Before the Event
November 03, 2018
Day 1
November 04, 2018
  • 0700 - 1800
    Registration Open
  • 1100 - 1245
    Young Professional & Student Orientation Brunch
    Young professionals and students should plan to attend this informative brunch, where you can benefit from career advice by professionals in the industry. It is also a great opportunity to network with your peers as you embark on the next several exciting days.
  • 1300 - 1500
    WORKSHOP: Data Integrity Strategy and Implementation
    Education Level: Intermediate/ Executive
    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.
    During the interactive group discussion, delegates and speakers will engage in an interactive discussion session to explore how to implement a data integrity strategy and data governance within their organizations, with focus on people, process and technology.
    Session Leaders
    Regional CSV Consultant
    Waters Corporation
    [Defining, Implementing & Monitoring Data Integrity Controls ]
    Speaker: Doug Shaw, CISA
    The presentation provides a background and references to data integrity requirements before outlining how to Plan, Implement, Monitor and Control data integrity within an organization. The session includes examples of data flows and control measures across the different stages in the data life cycle. || [Preparing your Laboratory for a Data Integrity Audit ]
    Speaker: Mark Newton
    This session will discuss the different viewpoint that is needed to prepare for a data integrity, rather than a traditional, inspection. Adopting that viewpoint, session will cover critical quality system documents that must be ready, elements of a lab preparedness walkthrough, and some reports/data extracts that can demonstrate your readiness for inspection, or expose your vulnerabilities. || [Data Integrity Considerations in Manufacturing]
    Speaker: Charlie Wakeham
    Data integrity in manufacturing is especially challenging because of the diversity of systems and suppliers, the quantity of data generated and the need to collate all the data into a complete, consistent and accurate batch report for human review. This presentation explores the complexities inherent in the manufacturing realm and establishes the importance of understanding GxP data flows and managing interfaces.
    Speakers
    Director, CSV & IT Consulting
    Azzur Group
    Principal
    Heartland QA
    Regional CSV Consultant
    Waters Corporation
  • 1300 - 1500
    WORKSHOP: Equipment Reliability and Preserving Functional Requirements
    Education Level: Fundamental/ Intermediate
    Physical Assets are purchased, commissioned, operated, and maintained to produce a specific, high quality product reliability, consistently, and economically. ISO-55000 Asset Management provides a guide to what things an organization can do to establish a clear, open, and effective asset management program. Most organizations already perform some of steps. This session will help you identify which ISO-55000 requirements your organization already meets and which ones you can add to make your asset management strategy more effective. In this session participants will use this knowledge to outline an Asset Management Policy and Strategic Asset Management Plan for their organization.
    Session Leaders
    Asset Management & Reliability Specialist
    Commissioning Agents
    [The ISO-55000 “Shall” Statements ]
    Speaker: Robert Smith
    ISO-55000 Asset Management is a highly flexible system that tells an organization what to do but not howto do it. It provides a structure for maximizing value from assets for any size organization or type of asset. || [What is Asset Management? ]
    Speaker: John Hughes, CAMA, CMRP
    || [Writing an Effective Asset Management Plan]
    Speaker: John Hughes, CAMA, CMRP & Richard Tree
    Speakers
    Radiopharmaceutical Production Manager
    International Isotopes Inc
    Asset Management & Reliability Specialist
    Commissioning Agents
    Asset Management & Reliability Specialist
    Commissioning Agents
    Vice President, North America
    CAI
  • 1300 - 1500
    WORKSHOP: Building a Framework for Success: A Tale of Two Site Master Plans
    Education Level: Executive
    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
    Science and Technology Planner/Architect
    Flad Architects
    Speakers
    Senior Manager
    Ethicon
    Science and Technology Planner/Architect
    Flad Architects
    Director of Operations
    Johnson & Johnson
  • 1300 - 1500
    WORKSHOP: Lifecycle Process Validation
    Education Level: Fundamental/ Intermediate/ Advanced/ Executive
    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. This session will discuss real world compliance gaps experienced in PV / sampling plan development and will offer potential solutions (via lecture, interactive workshop, and through review of the upcoming PV Good Practice Guide) for these problems.
    Session Leaders
    Principal Engineer
    Johnson & Johnson Consumer Inc.
    [The Goldilocks of Enhanced Sampling: Not Too Much and Not Too Little ]
    Speaker: Katherine Giacoletti
    This presentation focuses on the broadly recognized need for enhanced sampling during PPQ and Stage 3a. 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. || [Interactive Group Workshop: Preventing 483s in Process Validation]
    Regulatory Facilitator: Carmelo Rosa, Psy.D.
    || [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. || [Lifecycle Process Validation: How Are We Still Getting This Wrong?]
    Speaker: Shawn Gould
    This presentation will discuss how lifecycle process validation continues to generate confusion within the pharmaceutical industry as evidenced by the recurrence of several items on FDA 483s and Warning Letters. 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.
    Speakers
    Partner
    SynoloStats LLC
    Director, Division of International Drug Quality
    FDA/CDER/OC/OMQ
    Director, Product Lifecycle Managment
    ProPharma Group
    Director, Compliance
    Johnson & Johnson
  • 1300 - 1500
    WORKSHOP: The Use of Descriptive Statistics in the Pharma Industry
    Education Level: Fundamental/ Intermediate/ Executive
    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
    Turesol
    [An Overview of Process Capability Indices and Their Use in Conjunction with Other Monitoring Tools ]
    Speaker: Yiming Peng
    || [The Economic Value of Process Capability Indices and Their Impact on Quality ]
    Speaker: Eda Ross Montgomery
    || [Use of Process Capability Indices in Real Life Scenarios ]
    Speaker: Tara Scherder
    Speakers
    Statistical Scientist
    Genentech Inc
    Sr Dir, Tech Steward, Global Pharma Tech
    Shire Pharmaceuticals Co.
    Partner
    SynoloStats, LLC
  • 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.
    [Smooth Supply Chain and Optimized Pharmaceutical Processes]
    Speaker: Peter Soelkner
    Vetter’s Ravensburg West facility sets new industry standards for transportation, warehousing and quality assurance of pharmaceutical products. Find out the key factors to become a Facility of the Future. || [Flexible Facility Design for Rapid Response to Pandemic Threats]
    Speaker: Dan Rudolph, PhD & Dave Kemp
    This presentation will provide a synopsis of the facility design and layout.Delegates will be able to design considerations for a flexible facility or why a flexible facility is important for current biotech design and understand how single use systems allow rapid response and redesign of a facility but require appropriate management of materials, supplies and suppliers || [Shire Los Angeles, Building 6, QC Labs - 2018 Operational Excellence Award]
    Speaker: Bert Chai
    Through series of Kaizen and lean workshops with floor staff and supervisors, the team was able to realize the vision for a best-in-class laboratory design, with minimal footprint. Electronic tools such as 3D models and virtual walk-throughs were also used for design and project execution. || [World's 1st LEED Platinum Pharmaceutical Manufacturing Plant constructed at a greenfield site in Suzhou China.]
