the pharmaceutical industry is changing lives every day.
    Session Leaders
    Vice President
    Commissioning Agents Inc.
    [From Vision to Reality: Delivering Next Generation Diabetes Treatment]
    Speaker: Lars Fruergaard Jørgensen
    As Novo Nordisk moves toward a regulaotry submission of its new oral semaglutide, hear from it's CEO on how to strive for leadership in diabetes management and simultaneously provide groundbreaking innovation in manufacturing. || [How Diabetes Drives My Success]
    Speaker: Becky Furata
    ISPE presents an inspirational look at the impact of our industry’s work on the health and lives of patients who benefit from today’s medicines. Becky Furata is a dynamic ambassador for Team Novo Nordisk, the world's first all-diabetes cycling team. Becky will share her personal journey, living with diabetes, and the possibilities that effective treatment has opened for her. || [Manufacturing & Supply: Vision Becomes Reality]
    Speaker: Kirsten Lund-Jurgensen
    Pharmaceutical manufacturing and supply organizations respond to high expectations from R&D and commercial organizations, regulators, and shareholders. Learn how Pfizer’s global supply team manages these expectations, emerging technologies, and complex supply chains to deliver important medicines to patients now and in the future.
    Speakers
    President & CEO
    Novo Nordisk A/S, Honorary Chair-Annual Meeting
    Ambassador, Team Novo Nordisk and Health Care Policy Consultant
    Team Novo Nordisk Diabetes Cycling Team
    Executive Vice President and President
    Pfizer Global Supply, Pfizer Inc.
  • 1700 - 1900
    Professional Poster Display in Expo Hall
    [ Industrial Vacuum Liquid & Wastewater Conveyance Systems in Cleanrooms ] "As healthcare advances, so do opportunities for combining drugs with medical devices. Many traditional pharma companies are now moving into the combination product space. Not only are there are significant differences between the development processes for drugs and devices, but there are also cultural differences between pharma and device companies. It is important to appreciate and respect these differences in order to successfully develop a drug-device product. This session is intended to help pharma professionals now faced with developing combination products comprehend the nuances related to devices, including quality, risk management, design controls, and clinical development. Through targeted Q&A and case studies, speakers will engage the audience in a philosophical discussion on cultural differences between the industries. Regulatory professionals, engineers, academics involved in drug development will benefit from this session. Participants will develop and appreciation for differences between the core philosophies of pharma and medical device industries; and they should walk away feeling confident in collaborating with device partners in order to build a successful drug-device product."
    Speakers
    Head of Executive Quality
    ZETA Biopharma Gmbh
    Project Farma
    Ecolab Life Sciences
    Jacobs Engineering Group
    Pharmatech Associates
    Industrial Segment Sales Manager
    Aqseptence Group / Airvac Division
    Project Manager
    Bristol-Myers Squibb Co
    Project Manager
    Clarke Engineering Services
    Technical Service Specialist
    STERIS Corporation | Life Sciences
    Technical Services Manager
    STERIS Corp
    Global Sales Manager- Isolation Technology Division
    Comecer Group
    Technical Services Senior Manager
    Steris Corporation
  • 1730 - 1900
    Expo Hall Open
  • 1730 - 1900
    Career Solutions Job Fair in Expo Hall
  • 1730 - 1900
    ISPE Booth and Bookstore Open in Expo Hall
  • 1730 - 1900
    Sunday Welcome Reception in Expo Hall
  • 1900 - 2200
    FOYA Banquet Table
  • 1900 - 2200
    Facility of the Year Awards Banquet (Marriott)
    Join us as we formally recognize and celebrate the winning companies during an award presentation ceremony and dinner.
Day 2
November 05, 2018
  • 0630 - 0800
    10th Annual 5K Charity Run/Walk (Marriott)
    Start the day with a run/walk by the scenic Boathouse Row along the Schuylkill River. Join in the competition or have a nice walk by the river. Buses depart at 0630 from Marriott lobby. Includes: Transportation, Race Timing, and Event T-shirt Sponsored By: BeliMed Infection Control. Benefitting: American Diabetes Association.
  • 0700 - 0815
    New Member/First Time Attendee Orientation
    New to ISPE? Is this your first ISPE Annual Meeting & Expo? Learn more about the benefits of membership and also how to make the most of your experience. (Included in full education registration).
  • 0700 - 1730
    Registration Open
  • 0830 - 1000
    PLENARY SESSION
    Advancements in biologics dominate the agenda for Monday's opening session. Hear innovators from bluebird bio and WuXi Biologics, who have forged new paths for the development, manufacturing, and delivery of cutting-edge therapies.
    Session Leaders
    VP Project Lead Biologics Expansion, Janssen Pharmaceutical
    Janssen Pharmaceuticals
    [Gene Therapy: Bringing it to Life]
    Speaker: Nick Leschly
    Development and delivery of gene and cell therapies in clinical and commercial settings presents new challenges for biotech companies and their partners, and new opportunities to innovate at all levels, including manufacturing. Nick’s talk will delve into the ways that companies can leverage in-house capabilities and strategic partnerships to deliver cutting edge therapies to patients with genetic diseases and cancer, and what’s still needed in order to make these therapies widely available.
    Speakers
    CEO
    Bluebird Bio
    CEO
    WuXi Biologics (Shanghai) Co., Ltd.
  • 1000 - 1100
    Networking Break in Expo Hall
  • 1000 - 1600
    Expo Hall Open
  • 1000 - 1600
    ISPE Booth and Bookstore Open in Expo Hall
  • 1000 - 1600
    Professional Poster Display in Expo Hall
    Speakers
    Head of Executive Quality
    ZETA Biopharma Gmbh
    Project Farma
    Ecolab Life Sciences
    Jacobs Engineering Group
    Pharmatech Associates
    Industrial Segment Sales Manager
    Aqseptence Group / Airvac Division
    Project Manager
    Bristol-Myers Squibb Co
    Project Manager
    Clarke Engineering Services
    Technical Service Specialist
    STERIS Corporation | Life Sciences
    Technical Services Manager
    STERIS Corp
    Global Sales Manager- Isolation Technology Division
    Comecer Group
    Technical Services Senior Manager
    Steris Corporation
  • 1000 - 1600
    Career Solutions Job Fair in Expo Hall
  • 1100 - 1230
    Education Session: Manufacturing & Supply Chain Capacity Planning Using Discrete Simulation
    Capacity planning for operations with multiple manufacturing steps and interdependencies can be challenging. For fast growing businesses, the importance of proactively understanding capacity constraints is a critical factor between success and failure. Discrete simulation enables scenario planning on a risk-free yet reliable environment to support the decision- making process for large capital investments and staffing plans These presentations will discuss simulation case studies demonstrating how all work centers will perform before implementing changes in a live system (e.g. "what if" changes to Kanban Levels, Manufacturing Frequency, Lean Pull Replenishment Strategies, etc.). The case studies are based on two successful implementations: 1) An established high volume/ high complexity plant and 2) a fast-growing business. Upon implementation of a weekly simulation and optimization process, customer service levels increased to unprecedented levels, while plant financial performance became enterprise benchmarks. Additionally, the process knowledge acquired by the team during the implementation also resulted in a shift in the nature of the work of the planning organization, moving a department from a group of schedulers to a team of holistic capacity planners. Finally, the realization of a formerly unknown capacity bottleneck triggered a significant capacity improvement project involving capital equipment and staffing.
    Session Leaders
    Director of Operations
    Johnson & Johnson
    [Simulation Case Studies: Complex Processes and Fast Growth Products]
    Speaker: Alvaro Brisolla, MBA
    || [Applicability of Simulation to all Pharma Product Forms ]
    Speaker: James Curry
    Speakers
    Director of Operations
    Johnson & Johnson
    Owner/CEO
    OpStat Group Inc.
  • 1100 - 1230
    Education Session: Regulatory Affairs Before & After a Natural Disaster
    The only reliable forecast statement that may be made regarding Natural Disasters is they will continue to occur. What will they look like? Where will they happen? What will be the depth of impact? These are all unknowns in advance. Despite the unpredictability of these events, there are meaningful steps which can be taken, before and after disaster strikes, to mitigate their impact on drug supply, which will ultimately minimize drug shortages.

    Highlighting recent examples from Hurricane Maria and more, this session will include presentations by Drug Shortage experts from Merck, the University of Utah Health, and the FDA, and has been designed to share important learnings for industry preparedness and public health.
