Agenda

Before the Event
Friday, 25 October 2019
Before the Event
Saturday, 26 October 2019
  • 0800 - 1800
    FOYA Displays
  • 0900 - 1700
    2019 ISPE Student & Young Professional Hackathon
    New to the ISPE Annual Meeting! ISPE Student & Young Professionals - join the first Hackathon to be held at ISPE Annual Meeting. Spend the weekend working with students and YPs from around the globe to solve real-world challenges relevant to Pharma/Biotech Manufacturing & Engineering and, as part of a team, develop competitive presentations that will be judged by ISPE Industry Professionals. Meet and connect with other students, YPs, industry professionals, and ISPE Board and staff members, learn, and have fun with this highly educational and collaborative program. Space is limited - contact ask@ispe.org to register.
  • 1300 - 1700
    Registration Open
Day 1
Sunday, 27 October 2019
  • 0700 - 1800
    Registration Open
  • 0800 - 1100
    2019 ISPE Student & Young Professional Hackathon
    Hackathon teams complete their presentations and work with coaches to finalize in preparation for the Student & Hackathon Judging/Brunch, where each team will present its solutions to Industry Professionals who will identify the winning team!
  • 0800 - 1730
    Speaker Ready Room
  • 0800 - 1730
    Press/Interview Room
  • 0800 - 1730
    Volunteer Room
  • 0800 - 1800
    FOYA Displays
  • 1100 - 1300
    2019 ISPE Student & YP Hackathon Judging & Brunch
    All Students and Young Professionals are invited to join the Student & YP Hackathon Judging and Brunch, where the Hackathon participants’ presentations will be judged. In this exciting conclusion to the Student & YP Hackathon, watch the Hackathon teams’ present their potential solutions to industry-relevant real-world challenges to the Hackathon judges, and network with your peers and colleagues over brunch. If you are not a Hackathon participant, please be sure to register by contacting ask@ispe.org.
  • 1300 - 1500
    WORKSHOP: What is Next for the PV Lifecycle Approach? • Going Beyond Compliance
    The pharmaceutical industry has now been implementing the PV Lifecycle approach for several years, with a focus on complying with the requirements, especially for CPV. This session will look at ways in which companies are beginning to leverage the lifecycle approach to identify and close gaps to improve manufacturing robustness, and to find solutions to challenges that have arisen in using the lifecycle approach.

    Panel Discussion

    Dave White, Associate Director, On Market Technical, Chemical Development, AstraZeneca
    Sandy Hopkins, Regional Director, MS&T, AstraZeneca
    Bruce Davis, Principal, BD Global Consulting
    Tara Scherder, Partner, SynoloStats, LLC
    Daniel Peng, Director, Regulatory Affairs CMC Biologics, Merck & Co Inc
    Session Leaders
    Sr. Technical Manager, Product Robustness CoE
    AstraZeneca
    Speakers
    Associate Director, Technical Operations for Commercial Drug Substances
    AstraZeneca
    Regional Director, MS&T
    AstraZeneca
    Director, Regulatory Affairs CMC Biologics
    Merck & Co Inc
    Partner
    SynoloStats, LLC
    Principal
    BD Global Consulting
    Presentation Information
    [Application of Control Strategy as an Enabler for Robustness & Validation Lifecycle]
    Speakers: Dave White & Sandy Hopkins
    The focus of this presentation is on the lifecycle management of the control strategy from design and development through to implementation and management at the commercial scale. Control Strategy lifecycle management can be seamlessly managed through the right level of visibility & simplification to support development and ensure that the product remains in a state of control linked to process understanding and product performance.
    || [Leveraging DOE to Define the Control Strategy – Choosing the Optimal Design]
    Speaker: Tara Scherder
    || [Challenges in Applying the 3 Stage PV Lifecycle Approach to Cell & Gene Therapy Products – A European Perspective]
    Speaker: Bruce Davis
  • 1300 - 1500
    WORKSHOP: Digital Solutions for Lifesciences Manufacturing
    During the last decade digitalization has disrupted our business models and operations, providing interesting alternatives to improve, and in some cases completely change, the operations. The use cases most targeted by companies in manufacturing lie in one (or a combination of) four digitization domains: (1) Monitoring & control (2) Predictive performance (3) Digital assistance (4) Process automation.

    The workshop will focus on the applications of Digital Assistance, and how digital technologies can help people do their work in a better way. Human error is one of the key elements of productivity and quality loss in the pharmaceutical production, and it is key to exploit new technologies to reduce those errors to a minimum.

    Of the different approaches to this improved way of working, two of the high-impact approaches will be presented: (1) Digital training, and (2) Digital Standard Operating Procedure (eSOP).

    The workshop will present these solutions, as applied by other companies, to give fresh ideas to the attendees; the workshop will introduce the four domains of use cases, with examples, to give an overview of the current state-of-the-art. Participants will work in groups to develop their own use cases in order to better understand what is required, the benefits and the potential hurdles.
    Session Leaders
    Managing Director Altran World Class Center for Advanced Manufacturing
    Altran
    Speakers
    Pharm.D Specialist, Life Sciences Process Excellence World Class Center
    Altran
    Managing Director Altran World Class Center for Advanced Manufacturing
    Altran
    Presentation Information
    [Digital Solutions for Life Sciences Manufacturing: Real-world applications improving operations & performance]
    Speaker: Olivier Michel & Ramon Antelo
  • 1300 - 1500
    WORKSHOP: Electronic Batch Recording
    EBR/MES systems are typically regarded as extremely complex to implement and very daunting in scope for all but the largest manufacturers. This presentation is a case study on a project where these issues were overcome through a strong collaboration between customer and vendor. Key points in the presentation will include
    (1) how project risks were identified and managed
    (2) how parallel testing efforts were coordinated
    (3) how iterative/agile-like reviews lead to a better validation.

    Important take-aways:
    (1) With modern approaches and technology, implementing these systems is not the complex daunting task many perceive it to be.
    (2) Project risks can become project success stories when they are well understood and managed.
    (3) A collaborative, almost partnership type, approach between customer and vendor is critical to working through project challenges quickly and effectively.

    The presentation will focus on a case study of the Nephron Pharmaceutical EBR implementation for its 503B operations. This is co-presented by Nephron (the customer) and Lonza (the system vendor in this case) providing perspective from both sides of the project on how the strong collaboration was key to project success. Both presenters were key resources involved in the project's execution.
    Session Leaders
    Placeholder Person Graphic
    Sr Product Strategist
    Lonza Biologics Inc.
    Speakers
    VP, Information & Automation Technology
    Nephron Pharmaceuticals
    Placeholder Person Graphic
    Sr Product Strategist
    Lonza Biologics Inc.
    Presentation Information
    [Paper to EBR in 9 Months – How a Strong Collaboration Leads to Project Success ]
    Speakers: Geoffrey Swafford & Bryan Beck
  • 1300 - 1500
    AI and Data Analytics in the Pharmaceutical Industry
    Artificial Intelligence (AI) and Data Analytics are transforming our world, the industries in which we work, and the possibilities of tomorrow. The information behind these disruptive technologies serve as the “power” and the means by which we may transform our own environments. This session explores how that information, and the science behind these novel capabilities, are being used to improve manufacturing, innovate clinical systems, and advance engineering. No longer are the electronic days of old, it’s time to welcome the next “digital frontier”!
    Session Leaders
    Vice President of Compliance
    Genpact
    Speakers
    CEO
    Vyasa Analytics
    Director, Analytics Solutions North America Tessella
    Altran
    Vice President of Compliance
    Genpact
    Presentation Information
    [Deep Learning Analytics in Pharmaceutical Engineering]
    Speaker: Christopher Bouton
    || [How to use AI and data to improve Manufacturing Process ]
    Speaker: James Sokolowski
    Manufacturing process issues have major impacts ranging from profitability to the broader supply chain. The vast quantities of data generated in modern manufacturing processes combined with modern big data analytics techniques such as AI and machine learning bring new weapons to this fight. These advanced data analytics tools have the power to resolve quality issues such as product yield or batches failures, enable finer process control, and provide earlier and more accurate product quality predictions.
    This presentation will explore real manufacturing process challenges where the application of advanced analytics techniques has released business value. It will show how the application of a disciplined AI project methodology, Tessella RAPIDE, was used to do this and discuss why such systematic advanced analytics approaches have the potential to transform manufacturing process. Participants will gain knowledge on how to seize the opportunity afforded by big data and AI and Machine Learning to improve manufacturing process.
    || [Use and Compliance of Artificial Intelligence (AI) for Clinical Systems (Genpact) ]
    Speaker: Eric Staib
    The industry is increasingly relying on software to automate many functions previously performed by humans. As our computer systems become more integrated and data sets become more robust, computer science is advancing our ability to learn from that data and draw conclusions about what might or should happen next. We are now reaching a point where these algorithms are sophisticated enough to begin making decisions for us in the form or artificial intelligence (AI). This presentation will highlight how AI is being used in clinical research and how/what companies are doing to ensure its compliance with predicate rule and the latest regulatory guidance on data integrity (DI).
  • 1300 - 1500
    WORKSHOP: Integrating Technology Adoption into Quality Risk Management and Continuous Improvement Strategies
    Depending on the potential impact of proposed changes (e.g. quality risk analysis outcomes), some changes can be managed through internal pharmaceutical quality systems while others will involve external post-approval change processes. We will refer to the key concepts in ICH Q8-12 and industry publications to discuss data-driven change decisions based on improved process understanding, whether through prior knowledge, process development, or manufacturing experience. The exercises will help the participants understand the rationales behind the change decisions and support the changes by methodically presenting updated automation and human activities.
    Session Leaders
    Global Automation & IT Lead
    Commissioning Agents, Inc.
    Speakers
    Founder and Consultant
    KoCreation Design LLC
    Qualification Expert
    VTU Engineering GmbH
    Global Automation & IT Lead
    Commissioning Agents, Inc.
    Presentation Information
    [Change Management Process for Technology Adoption, Quality Assurance, and Continual Improvement ]
    Speaker: Peiyi Ko
    Continual improvement and technology adoption involve changes that are also important investment to stay compliant and keep up with regulatory commitment (ie established condition). Depending on the potential impact of proposed changes (e.g. quality risk analysis outcomes), some changes can be managed through internal pharmaceutical quality systems while others will involve external post-approval change processes. Continued Process Verification (CPV) signals and responses decisions for ongoing quality assurance is an example of important data-driven decisions pertaining change management. Process understanding, whether through prior knowledge, process development, or manufacturing experience, is the key foundation of the discussions. Process Analytical Technologies (PAT) is a desirable option for companies to implement an ongoing process monitoring program to be GMP compliant and manage quality risks effectively. With the Quality by Design (QbD) approach, constructing design space to inform process control strategy could even shorten the timeline for a post-approval change. In this section, we will refer to the framework and key concepts in ICH Q8-12 and industry publications to discuss best practices for change management before reviewing the decisions and mechanics of internal change management in the context of establishing and updating a Stage 3 Monitoring Plan. Illustrative examples and exercises will help the participants understand the rationales behind the change decisions and support the changes by methodically presenting updated automation and human activities. If time permits, demonstration of a tool to leverage existing knowledge base to put these concepts in practice will be provided.
    || [How to Implement a Modern Life-Cycle Risk-Management-Process]
    Speaker: Brigitte Gübitz
    he use of medicinal products and medical devices always involves a certain risk for patients and other users. To make this risk manageable and to reduce the residual risk for patients and users to an acceptable level, the establishment of a life cycle risk management process is required by law in the drug and medical device sector.
    || [Quality Risk Management for Automation and Data Systems]
    Speaker: John Hannon
    Quality Risk Management (QRM) is gaining global acceptance as a technically more complete and smarter approach to Commissioning & Qualification. QRM for computer system validation (CSV) applies QRM principles to existing CSV structures and examines data and meta-data in the same context as quality critical aspects. The approach is transformative in that it allows risk mitigation to occur more efficiently, with more focused testing. The same QRM principles being used to revise the C&Q Baseline Guide apply to computer system validation as well but are not (yet) enumerated in the GAMP Guide. While GAMP offers a risk-based approach, it still relies on the risk related to software and hardware architectures as opposed to actual relationships to the critical-to-quality aspects. Without a QRM approach to CSV, system and data integrity risks may not be fully mitigated. For example, per GAMP, operating systems are low risk requiring minimal testing. However, if the policy settings on a server’s operating system causes it to perform updates while performing a lab test, the test will be inadvertently aborted, and data could be lost. This presentation will address tools and processes to enhance and streamline existing CSV program deliverables and risk assessments, as well as how to apply QRM for critical aspects to data and meta-data.
  • 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 2019 Facility of the Year Awards Program Winners.
    Session Leaders
    Connected Biomanufacturing Program Manager
    GE Healthcare Life Sciences
    Speakers
    Consultant Process Engineer
    Eli Lilly
    Sr. Director, Digital GxP Systems
    Moderna Therapeutics
    Management Board
    Kantonsapotheke Zurich
    Sr. Director of Technical Operations
    AveXis
    Sr. Maintenance Supervisor
    Janssen Cilag Spa
    Sr. Engineering Advisor
    Eli Lilly and Company
    Plasma OpU Lead, Capital Projects & Portfolio
    Takeda
    Director of Global Engineering
    Pfizer Inc.
    Senior Director, Global Project Engineering
    Celgene Int. Sarl
    Presentation Information
    [IE2 Small Volume Continuous Facility]
    Speaker: Raymond Boyse & Martin Johnson
    Eli Lilly has been applying continuous processing technologies in drug substance manufacturing for over a decade. Continuous processing has allowed new product development to leverage alternative chemistries for innovative process control strategies. This has translated into safer processes at the manufacturing site as well as offering the potential for greener and more productive processes. The construction of a new Small-Volume Continuous (SVC) Manufacturing facility at the Eli Lilly Kinsale manufacturing site is the next step on the journey to harness the benefits of continuous manufacturing. This facility has offered a platform for process innovation leading to more robust chemical processes with shorter development times to bring important new medicines to the patient.
    || [New cGMP Clinical Manufacturing Facility ]
    Speaker: Roland Smith
    || [KAZ – Kantonsapotheke Zürich Turning Challenges into Opportunities ]
    Speaker: Heinz Obertüfer
    Small Scale big Variety Manufacturing
    The KAZ project raised the GMP Level of hospital pharmacy to industrial level Mission and future oriented operational Strategy regarding Hospital Pharmacy High professional and fast project realization to adopt fast changing trends in therapeutical medical care State of the art and future oriented facility design with maximum flexibility to react on future technical Needs
    Revolutionizing hospital pharmacies
    Using state of the art Automation Technologies e.g. Robots High Speed Processes: 60-90 Minutes from Diagnosis to Manufacturing to application at Patient
    || [A Next-Generation Facility for a Next-Generation Therapy ]
    Speaker: Scott Bertch
    AveXis is reimagining the treatment of rare diseases by pioneering the research and development of gene therapies for patients and families affected by life-threatening neurological diseases, including spinal muscular atrophy (SMA), Rett syndrome and a genetic form of amyotrophic lateral sclerosis (ALS). As one of the first companies to successfully scale-up the manufacturing process for gene therapy from an academic process to the commercial level, we will discuss how we were able to build our state-of-the-art manufacturing facility through innovative executive, while meeting the deadlines for a very aggressive timeline, and how we have since replicated our initial facility and equipment design approach on an even larger scale
    || [Dosepak Equipment Project ]
    Speaker: Nello Troccia
    New product requirements are rapidly changing passing from the standard blisters and bottles to more complex packaging. Some of the special requirements added to the standard packaging are calendarization, child resistant protection and I-Smart technology. The Dosepak Equipment condenses all these needs into one machine.The project results in the design, installation and qualification of a state-of-the-art equipment that integrates advanced robotics and automations into standard packaging process steps.The equipment makes Janssen Latina ready to launch new products with innovative packaging, while keeping production processes lean, flexible and sustainable.
    || [Takeda’s Georgia Manufacturing Facility]
    Speaker: Eric Schnake
    Every year millions of patients depend upon plasma-derived therapies obtained through plasma fractionation processes. Takeda’s new 1.1 million square feet state-of-the-art Plasma Protein Manufacturing facility is the cornerstone of a global strategy ensuring patients world-wide have access to its medications. Takeda relied on a global team of experts and innovative risk management strategies to successfully plan, design, and construct a facility meeting current production requirements, that is also expandable for future needs. The Project’s award winning safety program was a top priority, leading to the 2015 CURT Construction Industry Safety Excellence Award by the Construction Users Roundtable. The Education Session will explore the project development and success factors leading to its exemplary safety record!
    || [Pfizer Hangzhou China Biotechnology Center ]
    Speaker: Robert Myers
    This presentation will address the ability to accelerate Pharmaceutical Product Delivery in China. Several key success factors in executing a complicated, challenging fast track project in China, including successful project execution strategy, construction safety, government relations and strategic partnering with industry leaders will be outlined.
    || [Celgene’s Couvet Switzerland Facility, Green and Sustainable ]
    Speaker: Philippe Servais
    Celgene's Couvet Switzerland Facility wins ISPE Facility Of the Year Award for Sustainability. We will share our project's success story during the FOYA Education Session which will be held on Sunday, 27 October 2019. The new Couvet production site, “The Green Fairy” project, a greenfield project, was constructed between 2016 and 2018 as the result of Celgene’s decision to develop its production activities in Switzerland. By building the Couvet facility from the ground up, we had the opportunity to ensure that the site was aligned with Celgene’s principles for sustainability and environmental responsibility. The site’s sustainability practices were based on factors such as climate, solar exposure and ground soil properties. The attendees will learned more about this unique and innovative site energy concept, which reduces greenhouse gas emissions by approximately 70% – or 1,400 metric tons of carbon dioxide – per year when compared to a standard building construction.
  • 1500 - 1530
    Networking Break
  • 1530 - 1730
    Opening Plenary Session
    Session Leaders
    CEO and President
    ISPE
    Vice President, Lead Biologics Expansion
    Janssen Pharmaceuticals
    Speakers
    CEO and Owner
    Nephron Pharmaceuticals
    Chief Executive Officer
    Roche Pharmaceuticals
    Patient Presenter
    Placeholder Person Graphic
    Head of Global Pharma Technical Operations
    F. Hoffmann-La Roche, Ltd.
    Presentation Information
    [Training Tomorrow’s Workforce]
    Speaker: Lou Kennedy
    || [Every Patient Matters — Transforming to Deliver Breakthroughs Faster ]
    Speakers: Bill Anderson
    Bill Anderson, CEO Roche Pharmaceuticals, shares how Roche is transforming to bring more breakthroughs from bench to bedside, faster. Hear his insights into how Roche pursues new solutions for life-threatening diseases, like cancer and neurological disorders, by combining advanced diagnostics, big data/ analytics and targeted therapies to provide better, more personalized care for each patient.
    || [Thriving in My New Normal ]
    Speaker: Jessica H.
    || [Transforming Big Pharma Manufacturing: Dream or Reality?]
    Speaker: Pierre-Alain Ruffieux
    Pierre-Alain Ruffieux, Head of Pharma Technical Operations at Roche, will talk about leading a journey of transformation for Roche TechOps to enhance speed and delivery, while maintaining high quality, and doing what is right for employees, patients and society. On this journey of continuous improvement, Roche is focused on long term results and setting up the organization of the future, while also delivering short-term wins. Is it possible to do both in today’s rapidly-evolving environment? The answer is yes, and Pierre-Alain will share insights as to the need to deliver today, while creating the right organizational mindset and agility in the organization to deliver the products of tomorrow.
  • 1730 - 1900
    Sunday Welcome Reception in Expo Hall
  • 1900 - 2200
    FOYA Reception and Banquet
    Separate ticketed event
Day 2
Monday, 28 October 2019
  • 0630 - 0800
    11th Annual 5K Charity Run/Walk and Team Challenge
    Checkin and start/finish line located Tour and Travel Entrance located on the main casino level
  • 0700 - 0815
    New Member and First Time Attendee Networking Breakfast
    Enjoy breakfast with ISPE leadership and colleagues while learning about significant achievements made by industry in 2019. Be among the first group to recognize the Overall New Member and First Time Attendee Networking Breakfast: Winner of the 2019 Facility of the Year Awards (FOYA) and celebrate with your peers as the ISPE International Honor Award and the International Student Poster Competition Award winners are presented.
  • 0700 - 1730
    Registration Open
  • 0700 - 1730
    Speaker Ready Room
  • 0700 - 1730
    Press/Interview Room
  • 0700 - 1730
    Volunteer Room
  • 0800 - 1800
    FOYA Displays
  • 0830 - 1000
    Plenary Session
    Session Leaders
    President & CEO
    Lachman Consultant Services, Inc
    Speakers
    Chairman & CEO, Co-Founder
    Amicus Therapeutics
    Senior Vice President, Head of Cell & Gene Technologies.
    Lonza AG
    Principal Deputy Commissioner
    FDA
    Presentation Information
    [When Drug Research is Personal: A Lifetime Journey to Discover, Create and Manufacture Medicines for Rare Diseases]
    Speaker: John Crowley
    || [How to Achieve Industrialization and Bring Curative Therapies to Masses]
    Speaker: Alberto Santagostino
    - The cell and gene therapies are at an inflection point, reaching commercialization
    - The complexities around manufacturing of cell and gene therapies at a large scale
    - Is the industry ready for it?