    Speaker: Paul Chiu, PE
    This presentation will discuss how to achieve high sustainability when designing a new pharmaceutical manufacturing facilty in an environmentally challenging region. || [STEP TO GPO 4.0 :To become a sustainable leader in Thai's Pharma industry]
    Speaker: Mukdavan Prakobvaitayakit, PhD, CPIP
    Step to GPO 4.0, the journey of the Government Pharmaceutical Organization (GPO) to become a world-class stanadard FPP manufacturer. Using integrated information technology for being a sustainable leader in pharmaceutical industry. || [Shire - Los Angeles Building 8 -2018 Facility Integration Award ]
    Speaker: Brian Danahy
    This presentation will focus on facility integration was imperative to project success and optimizing operational efficiency. || [BioMarin’s Project FAITH ]
    Speaker: Carl Alberston
    As disruptive technologies become more prominent in the industry drug programs need to react with speed and flexibility to maintain a foot hold in the market place. Over time GMP manufacturing projects have continued to reduce in duration, with the current duration averaging 3 - 4 years from concept to operation. To be first to market in a competitive environment BioMarin successfully completed this same effort in 54 weeks. At project kickoff the team had an existing storage warehouse, a draft layout, large process equipment identified, a phase 1 production process and a single manufacturing employee. Simultaneously, the team successfully developed a GMP manufacturing process, executed scale up and tech transfer activities while designing, building, and qualifying the facility. This, all while facing technical challenges typical of scale up, gene therapy design considerations, fill finish technologies, coupled with strict local and federal regulations and the worst winter in the bay area in 10 + years. The project has received an award for project execution from ISPE and is a current contender for the 2018 project of the year award. Join us in learning how Biomarin, partnered with CRB engineers and Novo construction made the imposable project a reality without compromising on quality, schedule or cost.
    Speakers
    Principal Engineer, Manufacturing Development
    Emergent BioSolutions
    Associate Director Engineering
    Shire
    Director, Global Engineering
    Pfizer Inc.
    Deputy Managing Director
    GPO Thailand
    Director of Engineering
    Shire
    Director Capital Project GMP
    BioMarin Pharmaceutical Inc
  • 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.
  • 1730 - 1900
    Expo Hall Open
  • 1730 - 1900
    Welcome Reception in Expo Hall
  • 1730 - 1900
    Career Solutions Job Fair in Expo Hall
  • 1730 - 1900
    ISPE Booth and Bookstore Open in Expo Hall
  • 1730 - 1900
    International Student Poster Display in Expo Hall
    On display with the Professional Posters in the Exhibit Hall are the posters created by the undergraduate and graduate students participating in the International Student Poster Competition. Meet the students who were the champions at the local levels' Student Poster Competitions, and who will be presenting their posters to ISPE judges during the conference. Learn more about their unique posters that cover a wide range of relevant topics.
  • 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 (depart From 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 Networking Breakfast
    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 - 1300
    International Student Poster Display in Expo Hall
    On display with the Professional Posters in the Exhibit Hall are the posters created by the undergraduate and graduate students participating in the International Student Poster Competition. Meet the students who were the champions at the local levels' Student Poster Competitions, and who will be presenting their posters to ISPE judges during the conference. Learn more about their unique posters that cover a wide range of relevant topics.
  • 1000 - 1600
    Expo Hall Open
  • 1000 - 1600
    Professional Poster Display in Expo Hall
    [Unique component identification & end-to-end traceability from design to operation]
    Speaker: Clemens Borkenstein
    Traceability of components and traceability of the work of the executing staff members count among the most important requirements for GMP compliance. It is inevitable to have a unique identification for all built-in components beginning with the design specification phase, plus an identification system of labour in place. Traceable and consistent documentation for each component from the manufacturer, along the entire assembly process and through to operational service is needed. In this poster, necessary prerequisites as well as individual steps of an integrated material tracking system will be shown. The different steps of GMP compliant supply chain management from the design phase to procurement, delivery and incoming inspection, through to fabrication, quality assurance as well as qualification are shown with examples. || [Complexities of Renovating a Laboratory – Biologics Development Lab Renovation and Building ]
    Presenter: Beth Starr & Luke Gong
    The poster will highlight the renovation of an existing biologics development facility from the Facility Engineering and AE Design Consultant's perspective and will include lessons learned and strategies for dealing with similar projects. || [Utilizing Automated Systems for Packaging Inspection]
    Presenter: Stacy Capek
    A decade ago, nearly ¾ of all product recalls were attributed to mislabeled product, costing companies billions of dollars annually. That percentage has decreased to about 20% in 2017. Much of this improvement can be attributed to the increase in use of automated inspection systems to inspect final packaging. This poster will reflect different types of automated inspections for final packaging. The poster will present learnings and case studies from actual deployments of automated inspection systems, in addition to key advantages/disadvantages among types of systems and financial impacts. || [API Manufacturing: Is aqueous-based detergent cleaning possible? ]
    Presenter: Thomas Altmann
    || [Key Elements for Sustainable Cleaning Processes in the GMP Industry]
    Presenter: Elizabeth Rivera
    Cleaning procedures are required for maintaining safe and optimally performing manufacturing equipment and facilities. The use of cleaning products to effectively remove process residues, dust, allergens, and infectious agents may be crucial to prevent product contamination that could adversely affect patient safety. But the use of cleaning products may also present health and environmental concerns. For example, some cleaning products are environmentally hazardous, containing ingredients that must undergo significant treatment (e.g. pH adjustment) before they can be safely discharged. Since the use of some products creates potential handling, storage, and disposal issues for users, these use factors are increasingly becoming components of the selection criteria when new or current cleaning processes are being developed.
    Speakers
    Head of Executive Quality
    ZETA Biopharma Gmbh
    Ecolab Life Sciences
    Jacobs Engineering Group
    Project Manager
    Bristol-Myers Squibb Co
    Director of Engineering
    Clarke Solutions
    Global CIP/COP Technical Manager
    Ecolab Deutschland Gmbh
    Technical Services Manager
    STERIS Corp
  • 1000 - 1600
    ISPE Booth and Bookstore Open in Expo Hall
  • 1000 - 1600
    Career Solutions Job Fair in Expo Hall
  • 1100 - 1230
    Education Session: Moving Cell & Gene Therapies Toward Commercialization
    Education Level: Intermediate
    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.
    Session Leaders
    Associate Director, Process Development
    Voyager Therapeutics
    [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
    Sr Associate Scientist, Analytical Sciences
    Voyager Theapeutics
    Associate Engineer, Drug Product Sciences
    Voyager Therapeutics
  • 1100 - 1230
    Education Session: Next Generation Manufacturing Control
    Education Level: Intermediate
    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
    Robotics Program Lead
    Eli Lilly & Co
    VP of Business Development
    Bigfinite Inc
  • 1100 - 1230
    Education Session: Renovating an Existing Biotech Plant
    Education Level: Intermediate/Advanced/ Executive
    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
  • 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 & Fast Growth Products]
    Speaker: Alvaro Brisolla, MBA
    || [Applicability of Simulation to all BioPharma Product Processes]
    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
    Education Level: Intermediate
    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.
    Session Leaders
    Director, Merck Manufacturing Division PMO
    Merck & Co Inc
    [Regulatory Affairs Before and After a Natural Disaster]
    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. || [Drug Shortages – Minimizing Patient and Clinical Impact ]
    Speaker: Erin Fox, Pharm D
    || [Regulatory Affairs Before and After a Natural Disaster]
    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
    Director, Merck Manufacturing Division PMO
    Merck & Co Inc
    Senior Director, Drug Information & Support Services
    University of Utah Health
    Senior Program Management Officer
    FDA/CDER/OCD/DSS
    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
    Director of Process Development
    Amgen Inc
    [Strategies to Enable Rapid Technology Transfers ]
    Speaker: Jose Caraballo
    The number of transfers is expanding, with increased need for coordination with development and manufacturing organizations. Best practices are needed to ensure timely and successful transfers. This requires understanding of the risks involved, excellence in planning, and robust knowledge transfer practices. This session will cover strategies for TT acceleration while also meeting product quality requirements and commercial timelines. || [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
    Unit Manager, Inspectorate Strategy and Innovation
    MHRA
    Director of Quality, Product Quality Steward, Product Supply Biotech
    Bayer US
    Vice President, Manufacturing Operations
    Celldex Therapeutics, Inc.