    [Regulatory Affairs Involvement Before and After a Natural Disaster is Integral to Mitigating Impact ]
    Speaker: Erin Tynebor
    This presentation will highlight meaningful steps Pharmaceutical Companies may take, both before and after a large scale disaster strikes, to mitigate the impact of a significant business disruption on drug supply, which will ultimately minimize drug shortages. || []
    Speaker: Erin Fox, Pharm D
    || [Regulatory Affairs Involvement Before and After a Natural Disaster is Integral to Mitigating Impact]
    Speaker: FristName LastName
    This presentation will highlight meaningful steps Pharmaceutical Companies may take, both before and after a large scale disaster strikes, to mitigate the impact of a significant business disruption on drug supply, which will ultimately minimize drug shortages.
    Speakers
    US FDA, Invited
    Director, Regulatory Affairs
    Merck & Co., Inc.
  • 1100 - 1230
    Education Session: Technology Transfer Acceleration
    Faster and more effective technology transfers (TT) that meet regulatory, quality and supply chain requirements are increasingly expected by industry. The number of transfers is expanding, with more use of third parties, greater internationalization, closer coordination with development and manufacturing organizations and increasingly complex products. Flexible and yet robust transfer practices are required to ensure Control Strategies, Technology and Knowledge is successfully transferred. This requires understanding of the risks involved, developing close cooperation between Sending and Receiving Units, enabling robust knowledge transfer and putting in place secure project management processes. This session will cover the latest advances in TT practices, how to manage overlapping phases for TT acceleration while also meeting product quality requirements and commercial timelines. It will include reference to case studies and give real examples of successful transfers. In this session participants will learn transfer fundamentals and current best practices illustrated by recent case studies.
    Session Leaders
    Facilities and Engineering
    Amgen Inc
    [Strategies to Enable Rapid Technology Transfers ]
    Speaker: Jose Caraballo
    || [Utilization of accelerated technology transfer principles for small to mid-size companies ]
    Speaker: Nicholas Vrolijk, PhD
    || [Technology Transfer Guide, 3rd Edition ]
    Speaker: Bruce Davis
    Current Technology Transfer Acceleration Guide is being updated to relfect lastest industry and regulatory views.
    Speakers
    Director of Quality, Product Quality Steward, Product Supply Biotech
    Bayer US
    Vice President, Manufacturing Operations
    Celldex Therapeutics, Inc.
    Principal
    Global Consulting
  • 1100 - 1230
    Education Session: Moving Cell & Gene Therapies Toward Commercialization
    Cell and gene therapies continue to gain interest and increasing momentum as viable and effective treatments for a wide array of diseases. As building positive clinical data pushes these therapies forward, unique bioprocessing and manufacturing challenges must be addressed to ensure a smooth transition from development to commercialization. While showing great promise, these therapies are relatively new to the biopharmaceutical manufacturing field and bioprocessing engineers and scientists. Further understanding of these new modalities and their respective critical process parameters and critical quality attributes becomes paramount. This session will provide a number of examples from various companies and/or groups which have taken on these bioprocessing challenges of their respective cell and gene therapies. The particular challenge, why it matters to the particular therapeutic, and how it is actively being addressed will be discussed.
    [Implementation of Improved Process Control to Ensure Commercial Supply of LVV for Gene Therapy]
    Speaker: Michael Burns, PhD
    This presentation will discuss the identification and subsequent control of process parameters to improve both the reproducibility and quality of the lentiviral vector in preparation for commercial production. || [Increasing Precision and Accuracy for the Analysis of Viral Vector Titer and Potency ]
    Speaker: Joesph Mombeleur
    Speakers
    Scientist, Process Development Group
    BlueBird Bio
  • 1100 - 1230
    Education Session: Next Generation Manufacturing Control
    The Digital Plant - sometimes referred to as Industry 4.0 or Pharma 4.0 - describes the next major evolution of pharmaceutical manufacturing. A next generation digital plant will incorporate emerging digital and information technologies such as advanced analytics, robotics, artificial intelligence, and predictive modeling, to name just a few. Using case studies this presentation will detail engineering applications of these technologies that are already in use, including strategy, business case, and implementation. Also included are the next wave of initiatives including software and multiple case studies that demonstrate how to implement these emerging digital technologies throughout the pharmaceutical supply chain. The presentation will give participants insights into some of the key challenges in applying new Pharma 4.0 technologies and related innovation processes. The focus will be on digital maturity and how to prepare the organizations to be ready to accept changes related to adoption of the new technology.
    Session Leaders
    Consultant - Business Operations
    Eli Lilly & Co
    [Applying Quality and Predictive Control ]
    Speaker: Gilad Langer, PhD
    Speakers
    VP of Business Development
    Bigfinite Inc, Headquarters
  • 1100 - 1230
    Education Session: Renovating an Existing Biotech Plant
    Most biotechnology organizations have designed their monoclonal antibody (mAb) production operations to handle 1 to 4 g/L titers. The typical design features a cluster of large-scale (=10,000 L) batch bioreactors or multiple trains of 1,000-liter reactors. The bioreactor turnover is generally such that a harvest happens every few days, and, when sequenced properly, a single downstream purification train can handle the output of the several bioreactors. In the world of perfusion, the downstream columns are small and dedicated to the perfusion "train." Through a better understanding of media needs and improved clonal selection, processes are reaching the next level of titers in the 5 to 15 g/L range. As a result of these increased titers and the strategies employed to produce higher titers, the next-generation biotech facility is needed. While some product portfolios might be a good fit for 2,000 L single-use scale, high titers for high-demand products can reap a significant reduction in cost of goods using large-scale trains and can minimize capital by using existing assets. Existing facilities will need to adapt. This session will discuss the process impact and modernizations required for facility from a holistic standpoint. This will discuss the use of single use systems (SUS) and reallocation of space and utilities.
    Session Leaders
    President
    BCS LLC
    [Higher Titer Process Renovation Considerations
    Case Study 20kL Bioreactor Train Renovation for High Titer ]
    Speaker: Erich Bozenhardt
    Speakers
    Process Manager
    IPS
  • 1230 - 1345
    Monday Lunch in Expo Hall
  • 1330 - 1700
    Student Poster Competition
  • 1345 - 1515
    Education Session: Robust, Resilient, Reliable Facilities • Lessons Learned from Hurricane Maria
    Hurricane Maria struck Puerto Rico on Sept 20, 2017. This Category 4 Hurricane was like no other in recent history. The BioPharma industry has always designed for and planned for redundancies and potential failures. However, this hurricane would put the BioPharma industry in Puerto Rico to the ultimate test to maintain product supply to patients. This case study will review the design strategies and infrastructure approaches in place prior to the hurricane. We will also review the performance of the facility and systems during and immediately after the hurricane. And most importantly, share the experience of the recovery for the many weeks and months afterwards. Attendees will learn facility design strategies that address business continuity planning and minimize operational and supply chain risk. In addition, attendees will gain an understanding of best practices and key takeaways for an Emergency Response Management where the improbable became reality.
    Session Leaders
    Director Biologics Capital Strategy
    Bristol-Myers Squibb
    [Business Continuity…a Holistic Readiness Strategy ]
    Speaker: Desiree M. Muniz
    We will share the Crisis Management process, while providing information about the lessons learned and how to ensure Business Continuity from an Engineering perspective when facing similar events in PR or in the Mainland. Facilities readiness, Communication infrastructure, People Management, External partnerships, Materials and Supply management, are some of the Engineering focus areas included in our Engineering strategy to ensure Business Continuity.
    Speakers
    Sr. Director of Global Engineering Operations
  • 1345 - 1515
    Education Session: Accelerated Product Development through Inspection & Launch•Part 1
    There is a need for an increased focus on?expedited product?development, the CMC regulatory challenges they pose, and the Pharmaceutical Quality systems required to bring highly innovative and life-saving?products to patients, safer and faster.? We all face many and varied global accelerated program expectations. Global convergence and harmonization of both industry and regulators of these expectations will be key to our success.? The GMP aspects associated with process & method validation, preparation for PAI, closure of observations, and preparation for launch are just a few examples of?demanding areas that require more discussion and alignment.? These two sessions are intended to build on the framework initiated at the 2018 ISPE Quality Manufacturing Conference with a more specific focus on the GMP elements.? Accelerated Product Development-Part 1 will include case studies describing lessons learned and innovative risk-based approaches from the industry and regulatory perspective for both small molecule and biotechnology products.? Part 2 is designed as a round-table session to discuss these themes and to develop an understanding and best practice that establishes a framework to support both industry and regulators?to more expeditiously make these medicines available for patients.
