Agenda

Day 1
June 06, 2018
  • 1300 - 1445
    Opening Plenary Session
    With the promise of an agile and highly capable manufacturing platform, the pharmaceutical industry is adopting continuous manufacturing of drug products at an accelerated pace.  The collaboration between industry, regulatory agencies and academia is delivering advancements in the technical understanding, infrastructure investments and regulatory framework needed to implement this emerging technology.  Recent success stories on the approval of several drug products using continuous manufacturing proves that the approach is feasible and attractive for development of new drugs and for increasing efficiency in legacy products, while still meeting high quality standards.  But uncertainty in the future of continuous manufacturing as a widely adopted technology still remains, with particular focus on the challenges to industry regarding technology investment, quality management risks, and the lack of global harmonization of regulatory requirements.  In the plenary session, we will explore the vision of a pharmaceutical manufacturing sector that is highly capable of producing quality drug products through the implementation of advanced manufacturing approaches.  We will also hear about the industry innovative thinking and strategic approaches that help drive decision-making on the adoption of new technology.  Finally, the plenary will address the progress of industry-academic-regulatory consortia that can drive innovation through active research and development of the processes, equipment and people needed to address these challenges.
    Session Leaders
    Director, Division of Product Quality Research
    FDA/CDER/OPQ/OTR/DPQR
    Speakers
    Global Head and Executive Director, GRACS CMC Policy
    Merck & Co.
    Vice President, Manufacturing & Quality Learning Center
    Eli Lilly and Company
    Senior VP, Global API and Dry Products Manufacturing
    Eli Lilly and Company
    Deputy Director, Office of Pharmaceutical Quality
    FDA/CDER/OPQ
    Associate Director
    Rutgers University/C-SOPS
  • 1515 - 1700
    Continuous Manufacturing of API
    Where we are today and where we’ll be tomorrow: Manufacturing (CM) for Active Pharmaceutical Ingredients (API) has not been talked about in symposia as extensively as has Continuous Manufacturing Drug Product.  While the adoption level for CM API appears small, much work has actually been accomplished. This session will demonstrate where the industry stands in regard to overall network capability, and with regard to executing CM API at commercial scale.  We will also look at where the technology could take the industry in the near future.
    Session Leaders
    Senior Director
    Eli Lilly and Company
    [Continuous Manufacturing of a Small Molecule API from a Four Step GMP Process Using Small Volume Continuous (SVC) Technology] Continuous manufacturing of a small molecule API from a four step GMP process using Small Volume Continuous (SVC) technology

    In 2016 Lilly invested in a new facility and technology platform known as small volume continuous (SVC) for continuous manufacturing of small molecule API. The first API was produced in the SVC facility in 2017. An overview of the facility, technology and process is provided.

    Learning Objectives:
    • 1. Introduction to Small Volume Continuous (SVC) equipment platform and facility;
    • 2. Overview of a multi-step process manufactured using the SVC platform;
    • 3. Introduction to control strategy elements including PAT approach and divert strategy.
    Speakers
    Principal Scientist
    Amgen Inc.
    Consultant Scientist, Technical Services / Manufacturing Sciences
    Eli Lilly Kinsale Limited
    President and CEO
    Snapdragon Chemistry, Inc.
  • 1515 - 1700
    Control Strategies for Continuous Drug Products
    Comparing Approaches to Process Control and Monitoring: The approaches to control strategies being used in industry for small-molecule direct compression drug products are compared in this interactive session with experienced industry and FDA representatives. While several approaches comprise of a hierarchy of controls to ensure quality attributes for the drug product are met; the level of redundancy, process monitoring, and rejection criteria differ. This session will highlight varying approaches for use of PAT, process models and data collection/reporting procedures. Through presentation and panel discussion, obstacles and best practices to implementing efficient, robust and modernized process controls will be highlighted. The diverse panel will provide their personal experiences of both development and implementation of continuous direct compression processes.
    Session Leaders
    Director, Center for Materials Science and Engineering
    Merck & Co., Inc.
    [Operating Control Strategy for a Commercial Continuous Direct Compression Process] This presentation addresses the industry need for sharing knowledge around Continuous Manufacturing Operating Control Strategies that can be used as part of commercial manufacturing.

    The manufacture of Drug Product has been performed historically using a batch process. The transition to a Continuous Direct Compression Manufacturing process results in new challenges for defining and implementing an Operating Control Strategy. This presentation will discuss items that should be considered in commercial manufacturing including residence time distribution model, feedback and feed forward controls, PAT tools and elements for collection decisions.