  • 1000 - 1100
    Free Headshots
  • 1000 - 1100
    Networking Break in Expo Hall - Professional & Student Poster Presentations in Milano Foyer
    Speakers
    Business Development Manager
    Bosch Packaging Technology
    Placeholder Person Graphic
    Senior Process Engineer
    PM Group
    Technical Services Manager
    STERIS Corporation | Life Sciences
    Senior Process Design Engineer
    IPS
    Technical Executive
    Exyte USA
    Presentation Information
    [A Pragmatic Approach to Transitioning to Continuous Oral Solid Dose Production Using Xelum]
    Presenter: Simon Cashmore
    The movement towards continuous manufacturing is slowly gathering pace. Bosch has taken this challenge and created a concept that allows for a more practical implementation making it more feasible for more of the industry. This will help an increasing number companies to develop products while generating a higher level of process and product understanding driving and greater degree of product quality and robustness.
    || [Recycling Technology for Reuse of Solvent Back into Production ]
    Presenter: Jahnavi Kv
    Case Study: Separation of 2-Butanol from 2-Butanol+water azeotrope, with boiling point of 98 degree C & water-100 degree C, was very difficult & Solvent was sent to Effluent Treatment Plant (ETP), creating huge load on ETP plant and also causing environmental damage & Air Pollution.

    We developed a process and installed Rectification Column in which Solvent – Azeotrope, 2- Butanol + Water is recovered by using the FCE (Forced circulation evaporator-single effect) followed by two distillation Columns, which can treat 3kl/hr of solvent reducing the load on ETP plant.
    || [How a Contamination Control Program Impacts Product Sterility]
    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 the final product. However, in order to maximize efficiencies in production, organizations must streamline pre and post sterilization cycle productivity while minimizing risk to the finished product.

    Selecting the most effective decontamination products against environmental isolates, rotating these products, and maintaining surfaces free from residue build-up are essential pieces of a contamination control program. Case study examples demonstrate how adding protection over critical surfaces greatly improves product sterility assurance.
    || [Ergonomics of Continuous OSD Manufacturing Systems]
    Presenter: Lonna Gordon
    Continuous OSD brings a new paradigm to oral solid dosage manufacturing. The systems tend to be vertically integrated, complex, and require frequent disassembly. This brings new challenges to the health and safety of the working environment. This poster will address some of the new ergonomic challenges posed by CM systems, and provide illustrations for how good facility design and equipment layout can address them. Examples will be based on existing continuous systems.
    || [Project Success Horizon]
    Presenter: Christine Farner
    Capital Project Success is something that each Pharmaceutical company works for and expects to achieve, every time. There is great anticipation at the beginning that the team is prepared, skilled and will do a great job. We have selected wonderfully skilled EPC(CQV) partner(s) and begin with all things on track for a perfect outcome. Then why are so many projects completed less than successfully? Look at this poster and see the elements of success defined, they are not difficult, only infrequently implemented.
  • 1000 - 1600
    Exhibit Hall/Discovery Stage/ISPE Booth Open
  • 1000 - 1600
    Career Fair
  • 1000 - 1800
    Professional and Student Poster Displays
  • 1100 - 1230
    Working Smart for Critical Container Closure System Performance Through Supply Chain
    There have been many technical challenges throughout the supply chain of vial container closure system (CCS). The vial CCS is the most popular packaging format widely used globally in pharmaceutical industry. The supply chain includes CCS components, pharmaceutical processing, and storage/transport. The compatibility of these CCS components together with proper pharmaceutical process setup is crucial to safeguarding reliable drug efficacy and patient safety in full compliance with regulations. This session is designed to focus on following key scopes with the latest resultant development progress and scientific insights:

    1) Some holistic considerations are given to critical aspects through the CCS supply chain, especially such as mandatory container closure integrity (CCI) requirement to be rigorously ensured together with minimizing visual defect through pharmaceutical manufacturing process.

    2) There is an extensive amount of QC/QA data existing for CCS components and pharmaceutical processing collected, accumulated, and updated in real time through the supply chain - a source of big data. This huge data set is an invaluable asset to be readily capitalized for CCS performance optimization with direct and positive impact on end CCS applications. This big data approach is a combination of computer simulation, advanced data processing, information technology, and database management for critical data-driven risk management through CCS supply chain.

    3) Frozen or cryogenic state operation becomes an essential part of cold-chain management for processing, storage, and transport, especially in the space of biopharmaceuticals as well as gene & cell therapy applications. There are some technical challenges for maintaining robust CCI performance during cold-chain operation. All these critical challenges need to be properly evaluated and addressed through the cold-chain operation.
    Session Leaders
    Fellow, & Technical Director
    West Pharmaceutical Services
    Speakers
    Fellow, & Technical Director
    West Pharmaceutical Services
    Associate Director & Head, Parenteral Packaging Within Parenteral Science & Te
    Bristol Myers Squibb
    Principal Engineer
    Johnson & Johnson
    Presentation Information
    [Data-Driven Optimization for Container Closure System Performance in the Digital Age]
    Speaker: Qingyu Zeng
    A compatible combination of container closure system (CCS) together with proper pharma process setup will be crucial to ensure its optimal CCS performance, and the CCS optimization can be executed through big data approach to its full extent.
    || [Balancing CCI and Aesthetics for Robust Sterile Packaging]
    Speaker: Ankur Kulshrestha
    One common container closure system for parenteral drug products includes a glass vial, rubber stopper and an aluminum crimp seal. The capping process is key to ensuring an optimal seal, from both an aesthetic and CCI perspective. A useful methodology of selecting appropriate components and capping process parameters using a scaled-down approach to achieve both the elegant seal quality and CCI simultaneously will be presented.
    || [The Packaging Challenge in Cold Chain Risk Management]
    Speaker: Chris Folta
    Rapid growth in primary cell, stem cell, and immunotherapy in the last ten years and the need to package these biologic products at very low (cryogenic) temperatures has lead to significant research and development both in existing parenteral package and new package designs. Common components which perform well at ambient cease to when exposed to low temperatures. Progress has been made over the last several years in developing cryo test methods, understanding how these packages work and fail, and determining what factors are critical for developing a package to work under these conditions. This paper summarizes the state of packaging and testing technology, provides a detailed explanation of the cryo failure mode, and gives in-depth recommendations for developing working parenteral cryo solutions.
  • 1100 - 1230
    Classified Areas Best Practices in Design and Operation
    This session will provide information on the following:

    -The latest section of ISO 14644 - part 16 energy efficiency with a lighthearted presentation
    -On the best practices for HEPA filter testing - is particle counting the answer to an engineer’s prayers?
    -Best practices in the design for a cell or a gene therapy facility
    -Best practices in the design of a change area - a common source of environmental monitoring excursions and regulatory observations - What does Annex 1 really want? What are the current best practices?
    Session Leaders
    Placeholder Person Graphic
    Senior Specialist QA
    Amgen Inc.
    Speakers
    Senior Manager-Corporate Facilities & Engineering
    Amgen
    SME HVAC
    Novo Nordisk A/S
    Life Science Lead
    Energy Efficiency Consultancy Ltd.
    President
    Genesis Engineers Inc
    Presentation Information
    [Best Practices in HEPA Filter Testing ]
    Speaker: Ulla Thomsen

    •EN1822 vs ISO29463
    • The battle between leak testing with photometers and particle counters
    • Life expectancy for HEPA filters and how to reduce the number of leaks
    • Does the 0,01% leak criteria (always) make sense
    || [Best Practices in Cell and Gene Therapy Facility and HVAC System Design]
    Speaker: Norman Goldschmidt
    Looking at an optimized area layout and the design of the supporting HVAC system – showing best practices in energy conservation.

    Is your Change Room a Problem or a Solution to Environmental Monitoring Excursions
    Speaker: Norman Goldschmidt
    Do you understand the EU regulatory guidance? – what are current best practices in change room design and the associated HVAC given the pressure to minimize the room size, but still obtain satisfactory Environmental Monitoring (EM) results – Change areas are often the culprit for EM excursions, and regulatory observations.
    •Change rooms v airlocks – difference
    •Physical barrier v dual grade – step over bench – issues and solutions
    •Optimizing the layout to suit available space
  • 1100 - 1230
    Pharma 4.0
    Pharma 4.0 is based on a well-oriented business strategy, a quality risk management process running over the whole product lifecycle and of course on a set of innovative concepts that turn data into knowledge. This session will address some of the most discussed questions facing our industry and Pharma 4.0 today:
    œ How does the current global emphasis on data integrity impact Pharma 4.0 and what do we need to be ready for Pharma 4.0?
    œ How is the use of novel technologies preparing industry for Pharma 4.0?
    œ How can artificial intelligence help to realize the pharma factories of the future and what use cases can be applied ensuring a quick win?
    œ How can we implement a software supported risk management process supporting Pharma 4.0 over the entire product life cycle
    œ What are the key benefits of using a software-supported risk management process?
    œ How will Pharma 4.0 impact future US FDA regulatory inspections?