    Session Leaders
    Associate Director
    Bristol-Myers Squibb
    Speakers
    Senior Director, Regulatory Affairs-CMC
    AstraZeneca
    Branch Chief, Division of Inspectional Assessment
    FDA/OPF/OPQ/CDER
  • 1345 - 1515
    Education Session: From Industry 4.0 to Pharma 4.0 - A Holistic Concept
    The new Industry 4.0 approach to Product Lifecycle Management /PLCM across the supply and value chain needs special implementation in the pharmaceutical industry. The Pharma 4.0 approach is tailored to the special requirements in the pharmaceutical Industry. The Session will outline the concept of the Pharma 4.0 Operating Model out of the results from the ISPE Special Interest Group Pharma 4.0. You will learn how, in the future, the holistic Operating Model of Pharma 4.0 for the pharmaceutical industry will have an ICH based Holistic Manufacturing Control Strategy Lifecycle Management approach, which will enable the Six Sigma Quality paradigm expected by the regulators. Also, through practical case studies, you will learn how this change will be empowered by the disruptive landscape of Industry 4.0 technologies applied as Pharma 4.0, a way road to Data Integrity by Design, picking up the Quality by Design paradigm.
    Session Leaders
    Senior Director Global Accounts
    Werum IT Solutions
    [Digital Maturity: Digitalization of SOPs ]
    Speaker: Heike Röder
    || [Case Study: Manufacturing Control Strategy Facilities Design ]
    Speaker: Line Lundsberg-Nielsen, PhD
    || [Pharma – 4.0: Data Integrity by Design and Digitalization ]
    Speaker: Volker Roeder
    Speakers
    Head of Process & Knowledge Management
    Bayer AG
    Global Technology Partner
    NNE
    Management Consultant
    ARCONDIS Group
  • 1345 - 1515
    Education Session: Computational Strategies for Bioprocess Performance
    This session will focus on computational strategies and methods that can be used to improve understanding, control, and visualization of bioprocess performance. Novel approaches, leveraging machine learning, advanced analytics, and computational modeling will be described.
    Session Leaders
    Principal Engineer
    Amgen
    [Applying Next-Generation Data Analytics Toward Improved Biopharmaceutical Manufacturing ]
    Speaker: Myra Coufal, PhD
    || [Moving to Prescriptive Maintenance with AI: A Success Story]
    Speaker: Blair Fraser
    OEE (overall equipment effectiveness) improvement increases capacity, reduces cost and potentially also reduces capital investment. During this session, you will have the opportunity to review a case study and learn how the use of artificial intelligence in processing the equipment condition monitoring data improves manufacturing OEE || [Advancement of Industry 4.0 and Digital Architecture in Biopharmaceutical Manufacturing ]
    Speaker: Sarath Moses
    Speakers
    Principal Scientist
    Amgen
    Leader, Digital Transformation
    Lakeside Process Controls Ltd
    Director, Biologics Commercialization
    Merck
  • 1345 - 1515
    Education Session: Security in the Regulated World
    This practical session is an excellent opportunity for participants to hear about important security and integrity concerns associated with their data and gain an understanding of how these concerns can be managed. The session includes: An overview of blockchain technology, a demonstration of what it actually does, use cases of companies that have tried it, lessons learned, what works well, and what does not. Cybersecurity risks in continuous manufacturing and recommendations on best practices and actionable steps to take using the NIST Cybersecurity Framework. PIC/S / EU Annex 11-5 states data in transit needs be protected - what does that mean for manufacturing systems using wireless communications. The session will include standards to use, risk and vulnerability assessment, identifying requirements, identifying testing requirements, and maintaining data integrity in operation.
    Session Leaders
    Consultant/Retired
    Factorytalk Co., Ltd.
    [Blockchain- reshaping the way we share and trust data ]
    Speaker: James Canterbury
    There is a lot of hype around blockchain and distributed ledger technologies, but will it really revolutionize the way we trust and share data? Yes! maybe? In this session we will provide a short overview of the technology, a demonstration of what it actually does, and present use cases of biopharma companies that have been experimenting with it – including lessons learned of what works, and what challenges can we expect. || [Cybersecurity in the Continuous Manufacturing Operations ]
    Speaker: Thomas House
    || [Cyber Security Threats and Solutions to Batch Record and Packing Line Serialization Data Integrity Requirements]
    Speaker: Jason Young
    This presentation will cover effects of a successful hack breaching data integrity protections to a batch record on a packing line serialization system where the international identification number and unique serialization number are stolen to produce and distribute fake pharmaceuticals. This will be followed by how industry best business practices for cybersecurity can be used to provide protections with traceability to data integrity controls for regulated systems.
    Speakers
    Principal
    Ernst & Young LLP
    Network Security Business Leader
    Rockwell Automation
    CEO
    Silver Bullet Security
  • 1345 - 1515
    Education Session: Implementing a Sterile Oncology Facility in China
    OncoGenerix, Hailin, China will be presented as a case study describing the strategy, challenges and benefits of implementing a sterile oncology vial filling facility in China. The case study will discuss the diverse and complex steps required to establish a fully integrated self-sufficient isolator-based manufacturing facility to meet global quality and market needs including, design, construction, qualification, resourcing, global quality management system implementation, product selection and regulatory approval. The case study will review how OncoGenerix used a defined risk-based lifecycle approach to integrate guidance's from the International Conference on Harmonization, PICS and ISPE (including GAMP) as the basis for facility design, qualification and operation to ensure that regulatory requirements established by the China CFDA, US FDA and EU EMA were fully addressed throughout the implementation process minimizing the potential challenges to regulatory approval during the commercialization process. This case study represents an excellent opportunity for participants to gain an understanding of the key activities/considerations associated with implementing a sterile manufacturing facility from design through commercialization and regulatory approval in a challenging geographical and cultural environment.
    Session Leaders
    CEO
    OncoGenerix Usa Inc
    [Product Selection & Facility Commercialization ]
    Speaker: Roland, franke, PhD
    Speakers
    VP of Business Development
    OncoGenerix Usa Inc
  • 1515 - 1600
    Networking Break in Expo Hall
  • 1600 - 1730
    Education Session: Pharma 4.0 - Plug & Produce
    The Special Interest Group Pharma 4.0 initiated an ISPE working group "Plug & Produce". The goal is to define how the Industrie 4.0" approach enables an easy integration of shop floor equipment. The smart factory will be integrated horizontally and vertically integrated by standard interfaces, which will ease integration of prequalified equipment. This is already established in the semiconductor and other industries, where automation components and software solutions follow international standards. Integration for plug-in compatibility should also comply with data integrity requirements (such as audit trail); data security; seamless integration of online, inline, and at-line PAT instrumentation process control; and RTRT or packaging serialization and track and trace. Future integration concepts should follow this plug-and-produce concept to reduce costs and enable flexible production solutions and provide a cost-efficient lifecycle management interface. In this session you will learn how a holistic integration concept is planned, designed and standardized across the pharma organization, without reinventing the wheel for integration standards, like Pack-ML, Open-SCS or OPC.
    Session Leaders
    Senior Director Global Accounts
    Werum IT Solutions
    [Pharma 4.0 Plug & Produce Case Study: Insights from the Lab ]
    Speaker: Wolfgang Winter
    This session discusses root causes for the complexity of end-to-end integration in manufacturing, including the lab. We explore strategies to drive a sustainable long-term Plug and Produce solution and provide examples from recent pilots and PoC projects. || [Pharma 4.0 Working Group Plug & Produce ]
    Speaker: Wolfgang Winter
    This session explains how Industry 4.0 needs to be augmented with pharma-specific requirements, the approach defined by the ISPE Plug and Produce working group and how this complements other initiatives. || [Case Study: Applied Plug & Produce in OSD Manufacturing ]
    Speaker: Thomas Hofmaier
    Speakers
    Head of Design-In (Technical Marketing)
    Agilent Technologies R&D Mktg GmbH & Co KG
    Head of Design-In (Technical Marketing)
    Agilent Technologies R&D Mktg GmbH & Co KG
    Head of Business Unit
    Glatt GmbH
  • 1600 - 1730
    Education Session: Dynamic Modeling for Sustainable Manufacturing Faciliites
    The use of cutting edge building modelling during design of new manufacturing facilities optimizes operational costs, installed utilities, energy consumption, etc. This insight enables value added decisions around site location, orientation, and implementation of complementing technologies. These modeling techniques are currently being used with promising results. Modeling the interactions of different facility technologies makes optimization possible and a more complete integrated sustainable facility solution. A case study will present how analytical and empirical modeling was used to improve production cleanroom performance at lower air change rates, increasing product and personnel safety while reducing energy use. This approach can be deployed at the early facility design and through the lifecycle of the production area. Attendees will learn how these modeling techniques from facility to production suites can be used to bring value through optimal and sustainable facilities by enabling the designers and stakeholders to make value added decisions early in the design process.