    Learning Objectives:

    1. Understand elements considered for collection or rejection of material
    2. Manage use of PAT for detection of non-conforming material || [Control Strategy] The presentation will discuss the definition, identification, and filing of a control strategy for a continuous manufacturing process. All aspects that are common to and/or differ from a batch process control strategy will be discussed. The presentation will enable delegates to gain some clarity for how a control strategy could be prepared and filed for a CM process.
    Speakers
    Senior Principal Engineer
    Janssen Pharmaceuticals
    Manufacturing Operations Manager
    Eli Lilly and Company
    Research Fellow, Global CMC
    Pfizer Inc.
    Director, Division of Product Quality Research
    FDA/CDER/OPQ/OTR/DPQR
    Director for Advanced Technologies Center of Excellence
    Janssen Supply Chain, Johnson & Johnson
  • 1700 - 1800
    Welcome Reception
Day 2
June 07, 2018
  • 0800 - 0945
    Continuous Process Verification:Drug Product+Drug Substance
    Continuous Process Verification is an alternative approach to traditional process validation and is an appropriate method for validating continuous processes. This session will cover regulatory expectations of and industry perspective on implementing Continuous Process Verification as process validation approach for continuous manufacturing.
    Session Leaders
    Senior Director, Technical Operations
    Vertex Pharmaceuticals, Inc.
    Speakers
    Deputy Director-Inspection, Enforcement & Standards, Head of Inspectorate
    MHRA
    Global Statistics and PAT Head, Manufacturing Science and Technology
    Novartis Technical Operations
    Senior Director, Drug Product Manufacturing-Technical Operations
    Vertex Pharmaceuticals
  • 1015 - 1200
    OSD Continuous Manufacturing Process/ Equipment/ Facility
    Challenges and Opportunities: Have you heard about continuous manufacturing, but are doubting what equipment to install? Or perhaps you have the equipment already but are having issues and are wondering if other companies are having issues as well? Do you wish you could pick up the phone and ask how the competition is doing this?

    What if you were told that there is no competition with regards to the technology itself? We all team up! Do you want proof? Come to the Equipment Design Session at the ISPE CM conference and you will not believe your ears. Vertex will share the equipment related difficulties they faced, and how they were mitigated. GSK will give a nice overview of what equipment is currently available, how this is evolving, and the gaps that still need to be closed. Afterwards, there will be five pharma companies on stage teaming up to explain their different strategies and how equipment design will help their strategies forward.
    Session Leaders
    Senior Principal Engineer
    Janssen Pharmaceuticals
    Director of Pharmaceutical Process Technology
    CRB
    [Understanding the Complexities of the OSD Continuous Manufacturing Process] This presentation will address the long equipment turnaround times (disassembly/cleaning/reassembly) and variation between assemblies.

    I will discuss the complexity and time needed to disassemble, clean and reassemble a continuous OSD dry granulation line and how slight variations in equipment re-assembly can lead to process variation. Next I will discuss ideas on how to reduce turnaround times and variation between assemblies by utilizing lean manufacturing principles.

    Delegates will gain a better understanding of the complexities involved with equipment turnovers of a continuous OSD processes and ideas on what can be done to improve and standardize such processes.
    Speakers
    Senior Process Engineer
    Eli Lilly & Co
    Process Engineer
    Vertex Pharmaceuticals
    Technology Industrialization Lead
    GSK
    Principal Scientist
    Merck & Co., Inc.
  • 1015 - 1200
    Continuous Separation & Purification for API
    With access to an ever-growing range of chemistries in flow and equipment to support the development and operation of continuous synthetic processes, so the needs to realise the potential benefits of continuous operation through subsequent downstream operations must be realised. This session, complements other sessions in this workshop and will include a number of presentations that highlight recent progress and case studies in continuous work-up, crystallisation and isolation.
    Session Leaders
    Professor and Centre Director
    CMAC Research Hub, Strathclyde University
    [Developing a Platform for Continuous Filtration] This presentation focuses on addressing the critical gap associated with; filtration, washing and drying, in the available tool kit for continuous isolation of APIs. This is exemplified by a novel technological solution.

    The isolation challenges are identified: Avoid product loss by dissolution, remove impurities by washing to meet specification, avoid precipitation of impurities or product during washing, minimise lumping / granulation during drying. The evolution of an innovative continuous platform which embodies solutions to these issues is presented.

    Learning Objective:
    • Appreciation of the challenges of continuous filtration washing and drying and therefore risks to mitigate.
    • Understand the complexities of wash solvent selection and be aware of a strategy to address these.
    • Awareness of the gap in continuous isolation technology and the barrier this represents to implementing end to end continuous pharmaceutical manufacturing.
    • || [Continuous Crystallization Modeling and Process Design] This topic addresses the approach of continuous crystallization process design from experiment to manufacture. Discussed will be applications of crystallization modeling as well as process monitoring.

      The presentation will walk through a proposed process design workflow including experimentation, modeling and optimization. Additionally, aspects of particle size control will be explored from both a practical and model-based perspective.