    Principal
    Global Consulting
  • 1230 - 1345
    Monday Lunch in Expo Hall
  • 1330 - 1700
    International Student Poster Competition
    Each year, student members of ISPE Affiliates and Chapters around the world participate in local poster competitions. The winning undergraduate and graduate students are invited to attend the ISPE Annual Meeting and compete in ISPE's International Student Poster Competition. Their posters will be on display for all to see, and the students will present their posters to a panel of judges. Winners will be announced during the Membership & Awards Breakfast Tuesday, 6 November.
  • 1345 - 1515
    Education Session: Security in the Regulated World
    Education Level: Intermediate
    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
    Retired Consultant
    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. || [Cyber Security ]
    Speaker: Thomas House
    Cybersecurity threats are ubiquitous and far-reaching. The stakes are highest when the threats impact the critical supply chain of pharmaceutical products. National and industry organizations provide guidance regarding how to best protect critical manufacturing control systems. Still, companies must determine how to incorporate actionable items within the context of their organizational structure, risk tolerance and objectives. Rockwell Automation will discuss recent cybersecurity attacks that have affected industries around the world. Attendees will walk away with insights on best practices and actionable steps organizations can take in context of the NIST Cybersecurity Framework to identify, protect, detect, respond, and recover from these threats. || [Cyber Security Threats and Solutions ]
    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
    Senior Manager
    Ernst & Young LLP
    Business Development Lead
    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
    [Product Selection & Facility Commercialization ]
    Speaker: Roland, franke, PhD
    || [Implementing a Sterile Oncology Facility in China  ]
    Speaker: Austin McDonald
    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.
    Speakers
    Chief Scientific Officer & VP of Business Development
    OncoGenerix
    CEO
    OncoGenerix
  • 1345 - 1515
    Education Session: Robust, Resilient, Reliable Facilities • Lessons Learned from Hurricane Maria
    Education Level: Fundamental/ Executive
    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. || [Planning for the Unpredictable- Facility Readiness]
    Speaker: Anthony Cable
    Speakers
    Sr. Director of Global Engineering Operations
    Director Biologics Capital Strategy
    Bristol-Myers Squibb
  • 1345 - 1515
    Education Session: Accelerated Product Development through Inspection & Launch • Part 1
    Education Level: Intermediate/ Advanced/ Executive
    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, Manufacturing Science and Technology
    Bristol-Myers Squibb
    []
    Speaker: Geraldine Taber, PhD
    || [Innovative Validation Strategy to get Drug to Patients]
    Speaker: Gregory Rullo
    Accelerated product development is critical to bring highly innovative and life-saving products to patients faster. Accordingly, global convergence and harmonization of marketing application requirements are fundamental to successful approvals, and generally remain the focus of both industry and regulators. However, accelerated development presents complex CMC challenges beyond the initial approval. Limited experience may also result in challenges with drug substance and drug product validation activities, either leading to a highly constrained validation envelope or with difficulties in achieving validation criteria, leading to challenges to achieve successful product launch. This presentation will include a case study in which a close partnership between FDA and industry on a breakthrough product resulted in a novel approach to drug product validation to get a life-saving medicine to patients as soon as possible. || []
    Speaker: Zhihao (Peter) Qiu, PhD
    Speakers
    Senior Director, Pharmaceutical Sciences Team Lead
    Pfizer
    Vice President
    AstraZeneca
    Branch Chief, Division of Inspectional Assessment
    FDA/OPF/OPQ/CDER
  • 1345 - 1515
    Education Session: From Industrie 4.0 to Pharma 4.0 - A Holistic Concept
    Education Level: Intermediate/ Advanced
    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
    [Digitalization of SOPs - One Step Towards Digital Maturity]
    Speaker: Heike Röder
    || [The Manufacturing Control Strategy and the Impact on Facility Design ]
    Speaker: Line Lundsberg-Nielsen, PhD
    Establishing the Manufacturing Control Strategy is an enabler for Pharma 4.0. How does it impact the different lifecycle phases such as aspects of a facility project (layout, automation and IT architecture, qualification and validation), commercial operation, process optimisation and lifecycle management? The presentation will include a case study on how the manufacturing control strategy is used as the foundation for these activities. || [Pharma – 4.0: Data Integrity by Design ]
    Speaker: Volker Roeder
    The Pharma 4.0 SIG is currently working on the opportunities to:
    Enable Quality & Data Integrity by Design by applying known standards (like ICH-Q10 & Q12), tools and methods to determine actual business & manufacturing processes and the associated data to implement ALCOA-Principles
    Re-Assess and challenge actual processes and Data Flows to identify redundant data, eliminate unused data, detect different formats of the same data, question interfaces (manual & automated) detect data integrity issues
    Speakers
    Head of Process & Knowledge Management
    Bayer AG
    Global Technology Partner
    NNE
    Management Consultant & Service Responsible "Compliance"
    Arcondis AG
  • 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
    Director of Data Sciences
    Amgen
    [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
    The rapid advancement of digital innovation coupled with the data rich environment of a biopharmaceutical manufacturing process presents a tremendous opportunity to improve process efficiency, product fidelity and driving patient and business benefit. This talk will discuss these advancements, the possibilities of achieving a fully digital manufacturing operation leveraging emerging technologies like IIoT & Big Data and the challenges of converting legacy systems and business process transformation to achieve Industry 4.0 aspirations. || [Applying next-generation data analytics toward improved biopharmaceutical manufacturing]
    Speaker: Yingying Zheng, PhD
    In this talk, we will share several examples, including raw material screening, non-conformance root cause analysis, technology transfer/scaleup improvement, and using text analytics to better leverage historical manufacturing experience.
    Speakers
    Reliability Solutions
    Lakeside Process Controls Ltd
    Director, Biologics Commercialization
    Merck
    Sr Engineer
    Amgen
  • 1515 - 1600
    Networking Break in Expo Hall
  • 1600 - 1730
    Education Session: From Aging Facilities to Facilities of the Future
    Education Level: Intermediate
    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, Compliance Consulting
    NNE
    Senior Pharmaceutical Engineering Specialist
    CRB
    [Rebooting the ISPE Survey on Fill Line and Barrier installations]
    Speaker: Jessica Frantz
    Join in on the plans to reconfigure and reissue the heavily used survey of fill line and barrier installations, approaches and trends and find out how you can be a part of the next generation of statistical data gathering regarding the capacities and approaches of the fill lines in the pharmaceutical industry. || [A Manufactoring Company Perspective of Managing Aging Facilities ]
    Speaker: Jörg Zimmermann
    Speakers
    Product Specialist
    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
    CAI
    [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. || [Training the Workforce of the Future]
    Speaker: Richard Tree
    Speakers
    External Engagement Leader
    Procter & Gamble
    Vice President, North America
    CAI
  • 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
    Director Quality Assurance
    AbbVie
    Associate Director, Manufacturing Science and Technology
    Bristol-Myers Squibb
    [Hot Topics Overview]
    Speaker: Stephen Tyler
    Speakers
    Branch Chief, Division of Inspectional Assessment
    FDA/OPF/OPQ/CDER
  • 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: 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.This session also explains how Industry 4.0 needs to be augmented with pharma-specific requirements, the approachdefined by the ISPE Plug and Produce working group and how this complements other initiatives. || [Case Study: Applied Plug & Produce]
    Speaker: Thomas Hofmaier
    The Special Interest Group Pharma 4.0 initiated an ISPE working group "Plug & Produce". The goal is to define how the Industry 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.