    Session Leaders
    Principal Mechanical Engineer
    Gilead Sciences, Inc.
    [Case Study: CGMP Air Change Rate Optimization Provides Opportunity for AHU Consolidation ]
    Speaker:Russell Watters, PE, CEM, CVCP
    || [Case Study: CGMP Air Change Rate Optimization Provides Opportunity for AHU Consolidation ]
    Speaker: Steven Chan
    || [Sustainable Manufacturing Facilities through Dynamic Modeling ]
    Speaker: Kieth Beattie, PE
    || [Leveraging Modeling in a Regulatory Environment ]
    Speaker: Norman Goldschmidt
    Speakers
    Genesis Engineers Inc
    Project Engineer
    Eichleay Engineers Inc
    Life Science Lead
    Energy Efficiency Consultancy Ltd
    President
    Genesis Engineers Inc
  • 1600 - 1730
    Education Session: Cloud Computing in a Regulated Environment
    This session will also address both development of GxP cloud solutions and the evaluation of suppliers of cloud services. Regulated industries are wary of cloud services because they typically do not guarantee security and compliance to regulations for GMP data. With an appropriate policy on how cloud services can be used, industry can mitigate security and compliance risks. - Understand types and definitions of cloud services, - Understand information requests to support audits, regulatory inspections, and data integrity, - Understand cloud-based service level agreements. - Understand Security, data archival, backups, and other regulatory related topics Cloud services offer companies opportunities for greater efficiencies but can lead to assumption of unnecessary risks if not approached properly for regulated systems. There a trend in the biopharmaceutical industry of increasing dependence on outsourced IT resources. With this there are often drivers pushing toward the use of providers who are not traditional GxP suppliers. Complicating the issue, some of these are immense organizations who are not amenable to audit by biopharma QA. Financial IT methods can be leveraged for evaluating GxP suppliers by adapting the SOC 2+ process, which uses independent third-party audit supported by testing, to support Sarbanes-Oxley compliance to include assessment of controls important for validation and data integrity.
    Session Leaders
    Retired
    Novartis Pharmaceuticals
    [Cloud Computing in a Regulated Environment]
    Speaker: John Hannon, CPIP
    Speakers
    VP, Global Automation and IT
    Commissioning Agents Inc
  • 1600 - 1730
    Education Session:From Aging Facilities to Facilities of the Future
    Leaders of the Sterile Products Processing Community of Practice will discuss results from the latest industry survey regarding aging facilities, the state of technology and improvements in the industry. How many aging facilities are out there? Is your facility on borrowed time? Think your facility is safe and up-to-date? Are you sure? Come learn about the state of the sterile products industry and how the industry is responding to advances in technology and the increasing expectations from regulators, including the advancing sterility assurance and where risks lie in the industry.
    Session Leaders
    Partner, Front End
    NNE
    Senior Pharmaceutical Engineering Specialist
    CRB
    []
    Speaker: Jessica Frantz
    || [State of the Sterile Products Industry: 2018 Survey Results ]
    Speaker: Charlotte Enghave Fruergaard, PhD
    || []
    Speaker: Jörg Zimmermann
    Speakers
    Field Marketing Manager
    Sartorius Stedim Biotech
    Vice President/Bereichsleiter
    Vetter Pharma-Fertigung GmbH & Co.
  • 1600 - 1730
    Education Session: Improving Supply Chain Through Human Performance
    The empirical evidence shows the best performing supply chains come from firms that combine quality, dependability, and flexibility as priority objectives and that relegate cost reductions to secondary importance. The right management principles, systems, and procedures play an essential role, but the capabilities that create a competitive advantage come from people-their skill, discipline, motivation, ability to solve problems, and their capacity for learning. This session brings the participant's attention back to the time-tested approaches to improving human skills through training in a way that they may have never experienced before. Leadership creates and reinforces the culture of quality in an organization. A common cultural challenge is human error which can lead to poor quality, significant costs, customer service outages, and significant regulatory risk. This session also covers the 5 leadership keys to success for improving human performance to equip you to become a change agent in your organization.
    Session Leaders
    Vice President, North America
    Commissioning Agents, Inc.
    [Improving Supply Chain Performance Through Human Performance ]
    Speaker: Steven Greer
    Leadership creates and reinforces the culture of quality in an organization. A common cultural challenge is human error which can lead to poor quality, significant costs, customer service outages, and significant regulatory risk. This session also covers the 5 leadership keys to success for improving human performance to equip you to become a change agent in your organization.
    Speakers
    External Engagement Leader
    Procter & Gamble
  • 1600 - 1730
    Education Session: Accelerated Product Development through Inspection & Launch-Part 2
    There is a need for an increased focus on expedited product development, the CMC regulatory challenges they pose, and the Pharmaceutical Quality systems required to bring highly innovative and life-saving products to patients, safer and faster. We all face many and varied global accelerated program expectations. Global convergence and harmonization of both industry and regulators of these expectations will be key to our success. The GMP aspects associated with process & method validation, preparation for PAI, closure of observations, and preparation for launch are just a few examples of demanding areas that require more discussion and alignment. These two sessions are intended to build on the framework initiated at the 2018 ISPE Quality Manufacturing Conference with a more specific focus on the GMP elements. Accelerated Product Development-Part 1 will include case studies describing lessons learned and innovative risk-based approaches from the industry and regulatory perspective for both small molecule and biotechnology products. Part 2 is designed as a round-table session to discuss these themes and to develop an understanding and best practice that establishes a framework to support both industry and regulators to more expeditiously make these medicines available for patients.
    Session Leaders
    Associate Director
    Bristol-Myers Squibb
    [Hot Topics Overview]
    Speaker: Stephen Tyler
    Speakers
    Director Quality Assurance
    AbbVie
    Branch Chief, Division of Inspectional Assessment
    FDA/OPF/OPQ/CDER
  • 1800 - 2130
    Women in Pharma Event
    Women in Pharma Event
  • 1900 - 2100
    YP Networking Event At Yards Brewing Company
Day 3
November 06, 2018
  • 0700 - 1730
    Registration Open
  • 0800 - 1000
    MEMBERSHIP & AWARDS BREAKFAST
    Enjoy breakfast with ISPE leadership and colleagues while learning about significant achievements made by industry in 2018. Be among the first group to recognize the winner of the 2018 Facility of the Year (FOYA) Overall Winner, and celebrate with your peers as the ISPE International Honor Award and the Student Poster Competition Award winners are presented.
    Session Leaders
    Vice President
    Commissioning Agents Inc.
  • 1000 - 1100
    Networking Break in Expo Hall
  • 1000 - 1600
    ISPE Booth and Bookstore Open in Expo Hall
  • 1000 - 1600
    Expo Hall Open
  • 1000 - 1600
    Professional Poster Display in Expo Hall
    Speakers
    Head of Executive Quality
    ZETA Biopharma Gmbh
    Project Farma
    Ecolab Life Sciences
    Jacobs Engineering Group
    Pharmatech Associates
    Industrial Segment Sales Manager
    Aqseptence Group / Airvac Division
    Project Manager
    Bristol-Myers Squibb Co
    Project Manager
    Clarke Engineering Services
    Technical Service Specialist
    STERIS Corporation | Life Sciences
    Technical Services Manager
    STERIS Corp
    Global Sales Manager- Isolation Technology Division
    Comecer Group
    Technical Services Senior Manager
    Steris Corporation
  • 1000 - 1600
    Career Solutions Job Fair in Expo Hall
  • 1100 - 1230
    Education Session: Streamlined Manufacturing: Continuous Manufacturing and Other Design Challenges
    Bringing medicines to market not only requires the development of an effective therapy, but also the innovation necessary to deliver an effective manufacturing process.