      Delegates will gain an understanding of the application of PAT tools to model building; the use of models to minimize experimental efforts and maximize chances at success, and consideration of methods for particle size control in continuous crystallizers.
    Speakers
    EPSRC Manufacturing Fellow
    University of Strathclyde
    Vice President, Business Development
    Compact Membrane Systems
    Associate Senior Consultant Engineer
    Eli Lilly & Co Ltd
  • 1300 - 1445
    Development Strategies for CM: Drug Product & Drug Substance
    Process development for continuous processes differs from the traditional batch approach in a number of important aspects including - scaling, tracking and traceability, just to name a few.  Continuous pharmaceutical manufacturing processes are predominantly run at near steady state conditions, not unlike petroleum refining or fine chemical production.  As a result, many of the engineering approaches from these fields are now being incorporated into continuous pharmaceutical manufacturing process development.  Continuous presents opportunities for understanding and controlling process dynamics virtually unavailable for batch processes.   This session will feature showcase early adopters and their approach taken to continuous pharmaceutical process development.
    Session Leaders
    Associate Director
    Rutgers University/C-SOPS
    [Continuous Drug Product Manufacturing– Development and Control of a Continuous Direct Compression Process] The focus of this presentation will include:

    • Developing a continuous direct compression process for clinical trial
    • Process and formulation development on screw feeding, blending and tableting unit operation
    • Establish control strategies with emphasis on error estimation and propagation
    • Verify process and control strategy with distinct API lots


    • Delegates will gain technical knowledge with respect to CM and development strategies.
    Speakers
    Head of Operations, Drug Product Continuous Manufacturing
    Hovione
    Scientist - SME Continuous Manufacturing
    Janssen Pharmaceuticals
    Principal Scientist
    Merck & Co., Inc.
  • 1300 - 1445
    Quality Systems Considerations and the Impact of PAT & RTRT
    The session will explore the implications of continuous manufacturing on our existing view of quality systems and a look at the knowledge management opportunities resulting from rich and high-volume data streams, not only for continuous manufacturing processes, but also for conventional processes. The concepts of Process Analytical Techniques (PAT) and Real Time Release Testing (RTRT) have assumed increased importance in the continuous manufacturing space and are positively impacting the robustness, efficiency and quality of our development and manufacturing processes.
    Session Leaders
    Vice President, Operations
    Werum IT Solutions
    Technology & Innovation Consultant
    NextGenTech Pharma Consulting
    Speakers
    Head QA Continuous Manufacturing
    Novartis AG
    Distinguished Professor of Chemical Engineering
    Rutgers University
    Vice President, Advanced Manufacturing Technologies
    GlaxoSmithKline
  • 1515 - 1700
    Communicating and Partnering with Regulators for Success
    Implementation of new pharmaceutical manufacturing technologies, like continuous manufacturing, can raise many questions related to the technical and regulatory acceptability of the development and implementation approaches. Fortunately, several of the major regulatory health authorities have established specialized groups help facilitate the advancement of new technologies through early interaction and continued conversations. This session will feature regulators from US, Europe and Japan (invited) to discuss their programs supporting innovative technologies. The regulators will be joined by a panel of experienced industry representatives who will share their communication strategies and pointers for successful regulatory approvals.
    Session Leaders
    Global Head and Executive Director, GRACS CMC Policy
    Merck & Co.
    [PMDA Activities for Implementation of Continuous Manufacturing]
    Speaker: Yoshihiro Matsuda, PhD
    In July 2016, the Pharmaceuticals and Medical Devices Agency (PMDA) established the Innovative Manufacturing Technology Working Group (IMT-WG) as part of our Projects Across Multi-Offices in PMDA. The IMT-WG initiated activities developing regulations that allow the introduction of new manufacturing technologies a more efficient manner and selected Continuous Manufacturing (CM) as our primary target. We started research into Quality Assurance of Pharmaceutical CM in August 2016, as the Japan Agency for Medical Research and Development (AMED) sponsored study group. As a result, we have written a report documenting our research about CM. In my presentation, I would like to share our knowledge, experience, and expectations for the industry gained through these activities.
    Speakers
    Deputy Director and Emerging Technology Team Chair
    Office of Testing and Research, FDA
    Director, CMC Regulatory Affairs
    Janssen Research & Development
    Associate Director, Global Regulatory Affairs-CMC
    Merck & Co., Inc.
    Associate Director, Global Regulatory Affairs, CMC
    Vertex Pharmaceuticals
    Research Fellow, Global CMC
    Pfizer Inc.
    Deputy Director-Inspection, Enforcement & Standards, Head of Inspectorate
    MHRA
    Senior Scientist for Quality
    PMDA

IMIS Description Character Cleanup