    The topics are examined from the broad experience of the speakers and numerous examples and solutions for the implementation of these relevant topics of Pharma 4.0 are presented.
    Session Leaders
    Qualification Expert
    VTU Engineering GmbH
    Speakers
    Qualification Expert
    VTU Engineering GmbH
    CSO & Co-Founder
    Bigfinite Inc, Headquarters
    President and CSO
    Pharmatech Associates
    Presentation Information
    [Quality Risk Management 4.0 – Benefits of a Software-Supported Risk Management Process ]
    Speaker: Brigitte Gubitz
    || [Driving Step Changes in Manufacturing Operations with Predictive Insights – Practical Application of Pharma 4.0]
    Speaker: Toni Manzano
    The presentation will share experiences from real life Pharma 4.0 initiatives and highlight the very significant possibilities they bring. The session will include the presenter’s personal view and direct experiences from several client projects where AI/ML techniques have been deployed to create compelling new insights and attractive results. Based on experiences in Pharma 4.0 journey taken by a number of global leaders and early adopter companies, this presentation will also offer a perspective on digital maturity and how to prepare the organizations to be ready to accept changes related to the adoption of new technology.
    || [How Are Regulatory Bodies Getting Ready for Pharma 4.0 Considering Data Integrity]
    Speaker: Bikash Chatterjee
    This presentation will address three big questions facing our industry and Pharma 4.0 today: How does the current global emphasis on data integrity impact Pharma 4.0 and what do we need to be ready? How is the use of novel technologies preparing industry for Pharma 4.0? How will Pharma 4.0 impact future US FDA regulatory inspections? Today's pharma landscape is rapidly changing with the integration of digital health and software elements across the drug development lifecycle. This presentation will explore the architectures and technologies being adopted to address data management and security elements to be able to demonstrate compliance to the FDA's predicate rules which are the baseline for all data management considerations today.
  • 1100 - 1230
    Particle Engineering at the Drug Substance/Drug Product Interface
    The interface of drug substance and drug product processing holds untapped opportunity to deliver engineered particles with transformative potential. This session seeks to provide an overview of proof of concept studies evaluating introduction of excipients during drug substance processing to addresses otherwise challenging API properties (such as flow, compactability, and redispersibility) for materials including high aspect ratio crystalline material, nano crystalline material and amorphous solid dispersions. Ideally, the ability to deploy particle engineering routes at the DS/DP interface enables the capacity to deliver composite particles amenable to downstream continuous direct compression for any API.
    Session Leaders
    Principal Scientist, Particle Engineering Labs
    Merck & Co., Inc.
    Speakers
    Director of Graduate Studies & Professor
    Department of Pharmaceutics, University of Minnesota
    Principal Scientist, Particle Engineering Labs
    Merck & Co., Inc.
    Placeholder Person Graphic
    Director, Division of Process Assessment I
    FDA/CDER/OPQ
    Presentation Information
    [Enabling Direct Compression of Low Dose Drugs Using Mesoporous Carrier - Drug Composites]
    Speaker: Calvin Sun
    Achieving a good content uniformity is a key challenge when making tablets containing a low dose of a drug. Conventional approaches to address this challenge are either ineffective or costly to implement. An efficient and robust approach to address this challenge is to form a drug-carrier composite using a porous carrier, which can be used to make tablets with excellent content uniformity and manufacturability. This enables the development of a formulation platform for manufacturing low dose tablets. Details of such an approach will be discussed in this talk.
    || [Emulsion-based Crystallization Processes for Novel API-Excipient Microparticle Formulations ]
    Presented on behalf of Saif A. Khan
    || [Case Studies – Opportunities for Transformative Properties]
    Speaker: Luke Schenck
    || [An FDA Perspective on Expanding Continuous Manufacturing to the Drug Substance - Drug Product Interface]
    Speaker: Rapti Madurawe
  • 1100 - 1230
    Innovation in Drug Delivery • The Drivers and Challenges Through Real Case Studies
    The way of administration of not-novel drugs is probably the only innovation path with highest value for the industry and the patients. The need for more reliable techniques is driving the industry to come up with solutions that may involve completely new drug-device products or to re-think traditional packaging. Behind this well-defined new trend there is also the need to reduce the contamination risks at the point of administration (main cause of death). While the device technology is allowing new formulations that before were not even imagined combining IoT technology as well as enhanced handy available sensoring, this journey is also revolutionizing the options for administration place (at hospital/at home). The idea therefore is to analyze two case studies (one coming from a large pharma company, the other from a small CMO) and a consulting firm working in the design of these new devices to give an overlook of the different challenges and of the regulatory perspective.
    Participants of this session will be able to get an insight about the milestones and the way of working to bring such new devices into the market, see the different approach and ultimately understand where the industry is moving into this field.
    Session Leaders
    Global Sales Manager- Pharma & ATMP Division
    Comecer Group
    Speakers
    Director, Program Management
    Pfizer Inc.
    Sr. Director, Global Value Chain Quality Design, Johnson & Johnson
    Johnson & Johnson
    Vice President/Bereichsleiter
    Vetter Pharma-Fertigung GmbH & Co.
    Presentation Information
    [Ready-To-Mix: New Perspectives and Possibilities to Administer Large Volume Parenteral ]
    Speaker: Wahid Khan
    || [Combination Products Risk Management ]
    Speaker: Susan Neadle
    || [Manufacturing Solutions for Drug/Device Combination Products ]
    Speaker: Jörg Zimmermann
  • 1100 - 1230
    Manufacturing Implications of Accelerated Development of Advanced Therapies
    Case studies demonstrate that CMC/Quality-related issues are rate limiting for all modalities developed using an accelerated development program designed to address unmet clinical need. This is especially the case for cell and gene therapies as examples of advanced therapies. Aside from safety-related issues that occur in the clinic, the greatest hurdle to approval for cell-based therapies is often not clinical efficacy but CMC and manufacturing, due to the nature of many of these therapies, their inherent high biological variability and the speed of the development program. It appears that risk-based solutions for CMC issues for all modalities such as identity, potency, specification testing, stability, and comparability are being worked out on a case-by-case basis.

    Two experienced industry presenters will be asked to highlight in case studies how manufacturing and quality issues have been addressed for advanced therapies developed using an accelerated program. FDA will also be invited to present on the regulatory considerations and approaches for advanced therapies.

    In addition to a Q&A and Panel Discussion, audience interaction will be facilitated with opportunities for the audience to be engaged.
    Session Leaders
    Regulatory Affairs - CMC
    Amgen Inc.
    Speakers
    Sr. Director Regulatory CMC
    Bluebirdbio
    Gene Therapy Product Reviewer
    FDA
    Senior Director, Global Regulatory Affairs
    AstraZeneca
    Presentation Information
    [Validation and Pre-Commercialization Challenges for Gene Therapy Products]
    Speaker: Michael Havert
    || [FDA Perspective: Accelerated Development of Advanced Therapies ]
    Speaker: Anurag Sharma
    || [Industry Perspective on CMC Challenges for Accelerated Products ]
    Speaker: Sarah Pope Miksinski
  • 1230 - 1345
    Lunch in Expo Hall
    Lunch in Expo Hall
  • 1345 - 1515
    Digitizing Pharma Manufacturing From End To End
    The current good manufacturing practices (CGMP) initiative encourages pharmaceutical manufacturers to leverage advanced technologies and pursue continuous improvement in order to consistently produce high-quality products. Aside from aligning with CGMPs, advanced technologies and digital transformation also enable companies to tap into the powerful data-driven intelligence central to Industry 4.0 and smart manufacturing.

    This presentation examines how today's manufacturing technology equips companies with the data and efficiency to accelerate their development life cycle for next-generation pharmaceutical products, as well as to effectively address the challenges and opportunities of global regulatory harmonization.

    Key takeaways: The competitive advantages of seamlessly integrating line operations, enterprise systems, quality, and regulatory compliance. Trends in breakthrough technologies, including cloud, automation, big data, machine learning (ML), the Industrial Internet of Things (IIoT), and predictive analytics.
    Session Leaders
    Operations Director
    Exemplar Compliance, LLC.
    Speakers
    Operations Director
    Exemplar Compliance, LLC.
    Director of Product
    MasterControl Inc.
    Presentation Information
    [Digitally Connecting Manufacturing with the Supply Chain]
    Speaker: Joy Langley
    A discussion of specific trends, technologies and best practices manufacturers should adopt to remain relevant and competitive in the future with a focus on digital solutions.
    || [Digitizing Pharma Manufacturing from End to End]
    Speaker: Terrance Holbrook
    A case study of real changes and competitive advantages in manufacturing and the supply chain after digital transformation. Learn about the advantages and statistics to track, how the problem was identified, and what was done.
  • 1345 - 1515
    Electronic Validation in Large Scale Pharmaceutical Construction Project
    Moving away from old school paper-based validation to a modern day electronic solution has the potential to yield big benefits for the initial validation process and the subsequent maintenance of the validated state. However, the barrier for implementing new systems and processes is either holding back organization or making them fail in the attempt.

    For many organizations the validation process is still paper based. Specification, protocols and report are produced using modern day information technology, but the underlying work process is still manual and closely linked to work processes of yesteryear. Electronic validation has the potential of transforming the entire validation work process and value chain. Everything from the requirement process over generation of protocols and test plans to reporting is based on database technology. This modernizes not only the initial validation process but also the subsequent life cycle management and maintenance of the validated state.

    The session will focus on the project specific solution, its implementation and benefits. It will describe the interface with and benefits on a corporate level and give an overview of the regulatory approach, challenges and feedback from regulatory authorities towards previous project. The session will give the participant an overview of challenges and benefits related to the project specific implementation, how the project has spearheaded maturing the systems and its implication on a corporate level and speak to regulatory implication and feedback.
    Session Leaders
    Project Director
    Novo Nordisk
    Speakers
    Novo Nordisk
    Sr. Manager, Project Quality
    Novo Nordisk
    Project Director
    Novo Nordisk
    Presentation Information
    [Electronic Validation in Large-Scale Pharmaceutical Construction Project ]
    Speaker: Kamilla Munk Petersen
    || [Electronic validation in large scale Pharmaceutical Construction Project]
    Speaker: Lisbeth Rosendal Mortensen
  • 1345 - 1515
    Data Integrity: Identifying and Implementing Strategic Controls
    Data Integrity continues to be a major focus for regulatory agencies and regulated companies. This series will focus on identifying and implementing strategic controls for maintaining the integrity of the data.

    The topics in this series include: Data Integrity fundamentals and how they impact the Pharma industry; How to maintain your data integrity program as current through annual review; The most efficient and effective DI approaches to use as part of your DI implementation strategy; and, The impact to the integrity of the data with increases in volume, sources, and complexity.
    Session Leaders
    Informatics Specialist
    Eli Lilly & Co
    Speakers
    Global Industry Principal
    OSIsoft, LLC Headquarters
    Informatics Specialist
    Eli Lilly & Co
    Serialization Subject Matter Expert
    Sequence Inc
    Manager QA Validation
    BlueBird Bio
    Presentation Information
    [A Data-Centric Organization is a Foundation for the Pharmaceutical Industry: What are the gains?]
    Speaker: Petter Moree
    || [Annual Review of Data Integrity – Strategies and Best Practices]
    Speaker: Robert Dillman
    There have been significant recent developments in regulatory expectations for better management of data integrity across the global pharmaceutical industry and are now starting to indicate the need for annual reviews to assure that integrity is maintained. This presentation will provide information into practical approaches and strategies for conducting an annual data integrity review. Various case studies will be presented to illustrate data integrity annual review strategies, best practices, and pitfalls. As a result of this session/presentation participants will learn techniques for streamlining the review, integrating with other processes, management involvement, and approaches for use in different business areas to enable participants to implement that knowledge in their own global organizations.
    || [The Agile Approach to Implementing a Data Integrity Program]
    Speaker: Matt Brawner
    “I know what Data Integrity is, but how do I assure it?”.

    This is an all too familiar question from those charged with transforming their organization to assure Data Integrity. This presentation moves past describing what Data Integrity is, and focuses on the most efficient ways Data Integrity can be achieved.

    In this session we will combine our knowledge of Data Integrity with Operational Excellence principles (Lean, Agile) to reveal the most efficient and effective DI approaches to use as part of your DI implementation strategy. . Each of these approaches have been proven in practice, and will be provided with a supporting rationale to help attendees understand and realize benefits within their organization.
    || [GMP & Data Integrity Basics – Foundational Pharma 101 ]
    Speaker: Leanna Marcum
  • 1345 - 1515
    Cell and Gene Therapy: A CMC and Biologics Perspective
    ATMP's (Advanced Therapeutic Medicinal Products) are fulfilling their promise of bringing a one-time potentially curative treatment to patients. However, these therapies don't quite fit the mold that has been established by industry for biologics manufacturing. In this session industry experts will share their unique experiences in the commercialization of novel ATMP's. The unique challenges and learnings will be shared regarding the commercialization of ATMP's from a CMC perspective. The speakers will review CMC strategies employed for licensing using accelerated regulatory pathways, post launch considerations, and facility design for autologous therapies, where one lot is manufactured for one patient.
    Session Leaders
    Senior Manager, MSAT
    BlueBird Bio
    Speakers
    Director Quality Engineering (QE)
    Kite, a Gilead Company
    Senior Manager, MSAT
    BlueBird Bio
    Sr. Director Quality Engineering
    Kite Pharma, Inc.
    Presentation Information
    [Commissioning, Qualification and Validation of New Cell & Gene Therapy Facilities]
    Speaker: Wilbur Williams
    In this session I will talk about the workflow of CQV for new CGT facilities and highlight some of the key differences between a typical Bio/Pharma facility and a CGT R&D and/or commercial facility.
    || [Path to Commercialization for Zynteglo: The First Gene Therapy for Beta Thalassemia]
    Speaker: Michael Burns
    Zynteglo is the first gene therapy on-track to be approved for the treatment of beta thalassemia in the EU. This presentation is a case study on the challenges that clinically accelerated (PRIME and Breakthrough) ATMP products present to CMC and what strategies were employed to ensure a robust CMC application and speed to market. The risk based approach to process characterization, process control strategy and validation will be discussed – highlighting success factors and lessons learned.
    || [Life after Launch in CAR-T]
    Speaker: Will Junker
    The presentation will point out some of the major lessons learned from a Quality perspective during the biopharmaceutical commercialization of a new advanced cell therapy receiving breakthrough designation for an unmet medical need.
  • 1345 - 1515
    Tech Transfer for Pharmaceutical Production Processes: Theory and Case Studies in Sterile Dosage Forms
    Tech transfers are happening every day, yet we run into the same obstacles over and over again. There is however help available in the form of the ISPE good practice guide. This session will lay out the basics and principles of tech transfers from the guide, followed by case studies from recent tech transfers. Attendees will take away valuable learnings on tech transfers and hear from people who have lived through them, specifically in the field of aseptic processing.
    Session Leaders
    Vice President/Bereichsleiter
    Vetter Pharma-Fertigung GmbH & Co.
    Speakers
    Placeholder Person Graphic
    Takeda Pharmaceuticals Inc.
    Principal Engineer, Parenteral Drug Products
    Biogen, Inc.
    Principal
    BD Global Consulting
    Presentation Information
    [Case Study: Tech Transfer of a Commercial Biologic ]
    Speaker: Amy Miller
    Tech Transfer Basics - This would be a basic session going over Tech Transfer and when and why it is applied with real world examples Introduction to Process Engineering – Process Engineering is a vital part of any new or existing process, this will cover the basics of what Process Engineering is, application and real world examples.
    || [Rapid Parenteral Tech Transfer: Use Of Disposable Platforms For Orphan Drug Products]
    Speaker: Brian Thome
    The nature of orphan drug manufacturing requires a nimble approach to process design and technology transfer due to the low manufacturing volumes and paramout importance of ensuring continuous drug supply. Using a platform approach that includes disposable mixing and filtration systems characterized up front can be used to ensure that process parameters and facility fit requirements are reduced to a minimum when transferring the process from one facility to another. This platform approach allows site to site technology transfer times to be greatly reduced. Case studies will be presented from several drug products, outlining things that went smoothly and lessons learned with the hope of preventing common mistakes from affecting future transfers.
    || [Introduction to Technology Transfers, Basics and Principles]
    Speaker: Bruce Davis
  • 1345 - 1515
    Drug-Device Combination Products requirements continue to evolve globally. Accompanying the evolving regulatory landscape are ongoing regulatory, development, and lifecycle challenges. As a result of this session, participants will have an increased awareness of the dynamic global regulatory environment and key challenges industry faces; they will benefit from the sharing of best-practices and lessons learned and will be able to distinguish between Drug Device Combination Products and Combination Therapies.