    Whether by continuous manufacturing approaches or novel process technology, leaders today must address many challenges to ensure key stakeholder engagement throughout the process, while ensuring delivery of consistent product quality, robust process control strategies, and final manufacturing flexibility for launch and post-launch.

    Through several real-world examples, this session will focus on the challenges faced when developing and implementing new processes and technologies to enable effective and successful manufacturing.

    Utilizing case studies, our presenters will walk through their experiences in effectively implementing continuous manufacturing processes and their experience with working with internal resources and with external resources. This session will also provide perspective on what it takes to utilize a virtual model in working with external partners to bring novel therapies and the related manufacturing processes to market effectively.
    [Continuous Processing in Single Use Equipment ]
    Speaker: Jørgen Magnus
    || [Strategic Approach to Product and Process Development by Continuous Manufacturing ]
    Speaker: Giustino Di Pretoro, PhD
    || [The Burden of Innovation: Development Challenges in a Virtual Model ]
    Speaker: Tara Barreira
    The model for drug development is changing and so are the rules. As companies outsource more of their development activities how do you tackle innovation, IP strategy and overall manufacturing success? Addressing critical factors in innovation in two and three party models using case studies from ongoing programs.
    Speakers
    Head Bioprocess Technology
    Bayer AG
    Associate Director Drug Product Development - Continuous Manufacturing
    The Janssen Pharmaceutical Companies of Johnson & Johnson
  • 1100 - 1230
    Education Session: Opportunities & Challenges in PAT: Considerations for ICHQ12
    The ICHQ12 guidance offers new possibilities to lower the reporting categories and to establish an efficient life cycle management. In this connection, the definition of established conditions plays a central role as these elements in a filing are legally binding and changes to an established condition must be reported. In this respect the concept of a performance based approach is very powerful and attractive in downgrading the reporting category of a certain established condition (e.g. the blending time and the batch size during blending monitored by a NIR). For this purpose, PAT procedures are crucial for achieving this kind of control and would be necessary to exploit the full potential of this kind of a control strategy. However, the flexibility for improving and changing these PAT procedures still poses a challenge for the industry. According to the current draft of the ICHQ12 document and also referring to the EMA NIR guideline, there are still constraints to adapt and improve PAT methods in a flexible manner. The session should highlight the views and perception from health authorities and industry how a life cycle of method for a performance-based approach, e.g. also in light of continuous manufacturing should be handled.
    Session Leaders
    Global Statistics and PAT Head, Manufacturing Science and Technology
    Novartis Technical Operations
    [ICHQ12 Tools for Regulatory Flexibility ]
    Speaker: Christine M.V. Moore, PhD
    Speakers
    Global Head and Executive Director, GRACS CMC Policy
    Merck & Co.
    US FDA, Invited
  • 1100 - 1230
    304-Digital Personal Medicines
    EDUCATION SESSION: Digital Personal Medicines
  • 1100 - 1230
    Education Session: Emerging Technology Approvals - Lessons Learned
    Emerging technologies are the Wild, Wild West of the pharmaceutical industry recently. Many new technologies are being investigated but none have completely transformed the industry. In, addition, there is great trepidation concerning how any new technology will be reviewed and hopefully approved by the regulatory agencies. This session will explore Emerging Technology regulatory submission challenges and provide valuable insight on how to increase the odds for a favorable outcome. This session will include a review of the FDA Emerging Technology submission process in detail so attendees can understand the key elements of each step. Additionally, the FDA's Project Manager for the Emerging Technology Team (ETT) will provide insight into key features of a submission and common missteps. The session will conclude with a question and answer period as attendees will further increase their understanding of the process. This session will offer attendees the opportunity to learn the FDA process for an ETT submission and hear directly from the FDA ETT PM as to what is most important in an Emerging Technology submission and how to best make their case for approval.
    Session Leaders
    Director, Project Management
    Longfellow Real Estate Partners, LLC
    [Challenges from an Operating Company Perspective ]
    Speaker: Brian D. Beck
    Speakers
    US FDA, Invited
    Director / TL - Engineering, Maintenance, Utilities
    Zoetis, Inc.
    Acting Quality Assessment Lead
    FDA/CDER/OPQ/OPF/DIA/BII
  • 1100 - 1230
    Education Session: Sustainable Serialization Solutions
    This session consists of three important angles on modern Serialization and what's still to follow. 1) Large and complex programs, such as Serialization, often represent a significant investment with many risks to an organization. They can last many years, are often multi-layered and quite dynamic in terms of scope, cost and schedule. They can involve unique challenges that are difficult to manage with conventional and proven project management principles. As such, many organizations have adopted very different approaches with very different results. Are we missing an opportunity to apply more of the basic Project Management principles to the benefit of these large programs? How do we manage a scope that is not always clearly defined or easily predicted? How should these programs be funded? How can expectations be managed without losing credibility? How should so many stakeholders be managed? Serialization is used as a case study to challenge how these programs are managed with reference to the ISPE Project Management Good Practice Guide. 2) In the near aftermath of the Serialization implementation it's important when Projects are handing over to Operation that the topic stays agile, focused and integrated into daily life routines. Legislations and business requirements are evolving even after enforcement are enacted to find the new level of cGMP. Supply Chain stakeholder awareness of business impact are also on the rise prompting more complexity. This part of the session will therefore focus on latest trends seen from the perspective of the remaining deadlines to enact. World map overview on trends and requirements. 3) In the rush to implement a serialization solution that will meet regulatory deadlines, it can be easy to lose sight of building a system and processes that will be sustainable for years to come. This session will discuss strategies for successful system management through software and hardware upgrades as well as product and regulatory changes. The session will present learnings from system deployments and upgrades.
    Session Leaders
    Global Technology Partner
    NNE
    [Deploying and Maintaining a Sustainable Serialization Solution]
    Speaker: Elizabeth Weaver
    The session will present learnings from system deployments and upgrades, system interface development, process standardization, and knowledge management. || [Project Management of Complex Programs Such as Serialization]
    Speaker: Alf Penfold, BSc, MBA
    Speakers
    Technical Subject Matter Expert, Serialization
    Clarke Solutions
    Senior Project Manager
    PM Group
  • 1100 - 1230
    Advances in our understanding of a wide range of diseases have resulted in new therapies, and new ways of administering those therapies. These include targeted application of a combination of drugs and/or biological products with medical devices to minimize adverse events, while maximizing treatment response and positive user experiences. These combination products, containing two or more different types of health authority-regulated constituents, bring added complexity in the product development process and life cycle management. They are the subject of a number of FDA regulations, and also evolving regulations globally beyond the US. This session will review the combination product trends and hot topics. In this session participants will benefit from best-practice and lessons learned, with FDA-Pharm-centric, and Device-centric organizational perspectives and case studies.
    Session Leaders
    Sr. Director, Global Value Chain Quality Design
    Johnson & Johnson
    Speakers
    US FDA, Invited
  • 1230 - 1345
    Tuesday Lunch in Expo Hall
  • 1345 - 1515
    GLOBAL REGULATORY TOWN HALL
    Accelerating Global Acceptance of Emerging Technology and Novel Therapies.

    Broad adoption of emerging manufacturing technologies in the Biopharmaceutical industry has not been as rapid as many regulators would wish. In part this is due to differences in regulatory expectations or acceptance globally which can lead to fragmentation of supply chains acting as a disincentive to investment. Similarly novel therapies present CMC technical and regulatory challenges for clinical evaluation and commercialisation. What are the critical Quality Attributes needed to characterise a product? What are suitable acceptance criteria for these CQAs so it can be reproducibly manufactured. Differences in perspectives from Regulatory authorities can make resolving these questions very challenging. This session will explore how regulatory authorities are approaching these challenging areas both individually and any through regional convergence or harmonisation initiatives.