    Speakers
    Head of Design-In (Technical Marketing)
    Agilent Technologies R&D Mktg GmbH & Co KG
    Head of Business Unit, Process Technology Pharma
    Glatt GmbH
  • 1600 - 1730
    Education Session: Dynamic Modeling for Sustainable Manufacturing Facilities
    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
    || [cGMP Air Change Rate Optimization Provides Opportunity for AHU Consolidation ]
    Speaker: Norman Goldschmidt
    Advancements in cGMP cleanroom performance prediction and verification have enabled room performance to be modeled and measured modeled with increasing precision and predicted with increasing accuracy. This has resulted in the ability to improve clean room performance at lower air change rates, increasing product and personnel safety while reducing energy use. End of life equipment replacements provide an opportune time to reduce air change rates and consolidate equipment. || [cGMP Air Change Rate Optimization Provides Opportunity for AHU Consolidation ] Advancements in cGMP cleanroom performance prediction and verification have enabled room performance to be modeled and measured modeled with increasing precision and predicted with increasing accuracy. This has resulted in the ability to improve clean room performance at lower air change rates, increasing product and personnel safety while reducing energy use. End of life equipment replacements provide an opportune time to reduce air change rates and consolidate equipment.
    Speakers
    Sr. Project Engineer
    Genesis Engineers Inc
    Senior Project Manager
    Eichleay Engineers Inc
    Group Managing Director and Founder
    EECO2
    Life Science Lead
    Energy Efficiency Consultancy Ltd
    President
    Genesis Engineers Inc
    Program Manager
    Genentech
  • 1600 - 1730
    Education Session: Cloud Computing in a Regulated Environment
    Education Level:Fundamental/ Intermediate
    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
    [SOC 2 Process for Assessing Cloud Service Suppliers]
    Speaker: Arthur D. Perez, PhD
    || [Cloud Computing in a Regulated Environment]
    Speaker: John Hannon, CPIP
    Speakers
    Retired
    Novartis Pharmaceuticals
    VP, Global Automation and IT
    Commissioning Agents Inc
  • 1900 - 2100
    Women in Pharma Dinner - Why is gender equality and diversity important in the workplace?
    Location: Fogo De Chao, 1337 Chestnut Street Philadelphia, PA 19107. Description: Our world is no longer just the country, state or city we live and work, but global.  Everything we do has a global element and it is a business necessity to embrace equality, diversity and change to improve our businesses.  Privilege and entitlement blind us to differences.   Statistics show that gender equality and diversity results in happier people, lower job turnover/attrition, higher retention, increased job satisfaction, higher productivity, increased profitability, access to a broader talent pool, and the list goes on.  Gender equality does NOT mean men and women have to be the SAME.  Having a diverse workforce benefits everyone and excludes no one.  Join us and share your perspective on how you can impact change in your organization. Here is the Ted Talk Link to Michael Kimmel.  It is interesting and thought provoking.  https://www.ted.com/talks/michael_kimmel_why_gender_equality_is_good_for_everyone_men_included
  • 1900 - 2100
    Women in Pharma Dinner - The #MeToo Movement and ... the backlash?
    Location at Morton's The Steakhouse 1411 Walnut St, Philadelphia, PA 19102. Description: It was just last October when The New York Times published its expose on Hollywood magnate Harvey Weinstein and the #MeToo hashtag went viral on Twitter. Since then, thousands of women have shared their stories of harassment in the workplace. Concerns have been raised, however, about a backlash to the movement. In January of 2018, Sheryl Sandberg’s LeanIn.Org Foundation and Survey Monkey ran a poll which found that 30% of male managers surveyed said they are uncomfortable working alone with female colleagues, over twice the percentage who said so in the past. Alarmingly, the number of male managers who have concerns about mentoring women more than tripled, from 5% to 16%. We will discuss the @MeToo Movement and the impact within our global work environments. We’ll analyze new campaigns such as #MentorHer and strategize ways to encourage positive, respectful and professional interactions and mentoring between colleagues.
  • 1900 - 2100
    Women in Pharma Dinner - Leadership - Fostering Talents and Identifying Gaps
    Location at Bank & Bourbon 1200 Market St, Philadelphia, PA 19107. Description: executive leadership requires a wide spectrum of skills, with some skills being more typical and anticipated than others. In a world of expanding diversity, one’s ability to develop and employ what may be perceived as “atypical” leadership skills become increasingly important for enhanced self-awareness, more effective communication, positioning, and general overall success. We will focus on that expanded spectrum of leadership skills and will be sharing experiences and insights in that space, while also discussing unique and creative opportunities for leadership skill development and identifying appropriate mentorship when needed.
  • 1900 - 2100
    Women in Pharma Dinner - Power of Your Personal Brand
    Location at Ocean Prime 124 South 15th Street Philadelphia PA 19102. Description: how do you distinguish yourself in our highly competitive world? It is your personal brand that will get you the next promotion, new job, or new opportunity. It is your personal brand that will get you a seat at the table and get you paid what you are worth. It is your personal brand that sets you apart from others who have a similar education, experience, and credentials. We will discuss what makes up a personal brand, how to develop it, and how to promote it to improve your opportunities and success.
  • 1900 - 2100
    Young Professional Networking Event at Yards Brewery and Taproom
    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 can see how beer is brewed and sample some of Yards' 20 different beers. After the tour, share drinks, food, ideas, and conversation while overlooking the Brewery at Yards' Mezzanine, while playing games and interacting with other attendees at the famous Philadelphia brewery. You don't have to be a young professional or over 21 to attend! Under 21? You can enjoy the entire event without the alcoholic beverages. Students are encouraged to join the party and network with young professionals! Includes: Great food, one drink voucher, nonalcoholic beverages, and Brewery tour with tasting. Hosted by ISPE's Young Professional Committee (cash bar after drink voucher is used).
  • 1900 - 2100
    Women in Pharma Dinner - Working Globally: How to prepare
    Location at El Vez 121 S 13th St, Philadelphia, PA 19107. Description: working globally requires knowledge, skillsets, and experience to succeed as you work in different regions of the world with different cultures. We will talk about how to prepare and succeed as you work in different countries of the world or with diverse team members.
  • 1900 - 2100
    Women in Pharma Dinner - Career Development Journey
    Location at Ocean Prime 124 South 15th Street Philadelphia PA 19102.  Description: developing a meaningful career path through use of a mentor and networking with peers can help accelerate your career, build diversity in your portfolio and get yourself elected to the career you really want. Actively seeking to participate in your organization’s toughest challenges can provide opportunities for exposure and career development outside of your everyday deliverables.
  • 1900 - 2100
    Women in Pharma Dinner - What Would Your Career Look Like If You Were Fearless
    Location at Ocean Prime 124 South 15th Street Philadelphia PA 19102. Description: how does risk inhibit or enhance your career opportunities? We will discuss and learn from each other how risk aversion potentially impacts career growth and ways to embrace risk to our advantage.
  • 1900 - 2100
    Women in Pharma Dinner - Become the Authentic Leader You Envision
    Location at R2L Restaurant 50 S. 16th Street – 37th Floor, Philadelphia PA 19102. Description: how do you conquer your inner critic and gain an executive presence? How does perception and authenticity work together to form your leadership identity? In this topic we will explore a framework for addressing self-doubt in your career. Using real-life experiences to cover topics from not allowing peer questions to become internal questions to pushing the limits of you comfort zone. Finally, checking-in, is your leadership style genuine? We will discuss what feedback to look for and how to keep self-evaluation constructive.
  • 1900 - 2100
    Women in Pharma Dinner - Encouraging YPs to Work in Engineering
    Location at Ocean Prime 124 South 15th Street Philadelphia PA 19102. Description: today the demand for engineers is increasing and we know that there will be a lack of engineers in the future. Young professionals have a different way of working compared to previous generations. We will discuss how the work environment impacts the choice of work place.
  • 1900 - 2100
    Women in Pharma Dinner - I Shouldn’t Be Telling You This– Success Secrets Every Gutsy Girl Should Know.  (A book by Kate White) - Get your copy of the book at dinner (while supplies last).
    Location: El Vez 121 S 13th St, Philadelphia, PA 19107.  Description: what if we were honest about what it takes?  The real truths about being successful and moving your career forward.  What it looks like, what it feels like, what it sounds like.  Christa and Kathryn will talk about success and how to plan for it.  This discussion will cascade into a round table conversation and networking event to build relationships that will lead to further success.  Come join us for a fun and vibrant evening!