    Panel Discussion


    Delma Broussard, PhD, Director, Clinical Safety Risk Management, Biologics and Medical Devices, CSL Behring,
    Kesley Gallagher, Director of Engineering, Amgen
    Lynn Hansen, Vice President of Regulatory Affairs, Pharmatech Associates
    Steven Hertz, PE, Consumer Safety Officer, FDA/CDER/OPQ
    Session Leaders
    Sr. Director, Global Value Chain Quality Design, Johnson & Johnson
    Johnson & Johnson
    Speakers
    Director, Regulatory Affairs
    Pharmatech Associates, Inc.
    Director, Clinical Safety Risk Management, Biologics & Medical Devices
    CSL Behring
    Director of External Engagement, Combination Products
    Amgen
    Sr. Director, Global Value Chain Quality Design, Johnson & Johnson
    Johnson & Johnson
    Consumer Safety Officer
    FDA/CDER/OPQ
    Presentation Information
    [Combination Products vs. Combination Therapies: What is the Difference?]
    Speaker: Lynn Hansen
    While the designation for what constitutes a Combination Product is clearly defined by the FDA, industry continues to push the boundaries for disease treatment with new and innovative breakthrough drug therapies. As regulators, the challenge we face is to align these new therapies with application-filing strategies including Investigational New Drug (IND), New Drug Applications (NDA), Biologics License Applications (BLA), or Medical Devices.

    As technology advances and experimentation with existing approved entities broadens, the possibility of providing safe and longer lasting options for patients will become a primary goal for all future product development. The use of “combination” will continue, and the proper use of it will be up to the regulatory professional to remind development teams of the differences as data becomes available. Strategic planning begins when management positions a concept, and the pathways that the resulting search may take will depend on your regulatory questioning and innovative directions.
    || [Combination Products Evolving Trends]
    Speaker: Susan Neadle
    Drug-Device Combination Products requirements continue to evolve globally. Accompanying the evolving regulatory landscape are ongoing regulatory, development, and lifecycle challenges. As a result of this session, participants will have an increased awareness of the dynamic global regulatory environment and key challenges industry faces; they will benefit from the sharing of best-practices and lessons learned.
    || [Regulatory Update on Combination Products]
    Speaker: Steven Hertz
    CDER-led and CDRH-led combination product submissions to the Agency continue to increase, which means increased volume of pre-submission meetings, intercenter consults, inspections, and post-market activities. Learn how the Agency is managing this workload, and of recent legislative and regulatory updates on combination products.
  • 1515 - 1600
    Networking Break in Expo Hall
    Networking Break in Expo Hall
  • 1600 - 1730
    CAR-T Projects: Planning, Execution & Challenges
    CAR-T is a growing technology that represents the next wave in targeted therapies for cancer and other diseases. CAR-T manufacturing comes with some interesting challenges that carry over into the planning and execution of the Commissioning, Qualification and Validation of the facility, equipment and process. The presentations will focus on the initial planning and then execution of the commissioning, qualification and validation activities. The focus will be on the interesting challenges presented by the CAR-T manufacturing process and how those are addressed during tech transfer, the C&Q phase, the Aseptic Process Simulation, methods validation, process validation and ongoing qualification. The presentations will have sections related to automation and implementing computerized systems. The presentations will use real examples from recent projects and will include lessons learned so that attendees can walk out of the session with a better understanding of the challenges and how to tackle them. As a result of this session, participants will have a better understanding of the CQV challenges particular to CAR-T, understand what needs to be considered at the beginning of the project in order to improve the chances of meeting project requirements and how to avoid some pitfalls that can impede completion of CQV activities.
    Session Leaders
    Senior Director, Validation Services
    IPS-Integrated Project Services, LLC
    Speakers
    Senior Director, Validation Services
    IPS-Integrated Project Services, LLC
    Presentation Information
    [Commissioning, Qualification, and Validation of CAR-T Projects]
    Speaker: Aaron Weinstein
  • 1600 - 1730
    Innovations in Aseptic Processing
    Over the last decades the pharmaceutical industry has changed from big blockbusters to more specialized medicines. This change leads to smaller batches and a need for more flexible production and thereby to the development of new and innovative technologies in the industry.
    More and more suppliers are developing flexible equipment for pilot scale, development and small-scale production. In this session some of these innovative technologies will be shown with presentations on modular smart robotic filling lines and a brand-new attempt to create an innovative continuous sterile liquid filling process from compounding to finish product. As a result of these presentations the audience will experience:
    - real case stories told by the end-user
    - a new modular robotic filling concept
    - an innovative approach to compounding and filling.
    Session Leaders
    Managing Consultant , Compliance Consulting
    NNE
    Speakers
    Director, Innovation Centre
    Ferring Pharmaceuticals AS
    Director, Aseptic Processing
    Johnson & Johnson
    Project Manager
    Ferring International Center SA
    Presentation Information
    [Aseptic Smart – The Way of Future Pharmaceutical Manufacturing ]
    Speaker: Dieter Bachmann
    || [An Innovative Continuous Sterile Liquid Fill & Finish Process ]
    Speakers: Samd Guizani & Robert Rönnback
    Pharmaceutical sterile liquid formulations are in most cases produced using batch processes. Batch production is characterized by long manufacturing lead-time, high product costs and often end product testing/release. This work presents an alternative and innovative way of producing such formulations. It is based on a continuous dissolution of API in solvent, followed by continuous filtering and filling. Such approach has numerous advantages over the traditional batch manufacturing:
  • 1600 - 1730
    Secure Digital Pharma 4.0
    With the rise of Pharma 4.0, IoT, and other tech advancements, the physical and digital worlds are blurring. At the same time, cyber threats are evolving. Pharmaceutical organizations must understand potential security risks to manufacturing operations, as well as the best response when faced with malicious activity. Moreover, organizations must consider how to optimize the outcomes of cybersecurity project investments.

    The session will share one manufacturer's journey, present a quantifiable approach to cybersecurity, and showcase an interactive simulation highlighting the complexity of cybersecurity in Pharma 4.0.
    Session Leaders
    Cybersecurity Manager
    Boston Consulting Group Platinion
    Speakers
    Cybersecurity Manager
    Boston Consulting Group Platinion
    Managing Director & Head of Cybersecurity Practice
    BCG Platinion NAMR
    VP Global Information Security
    Pfizer
    Director, Global Automation
    Pfizer
    Presentation Information
    [Systematic ROI for Cybersecurity in Pharma Manufacturing]
    Speakers: Sophie Ding, Brian Cincera & Michael Coden
    || [Interactive Simulation – Can You Select the Project Portfolio that Maximizes Cybersecurity ROI?]
    Speakers: Michael Coden, Brian Cincera & Sophie Ding
    || [Pfizer’s Industrial Cyber Security Journey]
    Speaker: James Labonty
  • 1600 - 1730
    Patient Centric Drug Development Through 3D Printing/Additive Manufacturing
    As experts who know what it is like to live with their condition, patients are uniquely positioned to inform the understanding of the therapeutic context for drug development and evaluation. Incorporating the patient's experiences, perspectives, needs, and priorities into the drug development and evaluation process is often referred to as "Patient-Centric Drug Development". This can be achieved by facilitating the use of systematic approaches to collecting and utilizing robust and meaningful patient and caregiver input to more consistently inform drug development and regulatory decision-making.

    Various additive manufacturing technologies, such as 3D printing, may be used to accommodate the patient's inputs into the development and manufacture of a personalized medicine. 3D printing has so far played a minor role in health care, with sporadic highlights such as the first US Food and Drug Administration approval of a 3D-printed drug in August 2015 and ongoing research efforts in academia and the biopharma industry to produce personalized dosage forms with tailored characteristics for optimized safety and efficacy of medications. Other drivers for 3D printing of oral medicines include on-demand capability, ability to manufacture in decentralized locations, for example, in case of remote pandemic events, for military applications or preclinical drug supply with flexible doses within a translational pharmaceutics framework.

    As the application of 3D printing technologies in pharma manufacturing is still relatively new, there are still regulatory concerns and a lack of appropriate regulation. This session intends to highlight some of the applications and challenges of 3D printing technologies in Patient-Centric Drug Development.
    Session Leaders
    Senior Staff Fellow (Pharmacologist)
    Office of Pharmaceutical Quality
    CDER/FDA
    Speakers
    CSO, Post-Doctoral Fellow
    Universita Degli Studi Di Milano
    Associate Principal Scientist
    Merck
    Senior Staff Fellow (Pharmacologist)
    Office of Pharmaceutical Quality
    CDER/FDA
    Presentation Information
    [Multi-Compartment Capsular Devices for Personalized Oral Drug Delivery: 3D printing and Robotic Filling ]
    Speaker: Alice Melocchi
    || [3DP: A Powerful Tool to Investigate Complex Formulation Challenges]
    Speaker: Melanie Marota
    Pharmaceutical 3D printing (3DP) is an area of major growth with a rapid increase in publications, emerging patents, and clinical experience. It can potentially be used as a powerful tool to expand the understanding of oral small molecules in Phase I. Here we show how the fused deposition modelling technique can be employed to generate a simple 3DP dosage form consisting of water soluble and insoluble polymer components and a liquid fill containing active. Initial results are promising but scientific and operational challenges remain in order to achieve routine implementation of 3DP in the Phase I clinical setting.
    || [Challenges and Opportunities of 3D Printed Drug Products from the Regulator’s Prospective. ]
    Speaker: Ahmed Zidan
  • 1600 - 1730
    Rapid Laboratory Reconfiguration Enables Expedited Fume-Hood-to-Launch Time Frames
    Drug discoveries have historically taken up to 20 years to develop and launch, an unsustainable time frame in today’s pharmaceutical industry. Success in current markets requires nimble, reconfigurable, and fully integrated development labs to shorten fume-hood-to-launch time frames.

    Eli Lilly & Company’s adaptable development laboratory offers key facility innovations targeted directly at the demanding reconfiguration needs of the pharmaceutical industry:

    -Labs are designed as large open spaces with no physical separation between the different groups, fostering collaboration, breaking visual barriers, and encouraging the sharing of equipment and knowledge.
    -An open utility ceiling grid system offers flexibility to relocate utilities and devices to support rapid reconfiguration.
    -Pre-assembled modules offer flexibility to access utilities, minimizing the downtime, required resources, improving MEP systems and installation costs.
    -Collaboration spaces inside the lab enable the users to have real-time interaction.
    -Integration of a Radio Frequency Identification (RFID) system throughout the facility enables tracking of critical equipment, reducing downtime.