    Session Leaders
    Global Head, Regulatory CMC
    AstraZeneca
    Speakers
    US FDA, Invited
  • 1515 - 1600
    Networking Break in Expo Hall
  • 1600 - 1730
    Education Session: Lessons From Global Data Integrity Case Studies
    Increasing relevance of digital systems in the life sciences industry has intensified the focus on data integrity. As this critical subject matures from awareness to application at global scale, data integrity experts have successfully devised several governance and control strategies. However, the sustainability aspect of such data integrity strategies has often been overlooked. This session presents TWO dimensions of sustaining data integrity in global organizations: 1. Cultural aspects 2. Forensic detection Every day, life sciences organizations leverage data to make decisions that could impact patient safety and product quality. As data matures to decision, each phase of the data life cycle plays a role in ensuring data integrity. People and computerized systems work together in advancing data through its life cycle. While machines can be programmed to behave with accuracy and consistency, people need not always be balanced in their thoughts and deeds. Thus, understanding how culture drives people’s behavior becomes essential. This session presents practical wisdom learnt from an Indian pharmaceutical manufacturing organization, as it went from being a domestic manufacturer to MHRA approved manufacturing facility. The second dimension of the session presents practical approaches and forensic strategies for Data Integrity Case Studies | detecting data integrity issues, determining the impact, and suggested means of remediation for those issues. Various case studies in forensic auditing will be presented to illustrate different systems and situations where data integrity issues can result in significant problems.
    Session Leaders
    Director - Quality & Strategy
    Archimedis Healthcare Private Limited
    [Forensic Auditing for Data Integrity]
    Speaker: Robert Dillman
    Speakers
    Informatics Specialist
    Eli Lilly & Co Mfg & Quality Learning Ctr
  • 1600 - 1730
    Education Session: Commissioning and Qualification Baseline Guide Volume 5 - Modernizing an Old Gem
    The ISPE Commissioning and Qualification guide was first issued in 2001 and reflective of that time. With emerging markets, changes in the regulatory landscape, advances in commissioning and qualification methodology, the commissioning and qualification CoP has rewritten the guide to align with present day requirements and best practices applicable to the current market. This guide considered applicable regulatory requirements as identified in ICH and ASTM E2500. Elements of the guide include an integrated approach for developing and executing a commissioning and qualification plan, risk assessments and verification. The guide was written with knowledge of various emerging markets as well as need to shift from traditional C&Q execution to verification. The session will contain presentations and a review of a guide example in which both will contain key examples to drive an efficient commissioning and qualification process. In this session, participants will have gained an overview of the new C&Q guide, cleary understand of the updates within the new Baseline Guide, apply the tools to projects to drive efficiency and to reduce duplication of C&Q efforts during execution.
    Session Leaders
    Director QA GMP
    Akebia Therapeutics
    [Supporting Practices Necessary for C&Q Success]
    Speaker: Mark Rezac, PE
    The session will contain presentations and a review of a guide example to demonstrate how to drive an efficient and compliant commissioning and qualification process. || [Quality Risk Management and the Core C&Q Relational Model ]
    Speaker: Nicholas Haycocks
    The session will contain presentations and a review of a guide example to demonstrate how to drive an efficient and compliant commissioning and qualification process. || [New guide summary and comparison to Baseline Guide 5]
    Speaker: Robert Myers
    The session will contain presentations and a review of a guide example to demonstrate how to drive an efficient and compliant commissioning and qualification process.
    Speakers
    Director Compliance
    IPS
    Senior Specialist QA
    Amgen Inc.
    Director of Global Engineering
    Pfizer
  • 1600 - 1730
    Education Session: Strategies for Deterministic Container Closure Integrity
    This session will offer both in-depth scientific review of unique Container Closure Integrity (CCI) applications comparing various methods and technologies as well as deliver explicit techniques to successfully deploy CCI methods. Presentations will address CCI for parenteral products and will review different approaches across different products and delivery systems. USP Chapter 1207 was formally published in 2016 and provided recommendations for the use of deterministic test methods as more reliable options for testing container closure integrity. The EMA's Annex 1 was released for public comment, and discusses more general quality guidelines surround sterile medical products. These new regulatory shifts both in the U.S. and European marketplaces are changing how CCI is being tested, validated and deployed for quality. The session will draw on active experiences and will reveal broader strategies for validating and deploying CCI test systems to assure success. A series of defining questions provides both a technically sound pathway for CCI and fulfills on a holistic approach of patient safety. The presentation will also touch on practical statistical tools and validation tips that apply to all parenteral CCI activities. The discussion will draw on the experience and feedback of regulators and drug manufacturers with a panel Q&A discussion.
    Session Leaders
    CEO-VP Inspection Technologies
    PTI Inspection Systems
    [Strategies for Deterministic Container Closure Integrity ]
    Speaker: Josh Lance
    || [Strategies for Deterministic Container Closure Integrity ]
    Speaker: Donald C. Singer
    Speakers
    US FDA, Invited
    Manager, Steriles Microbiology
    GSK
  • 1600 - 1730
    Education Session: Regulatory Considerations for New Manufacturing Technologies
    Many pharmaceutical companies are evaluating and investing in transforming their manufacturing processes and facilities to incorporate continuous manufacturing/ processing as a strategic element to contemporizing manufacturing technology. This approach is widely supported by FDA and some other major ICH regions. However, during the New Technology round table discussions at the ISPE Quality Manufacturing Conference in June 2017 there was much uncertainty and concern expressed about how continuous technologies will be accepted and viewed in global regulatory submissions and be utilized across global supply chains without costly segmentation. This session will explore current experience, challenges regulatory “lessons learned” with the goal of achieving global acceptance for the introduction of new technologies such as continuous manufacturing.
    Session Leaders
    Executive Director, Global CMC
    Pfizer
    Speakers
    Deputy Director and Emerging Technology Team Chair
    Office of Testing and Research, FDA
    US FDA, Invited
    Director, Early Development Projects, CMC Regulatory Affarirs
    GlaxoSmithKline
  • 1600 - 1730
    Education Session: Data Analytics and Security in an Integrated Manufacturing Environment
    The session will present case studies from the pharma industry that will provide insights into the practical application and implementation of data analytics in the manufacturing environment.

    As the expectations from both industry and regulators becomes increasingly focused on the understanding and control of the manufacturing process, the need for data from the process has also increased. Data in of itself, however, does not provide the answers to improving your process understanding, minimizing process variability or, potentially, enabling real time release. In order to achieve that state large amounts of data needs to be contextualized and analyzed in order for it to be of value.

    The session will provide three perspectives of the data collection, analysis and subsequent use of the results to provide tools and methodologies for both predictive and reactive responses.

    The session will also explore the considerations necessary when integrating automation and PAT tools and the implications for data security.
    Session Leaders
    Vice President, Operations
    Werum IT Solutions
    [Automation, Integration and Security: PAT in a Modern DCS ]
    Speaker: William Buie
    || [In Silico Modeling as Effective Tools to Manage Technological Risk ]
    Speaker: Pablo A Rolandi
    || [Practical Considerations for Implementing Predictive Big Data Analytics in Manufacturing]
    Speaker: Daniel Lasley
    Lessons learned from implementing a large scale Big Data predictive analytics system.
    Speakers
    CEO
    Prozess Technologies
    Engineering Specialist
    Baxter Healthcare Corp
  • 1600 - 1730
    Education Session: Building Facilities to Deliver on the Promise of Cell and Gene Therapy
    With something as critical as producing treatment for cancer, time is everything. In most construction types, a more efficient schedule results in cost savings. When building cGMP facilities, a more efficient schedule results in saving lives. Traditional timelines for cGMP facilities can take 24-48 months from the start of design to owner occupancy. Once construction is completed, the qualification and validation process, in addition to regulatory requirements (FDA, EU), all add significant days to project schedules and delay the life-saving treatment to the patient. The need for cell processing and production facilities at the National Institutes of Health (NIH) is critical to producing treatments for a variety of cancers. A design-build project delivery, coupled with modular prefabricated cGMP facility modules, can shave several months off of this schedule and administer patient treatment in a timelier manner. The project team will explore lessons learned on using prefabricated, modular cGMP facilities in a design-build format to design, build, and deliver production facilities in much shorter time frames. As NIH embarks on their first prefabricated modular cGMP facilities, all eyes are on this campus to see if this will work. This presentation presents compelling reasons for the predicted success of this delivery.
    Session Leaders
    Life Sciences
    DPR Construction Inc
    [Principles of the Design, Qualification, and Operationof a Gene Therapy Facility ]
    Speaker: Michele Levenson
    During this presentation, we will review the unique design and operational characteristics of a gene therapy facility designed to be compliant with the EU, Health Canada, and FDA regulations. Secondly, we will discuss the challenges of commissioning a qualifying the facility as well as the applicability of an ASTME2500 approach to a streamlined start-up. Lastly, we will review some of the considerations to take into account routine monitoring occurring during operations. || [From Construction to Cures: Exploring the NIH’s First Modular cGMP for Efficient Construction]
    Speaker: Jeffrey Welter
    || [Pfizer Gene Therapy Project - Today's Integrated Project Delivery]
    Speaker: Jeffrey Beck
    Speakers
    Sr. Program Manager, Validation
    Pharmatech Associates, Inc.