  • 1900 - 2100
    Women in Pharma Dinner - Career Sponsor vs Mentor And The Value Of Both
    Location at Del Frisco's Double Eagle Steakhouse 1428 Chestnut St, Philadelphia, PA 19102.  Description: we will discuss the difference between a mentor and a career sponsor – the importance of each and how to maximize these relationships for the acceleration of one’s career. For example, a recent HBA article describes the difference as the following: “while a mentor can tell you what doors you might open next in your career, a sponsor will knock and even open and walk through the door with you.”
  • 1900 - 2100
    Women in Pharma Dinner - Strengthening Your Voice AND Being Heard
    Location at LaScala's Restaurant 615 Chestnut St Philadelphia PA 19106. Description: many times, there is frustration that ideas, messages or constructive challenges are not being heard. What are some strategies to better position yourself and your messages to be heard and be effective?
  • 1900 - 2100
    Women in Pharma Dinner - Gender Intelligence
    Location at R2L Restaurant 50 S. 16th Street – 37th Floor, Philadelphia PA 19102. Description: since the pop psychology book ‘Men Are From Mars, Women Are From Venus’ was published in the 1990s, the debate around the differences between the genders has continued unabated. Words: Ruth Doris The term ‘gender intelligence’ was coined by world-renowned expert on gender, diversity and inclusive leadership, Barbara Annis (CEO of Gender Intelligence Group) to describe the differences between men and women from biological and cultural perspectives. However closer to home, psychologist and gender diversity expert Dr. Maureen Gaffney spoke more recently about how important gender intelligence is to understand the variation between the genders, especially in the workplace. Neuroscientists have identified around 100 differences between the male and female brains, Dr. Gaffney revealed on Newstalk’s Hard Shoulder in the run up to International Women’s Day [last month]: “Gender intelligence is really about understanding these differences because they certainly contribute to many of the observed differences that we see between men and women and how they interact with each other, how they interact with their own gender and the opposite gender.”
  • 1900 - 2100
    Women In Pharma Dinner - How to Be Heard - Owning Your Place At the Table
    Location at Del Frisco's Double Eagle Steakhouse - 1428 Chestnut Street, Philadelphia, PA 19102. Description: sometimes rising executives tend to hold back at meetings and in forums and look for affirmation from colleagues. Learn to be direct, brief, confident and accept your position with the knowledge that you earned it.
  • 1900 - 2130
    Women in Pharma Event
    Women in Pharma Event
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
    Professional Poster Display in Expo Hall
    [Aerosol Generation at the Point of Fill: Characterization and Impact on Barrier System ]
    Presenter: Christian Lavarreda
    Over fifteen years have passed since the Isolation Technology Task Force of the Parenteral Drug Association (PDA) published Technical Report No. 34 (TR 34), 'Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products,' yet considerable confusion still surrounds the suitability and favorability of the different types of Restricted Access Barrier Systems (RABS) and isolators in pharmaceutical fill-finish operations. Part of this confusion stems from an incomplete understanding and poor awareness of the size distribution of the particles that are generated by the fill-finish equipment during routine operation, the flight trajectory of the particles based on their point of origin, and their eventual location of deposition based on the barrier system design. In Part 1 of this study we used light scattering to characterize the particle size distribution of the fill medium aerosolized at the point of fill (as a function of flow velocity, vial head-space, needle motion profile, and fill medium properties) while using computational fluid dynamics (CFD) to qualify the measurement method. In Part 2 we characterize the flight path and location of deposition of the aerosol generated at the point of fill and elaborate corresponding recommendations for action. || [The Outsider’s Perception and Experience within the Pharma and Device Industries]
    Presenter: Kerri-Ann Mallet & Darin Oppenheimer
    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 poster will present 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. The intention is for audiences to develop an appreciation for differences between the core philosophies of pharma and medical device industries. || [ Industrial Vacuum Liquid & Wastewater Conveyance Systems in Cleanrooms ]
    Presenter: Philip Crincoli
    As Airvac evolved in the late 1960's, they quickly became known as the entity responsible for modernizing todays Vacuum Wastewater and Sewer Technology Systems. Today, Airvac® is considered the industry standard as both the U.S. EPA and the Water Environment Federation feature our patented system in their published technical manuals. In the 1970s, our company began applying their vacuum wastewater conveyance technologies in Cleanrooms and other industrial setting including FDA regulated companies such as Merck, Avara, Bayer, Eli Lilly, Upjohn (Pfizer) and Roche. FDA Regulated personnel including plant operations personnel and engineers assigned to infrastructure and capital projects from pharmaceutical companies and their third party vendors including specialized AEC firms should attend this meeting to learn about the unique advantages of vacuum wastewater conveyance technologies particularly in a Cleanroom setting. The technology will be explained via a short overview and then case studies involving problem solving at specific client sites utilizing the technology will be addressed. Clients included will be Avara, Merck, Eli Lilly, Pfizer, Roche and Bayer. Attendees will learn about this unique technology and also see that significant cost savings can be attained during a major plant renovation or addition depending upon the circumstances. || [Cleanroom Contamination Control: Disinfection Best Practices and Pre-sterilized Tools]
    Presenter: Aaron Mertens
    Maintaining microbial control in the pharmaceutical, medical device and biotech cleanroom environment is not only a regulatory requirement and expectation, but is absolutely critical to prevent contamination of the finished product. An effective cleaning and disinfection program alone is not sufficient to ensure product sterility. Adding layers of protection throughout the manufacturing process greatly reduces risk to critical surfaces and the final product. Using pre-sterilized cleanroom tools greatly reduces the risk of contamination to the cleanroom environment and critical surfaces. These tools are sterilized using validated ethylene oxide and gamma irradiation processes, minimizing the possibility of microorganism contamination upon introduction of these materials into the cleanroom. || [Cell & Gene Therapy Manufacturing: a real case to address scalability and compliance issues ]
    Presenter: Massimiliano Cesarini
    Cell and Gene therapy manufacturing offers the greatest challenges in terms of scalability and compliance. Since the first step into commercial manufacturing are being moved into this field, a large discussion in the industry is on which available technology (cleanroom, isolator, closed system, etc) best fits the specific process needs. In light of this wide challenge a real case study is presented along with some backgrounds infomation to show how isolator technology (widely used in the typical pharmaceutical industry) can address and provide a concrete solution. In the specific a performance approach from quality and cost perspective will be provided in comparing traditional cleanroom technology to a second generation isolator technology designed for cell culture that includes a modular incubation system. The real case study is at the moment considered the largest cell factory to be built with a capacity of 4'500 patients/year on the only autologous medication for cartilage defects approved by EMA. Therefore in the session the participants will understand the rationale behind the selection of the manufacturing technology, learn the key inputs to approach suppliers in this field as well as get detailed info on the regulatory issues to keep track of. || [Evaluating surface cleanliness using a risk-based approach ]
    Presenter: Paul Lopolito
    Regulated companies that use automated cleaning applications have always struggled with correlating rinse sample quality or visual inspection to surface cleanliness. The process typically involves performing 100% spray coverage testing, rinse recovery testing, specific or non-specific analytical method qualification, surface sampling and recovery testing of the sampling technique, and visual inspection performed during the cleaning validation. Each element of the justification needs to be reviewed and evaluated during the cleaning process design stage to defend a lean approach in continuously monitoring the cleaning process. A risk-based approach, supplemented with laboratory studies and information from published literature can be leveraged in the justification to reduce testing during cleaning qualification and continuous monitoring stages without impacting quality. Laboratory results from total organic carbon (TOC) and conductivity rinse sample for an alkaline detergent along with determining visible residue limits using multiple concentrations, light intensity, viewing angles, inspectors, and distances have been used by multiple biopharmaceutical companies. This approach has helped correlate rinse sample quality or visual inspection and justify a lean approach to continuously monitoring surface cleanliness.