    As a result of participating in this session, attendees will gain a better understanding of how large, open labs foster collaboration and sharing of knowledge and resources; how the flexibility in the lab, design, and MEP systems supports smooth reconfiguration, enabling the constant change in lab space to accommodate the science; and how real-time collaboration inside the lab streamlines just-in-time feedback.
    Session Leaders
    Manager - SMDD
    Eli Lilly & Co
    Speakers
    Associate, Laboratory Operations
    Eli Lilly & Co
    AP - Principal
    Flad Architects
    Senior Mechanical Engineer
    BSA LifeStructures
    Presentation Information
    [Living In and Managing a Changeable Lab Environment]
    Speaker: Gregory Brown
    || [Vision]
    Speaker: Marc Walker
    || [Infrastructure of a Changeable Lab ]
    Speaker: Kevin Mcnutt
  • 1600 - 1730
    Patient Centricity Amidst Increasing Global Complexity: Quality Overall Summary
    As presented in the FDA's January 2018 White Paper, the Quality Overall Summary (QOS) represents multiple opportunities for enhancement of benefit risk context, increases in assessment efficiency, and linkages to future initiatives (ICH Q12). Industry collaborators have identified additional opportunities and challenges with QOS utilization, including formatting constraints and lack of global buy in on the QOS approach. This session is designed to focus on key messages from both regulators as well as industry thought leaders regarding the QOS, while bringing strategic and collaborative opportunities to the forefront of the discussion. As a result of this session, participants will have a broader understanding of the current QOS paradigm, the desired future state from various industry and regulatory stakeholders, and potential future related initiatives.
    Session Leaders
    Senior Director, Global Regulatory Affairs
    AstraZeneca
    Director (Acting), Office of New Drug Products
    CDER/FDA
    Speakers
    Director, CMC Dossier Development & Operations
    Johnson & Johnson
    Associate Director, CMC - Global Regulatory
    Pfizer Inc.
    Director (Acting), Office of New Drug Products
    CDER/FDA
    Presentation Information
    [A Journey Towards New Patient-Centric Globally Aligned QOS ]
    Speaker: Eli Zavialo
    As the new vision for QOS evolves with active participation from industry and regulators, there are many opportunities to harness it as an effective summary of integral quality information and improve the overall quality of a submission as well as the efficiency of regulatory review process. This presentation will provide a summary of Janssen’s experience piloting the QbR-formatted QOS in several recent NME marketing applications. An overview of future opportunities such as a more comprehensive and transparent framework for control strategy and quality risks presentation, inclusion of established conditions and reporting categories, as well as key requirements from other major markets will be provided. Taken together, these steps should enable the development of a next-generation global QOS.
    || [Patient Centric Quality Overall Summary: A Case Study]
    Speaker: Connie Langer
    The comprehensive Quality Overall Summary (cQOS) can be used to establish a clear narrative that connects product attributes with process parameters and material attributes to effectively convey the robustness of the control strategy in a regulatory application. This presentation will discuss Pfizer’s first experience with a cQOS that was intended to form a fundamental baseline to facilitate understanding of the product and review of the application by expediting orientation to the content of Module 3. Global implementation has the potential to aid industry in management of inconsistency in global regulatory assessments as well as the lack of integration between inspections and assessments.
    || [Quality Assessment Enhancements: Quality Overall Summary]
    Speaker: Ramesh Sood
  • 1800 - 2100
    Women in Pharma® Networking Dinners
    The Women in Pharma® Networking community is offering complimentary topic-focused dinners, providing priceless insights and connections on Monday evening. Each dinner will be hosted by a leading executive in the pharmaceutical industry, who will facilitate a discussion around the topic of How to Strengthen Relationships and Develop Your Career. A $20.00 donation to the ISPE Foundation to be used towards WIP initiatives is suggested. Please visit ISPE Foundation - WIP Donation to make your donation and register for the WIP Networking Dinners through online registration. Enjoy the ISPE WIP Networking Dinner!
  • 1900 - 2200
    YP Networking Event
    A highlight for Young Professionals! Network with your colleagues and peers. Share drinks, food, ideas, and conversation while playing games and enjoying seeing old friends and meeting new ones. You don't have to be a Young Professional or over 21 to attend! Includes: food, two drink vouchers, nonalcoholic beverages.
Day 2 - Day 3
28 October - 29 October 2019
Day 3
Tuesday, 29 October 2019
  • 0700 - 1730
    Registration Open
  • 0700 - 1730
    Speaker Ready Room
  • 0700 - 1730
    Press/Interview Room
  • 0700 - 1730
    Volunteer Room
  • 0800 - 1000
    Membership & Awards Breakfast
  • 0800 - 1800
    FOYA Displays
  • 1000 - 1100
    Free Headshots
  • 1000 - 1100
    Networking Break in Expo Hall - Professional Poster Presentations in Milano Foyer
    Speakers
    Founder and CEO
    LifeAire Systems, LLC
    Placeholder Person Graphic
    Principal Process Engineer
    Jacobs Eng'g Singapore Pte Ltd
    USA Industrial Segment Manager
    Aqseptence Group / Airvac Division
    Sr. Program Manager, Validation
    Pharmatech Associates, Inc.
    Placeholder Person Graphic
    Vice President
    Jacobs Engineering India Pvt Ltd
    Technical Services Manager
    STERIS Corp
    Associate Director of Technical and Scientific Services
    PharmEng Technology
    Presentation Information
    [A Paradigm Shift in Cell Culture–Defined Environmental Metrics Critical for Improved Cellular and Clinical Metrics]
    Presenter: Kathryn C. Worrilow
    Current GMP metrics do not address cytotoxic levels of volatile organic compounds (VOCs) and low-level viable particulates present in the processing space of living cell culture environments in life science manufacturing facilities. Information will be presented to define the cellular metrics necessary to support the living cell during pharmaceutical processing and offer a paradigm shift in the current GMP-driven environment. The elimination of 99.99% of all known cytotoxic and airborne contaminants that compromise the development of the living cell has demonstrated statistically significant improvements in cell viability, cell potential, and the delivery of a successful cellular product to the patient. Airborne concentrations of VOCs are correlated to concentrations in the cell culture media and within the cell. Mechanisms of VOC cytotoxicity and comprehensive remediation will be discussed. The attendee will experience a greater understanding of this new and transformative information and how to optimize critical cellular metrics in personalized medicine. Attendees will learn how definitive control of all sources of ambient air can optimize the future facilities using recent and well-defined environmental metrics for the living cell. A roadmap for addressing known or detected environmental issues interfering with the optimal healthcare and life science manufacturing facility will be defined.
    || [Build-In-Advance, Lease: Bring Drug Faster and Cheaper]
    Presenters: Savitha Kamath & Anil Renal
    “Build-In-Advance” concept has been developed to bring the Biopharmaceutical drug faster and cheaper to the market without locking CAPEX in facility cost.

    The significance of this generic shell design, is its capability to manufacture an extensive range of biological product and meet the target product demand to reduce the design and construction timelines. This results in accelerated time to market as prerequisites such as production facility GMP requirements, Site Master Planning, Permitting & Government Clearances and infrastructure development are completed well in advance. Production Equipment is installed in a clean environment eliminating overlap with wet works.
    || [Vacuum Wastewater Conveyance In Pharmaceutical Applications]
    Presenter: Philip Crincoli
    The Airvac system solves the problem of implementing a wastewater conveyance system under circumstances where a gravity system is either not practical or possible. The Airvac system allows the wastewater piping to be easily placed withing walls, ceilings and crawl spaces rather that having to dig through concrete slabs to hook up to the drainage system, saving both time and money.

    The system offers an alternative especially during a plant renovation involving older infrastructure because it saves time, project labor and faciity disruption. Our presentation will include how a negative pressure system works, its application, its components and numerous problem solving case studies As a result of this session, the participants will come away with an overall understanding of a vacuum wastewater conveyance system, when and where it can be installed and why it is a better choice under the correct circumstances. Negative Pressure wastewater conveyance systems have been around for over 100 years in Europe and since the early 1970s in the USA. Airvac has several systems operating since the 1970s and clients include Merck, Pfizer, Avaya, Lilly, Roche in the FDA regulated space.
    || [Commissioning Versus Qualification: An HVAC Case Study]
    Presenter: Michele Levenson
    With all the pressures to operate more effectively and rapidly, while still being nimble, this presentation will explore methods to Commissioning and Qualification which result in risk based testing to demonstrate compliance and adherence to system specifications.
    || [Bridging the Gap Between Rinse Water Analysis and Surface Cleanliness]
    Presenter: Elizabeth Rivera
    || [Changing role of toxicology within Cleaning Validation with Regards to Industry Trends and Regulatory Requirements ]
    Presenter: Wendy Haines
    Many pharmaceutical industry cleaning programs don’t meet current regulatory expectations, which has a global impact for products manufactured or marketed within Europe . Historically, Cleaning Validation residue limits had to be practical, achievable and verifiable according to US and European requirements. However, newer changes indicate that residue limits should be based on a toxicological evaluation due to a revised European requirement. This transformation potentially results in new acceptance criteria being generated and also complete re-validation of the cleaning program with an ultimate goal of patient safety. Whereas an older cleaning program that may have shared the same goal, likely had a different pathway, which may have included amongst others mass based or dosage -based carryover calculations. Modern cleaning programs primarily focus on patient safety. They must include health-based exposure limits that take into consideration the identification of hazards and the assessment of the dose-response relationships. This is done by utilizing a pathway that may include, but is not limited to, TTC (Threshold of Toxicological Concern) and/or carryover calculations which incorporate PDE (Permitted Daily Exposure) or ADE (Acceptable Daily Exposure).
  • 1000 - 1600
    Exhibit Hall/Discovery Stage/ISPE Booth Open
  • 1000 - 1600
    Career Fair
  • 1000 - 1800
    Professional Poster Displays
  • 1100 - 1200
    Embracing Change: Keys to Implementing a Continuous Manufacturing Strategy
    The needs of patients, along with the health industry landscape, are changing in ways that render old methods of manufacturing unsustainable moving forward. Continuous manufacturing offers a means to meet the changing supply chain requirements through batch size flexibility to meet changing market demand, smaller and more flexible manufacturing footprints, streamlined development through scaling out and higher assurance of quality through continuous process control and monitoring. This session will cover topics spanning formulation and process development to design of manufacturing campaigns to optimize supply chain needs. Additionally, approaches for continuous process verification and optimization will be discussed to demonstrate how higher assurance of quality can be built into the process. The session presenters are expecting an engaging session and for the audience to come away with some new ideas and tools to leverage continuous manufacturing platforms in their drug product development needs.
    Session Leaders
    Director, Advanced Manufacturing Technology
    Merck & Co Inc
    Speakers
    Manager, Drug Product Manufacturing
    Vertex Pharmaceuticals
    Pharm.D Specialist, Life Sciences Process Excellence World Class Center
    Altran
    Director, Advanced Manufacturing Technology
    Merck & Co Inc
    Presentation Information
    [Continued Process Verification in Continuous Manufacturing ]
    Speaker: Shruti Gour
    Continuous manufacturing generates a large amount of process and product attribute data due to routine utilization of in-line, on-line, and/or at-line measurements performed at high frequency making data review resource and time-intensive. This presents challenges in Continued Process Verification (CPV), an activity that enables detection of variation in the manufacturing process which may impact product quality and eventually use to initiate process improvements (e.g. refining the control strategy) and support post approval changes. A data historian, Pi, was introduced to record and manage process data by time which enabled process status visualization as well as data export options. Additionally, Seeq, a browser-based application that can connect to data historians with no manual transfers, was utilized to visualize continuous process data and perform statistical analysis. This approach enabled more efficient identification of data trends and understanding of process variability, which will allow us to implement necessary modifications to ensure process control during routine commercial manufacture. As a result of this session, participants will have an increased understanding of the unique challenges associated with data storage and trending of a CM process.
    || [Continuous Manufacturing: Think of Your Process by Design Thinking? ]
    Speaker: Olivier Michel
    Pharma industry faces today major challenges in the way it conducts innovation technology and designs its manufacturing processes and their controls. True continuous manufacturing is still limited in its use. While there are regulatory incentives for emerging technologies the ‘how to?’ might seem still bound to old technologies with a touch of 4.0 on it. Design Thinking may be an approach to think out of the box (or the reactor) and think twice of advanced bio-manufacturing technologies and continuous manufacturing.

    Continuous manufacturing has been on the industry engineers table for long but is still quite recent in its use in pharma. Products applications are scarce and limited mainly to oral solids to date. Technology platforms in bio-production evolve as a standardization tools to deliver quality biologics in more robust ways with improved cycle times, and tend to integrate elements of continuous manufacturing (using Process Analytical Technology and Advanced Process Controls).
    || [Flexible Batch Sizes in Continuous Manufacturing]
    Speaker: Justin Moser
    As the benefits of continuous manufacturing come into greater focus, operations at the extremes of the technology continue to be challenged. At MSD, this problem is especially relevant because the first drug product commercialized with the technology could utilize batch sizes between 10kg and 10,000kg, over time periods spanning from 1hr to 100+ hours. These extremes challenge operations and controls, as a uniform strategy is sought to cover any combination of production rates and times. In this work, we describe such strategies and the experiments designed to test them.

    Across all conditions, we have sought to unify our operational procedures and control strategies, such that they are as flexible as the batch sizes they help to produce. Indeed, in this work we have found that it is possible to achieve this through careful consideration of the dominant characteristics at the extremes of production.
  • 1100 - 1230
    Efficient Facility Design and Project Delivery - A Key Part of a Successful Supply Chain Strategy
    Efficient Facility Design is a key part of building a robust Supply Chain. It starts with capital planning based on capacity and forecasted demand to clearly define project scope and objectives. Efficiency must continue through project delivery to make sure the project is completed and the product is manufactured when needed. Applying lean techniques and tracking key metrics from project concept through implementation keeps the team focused on efficiency and can help reduce capital investments, project schedule, operational expense.

    This interactive panel discussion will focus on three distinct viewpoints: Owner leadership, Design engineering, and Business/ Operational excellence to talk successes and lessons learned on recent projects. In this presentation, we will cover:

    o Securing initial funding to develop a plan and analyze options
    o Analyzing manufacturing capacity and cost justification to understand project requirements and flexibility of changing forecast demands for a robust supply chain
    o Lean project delivery to control cost and schedule
    o Keys to successful Integrated teams and shared incentives
    o Involvement of Op Ex and Operations to incorporate efficiency.
    o Metrics used to track progress and help the team be proactive instead of reactive.
    o Operational testing to prove out project assumptions.
    Session Leaders
    Director of Process Engineering
    Precis Engineering Inc
    Speakers
    Director of Pharmaceutical Services
    Wuxi Advanced Therapies
    Director, Pharmaceutical Services
    Precis Engineering Inc
    Director of Process Engineering
    Precis Engineering Inc
    Presentation Information
    [Efficient Facility Design and Project Delivery - A Key Part of a Successful Supply Chain Strategy]
    Speaker: Kristina Pumphrey & Holly Brunbeck & Mark Belllino
  • 1100 - 1230
    A Practical Guide on Implementing Risk-Based Qualification
    The newly issued Baseline Guide 5 has been developed to assist teams in planning and executing C&Q activities based on understanding the manufacturing process & equipment, and on evaluating the risks both can introduce to product quality. This new guide aligns perfectly with the concepts of Quality Risk Management and provides a lean approach to C&Q while meeting regulatory expectations. This presentation will explain the value the new Baseline Guide 5 brings to the C&Q process through real case implementation outcome. The presenters will identify the implementation roadmap and will present a hypothetical - yet practical - high level example on the implementation of the new methodology.

    The objective is to help C&Q professionals understand the new approach through guidance on the implementation process, coupled with an example of a common manufacturing system. This will enable attendees to apply the guide to a common application and clarify any ambiguity, enabling them to immediately start implementing the new methodology.
    Session Leaders
    Placeholder Person Graphic
    Project Director - Engineering & Property Services
    Johnson & Johnson
    Speakers
    AD QA Validation
    Takeda
    Placeholder Person Graphic
    Project Director - Engineering & Property Services
    Johnson & Johnson
    Engineering Lead
    GlaxoSmithKline
    Presentation Information
    [Practical Guidance on Implementing Risk Based Qualification]
    Speaker: Paul Meehan
    || [Risk Based Qualification]
    Speaker: Hazem Eleskandarani
    || [Practical Guidance on Implementing Risk-Based Qualification]
    Speaker: Graham Cameron>br/>
  • 1100 - 1230
    Blockchain Use Cases Within Regulated GxP Processes
    Blockchain technology has gained a lot of interest within the industry and is looked at by some to be the silver bullet for solving some of Life Sciences most intractable problems. This session will explore actual/practical use cases of the technology within the industry and show a demonstration of a blockchain in use. We will examine some of the more ambitious use cases of blockchain and discuss the challenges that are currently being faced in realizing them which include privacy, scaling, and governance of open sourced protocols. As a result of this session participants will gain a better understanding of the current state of blockchain within Life Sciences and a deeper understanding of how the technology works.
    Session Leaders
    Principal, Advisory
    Ernst & Young LLP
    Speakers
    Principal, Advisory
    Ernst & Young LLP
    Placeholder Person Graphic
    Senior Consultant
    HGP Deutschland GmbH
    CEO
    Chronicled
    Placeholder Person Graphic
    Merck Animal Health
    Presentation Information
    [GxP Considerations for Relying on Blockchain Networks ]
    Speaker: Edgar Röder
    Blockchain promises seamless logistics and fighting counterfeit. But it's also a complex technology involving lots of mathematics in the form of cryptographic hash-functions, parallel, and distributed computing.