    Associate Principal
    perkins+will
    Director, Projects
    Jacobs Engineering Group
  • 1900 - 2200
    Tuesday Night Party At Reading Terminal Market
    Experience the taste of the terminal with a wide variety of delicious cuisines and Philadelphia favorites. Reading Terminal is a 123-year old historic building located in the heart of Philadelphia. On the list of Top 10 places to visit in America, Reading Terminal hosts mouth-watering aromas, locally grown and exotic produce, fresh meats, seafood and poultry, baked goods straight from the oven, and the widest variety of restaurants under one roof. The night will be full of networking and entertainment. (included with full education registration) Includes: Dinner, Beverages, and Entertainment Sponsored in Part By: Burkert Fluid Control Systems, PM Group, Siemens Ingenuity for Life.
Day 4
November 07, 2018
  • 0700 - 1300
    Registration Open
  • 0800 - 0930
    Education Session: The Right Maintenance Strategy for Your Operation
    Current maintenance practices vary greatly across industries from paper-based preventive maintenance plans to sophisticated route monitoring to remote electronic monitoring. All may be appropriate depending on the nature of the operation, business needs and available resources. Some industries are on a very steep growth curve that relies heavily on reliable equipment uptime, while other industries continue to use a run-to-failure strategy. There is no single right or wrong answer, however the nature of your operation, long-term goals and business strategy should determine which maintenance practices fit best. Your organizational maturity related to calendar maintenance, cycle maintenance, condition maintenance, and overall business need, can have impacts on customer delivery. If they are not controlled, shutdowns, turnarounds and outages can threaten business continuity and the ability to supply the customer. This presentation, "Finding the Right Maintenance Strategy Fit for Your Operation," will discuss the challenges in choosing the right maintenance strategy and then implementing the long-term strategy for sustainable results. A case study will accompany this presentation detailing how one organization faced this same issue and how they were able to find their best strategy then build and deploy across their entire organization.
    Session Leaders
    Principal Consultant
    Life Cycle Engineering
    [The Right Maintenance Strategy for Your Operation ]
    Speaker: Michael Anderson
    Speakers
    Principal Consultant
    Life Cycle Engineering
  • 0800 - 0930
    Education Session: CAR-T Supply Chain: Challenging, Achievable, Realistic & Transformational
    CAR-T (Chimeric Antigen Receptor • T-cell) is a growing field of autologous therapies that use a patient's own immune system to help fight diseases such as cancer. Like all therapies, a supply chain must be utilized to get the manufactured therapy to the patient. However, unlike most supply chains which are linear (manufacturer-distributor-patient), the CAR-T therapy supply chain is circular (patient-manufacturer-patient). This creates a special set of challenges for the supply chain participants, including the manufacturer, treatment center and shipping company. This session will focus on the challenges that are inherent to the CAR-T supply chain including: Chain-of-custody, temperature control and monitoring, time sensitivity, scale-up and communication between all parties in the supply chain. The session will then explore how some companies are meeting these challenges through standardization, decentralization, real-time tracking, new technologies and strategic partnerships. People who attend this session will: œ Get an overview of the CAR-T Process œ Gain a better understanding of the supply chain challenges inherent to these therapies œ Learn about how technology, standardization and decentralization may be used to meet these challenges
    Session Leaders
    Senior Director, Validation Services
    IPS
    [Challenging, Achievable, Realistic & Transformational]
    Speaker: Donald Powers
    || [CAR-T Supply Chain: Challenging, Achievable, Realistic & Transformational ]
    Speaker: Orlando A. Serani
  • 0800 - 0930
    Education Session: New Modality Products: Who knows what the appropriate quality standards are?
    The early development portfolios of most companies now contain a wide array of new modalities spanning the synthetic, biotechnology and cell based therapies.? Regulatory guidance to support these new modalities is still evolving and there i4s often insufficient knowledge and experience to support product development of these new classes of products.? It therefore can be quite challenging to define a QTPP and appropriate CQAs to enable more efficient development.? Companies are using various strategies to tackle these challenges This session will explore both companies and regulatory agencies experience in this area to elicit best practice and facilitate further collaboration to accelerate evaluation and delivery of these new therapies to patient.
    Session Leaders
    Senior Director
    Astrazeneca
    []
    Speaker: Ingrid Markovic, PhD
    || [Developing Appropriate Quality Standards for Gene and Cell Therapy Products ]
    Speaker: Nancy Kavanaugh
    This session will address specific aspects to consider and challenge to address in the establishment of appropriate quality standards for early development and manufacturing cell and gene therapy products.
  • 0800 - 0930
    Education Session: Data Science Solutions-Accelerating Time To Market
    Data science refers to the task field of extracting knowledge from big data. For biopharmaceutical development and manufacturing, data science is a key enabler for biopharmaceutical development and process validation following Quality by Design principles. Today, biopharmaceutical manufacturing challenges such as process optimization, manufacturing process troubleshooting, and the identification and reduction of process variability are successfully addressed by methods of manufacturing data science. This enables advanced process characterization, accelerated process development and the reduction of failed batches in manufacturing. This session will address the large applicability of data science to the product life cycle.
    Session Leaders
    Head of Biochemical Engineering
    Vienna University of Technology
    [Data Integrity a fundament for excellence in the product lifecycle ]
    Speaker: Petter Moree
    In the presentation Use Cases from leading pharmaceutical companies will be presented on how they are enabling process validations and beyond as a fact of having trustworthy data in a good context.
    Speakers
    Global Industry Principal
    OSIsoft
    Lead Data Scientist
    Sartorius Stedim Biotech
  • 0800 - 0930
    Education Session: New Tools for Realizing Sustainable/Green Manufacturing Processes
    Creating and improving molecular manufacturing processes that not only enable economic viability but also straddle the many safety and environmental considerations is a major interest in today's hypercompetitive molecular marketplace. This session seeks to offer new tools to discover and implement sustainable processes: Our speakers will cover topics ranging from leveraging automation (robots and AI) to technologies directed at implementing intensified processes to new concepts in continuous crystallization.
    Session Leaders
    Program Manager, Defense Sciences Office
    Defense Advanced Research Projects Agency
    Sr Industrial Coordinator
    Green Chemistry Institute
    Speakers
    US FDA, Invited
  • 0800 - 0930
    Education Session: Transformative DATA: Aggregation & Analytics with Integrity
    If you agree with Sir Francis Bacon’s proverb that “Knowledge is Power” (1597), then you agree that data aggregation (collection) and analysis (analytics) must be critical factors in empowering an organization’s success.? But how can data collection and analytics be best used to add value in a GxP environment, especially considering our strict Data Integrity and qualification standards? This session will focus on the adoption of data aggregation and analytics within GxP companies. Specifically: - What are the primary factors that encourage/discourage adoption - How are systems being developed to maximize flexibility and ease-of-use (e.g. visualization), while also assuring compliance - The transformative effect this technology has of not only improving existing processes, but also providing new capabilities enabling greater efficiency and effectiveness. This session is intended for continuous-improvement-minded individuals interested in enhancing the performance of their GxP environment and shifting from a culture of reactive to proactive problem solving.