    Speakers
    Business Development Manager
    Bosch Packaging Technology
    Ecolab Life Sciences
    Jacobs Engineering Group
    VP, Clinical and Regulatory Affairs
    Pharmatech Associates, Inc.
    Industrial Segment Sales Manager
    Aqseptence Group / Airvac Division
    Technical Services Manager
    STERIS Corporation | Life Sciences
    Global Sales Manager- Isolation Technology Division
    Comecer Group
    Technical Services Senior Manager
    Steris Corporation
  • 1000 - 1600
    International Student Poster Display in Expo Hall
    On display with the Professional Posters in the Exhibit Hall are the posters created by the undergraduate and graduate students participating in the International Student Poster Competition. Meet the students who were the champions at the local levels' Student Poster Competitions, and who will be presenting their posters to ISPE judges during the conference. Learn more about their unique posters that cover a wide range of relevant topics.
  • 1000 - 1600
    ISPE Booth and Bookstore Open in Expo Hall
  • 1000 - 1600
    Expo Hall Open
  • 1000 - 1600
    Career Solutions Job Fair in Expo Hall
  • 1100 - 1230
    Education Session: Emerging Technology Approvals - Lessons Learned
    Education Level:Fundamental/ Intermediate
    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, a FDA Emerging Technology Team (ETT) representative 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 a FDA ETT member 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
    Acting Quality Assessment Lead
    FDA/CDER/OPQ/OPF/DIA/BII
  • 1100 - 1230
    Education Session: eClinical: Clinical Trial Data & GAMP Compliance
    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
    Director Technology Quality Management
    PAREXEL International
  • 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. || [How to Manage Large & Complex Programs Such as Serialization]
    Speaker: Alf Penfold, BSc, MBA
    The ISPE Project Management Good Practise Guide has been referred to in the context of large and complex programs with Serialization used as a case study. A particularly challenging program that is transforming our industry. Despite the many complexities and challenges associated with Serialization, it quickly becomes evident just how useful the guide may be when constructing these types of programs
    Speakers
    Technical Subject Matter Expert, Serialization
    Clarke Solutions
    Senior Project Manager
    PM Group
  • 1100 - 1230
    Education Level: Intermediate
    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
    [FDA Combination Product Highlights ]
    Speaker: Melissa Burns, FDA/CDER/OC/OMPT/OSMP/OCP
    FDA will provide highlights on combination product regulatory topics including: updates on initiatives related to 21st Century Cures, CGMP considerations for combination products, postmarketing safety reporting (PMSR) changes as a result of the related combination product PMSR final rule, and FDA’s ongoing improvements to combination product premarket review processes.
    Speakers
    Senior Program Management
    FDA/CDER/OC/OMPT/OSMP/OCP
    Head Device Development & Commercialization
    Novartis Pharma AG
  • 1100 - 1230
    Education Session: Streamlined Manufacturing: Continuous Manufacturing and Other Design Challenges
    Education Level: Advanced
    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.
    Session Leaders
    Director, CMC Operations
    Gemini Therapeutics
    [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
    Director, CMC Operations
    Gemini Therapeutics
  • 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
    Director (Acting), Division of Inspectional Assessment
    FDA/CDER/OPQ/OPF/DIA
  • 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
    Deputy Director and Emerging Technology Team Chair
    Office of Testing and Research, FDA
    Deputy Manager, Post-Approval Changes Office
    Anvisa
    Unit Manager, Inspectorate Strategy and Innovation
    MHRA
    Director, Division of International Drug Quality
    FDA/CDER/OC/OMQ
    Biologist
    FDA
  • 1515 - 1600
    Networking Break in Expo Hall
  • 1600 - 1730
    Education Session: Data Analytics and Security in an Integrated Manufacturing Environment
    Education Level: Intermediate
    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
    [In Silico Modeling as Effective Tools to Manage Technological Risk ]
    Speaker: Pablo A Rolandi
    || [Automation, Integration and Security: PAT in a modern DCS ]
    Speaker: Dong Xiang, PhD & Chelliah Navin, PhD
    As the need for regulatory compliance increase day after day due to U.S. Food and Drug Administration’s (FDA) stringent guidelines, industrial manufacturers have started to integrate advanced process analytical tools especially in the pharmaceutical sector to enable them to produce products with consistent quality in both R&D and production. Most importantly, the implementation of spectrometers as a process analytical tool has gained prominence due to its ability to provide in-line process measurements without the need to stop the production for off-line analyses therefore offering control for scientists, engineers and technicians to qualitatively and quantitatively monitor the products in real-time. Herein, we present a case study on the use Prozess real-time spectrometers for in-line process measurement and control in the continuous and batch pharmaceutical environments. Prozess spectrometers have been fueled, in large part, by leading manufacturing movements in Process Analytical Technology (PAT) and Quality by Design (QbD). These spectrometers are loaded with software suite which handles hardware control and chemometric analysis while ensuring that it remains fully compliant with the FDA’s strictest 21 CFR Part 11 guidelines on data integrity, security, electronic records and signature, the PAT initiative, and Good Automated Manufacturing Practices (GAMP). In addition, these spectrometers offer a full line of industrial communication options for easy integration and automation into different control systems such as EtherNet/IP, Modbus, OPC UA, and WiFi. Prozess real-time spectroscopy measurements and control solutions can be applied to a wide range of manufacturing processes to increase quality, yield, and productivity while reducing both risk and downtime. || [Practical Considerations for Big Data Analytics in Manufacturing ]
    Speaker: Daniel Lasley
    Lessons learned from implementing a large scale Big Data predictive analytics system.
    Speakers
    Director, Process Development
    Amgen
    Sr. Manager, Process Analytical Technology, Drug Product Development
    Celgene Corp.
    Chief Scientist
    Prozess Technologie
    Engineering Specialist
    Baxter Healthcare Corp
  • 1600 - 1730
    Education Session: Building Facilities to Deliver on the Promise of Cell and Gene Therapy
    Education Level: Intermediate
    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 CML
    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
    Speakers
    Life Sciences CML
    DPR Construction Inc
    Sr. Program Manager, Validation
    Pharmatech Associates, Inc.
    Associate Principal
    perkins+will
  • 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: Cultural aspects 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 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
    || [Cultural and Forensic Perspectives of Data Integrity ]
    Speaker: Duraisamy Rajan Palani, MS
    Every day, life sciences organizations leverage data to make decisions that could impact patient safety and product quality. As data backs critical decisions, each phase of the data life cycle plays a role in ensuring data integrity. People and computerized systems work together in advancing data through this 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.
    Speakers
    Informatics Specialist
    Eli Lilly & Co
    Director - Quality & Strategy
    Archimedis Healthcare Private Limited
    US FDA, Invited
  • 1600 - 1730
    Education Session: Advancements in Commissioning and Qualification
    Education Level: Fundamental
    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, clear understanding of updates in 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
    Education Level: Fundamental
    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
    PTI Inspection Systems
    [Strategies for Deterministic Container Closure Integrity ]
    Speaker: Josh Lance
    || [FDA Perspectives on Container/Closure]
    Speaker:Stephen Langille, PhD
    || [Strategies for Deterministic Container Closure Integrity ]
    Speaker: Donald C. Singer
    Speakers
    Associate Director, Chemistry
    Merck
    Acting Branch Chief, Division of Microbiology Assessment
    FDA/CDER/OPF/DMA
    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
    []
    Speaker: Sau (Larry) Lee, PhD
    || [Regulatory Considerations for API Continuous Manufacturing]
    Speaker:Aoife Corrigan, PhD
    Continuous processing offers great potential to increase safety, product quality, and manufacturing flexibility for the production of pharmaceuticals. Over the past decade Lilly has invested significantly in continuous processing technologies to support both drug substance (DS) and drug product (DP) manufacturing for new chemical entities (NCEs). While the introduction of continuous technology is widely supported by FDA and some other major ICH regions, there are aspects for which guidance is required. This presentation will focus on the challenges of process validation, process analytical technology and the management of process disruptions in respect to DS continuous manufacturing.