    - First, we examine building blocks and processes of the Blockchain architecture model.
    - Then we dive into the world of open source, where we trade "total control" versus "trust in a crowd of software geeks".
    - Finally, we learn, how to tame everything to get "confirmation by examination and provision of objective evidence that blockchain specifications conform to user needs and intended uses, and that the particular requirements implemented through blockchain can be consistently fulfilled".
    || [What We Have Learned Through MediLedger Over the Past 3 Years ]
    Speaker: Susanne Somerville
    The MediLedger Project started in 2017 bringing industry competitors and trading partners together to see how blockchain could transform the way supply chains in Life Sciences operates. Susanne will share learnings from along the way and describe the solutions that represent the beginning of the MediLedger Network, and the potential of where the technology can take us
    || [Tokenizing Assets on a Blockchain – Lessons Learned from a POC and Pilot]
    Speaker: Evan Tini
  • 1100 - 1230
    An Innovative Approach to Gene and Cell Therapy Facility Builds
    Discuss innovative approaches in gene and cell therapy facility builds. The panelists will cover:

    1) Understanding the site selection process including a “make vs. buy” business case analysis
    2) Utilizing modular and single use technologies, including emerging bioreactor technologies
    3) Setting up the build for success including creating proper project work streams
    4) Other considerations such as phased implementation, commissioning and qualification strategies, and change management

    The panelists will reference the gene and cell therapy builds at their respective companies and discuss the above as encountered at their respective sites/companies. Each panelist will give a 20-minute presentation and there will be a 30-minute panel discussion/Q&A session after the presentations conclude.
    Session Leaders
    Vice President
    Project Farma
    Speakers
    Vice President
    Project Farma
    Vice President of Pharmaceutical Engineering
    Sarepta Therapeutics
    Vice President of Manufacturing
    Kite Pharma, Inc.
    Senior Program Manager
    CSL Behring
    Presentation Information
    [An Innovative Approach to a Gene Therapy Facility Start Up]
    Speakers: Gregory Gara & Tony Khoury
    This session will cover: analysis of business cases - site selection processes and "make vs. buy", creating and maintaining work streams for project success, commissioning and qualification for emerging single-use technologies, remaining adaptable while maintaining flexible design and prioritizing operational readiness, and next steps: manufacturing expansion and growing pipelines.
    || [Driving Innovation For Autologous Cell Therapy Manufacturing]
    Speaker: Chris McDonald
    This session will cover: product overview and uniqueness of autologous cell therapy manufacturing, site selection process – how did we choose Urbana, MD, unique design solutions to improve schedule and reduce cost, automation technology driving a more robust and repeatable manufacturing process, innovative start-up strategies, and team and site culture development.
    || [Building a Gene/Cell Therapy Facility While Integrating It into a Larger Organization]
    Speaker: Brian Winstead
    This session will cover acquisition of start-up gene therapy company by CSL Behring, integration challenges of acquired company into existing network and infrastructure, build-out of a gene and cell therapy facility for clinical trials, and rapid expansion and on-boarding of team members to meet process demands.
  • 1100 - 1230
    Patient Centric Dissolution Specification for Extended-Release Solid Oral Products
    The development of patient centric or clinically relevant drug product dissolution specifications has been a much-debated topic over the past decade. In addition to presentations at national and international symposia as well as related publications, a recent FDA sponsored workshop provided substantial clarification with respect to general approaches to establish patient centric dissolution specifications for immediate release drug products. Like for IR products, connecting product quality to clinical performance through in vitro-in vivo relationships is a critical component for enhanced product understanding and to assure only product that is equivalent to consistently meets the safety and efficacy criteria established in pivotal clinical trials is released to patients. In this session, industry experts and FDA officer will be invited to present strategies towards establishing Patient Centric Dissolution Specification for Extended-Release Solid Oral Products. The development tools, modeling techniques, case studies and global regulatory challenges will be also discussed.
    Session Leaders
    Director, Regulatory Affairs CMC Biologics
    Merck & Co Inc
    Speakers
    Placeholder Person Graphic
    Research Fellow - Global Chemistry, Manufacturing, and Controls
    Pfizer Worldwide R&D
    Placeholder Person Graphic
    Director
    Merck & Co Inc
    Deputy Director, Office of Pharmaceutical Quality
    FDA/CDER/OPQ
    Presentation Information
    [Industry Case Studies in the Use of a Level A In-Vitro In-Vivo Correlation ]
    Speaker: Michael Cohen
    It can be argued that a Level A IVIVC sets the gold standard for patient-centric (i.e., clinically relevant) dissolution methodology, in that it establishes a direct bridge between the performance of the drug product and patient safety and efficacy. In addition, regulatory guidance for the development of an IVIVC and its application to setting meaningful specifications has been available for more than 20 years. Nevertheless, the number of IVIVCs remains relatively low. This presentation will cover case studies that delve into the challenges, both from a technical as well as a regulatory perspective, that continue to be present in the use of a level A IVIVC for setting specifications for two extended release oral products.
    || [Clinically Relevant Dissolution Specifications for Oral Dosage Forms- General Concepts and Applications ]
    Speaker: Andreas Abend
    In this presentation, a range of different approaches towards establishing clinically relevant dissolution specifications (CRDS) for IR and ER solid oral dosage forms will be presented. The presentation will highlight the benefits of establishing a link between in vivo PK and in vitro dissolution data from a pharmaceutical industry perspective. In addition, some of the current challenges with respect to global acceptance of CRDS will be discussed.
    || [Patient-Centric Dissolution Standards for Extended-Release Solid Oral Products: In Vitro and In Vivo Relationships]
    Speaker: Lawrence Yu
    The desired future state of in vitro dissolution testing for extended-release solid oral drug products is an in vitro dissolution test that provides predictive insight to in vivo performance. This ensures high quality drug products that maintain safety and efficacy throughout the product lifecycle. With an IVIVR, the impact of critical material attributes and critical process parameters on in vivo performance can be quantitatively assessed by in vitro dissolution. This provides scientific and risk-based knowledge to support patient-centric dissolution standards.
  • 1230 - 1345
    Free Headshots
  • 1230 - 1345
    Lunch in Expo Hall
  • 1230 - 1345
    GMP Basics for Young Professionals (Separate Registration Required. No Additional Fee)
    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.
    Session Leaders
    President & CEO
    Lachman Consultant Services, Inc
    Speakers
    Director, Science and Technology Practice
    Lachman Consultant Services
    VP, Biotechnology
    Lachman Consultant Services
    President & CEO
    Lachman Consultant Services, Inc
    Vice President, Chief of Staff
    Lachman Consultant Services
  • 1345 - 1515
    Global Regulatory Town Hall
    Session Leaders
    Senior Director, Global Regulatory Affairs
    AstraZeneca
    Vice President & Head of Global Chemistry, Manufacturing & Controls
    Pfizer Inc
    Executive Director and Team Leader, CMC Advisory Office
    Pfizer Inc
    Speakers
    Health Regulation and Surveillance Specialist
    Anvisa
    Regulatory Specialist
    Anvisa
    Team Leader, Drug Shortages Staff
    FDA
    Deputy Director, Office of Pharmaceutical Quality
    FDA/CDER/OPQ
    Executive Director and Team Leader, CMC Advisory Office
    Pfizer Inc
    Group Lead, Inspection Services, Prequalification Team
    World Health Organization
    Placeholder Person Graphic
    Director, Division of Process Assessment I
    FDA/CDER/OPQ
    Deputy Unit Manager, Inspectorate Strategy and Innovation (Expert GMP Inspector)
    MHRA
  • 1515 - 1600
    Networking Break in Expo Hall
  • 1600 - 1730
    Strategies for Container Closure Integrity: A Practical Look at Challenges Facing Pharmaceutical Packaging
    This session will offer practical insights and broad strategies from an expert panel to leverage container closure integrity into the global supply chain. Pharmaceutical manufacturers produce an array of product classes with different container integrity risk profiles.

    The panel will discuss best practices for CCI as they relate to FDA and EMA oversight. Regulatory interpretation of guidance documents and clarity into terminology will create an action plan for attendees to improve CCI strategy. Specific methods and alignment between the guidance offered in USP 1207 and EMA's Annex 1 will be reviewed to offer an improved global strategy for container integrity inspection.

    The session will draw on active experiences from regulatory activities as well as the practical implementation of CCI test methodology. The presentation will offer the perspectives from industry experts related to technology, data integrity, validation strategies and global technology roll-out. The panel will conclude with an engaging question and answer session for attendees to seek active guidance form the panel on current CCI challenges.
    Session Leaders
    CEO
    PTI Inspection Systems
    Speakers
    Principal Consultant
    Containsure, LLC
    Senior Microbiology Consultant
    ValSource
    CEO
    PTI Inspection Systems
    Presentation Information
    [CCIT Regulatory Landscape: Moving Towards Prevention ]
    Speaker: Brandon Zurawlow
    Historic regulatory language surrounding container closure integrity testing has led to the pervasive misconception that integrity is specifically tied to prevention of microbial ingress, in turn creating challenges for industry. Regulatory requirements and guidance set forth by USP and EU Annex 1, along with industry action, however, have expanded this definition. This presentation seeks to impart attendees with an understanding of the changing CCI regulatory landscape, use of different methods, as well as a framework for reconsidering modern CCI requirements through the lens of the 1999 Container Closure Systems FDA Guidance.
    || [Regulatory Trends Related to Container Closure Integrity: FDA Warning Letters ]
    Speaker: Stephen Langille
    Recent FDA warning letters citing container closure integrity issues share several common themes: contamination prevention, stability studies, and the handling/investigation of complaints. This presentation will focus on strategies designed to address each of those issues as well as regulatory approaches for the holistic evaluation of container closure integrity throughout development and over the product shelf life.
    || [The Shift in Container Closure Integrity ]
    Speaker: Oliver Stauffer
    Container closure integrity (CCI) is a vital aspect to product quality for the duration of the product life cycle within the supply chain. Simple but critical steps to better understand the dynamics of the product and container can improve CCI assurance for a safer supply chain.
  • 1600 - 1730
    Are YOU Inspection Ready? How to Achieve and Maintain cGMP Critical Utilities Compliance
    The focus of this seminar will be to provide guidance on how to achieve, maintain and demonstrate cGMP compliance of your critical utility systems to auditors and inspectors.Ê The most common pitfalls to these objectives will be discussed.Ê This material will be presented in detail within a forthcoming Good Practice Guide on the subject.Ê Much of the material will be specific to clean utilities although some portions are more universally applicable.Ê The key to successful audit hosting is to be in a genuine state of continuous readiness.Ê Best operational practices, their proper documentation and how to present this will be discussed.Ê Guidance from regulators regarding their expectations may not always be available however this presentation compiles the latest experiences from people who have been able to accurately present the compliant nature of their systems during inspections.Ê When possible, reference will be made to specific regulations and how their interpretation impacts auditor/regulator expectations.Ê Participation will be beneficial to anyone operating critical utility systems, especially helpful for small to midsize firms possibly with limited internal regulatory affairs support.
    Session Leaders
    President
    Cheme Engineering Inc.
    Speakers
    Senior Manager-Corporate Facilities & Engineering
    Amgen
    Associate Director, Quality Engineering
    Kite Pharma, Inc.
    Senior Utilities Engineer
    Johnson & Johnson
    Presentation Information
    [Are YOU Inspection Ready?]
    Speaker: Derek Mullins
    || [Are YOU Inspection Ready?]
    Speaker: Roderick Freeman
    || [Are YOU Inspection Ready?]
    Speaker: Ariel Kehati
  • 1600 - 1730
    The Future of eClinical System, Platform, and Data Compliance
    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.
    Session Leaders
    Principal Consultant
    Q-FINITY Quality Management
    Speakers
    Principal Consultant
    Q-FINITY Quality Management
    Sr. Director Safety Services
    PAREXEL International
    Placeholder Person Graphic
    Associate Director, Global Compliance Technology & Information Quality (TiQ)
    PRA Health Sciences
    Presentation Information
    [A Stitch in Time, Saves Nine - Proactive and Reactive Remediation Approaches after CSV Audits]
    Speaker: Oliver Herrmann
    || [Submissions of Safety Information to Sites Past, Present & Future ]
    Speaker: Frank Henrichmann
    || [Robotic Process Automation (RPA) - Lessons Learned ]
    Speaker: Brandi Stockton
  • 1600 - 1730
    Strategies for Integrating Science and Regulation
    For over a decade, ISPE’s Product Quality Lifecycle Implementation (PQLI) initiative has driven the integration of science and regulatory approaches for advancing manufacturing technology and pharmaceutical quality. Through multi-disciplinary and multi-national teams, PQLI has delivered dozens of publications, conference presentations, and Good Practice Guides. But moreover, PQLI teams develop regulatory pathways for real life problems.