    Session Leaders
    Principal Consultant
    Q-FINITY Quality Management
    [The Transformational Effect of DATA: Aggregation and Analytics with Integrity]
    Speaker: Matt Brawner
    This presentation will investigate factors encouraging and discouraging adoption, as well as how system integrators and providers have been developing solutions to maximize system flexibility while also ensuring compliance. Finally, we will investigate how automated data aggregation & analytics can not only enable greater operational efficiency, but can also transform your organization from a culture of reactive fire-fighting, to a culture of proactive strategic thinking. || [Cutting Through the Pharma 4.0 Paradigm- Data Best Practice ]
    Speaker: David Staunton
    Speakers
    Director, Sales Execution
    Sequence Inc
    Operations Manager
    Zenith Technologies
  • 0930 - 0945
    Networking Break
  • 0945 - 1115
    Education Session: Applying and Qualifying a PAT System for Life Science Manufacturing
    Application of PAT has been considering as a fundamental tool for the drug product's Quality by Design (QbD) approach that provides a collection of analyzers and models. This presentation is based on FDA's guidance "PAT - A framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance" with case studies of successful implementations in Pharmaceutical and Biological Drug Development and Manufacturing that shares the knowledge of PAT with you for the opportunity to streamline your production and business processes. Without a comprehensive understanding of your process and full command of your critical quality attributes, you'll fall behind in today's market. Process Analytical Technology (PAT) has been defined by the United States Food and Drug Administration (FDA) as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect critical quality attributes (CQA). With Process Analytical Technology (PAT) based manufacturing, you'll be able to integrate multivariate data and real-time process models to get critical quality attributes and predict final product quality at any time during production process. You'll also have the in-depth process understanding and closed-loop control you need for making quality-related process changes that ensure final product quality.
    Session Leaders
    Senior Consultant- Special Products
    CAI, Merck & Co., Inc (Retired)
    [Applying and Qualifying a PAT System for Life Science Manufacturing]
    Speaker: Jennifer Potter
    A presentation on the increasingly-important role of PAT in biopharmaceutical manufacturing, with a case study of PAT implementation in a fermentation process. || [SIPAT network for PAT ]
    Speaker: Pamela B. Docherty
    Speakers
    Life Sciences Industry Manager
    Siemens Industry, Inc
  • 0945 - 1115
    Education Session: Industry 4.0: What’s Next?
    Industry 4.0 can solve key challenges facing manufacturers from extreme supply, demand, and design variability, to emerging markets of one, to the growing need for rapid innovation. Leveraging the principles of Industry 4.0 and its enabling technologies to automate, integrate, and optimize manufacturing processes companies can shorten cycle times, improve product quality, and implement efficiency across their operations, as well as grow the manufacturing of highly customized products on a global scale.
    Session Leaders
    Principal
    HDR Company LLC
    [Life Cycle Management per Q12: Enhancing Process Chain Dimensions and Product Life Cycle Using Data Science Tools ]
    Speaker: Christoph Herwig, PhD
    Speakers
    Head of Biochemical Engineering
    Vienna University of Technology
  • 0945 - 1115
    Education Session: Modernizing Pharmaceutical Quality
    FDA has been invited to?provide?the very latest information relating to the two Federal Register Notices issued in June 2018. These FRNs announced?initiatives?to gather stakeholder feedback on the use of?quality metrics to modernize pharmaceutical quality systems and advance innovation. These initiatives involve voluntary formal meetings, a limited and structured pilot program, and site visit program. ISPE will provide feedback from a proposed industry-led framework for advancing pharmaceutical quality, the appetite for which is being tested with selected companies. Using CAPA as an example, the level of maturity is assessed and you decide if you wish to aspire to improve using tools and KPIs suggested. An industry integrated approach to understand maturity of product robustness will be given. Process Improvement options will be discussed. Finally, there will be a Q&A session to allow the audience to interact with presenters.
    Session Leaders
    Global Head Analytical Science & Technology, QC, OpEx
    Novartis Pharmaceuticals
    [Integrated approaches for Product Robustness ]
    Speaker: Sandy J. Hopkins
    || [ISPE’s Approach to Advancing Pharmaceutical Quality – The CAPA Example ]
    Speaker: Kira L. Ford
    Speakers
    US FDA, Invited
    Regional Director, MS&T
    AstraZeneca
    Director, Global Quality Systems
    Eli Lilly
  • 0945 - 1115
    Education Session: Analytical Method Lifecycle - An Industry Perspective
    There is a growing demand on the pharmaceutical industry to have established processes for analytical method lifecycle with ICH Q8, Q9, Q10, Q11 and draft guideline ICH Q12 providing basic information on how to implement an 'analytical method lifecycle'. These guidelines, however, do not provide information on how to achieve this in practice. This session will outline an interpretation of these guidelines in the context of analytical method lifecycle management and will take the reader through the definition, development and maintenance of analytical method lifecycle in three stages; analytical method design and optimization, validation and robustness and continued analytical method performance verification. This poster will describe a practical approach to the user requirements specification for the analytical method, analytical control strategy establishment and how to ensure the analytical method remains in a state of control and suitably validated throughout its' lifecycle.
    Session Leaders
    Sr. Scientist
    AstraZeneca
    [QC Enhancement Concept Making Continual Improvement of Regulatory Approved QC Procedures Possible – A Case Study ]
    Speaker: Anders Karlsson, PhD
    Speakers
    Sr. Principal Scientist
    AstraZeneca
  • 0945 - 1115
    Education Session: Accelerating the Delivery of Biosimilars to Chinese Patients
    To meet the increasing demands of patients in China, additional biopharmaceutical manufacturing capacity must be constructed. To achieve success, a project requires leadership of a focused, empowered, and committed client organization, and a selection of world-class teams, capable of making quick decisions, and maintaining focus on achieving aggressive cost, schedule, quality and safety goals. Pfizer has been successful in creating a Greenfield biopharmaceutical manufacturing campus in Hangzhou, China, from concept through realization, including the use of advanced technology, in one of the fastest delivery schedules ever, with a best-in-class construction safety record. Implementation of new technology included an entirely single-use process for both bulk and sterile fill, and accelerated schedule completion occurred using modular facility construction. Attend this session to learn about successful project execution strategies, including team-building of a seamless multi-national team, use of new manufacturing technology to streamline project delivery, methods to aggressively accelerate schedule, and tips on improving field safety in China.
    Session Leaders
    Director of Global Engineering
    Pfizer
    [Modular Facility Solutions to Enable Speed to Market, Using Multi-Product Single-Use Operating Platforms ]
    Speaker: Jon Van Pelt
    || [Lean Multinational Engineering Design Strategy for Highly Advanced Facilities]
    Speaker: Kevin Schreier
    Providing a successful design for a highly advanced production campus in China requires thorough planning, efficient communication across multiple time zones, and a highly motivated and qualified international design team. Success can be achieved by selecting a team blending a combination of knowledge of local standards and practices with proven practical experience of advanced aseptic technology.
    Speakers
    General Manager Enterprise Operations
    General Electric Health Care (GEHC)
    Manager, Process Engineering
    Jacobs Engineering Group Inc
  • 0945 - 1115
    Education Session: eClinical: Clinical Trial Data & GAMP Compliance
    The world of clinical trial management is continuously finding new ways to recruit and engage patients, collect data, and report outcomes. This session will explore the possibilities and challenges arising from these new solutions and outline how the new GPG Good eClinical Practice is a powerful tool to aid implementation. It will consider real-world challenges such as: - The special requirements of clinical trials with regards to data integrity in highly outsourced environments - Use of highly configurable clinical trials systems with web and mobile end user interfaces - The complex data flows in clinical trials across multiple real and virtual global organizations - Evaluation of associated Data Integrity issues and their impact on regulatory acceptance timelines and patient well being The session will then outline the layer model for eClinical platforms proposed in the new GPG Good eClinical Practice, and how it may be applied at the different technology areas down to infrastructure level.
    Session Leaders
    Vice President of Global Compliance
    PRA Health Sciences
    [The practical use of the GAMP Good eClinical Practice Guide]
    Speaker: Oliver Herrmann
    In facing the challenge of providing validated processes in conjunction with qualified computerized systems, the layer model for eClinical platforms proposed in the new GPG Good eClinical Practice can be a powerful tool to aid implementation. In this session, the relationship between this layer model to managing computerized systems and data integrity at a technological level will be explored at the different technological levels down to the infrastructure level. The session will also provide a forum for the audience's perspectives on this approach and what challenges and opportunities are associated with it.
    Speakers
    Principal Consultant
    Q-FINITY Quality Management
  • 1145 - 1700
    Adaptimmune Facility Tour (depart From Marriott)
    In January 2018, Adaptimmune announced that it started manufacturing the first SPEAR T-cells for a patient at its Navy Yard facility in Philadelphia. The state-of-the-art manufacturing facility can deliver cells for up to 300 patients per year, with the possibility of expansion that would enable manufacture for up to 1,000 patients per year. Adaptimmune is a fully integrated, cell therapy company focused on the development of novel cancer immunotherapy products. They are leading the field of engineered T-cell receptors (TCRs) with the SPEAR T-cell platform.

IMIS Description Character Cleanup