    Speakers
    Deputy Director and Emerging Technology Team Chair
    Office of Testing and Research, FDA
    Director, Early Development Projects, CMC Regulatory Affarirs
    GlaxoSmithKline
    QA Consultant
    Eli Lilly SA
  • 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
  • 0730 - 0930
    Education Session: GMP Basics for Young Professionals (Separate Registration Required)
    Basic GMPs are the foundation of the US and worldwide Pharmaceutical Industry. They are the “license to operate”. People who grew up on the shop floor, in laboratories, and in QA, know the GMPs by heart chapter and verse. More than knowing, they understand them and how they interrelate to day to day business. However, many people didn’t have the opportunity to live the GMPs and to know them. They started their careers removed from day to day life on the shop floor, and may feel unsure about them. Are you one of those people? This session will be an in-depth primer on GMPs and the questions you may be afraid to ask. Join Lachman Consultants Senior Management team as we take an in-depth and interactive journey through the GMPs. Send us your burning questions ahead of time so we can be sure to cover them.
    Session Leaders
    President & CEO
    Lachman Consultant Services
    [GMP Basics for Young Professionals]
    Speaker: Ricki A. Chase
    || []
    Panelist: Donna Gulbinski
    || []
    Panelist: Constance Richard-Math
    || []
    Panelist: Linda Evans O’Connor
    || []
    Panelist: James Davidson, PhD
    Speakers
    Director, Compliance Practice
    Lachman Consultant Services
    Vice President, Compliance Services
    Lachman Consultant Services
    Director, Compliance Practice
    Lachman Consultant Services, Inc.
    Vice President, Chief of Staff
    Lachman Consultant Services
    Vice President, Science and Technology Practice
    Lachman Consultant Services
  • 0800 - 0930
    Education Session: New Tools for Realizing Sustainable/Green Manufacturing Processes
    Education Level: Intermediate/ Advanced
    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
    [Sustainable Manufacturing Platform for APIs Based on Slug Flow]
    Speaker:Mo Jiang, PhD
    This talk focuses on the slug-flow crystallizer design, which is a particular form of tubular crystallizer that combines many of the strengths of other crystallizer configurations to provide enhanced control of crystal properties. Experimental validation confirms that the proposed designs reduce development time and equipment cost by orders of magnitude while suppressing secondary nucleation, attrition, and clogging/fouling—dominant but undesired phenomena that worsen the ability to quality control. || [Applications of AI and Automation to Sustainable Route Scouting] DARPA’s Make It program is building platforms for on-demand, automated synthesis of molecules using retrosynthetic software and reconfigurable flow synthesis. Together, these technologies allow for discovery of greener syntheses and enable a more efficient model of chemical production.
    Speakers
    Scientist II
    Biogen Idec
    Assistant Professor, Chemical and Life Sciences Engineering
    Virginia Commonwealth University
    Programs Manager, Defense Science Office
    Defense Advanced Research Projects Agency (DARPA)
  • 0800 - 0930
    403-Transformative DATA: Aggregation & Analytics
    Education Session: If you agree with Sir Francis Bacon's proverb that "Knowledge is Power" (1597), then you agree that data and information systems are critical factors in empowering an organization's success? However, with an overwhelming number of existing technologies to evaluate and new ones appearing daily, how can you choose the right solution for your GxP operation? A solution that not only meets your current business demands, but also supports future growth. This session will review the latest technologies having a transformative effect on our industry. It will also share the strategies that some of the most successful GxP companies are using to compliantly embrace the benefits of new and existing information technologies.? Specifically: - What technologies should be on your radar as having the greatest potential to add value to your GxP operation? - What barriers are preventing companies from adopting data aggregation and analytics solutions, and how are they being overcome? - How can GxP companies best use their data in support of evidence-based decision making to improve quality, reliability, and reduce waste? This session is intended for continuous-improvement-minded individuals interested in enhancing the performance of their GxP operation and shifting from a culture of reactive to proactive problem solving.
    Session Leaders
    Serialization SME
    Sequence Inc
    [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. || [Digital Transformation in the Regulated World]
    Speaker: Oliver Herrmann
    The buzz words "Digital Transformation" and "Blockchain" are poorly understood in the regulated industry. The education session will bring clarity and practical advice on how to implement disruptive technologies and understand the role of GAMP. || [Cutting Through the Pharma 4.0 Paradigm- Data Best Practice ]
    Speaker: David Staunton
    Speakers
    Serialization SME
    Sequence Inc
    Principal Consultant
    Q-FINITY Quality Management
    Operations Manager
    Zenith Technologies
  • 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: Get an overview of the CAR-T Process, gain a better understanding of the supply chain challenges inherent to these therapies , learn about how technology, standardization and decentralization may be used to meet these challenges.
    Session Leaders
    Senior Director, Validation Services
    IPS
    [CAR-T Supply Chain: Challenging, Achievable, Realistic & Transformational ]
    Speaker: Aaron D. Weinstein
    Speakers
    Scientific Fellow
    Janssen Pharmaceutica Inc
    Scientific Fellow, Program Architect CAR-T
    Janssen
    Senior Director, Validation Services
    IPS
  • 0800 - 0930
    Education Session: New Modality Products: Who knows what the appropriate quality standards are?
    Education Level: Intermediate 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/Global Regulatory Affairs
    AstraZeneca
    [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.
    Speakers
    Senior Director, Global Regulatory Affairs CMC
    Medimmmune
    Director, Corporate Product Quality
    Amgen
    Biologist
    FDA
    Deputy Director (Acting)
    Office of Process and Facilities (OPF)
  • 0800 - 0930
    Education Session: Data Science Solutions for Accelerating Time To Market
    Education Level:Executive
    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
    Professor
    TU Wien
    [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
    Head of Consulting
    Exputec, GmbH
    Lead Data Scientist
    Sartorius Stedim Data Analytics
  • 0930 - 0945
    Networking Break
  • 0945 - 1115
    Education Session: Applying and Qualifying a PAT System for Life Science Manufacturing
    Education Level: Intermediate
    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 Fermentation Process, Bio-pharm]
    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
    || [Innovative Approach to Modernize Bio-Pharmaceutical Manufacturing Processes through a PAT Application]
    Speaker: Jack C. Chu, PE
    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. PAT can also describe a broader change in pharmaceutical manufacturing from static batch manufacturing to a more dynamic approach that allows manufacturers to produce products with more consistent quality, real-time-release (RTR), less waste and lower cost of goods manufactured (COGM). PAT will allow for product yield optimization.
    Speakers
    Sr Engineer, Technical Operations
    Merck & Co Inc
    Life Sciences Industry Manager
    Siemens Industry, Inc
    Senior Consultant- Special Products
    CAI, Merck & Co., Inc (Retired)
  • 0945 - 1115
    Education Session: Industry 4.0: What’s Next?