    This session will provide an overview of the current PQLI activities and future deliverables in the areas of continuous pharmaceutical manufacturing, process validation, knowledge management, patient focused quality standards, and accelerated medicinal products. Through these activities, PQLI helps ISPE efforts to deliver technical and operational solutions and to remain at the forefront of regulatory science and innovation.
    Session Leaders
    Global Head and Executive Director, GRACS CMC Policy
    Merck & Co.
    Speakers
    Vice Provost, Academic Affairs
    University of Maryland, Baltimore County
    Executive Director, Knowledge Mgmt
    Merck & Co Inc
    Vice President, Quality and Regulatory Compliance, Product Supply Quality
    Novo Nordisk A/S
    Presentation Information
    [Facilitating Expanded Use of CM in Drug Product Manufacturing of Small and Large Molecules: On-going Work]
    Speaker: Antonio Moreira
    || [Knowledge Management – Development of Pragmatic Industry Guidance to Benefit Our Patients and Organizations ]
    Speaker: Martin Lipa
    || [ICH Q12: An Opportunity to Harmonize and Modernize Regulatory Oversight for Post-Approval CMC Changes and Facilitate Continual Improvement]
    Speaker: Andrew Chang
  • 1600 - 1730
    Ensuring Pharma 3.0 Before Moving to 4.0: Commissioning and Qualification of Complex Control Systems
    The purpose of this session is to present and discuss different approaches on how to commission and qualify (C&Q) manufacturing systems designated for PAT enabled control strategies including feedback control loops and a high automation level, e.g. using historians and MES. The discussion will be supported by case examples where an advanced control strategy was implemented, e.g. in the field of continuous manufacturing. In respect to Pharma 4.0, the impact of new approaches, such as artificial intelligence and self-optimizing systems, on qualification procedures will be elaborated.
    Session Leaders
    Managing Consultant
    NNE
    Speakers
    Placeholder Person Graphic
    Principal Scientist
    Pfizer
    Managing Consultant
    NNE
    Director
    Martin Warman Consultancy Ltd
    Global PAT Head, Manufacturing Science and Technology
    Novartis Technical Operations
    Placeholder Person Graphic
    Director, Division of Process Assessment I
    FDA/CDER/OPQ
    Presentation Information
    [Qualification of a PAT Enabled Continuous Manufacturing Line: An Approach to Validating PAT as part of an Integrated Control Strategy ]
    Speaker: Andrew Palm
    || [Ensuring Pharma 3.0 before moving to 4.0: Commissioning and Qualification of complex Control Systems ]
    Speaker: Line Lundsberg-Nielsen
    || [A Comparison Between the Classical and the Science & Risk-based Approach Applied to the Qualification of a PAT System for Manufacturing Systems.]
    Speaker: Martin Warman
    || [A Regulatory Perspective on Advanced Control Strategies including PAT and AI]
    Speaker: Rapti Madurawe
  • 1600 - 1730
    The Upcoming Transition of Biologic Products from NDAs to BLAs
    March of 2020 will be very significant month for sponsors of biological products who have applications with the US FDA. In that month, the FDA will convert all approved NDAs for biological products into BLAs. In addition, any pending NDAs for biological products will need to be withdrawn and resubmitted as BLAs. This presentation will provide details regarding the implementation of that transition and what sponsors should consider to be prepared for the change.
    Session Leaders
    VP, Biotechnology
    Lachman Consultant Services
    Speakers
    VP, Biotechnology
    Lachman Consultant Services
    Chief Technical Officer
    Hyde Engineering + Consulting Inc
    President and CSO
    Pharmatech Associates
    Presentation Information
    [The Upcoming Transition of Biologic Products from NDAs to BLAs]
    Speaker: Keith Webber
    || [Deemed to be a License: from CDER to CBER]
    Speaker: Ronald Berk
    || [Navigating the CMC Challenges of the HCT/Ps to BLA Transition]
    Speaker: Bikash Chatterjee
  • 1900 - 2200
    Tuesday Night Party
    You'll be Bowled Over, and Strike Gold at the Tuesday Night Networking Party at Brooklyn Bowl, just steps from Caesar's Palace. A vortex of alluring beats, eclectic eats, and bang up bowling await you. Harken back to your youth as you dance the night away to 70s and 80s pop music or try your hand at games of skill such as Foosball, Skee Ball and Air Hockey And if you'd like to relax, enjoy a beverage and catch up with old friends, visit the balcony area overlooking the night's activities or the library room for quiet conversation.
Day 4
Wednesday, 30 October 2019
  • 0700 - 1300
    Registration Open
  • 0700 - 1300
    Speaker Ready Room
  • 0700 - 1300
    Volunteer Room
  • 0800 - 0930
    Supply Chain, Design, and Safety Implications of Emerging SUTs
    Single-use technology (SUT) has become increasingly commonplace within the biopharmaceutical manufacturing environment as it addresses the dynamic and ever-growing demand of patients globally. Today’s emphasis on speed-to-market and Quality by Design makes SUT an ideal solution for Good Manufacturing Practices (GMP) processes - guaranteeing sterility, eliminating the need for cleaning validation, and reducing product changeover. Nevertheless, there are many nuances to SUT process design and material qualification. Visual management tools and material standardization during the design phase can ensure the completeness and accuracy of the design. As manufacturing sites mature, it is necessary to determine which proficiencies to develop • either internal capabilities or partnerships with external vendors to produce single-use assemblies.

    Regulatory agencies are focusing on interactions between container closure systems (CCS), manufacturing components, drug delivery devices, and final pharmaceutical product.? Companies need to identify and assess toxicological risks that could arise via such interactions.? A critical component of approval for a new drug is to ensure product safety via evaluating packaging interactions with drug product.? Extractables and leachables (E&L) can come from many sources and need to be assessed. E&L studies can be conducted successfully and ensure patient safety with appropriate planning, analytical tools, and subject-matter experts (SMEs).
    Session Leaders
    Associate Director of Technical and Scientific Services
    PharmEng Technology
    Speakers
    Associate Manager, Supply Chain
    BlueBird Bio
    Process Specialist, MSAT
    Bluebirdbio
    Associate Director of Technical and Scientific Services
    PharmEng Technology
    Presentation Information
    [Vendor Qualification and Set Up ]
    Speaker: Andrew Passarotti
    || [Tools and Methods for Selecting Consumables]
    Speaker: Marisol Hydock
    || [Ensuring Product Purity/Safety]
    Speaker: Wendy Haines
  • 0800 - 0930
    Integration of Design for Reliability
    Seventy percent of the life cycle cost is to operate and maintain assets; 30% of the life cycle cost is to build and deliver assets. The decisions that are made during the build and deliver phase of the asset lifecycle impact the Total Cost of Ownership (TCO). Identifying defects in the design stage (front end planning) reduces the TCO and improves the speed to market through a vertical startup of the systems.
    The design of a Seed lab’s Biozone (the air handling system, Fan Powered HEPAs, HEPAs) identified risks. Improvements through Design for Reliability reduced the impact of failure and the TCO.
    As a result of participating in this session, attendees will be able to:
    1. Learn from others: “Stakeholders” requires self-discovery and a vulnerable to hear a different perspective while admitting: “One doesn’t know what one doesn’t know”
    2. Apply Stakeholder requirements during the Front End Planning (FEP) and Front End Loading (FEL) • using Stage Gates as the Triggers in the Capital Project Process is fundamental to the timely application of Design for Reliability (DfR) specifications
    3. Capture Stakeholder requirements and ensure their timely application during the Capital Project Process is the fundamental benefit of a DfR Program and Toolkit.
    This topic transforms the current process of asset design. Integrating or unlocking the stakeholder knowledge and integrating that content into the asset design is transformative. Understanding how stakeholders can impact the timely application of DfR principles and requirements is core to identifying opportunities to challenge decisions, evaluate alternatives, and put forward good practices and subject matter expertise (SME).
    Session Leaders
    Strategic Consulting - Asset Management
    Jacobs Engineering Group, Inc
    Speakers
    Program Manager, Strategic Consulting - Asset Management
    Jacobs Engineering Group, Inc.
    Strategic Consulting - Asset Management
    Jacobs Engineering Group, Inc
    Presentation Information
    [Integration of Design for Reliability]
    Speaker: Marie Getsug
    When a client’s global capital project portfolio investment significantly increased due to the demand and success of their products, Design for Reliability (DfR) was identified as a strategic approach to optimize the Total Cost of Ownership (TCO) and ensure a reliable and sustainable product supply. To establish Flow during the transition from CapEx to the OpEx, DfR Processes and Tools were simultaneously developed and applied to current and future capital projects.

    This presentation will cover how to align the corporate vision, mission and core values to support massive Capital Portfolio growth. Integrating DfR into the Capital Project Processes by prioritizing and identifying key attributes to realize the expected value, cultural influence, reliability, and performance, or Flow, during the transition from CapEx to OpEx
    || [Integration of Design for Reliability: Discover Defects, Remove Failure Modes, and Eliminate Asset Shutdown ]
    Speaker: John Ganaway
  • 0800 - 0930
    Digital Transformation - Delivering Value Through Data & People
    The ISPE Pharma 4.0 initiative provides an overall Digital Transformation framework which includes Digital Maturity and Data Integrity by Design. This session will include an exploration of these Digital Transformation foundational elements including available technologies, methods for finding value, and the ecosystem required to pursue digital initiatives.It will then focus on a specific use case which details the conversion of data into information via an IoT analytic developed for Chromatography Transition Analysis. The session will conclude with an examination of the Human Impact of Digital Transformation highlighting a Human Centric transformation roadmap and positioning humans as the creators, architects, and accelerators of change.
    Session Leaders
    Life Science Information Business Manager
    RoviSys
    Speakers
    Subject Matter Expert - IoT & Industry 4.0
    SNC Lavalin
    Life Science Information Business Manager
    RoviSys
    Managing Director Altran World Class Center for Advanced Manufacturing
    Altran
    Presentation Information
    [From Connected Machines to Advanced Analytics: Demystifying the Big Data Journey for Pharma]
    Speaker: Bessem Zakhary
    As we shift from Industry 4.0 to Pharma 4.0, the ISPE Special Interest Group has developed an operating model that provides an overall framework for Pharma 4.0. Digital Maturity is an overarching and fundamental aspect in Pharma 4.0 along with Data Integrity by Design. Drawing on our experience and exposure of different use cases within the Pharmaceutical Industry, we will explore setting the foundation and stepping into Digital Maturity.
    || [A Practical IIoT Use Case Involving Chromatography Transition Analysis ]
    Speaker: Anthony Barrancotta
    || [Human at the Core of Digital Transformation]
    Speaker: Ramon Antelo
  • 0800 - 0930
    Novel Technologies and Methods to Increase Biologics Manufacturing and Development Productivity
    Innovative next generation bioprocessing techniques pave the way to less expensive quality production of pharmaceutical biologics. Examples include equipment advances, next generation bioprocessing strategies or novel characterization methods that compress time-to-market. The session's presenters are industry leaders representing leading equipment manufacturers, engineering solution providers and drug substance manufacturers.

    Thomas Maischberger (PhD., Zeta GmbH) will be sharing his extensive experience using a novel bioreactor characterization methodology to optimization bioreactor yield. Lilong Huang (PhD., Emergent BioSolutions) will be presenting a case study on productivity and economics of continuous downstream manufacturing. Colton Mitchell (ABEC Inc.) will round out the session with a summary of E.coli performance in single-Use microbial fermentation technology.
    Session Leaders
    Placeholder Person Graphic
    Principal Engineer
    Emergent BioSolutions
    Speakers
    Placeholder Person Graphic
    Principal Engineer
    Emergent BioSolutions
    Process Engineer & Project Developer
    ZETA GmbH
    Placeholder Person Graphic
    Product Engineer
    ABEC
    Presentation Information
    [A Road Map to Licensure of Mab Manufacturing Implementing Multicolumn Capture Chromatography ]
    Speaker: Lilong Huang
    Process intensification is regarded in industry as the future of biologics manufacturing. It enables significant reduction of Cost of Goods (COGs), cGMP footprint, and enhanced product quality control. An integral part of these Next Gen Processes includes application of multicolumn chromatography for affinity capture in biologics manufacturing, which has significant potential for cost savings from reduced sorbent and buffer requirements to process. A road map is presented toward licensure of Mab manufacturing implementing multicolumn capture chromatography. A case study, spanning from proof of concept studies through risk-based approach toward sBLA filing and licensure will be presented investigating multicolumn chromatography for capture into an existing commercial monoclonal antibody manufacturing platform.
    || [Opening the Black Box: Novel Characterization Methodology to Increase the Yield and Productivity of Bioreactors ]
    Speaker: Thomas Maischberger
    In line with the evolution of bioprocessing techniques, there is an emphasis on expression system improvements. Currently, the demands on bioreactors are ever more exacting, requiring constant innovation in optimization, design and characterization.

    The mass transfer coefficient, kL, and the value of the interfacial area, a, is used to characterize bioreactor systems for oxygen transfer capability. The kLa-value and the mixing time are the key performance indicators for bioreactors. Only a few publications, reporting on large scale bioreactors, are available, as calculation and modelling of these parameters is extremely complex in highly aerated systems.

    Apart from demonstrating how experimental characterizations of existing bioreactors (25L to 15 m³) can be planned and set up, this presentation, incorporating QbD techniques and validated CFD simulations, will give new insights on novel and innovative hydrodynamic modelling and how a comprehensive understanding of process parameters can be implemented in engineering concepts to boost productivity.

    Based on scientific case studies, this innovative approach will detail the results of extensive research work. The presentation will also discuss additional parameters influencing success: media design, temperature profiling, vessel and agitator geometry and aeration rates – informing end-users how to conduct targeted process improvements at commercial, pilot or lab scale.
    || [Performance of Single-Use Microbial Fermentation Technology Combining Traditional Multi-Impeller Configuration with the Advantages of Disposable Containers ]
    Speaker: Colton Mitchell
  • 0800 - 0930
    BioPhorum Plug and Play: The Benefits of Standardization in Biopharmaceutical Manufacturing
    The industry's movement away from large scale, fixed tank facilities to more flexible, single use technologies has demonstrated the desire to move toward modular and agile process design and equipment. As a result, automation systems need to be more flexible too. Process systems need to be adaptable in a cost-efficient way, so that facilities and process flows can be built and reconfigured, without the need for large scale automation development efforts. Modular automation is seen as the key enabler to achieve this.

    The presentations describe the benefits, development and implementation of an interface standard that allows a supervisory control system to interface to an intelligent process skid on the ISA-88 phase level. The standard consists of an operational model and an equipment class specific data model. The initial development describes 3 equipment classes, Bioreactor, Chromatography and filtration skids. Future developments include the full range of equipment classes for Biopharmaceutical production. The operational model and structure of the Bioreactor model will be discussed in detail.

    The standard allows a supervisory system's batch engine to execute standard functions within the equipment with a predefined set of process parameters and generating a defined set of report data.
    Session Leaders
    Senior Specialist
    Merck & Co Inc
    Speakers
    Automation Engineer
    Siemens
    Senior Specialist
    Merck & Co Inc
    Automation Subject Matter Expert
    PM Group
    Presentation Information
    [Plug and Play: Enabling the Facility of the Future]
    Speaker: Michel Claes
    || [Plug and Play: The Value]
    Speaker: Chun Lai
    || [Plug and Play: The Story so Far]
    Speaker: Keith Morris
  • 0800 - 0930
    Pharma Quality System (PQS): How the PQS Supports Lifecycle Management
    This session explores the linkage between the Pharmaceutical Quality System (PQS) and Established Conditions in enabling continuous improvement throughout the Pharmaceutical Lifecycle. Content will include insights from ICH Q12 Expert Working Group members as well as an actual case study where Established Conditions were included in a recent prior approval supplement (PAS) for an oral, immediate release oncology product. The submission described in the case study includes proposed Established Conditions based on enhanced process knowledge, product understanding, risk assessments and the overall control strategy. This submission has been accepted into the FDA pilot program on ECs, and the real case experience will be used by Pfizer to identify challenges and establish best practices for implementation of the new ICH Q12 guideline.
    Session Leaders
    Director
    J&J Corporate
    Speakers
    Associate Director, CMC - Global Regulatory
    Pfizer Inc.
    Global Head, Regulatory CMC
    AstraZeneca
    Senior Scientific and Policy Advisor (Acting), Office of Process and Facilities
    FDA/CDER/OPQ
    Presentation Information
    [Case Study: Using Established Conditions to Enable Post-Approval CMC Changes ]
    Speaker: Connie Langer
    Established Conditions (ECs) are integral to the goal of implementing post-approval CMC changes with a science- and risk-based level of regulatory oversight. This presentation will provide a summary of Pfizer’s first experience with submitting an application for review of proposed ECs. ECs and their linkage to enhanced process knowledge, product understanding, risk assessments and the overall control strategy were clearly defined with the goal to introduce provisions for reducing the lifecycle management burden while providing quality assurance throughout the product lifecycle. This submission has been accepted into the FDA pilot program on ECs, and the real case experience will be used by Pfizer to identify challenges and establish best practices for implementation of the new ICH Q12 guideline.
    || [The Interdependence of Established Conditions and PQS to Enable Continuous Improvement]
    Speaker: Frank Montgomery
    The presentation will illustrate ICH Q12 EWG thinking on the topics and how AstraZeneca are implementing ICH Q12 into the organisation along with initial approaches to registration of ECs through FDA pilot.
    || [How the Pharmaceutical Quality System (PQS) Enables Pharmaceutical Lifecycle Management]
    Speaker: Mahesh Ramanadham
    This presentation will focus on practices to risk assessment and change management at the product oversight level that drive effective identification and maintenance of ECs.
  • 0800 - 1300
    FOYA Displays
  • 0930 - 0945
    Networking Break
  • 0945 - 1115
    An Integrated Approach to Advancing Pharmaceutical Quality
    Advancing Pharmaceutical Quality continues to be a hot topic as industry sees the benefit in an industry-for-industry program to advance continual improvement. FDA continues to reflect on the messages it is hearing in response to the 2018 FRNs, Modernizing Pharmaceutical Quality Systems and has embarked on a feedback period with initial output potentially available for this session.?
    To meet FDA’s challenge to advance pharmaceutical quality, ISPE in conjunction with other associations and academia have established significant programs such as ISPE’s Advancing Pharmaceutical Quality program and St Gallen University’s research on quality metrics sponsored by FDA.
    Session Leaders
    Global Director, Quality Systems
    Perrigo
    Speakers
    Director, Institue of Technology Management
    University of St. Gallen (Switzerland)
    Global Director, Quality Systems
    Perrigo
    Global Director, Quality Systems
    Perrigo
    Director
    J&J Corporate
    Presentation Information
    [FDA / St. Gallen Quality Metrics Research- A First Glance to Year 3 Outcomes]
    Speaker:Thomas Friedli
    The presentation provides a first glance at the findings of the third year of the FDA Quality Metrics Research conducted by the University of St. Gallen. The main focus lies on the introduction of the extended Pharmaceutical Production System Model. A deeper insight will follow at the ISPE Global Pharmaceutical Regulatory Summit in December.
    || [ISPE Cultural Excellence Work]
    Speaker: Tami Frederick
    || [Update on ISPE’s Advancing Pharmaceutical Quality Framework ]
    Speaker: Tami Frederick
    || [FDA Quality Metrics Feedback]
    Speaker: Betsy Fritsche & Mahesh Ramanadham
  • 0945 - 1115
    Aging Facilities: How to Prolong Their Life and Avoid Quality Problems
    The Biopharm Industry is no longer new and neither are its production facilities. As facilities age, quality and reliability problems arise. These issues will often lead to supply and regulatory problems which harm patients and decrease the market value of the firm.
    Two industry veterans will present case studies from their experience showing how they have addressed these issues. We will compare and contrast how companies started, the resulting differences in culture and capabilities (which often persist over time), and present our ideas of how to avoid the worst possible outcomes (Consent Decree, loss of market exclusivity and loss of reputation with the FDA). In two of these cases we will show what was done when an established manufacturing facility is purchased and then brought up to cGMP and company standards. In two other cases we will show what happened when continuous improvement and regular investment was not part of the company strategy.
    Attendees should expect to learn the due diligence to follow when acquiring a company's facilities that may not be up to standard, and what to do when you find yourself in charge of a facility that has fallen behind the cGMP standards.
    Session Leaders
    Principal, Science & Technology
    Stantec
    Speakers
    Placeholder Person Graphic
    Senior Specialist QA
    Amgen Inc.
    Principal, Science & Technology
    Stantec
    President
    Genesis Engineers Inc
    Presentation Information
    [What to Look For When Assessing an Older Facility]
    Speaker: Nicholas Haycocks
    || [What to Look For When Assessing an Older Facility ]
    Speaker: Doyle Johnson

    Best Maintenance Practices to Slow the Aging Process of Facilities
    Speaker: Doyle Johnson

    || [What to Look For When Assessing an Older Facility]
    Speaker: Norman A. Goldschmidt

    How to Properly Plan for Capital Spending in Aging Facilities
    Speaker: Norman A. Goldschmidt
  • 0945 - 1115
    Extracting Business Value From the Digital Asset
    The identification of the digital representation of a physical asset as a managed asset (the digital asset) opens up the possibility for organisations to align this digital asset with the aim to realise business values.

    This session covers the information governance requirements for the digital framework and the full digital asset lifecycle. The session will also seek to cover the concepts of creating a digital asset through the CAPEX project phases (engineer, procure, construct, commission and qualify) whether greenfield or brownfield. The session will also cover the principles of delivering the digital asset to operations (custody transfer) along with how the extract value from it. This becomes a foundation for the use of a digital twin.
    Session Leaders
    Associate Director/Pharmaceutical Sector Business Development Director
    PM Group
    Speakers
    Information Management Strategist
    PM Group
    Associate Director/Pharmaceutical Sector Business Development Director
    PM Group
    Presentation Information
    [Creating a Digital Asset in Capex Projects ]
    Speaker: Colum Lynch & Jeremy Freeman

    Creating a Digital Asset in Capex Projects
    Speaker: Colum Lynch & Jeremy Freeman

    Delivering a Digital Asset to Opex
    Speaker: Colum Lynch & Jeremy Freeman

  • 0945 - 1115
    Enabling Productive and Flexible Facilities from the Nuts and Bolts to Bits and Bytes
    Session Leaders
    Vice President, CSR, Single-Use
    ABEC
    Speakers
    Lead Automation Engineer
    GE Healthcare
    Unit Head, PTD Biologics
    Bayer- US LLC
    Vice President, CSR, Single-Use
    ABEC
    Presentation Information
    [Software Standardization Paves a Smooth Road with Efficient use of Software Developed for SUT Processes ]
    Speaker: Chelsea Sanborn Kuranda
    The biopharmaceutical industry has been evolving into a more flexible industry. This evolution has driven companies to learn about how to deal with changes and design operations that allow quick adjustments, reduce costs and maintain quality. Fundamental components that support this need to be flexible include Single-Use Technology and DeltaV controls. The flexible equipment of Single-Use Technology benefits from having a control system platform designed to be correspondingly flexible. Baseline software utilizes DeltaV’s PCSD library and builds flexibility into Equipment Modules. The standard PCSD equipment modules are used as templates and adapted/customized for specific single-use system features. This standardized baseline software is made to be easily adapted for routine changes during its implementation. This approach makes it easier to develop the phases and simpler to write the recipes. The software structure can address 80-90% of the applications without additional customization. These modules are applied in several types of equipment and at multiple scales. The equipment includes the typical unit operations in a biomanufacturing process and with a range of sizes from benchtop volumes to 2500 liters.
    || [Closed Processing and the Impact on Single-Use Technology Facility Designs]
    Speaker: Scott Probst
    Designing a closed process is one thing. Proving the process is consistently closed is another. Proof of closure is what is needed to realize the full benefit of a closed system design. Closed process designs impact facility segregation, environmental controls, gowning and procedures.
    || [Demonstrated Performance for Large-Format, Single-Use Bioreactors and Fermenters]
    Speaker: Eric Rudolph
    Early Stage and/or Launch Facilities for Bulk Drug Substance manufacturing can be limited in Scale and Flexibility which inturn limits the potential output of the facility and return on investment to the owner. Facility Equipment Design can enable Single Use technology to deliver Multi-Product and Multi-Process Facilities that can allow transfer of varied products and processes

    Case Study of Emergent BioSolutions Deployment of ABEC CSR equipment relative to Facility Design Consideration, Equipment Design Consideration, Demonstration of Equipment Capabilities from Modeling, Performance Testing and Production. take-aways Scale-down and scale out of 4000L Single-Use Bioreactors (SUBs) are a demonstrated alternative to large-scale (20,000L Stainless Steel) manufacturing while expanding facility capability and flexibility. Schedule risk can be decreased through effective Owner/Supplier relationship management which speeds up design, delivery, testing and implementation. Emergent and ABEC effectively addressed the challenges of scale-change and platform-change through classic engineering techniques which was facilitated by the traditional stirred tank design, mechanical drive of the Custom Single Use (CSR) platform and industry standard single-use product contact materials.

    Demonstrating Cell Culture in Single Use at a 4,000 L Scale and flexibility of equipment design to enable multi-product multiprocess capabilities serves to modernize the approach for more flexible facilities today.
  • 0945 - 1115
    New Transformative Therapies = New Challenges + New Opportunities
    Transformative therapies (including cell and gene therapies) are offering new hope to patients and their families. However, these opportunities bring with them new challenges that must be addressed for the therapies to realize their full potential. Join us for this session as industry leaders from different disciplines share case studies in manufacturing facility and process design, technology transfer, and clinical supply chain management. You'll learn how these leaders are approaching our shared mission of overcoming these challenges and delivering potentially transformative therapies to the patients that are waiting on them.
    Session Leaders
    Vice President, Vector Manufacturing
    Bluebird Bio
    Speakers
    Vice President, Vector Manufacturing
    Bluebird Bio
    Project Engineer
    DPS Group
    Director of Technical Services, External Manufacturing
    Alexion
    Presentation Information
    [The Scaling Challenge for a New Gene Therapy ]
    Speaker: Thomas Leitch
    It’s finally here. After decades of scientific breakthroughs and development, we now live a world where cell and gene therapies are transforming how we treat severe genetic diseases and cancers. And this is just the beginning. In the coming years there is the potential for dozens of new therapies to be approved, giving hope to patients and their families battling these diseases. However, there is a catch. Realizing our full potential will be inextricably linked to our ability to reliably supply these novel therapies.
    Join us for this discussion as we share lessons learned from the tech transfer of a new gene therapy. Through this real-word case study we will explore how the team met the challenge of supplying a therapy for an unmet medical need. We will examine what it takes to expand our processes to commercial scale, and you’ll see the key enablers and decisions that went into bluebird’s commercial manufacturing facility in North Carolina’s Research Triangle.
    || [Novel Therapeutic Facilities & Design Challenges ]
    Speaker: Jeffrey Kent
    “Facilities of the Future,” - associated with novel therapeutics, flexible suites and single use platforms – are increasingly coming online to serve the next wave of therapeutic products. These facilities help to bridge the gap from lab scale processes into clinical and small-scale commercial manufacturing. Drug manufacturers who seek to mitigate investment risk are leveraging single use systems, closed processes and modular technologies to simplify the design of flexible facilities. While advances in equipment technology have made flexible manufacturing more appealing than ever by reducing the effort to design and validate new processes, the flexible novel therapeutics facility brings its own unique design challenges. Understanding the complexities of novel processes and providing value added flexibility are the primary challenges when designing a facility of the future. The engineering design team is tasked with balancing current needs with the owner’s projected scales and unit operations. Prioritizing product segregation and future-proofing of facility infrastructure add layers of flexibility to the owner but come at risk of project cost and design complexity. Gene and viral therapy processes can also require demanding containment strategies with impacts to both facility infrastructure and operating costs. This presentation will explore these challenges and reference some design cases.
    || [QC Micro and Safety Advantages – Even More Pros for Single Use Technology ]
    Speaker: Katherine Leitch
    Single-use Bioreactors (SUBs) and Single-use Mixers (SUMs) are commonly touted as offering speed and flexibility for new products and programs. Less commonly discussed are the significant advantages for bioburden control and reduced safety hazards to operators from an Environmental, Health, and Safety (EHS) perspective. This presentation will explore Alexion’s experiences with single-use technology in both external manufacturing and as part of an on-going capital project at Alexion Athlone Manufacturing Facility.
  • 0945 - 1115
    True Patient Value vs Fear of Non-Compliance - A Paradigm Shift to Reap Substantial Business and Patient Benefit
    Modern initiatives and technologies certainly enable the mission of the industry. But is there substantial opportunity to improve outcomes from an older paradigm with little capital investment? The answer is yes, but it will require a mindset change by both industry and regulators. The opportunity lies in the widespread adoption of true lean thinking; any activity that is not value-added to the patient (waste in lean terms) ultimately inhibits true patient value - the delivery of the right product, at the right time, at the right cost. Waste commonly results from a perceived risk of non-compliance, when in fact, there can be a leaner approach that does not introduce patient risk. Such activities occur across all aspects of pharmaceutical manufacturing, typified by unnecessary testing/analysis, overly complex documentation, unnecessary rework, inflexibility, etc. This session is meant to challenge our focus and begin the conversation needed for the paradigm shift of “more” in the name of compliance is not necessarily better for the patient, nor is lean contrary to assurance of quality. Participants will have the opportunity to submit situations of value vs fear of non-compliance for panel discussion.

    Panel Discussion


    Vivianne Arencibia, Arencibia Quality Compliance Associates
    Mahesh Ramanadham, Pharm.D./M.B.A., RPh, Senior Scientific and Policy Advisor (Acting), Office of Process and Facilities, FDA/CDER/OPQ
    Eric Thostesen, Sr. Director Regulatory Compliance, Strategic Business Support, Janssen Pharmaceuticals
    Timothy Watson, PhD, Executive Director and Team Leader, CMC Advisory Office, Pfizer Inc.
    Session Leaders
    Partner
    SynoloStats, LLC
    Speakers
    Independent Consultant
    Arencibia Quality Compliance Associates
    Executive Director and Team Leader, CMC Advisory Office
    Pfizer Inc
    Senior Director Regulatory Compliance
    Johnson & Johnson, Inc.
    Senior Scientific and Policy Advisor (Acting), Office of Process and Facilities
    FDA/CDER/OPQ
    Partner
    SynoloStats, LLC
    Partner - Food, Drug, and Device Group
    Covington & Burling LLP
    Presentation Information
    [Challenging the Status Quo – Why “More” is Not Always Better]
    Speaker: Tara Scherder
    || [Balancing Compliance and Efficiency for Patient and Business Benefit]
    Speaker: Thomas Cosgrove
  • 1200 - 1530
    Oasis Biotech Tour
    Tour requirements:

    Bus Departs from the Tour and Travel Entrance between Vanderpump and the Colosseum located on the main casino level
    Bus will load between 1200 & 1225 & depart at 1230
    Box lunch will be available for you on the Bus
    Comfortable walking shoes are recommended
  • 1200 - 1530
    Solaris Farms (Cannabis) Tour
    Tour requirements: Tour requirements:

    Bus Departs from the Tour and Travel Entrance between Vanderpump and the Colosseum located on the main casino level
    Bus will load between 1200 & 1225 & depart at 1230
    Deli Lunch will be available at the Farm
    Comfortable walking shoes are recommended
  • 1230 - 1645
    Hoover Dam - National Historic Landmark
    Tour requirements:

    Bus Departs from the Tour and Travel Entrance between Vanderpump and the Colosseum located on the main casino level
    Bus will load between 1200 & 1225 & depart for the Hoover Dam at 1230
    Box lunch will be available for you on the Bus
    International Guest must have their Passport with them to participant in the tour
    Comfortable walking shoes are recommended