    Education Level: Intermediate/ Advanced
    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
    Professor
    TU Wien
  • 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 & Maneesha Altekar, PhD
    A challenging area in the production of commercial products is integrating product knowledge, control strategy and process performance. The relationship between the controls and their relative impact on the critical quality attributes needs to be clear, connected and alive. Life cycle management of the control strategy (creation, transfer and maintenance) is a key mechanism for ensuring robust supply. The requirements of the control strategy reprocess design, material consistency, equipment & measurement capability, standardized methods, training approaches, and other controls must link back to prior knowledge, experimental data and commercial manufacturing experience. These factors combined create the understanding for cause and effect relationships such that the controls established effectively manage variability. The quality and quantity of process understanding coupled with the effectiveness of the control strategy can drive our approaches on how we continually improve our products. The purpose of this discussion is to describe a method to maximize the effectiveness of the control strategy across the lifecycle through integration of product knowledge, which is aligned to how performance is maintained or improved on a day to day basis. Additionally, perspectives will be provided on the use of robustness indicators derived from a risk-based approach for managing product performance. || [Striving for World Class Performance ]
    Speaker: Thomas Friedli, PhD
    The presentation draws from the findings of the second year of the FDA Quality Metrics Research conducted by the University of St.Gallen. The main focus lies on patterns for high performance and brings together a unified quality and operational excellence perspective. The conclusions from the findings for regulators, industry and academia are summarized at the end. || [ISPE’s Approach to Advancing Pharmaceutical Quality – The CAPA Example ]
    Speaker: Kira L. Ford
    Speakers
    Regional Director, MS&T
    AstraZeneca
    Senior Science Policy Advisor
    FDA/CDER/OPQ
    Director of Institute of Technology Management
    University of St. Gallen (Switzerland)
    Sr. Technical Manager, Product Robustness CoE
    AstraZeneca
    Director, Global Quality Systems
    Eli Lilly
  • 0945 - 1115
    Education Session: Analytical Method Lifecycle - An Industry Perspective
    Education Level: Intermediate/ Advanced/ Executive
    The lifecycle phases of an analytical method comprise of design, validation and continued method performance verification. It is not uncommon for some analytical methods to be in commercial use for 20+ years; therefore, it is important that analytical methods are designed to be rugged and robust during their entire lifecycle and that they can be readily updated to ensure continuous improvement of quality control methods keeps pace with scientific progress and manufacturing improvements. By designing quality into analytical methods, this decreases the burden on method performance verification and post-approval changes as well as minimizing the risk of method related out-of-specification results. The concept of quality by design (QbD) was first introduced by ICH in 2009 with publication of the ICH Q8 Pharmaceutical Development guideline; however analytical methods were not specifically described. The concept of Analytical QbD / lifecycle approaches to analytical methods however has evolved over the last 10 or so years with trade associations (e.g. EFPIA, PhRMA, AMED), regulatory authorities (e.g. FDA, ANVISA) and Pharmacopeias (e.g. USP, BP) all developing guidance and publishing papers in this area. This session will introduce analytical method lifecycle as a concept and describe how some companies are using analytical quality by design approaches to gain post-approval flexibility. Following this we will have a session on the recently announced Analytical ICH Topic which will include a revision of the ICH Q2 analytical validation guideline and the introduction of a new guideline ICH Q14 covering analytical procedure development; where we will discuss the merits of the current ICH Q2 and what needs to change to meet the requirements of the modern day pharmaceutical environment. Finally, we will explore the forthcoming new ICH Q12 Pharmaceutical lifecycle guideline, specifically in relation to the analytical method post approval environment. The session will also explore the regulators perspective on lifecycle management for analytical methods and expectations for the new ICH topics (Q2 revision & Q14).
    Session Leaders
    Team Manager
    AstraZeneca
    [Opportunities to include Analytical Method Lifecycle concepts into ICHQ2, Q12 and Q14 ]
    Speaker:Phil Borman
    The recently announced Analytical ICH Topic which will include a revision of the ICH Q2 analytical validation guideline and the introduction of a new guideline ICH Q14 covering analytical procedure development will be discussed. The merits of the current ICH Q2 will be presented along with what needs to change to meet the requirements of the modern day pharmaceutical environment. || [Continual Improvement of Regulatory Approved QC Methods]
    Speaker: Anders Karlsson, PhD
    Quality Control methods play an important role in the overall Control Strategy for drug manufacturing. However, efficient life-cycle management and continual improvement are hindered due to a variety of post-approval variations across territories. This presentation present how to secure the high quality of the regulatory approved QC method throughout its whole life-cycle putting scientific based decisions in focus. || [Regulator’s Perspective on Analytical Method Lifecycle: Current Brazilian Regulation and Expectations ] This presentation will give an overview of the current situation for analytical methods changes in Brazil and ANVISA's expectations for the recent ICH Q12 draft guideline, Q2 review and Q14 proposal.
    Speakers
    Sr. Principal Scientist
    AstraZeneca
    Deputy Manager, Post-Approval Changes Office
    Anvisa
  • 0945 - 1115
    Education Session: Education Level: Fundamental/ Intermediate - Digital Health- Opportunities and Challenges of Transformed Healthcare Delivery
    Few technical advances offer to radically transform the delivery of healthcare as much as the emerging digital health technologies do. Just like smartphones have fundamentally changed the way we consume information, and e-Bay and Amazon the way we shop, so too digital health has the potential to fundamentally change the way we monitor our health, control consumption of medication, engage with healthcare professionals and research new therapies. The relationships between pharmaceutical company, healthcare professional and patients will inevitably change creating new possibilities and threats. This session will explore the opportunities that are arising in the digital health arena, and what it means for our industry, including the challenges that are foreseen. We will hear about digital health from the pharmaceutical companies' point of view, and from technology vendors' point of view. This session will offer attendees opportunity to better understand what digital health means and equip attendees with the questions to answer as we start to engage with the brave new Digital world of healthcare.
    Session Leaders
    Astra Zeneca
  • 0945 - 1115
    Education Session: Accelerating the Delivery of Biosimilars to Chinese Patients
    Education Level: Fundamental/ Intermediate/ Executive
    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
    || [Our Successful and Innovative Project Execution Strategies]
    Speaker: Robert Myers
    || [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
    GE Healthcare
    Director of Global Engineering
    Pfizer
    Manager, Process Engineering
    Jacobs Engineering Group Inc
  • 1145 - 1700
    Facility Tour (depart From Marriott)
    Attendees will go to both facilities and start with lunch. At AdaptImmune, there will be a facility tour and at WuXi AppTec they will show a video highlighting the facility. The tour will be split into two groups with one going to one location and then rotating to the second location. 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. WuXi AppTec was one of the first companies to set-up a location in the Philadelphia Navy Shipyard, with its first building established in 2004. A second facility was added in 2014, and a third in 2016, which was a 150,000 sq. ft state-of-the art manufacturing facility. This building supports late-stage GMP production of gene-mediated cell therapies, viral vectors, and oncolytic virus, with the capability to expand and add suites as needed to support customer and industry growth. A fourth building at the Navy Shipyard is in the planning stages, to be opened late 2019. WuXi AppTec Advanced Therapies is a full service CDMO, capable of supporting early and late stage cell and gene therapy manufacturing, with centralized analytical and biosafety testing, as well as quality control and in-process laboratories from an industry leading process development team.
  • 1145 - 1730
    Fedegari US Tech Center Tour
    Fedegari US Tech Center has been designed to allow pharmaceutical operators as pharma companies, regulators, experts and OEMs to physically interact and share experiences while working on various fully operating process machines. Exploring the opportunities offered by the combination of different equipment and processes into cost-effective integrated solutions for drug manufacturing and packaging is the scope of the visit at the state-of-the-art Fedegari Tech Center. The 10.000 square-foot facilities in Sellersville (PA), currently under expansion, has recently been equipped with a machine prototype intended to wash, sterilize and dry aluminum kegs to be filled with sterile powder inside a gloveless robotized isolator downstream of the process machine. The project will be presented by the Head of Engineering of Fedegari, Mr. Riccardo Marsili, in collaboration with Jim Agalloco, and Pierre Winnepenninckx of No Deviation. The experts will explain how to introduce such disruptive solutions in regulated manufacturing environments.

IMIS Description Character Cleanup