Agenda

Day 1
18 June 2019
  • 0700 - 1700
    Registration Open
  • 0815 - 1015
    Innovation in Manufacturing Transformative Medicines
    Smaller, faster, personalized, flexible, rare disease….it's not your parent's biopharma industry anymore. Hear details of these challenges and how a major manufacturer is adapting to meet them.
    Session Leaders
    Principal
    Walker BioPharm Consulting
    Session Description
    [Advancing Tomorrow's Medicines - Overcoming the Manufacturing Challenges Today ]
    Speaker: Steve Bagshaw
    Advanced Therapies from siRNA to Gene Therapies to Cell Therapies offer the unprecedented promise of lasting cures for intractable diseases over the coming decades. Turning these Advanced Therapies from ideas into practical, affordable medicines is an area of huge interest and activity across the biomanufacturing industry as the first products tackle scale-up and commercialization. Fujifilm Diosynth is one of the companies developing ways to support these products - Steve will use his keynote to offer some ideas on how these challenges are reshaping our industry across asset design, technology investment, people development, regulation and government support.
    || [Boston Chapter Welcome]
    Speaker: Kevin Chronley
    || [Innovation in Transformative Medicine: What's Changing the Bioprocessing Landscape]
    Speaker: Eric Langer
    We present findings and analysis from BioPlan’s 16th Annual Report and Survey of Biopharmaceutical Manufacturing. This includes summaries of critical industry trends affecting the bioprocessing landscape, and analysis of emerging innovations that are changing how biologics are produced. We specifically cover trends in Cell and Gene Therapy, shifts in contract manufacturing for novel therapies, and the challenges being faced by CMOs and therapeutic innovators. We cover the emerging global bioprocessing environment, especially China’s emergence on the world stage, as well as the shifts in global capacity, as the industry expands to meet growing needs.
    || [mRNA Medicine (Moderna) – Industrializing a New Platform]
    Speaker: Juan Andres
    || [Welcome and Opening Remarks]
    Speaker: John Bournas
    Speakers
    Chief Executive Officer
    Fujifilm Diosynth Biotechnologies
    Vice President
    A/Z Corporation
    President & Managing Partner
    BioPlan Associates, Inc.
    Chief Technical Operations and Quality Officer
    Moderna Inc.
    CEO and President
    ISPE
  • 1015 - 1100
    Networking Break- Exhibits and Poster Presentations
    Session Description
    [Reducing Time and Cost for Large-scale Biopharma Plant Construction Utilizing Robust and Secure PMI Methodology]
    Poster Presenter: Clemens Borkenstein
    The poster will explain the current challenges in material traceability by following heat numbers and proposes the use of another technology with many advantages instead. Typically, the heat number of individual components is used as the preferred method of identification and tracking. However, this does not ensure identification security if the heat number is lost during fabrication. There is a faster, cheaper and more secure alternative - positive material identification (PMI) – technique which detects types of stainless steel, with near 100% accuracy, utilizing hand-held x-ray fluorescence (XRF) instruments. The quality of the product contact surfaces, as well as the chemical composition of the steel, is critical for avoiding corrosion for the lifetime of the process systems. XRF Systems allow for this additional monitoring. The poster will explain the many advantages of the PMI Technology, and show a case study of a large-scale cell culture facility construction project, consisting of 6.3Km of pipes, 9,500 components and 45 vessels (ranging from 100 to 30,000L). This robust method uses XRF innovatively to analyze the chemical ingredients of the stainless steel to guarantee specification.
    || [Single-Use or Stainless Steel? Hybrid Systems May be the Solution the Industry is Looking For]
    Poster Presenter: Lindsay Smart
    Single-use assemblies are highly manufacturer specific and if these components do not comply with the individual production process of the API, they can be used only in a limited way, possibly ineffectively, and often at higher costs. Furthermore, there is a risk of contamination from extractables and leachables, which can negatively impact product quality. In contrast, customized stainless steel solutions, which do not have these disadvantages, can tend to be less flexible and require time-consuming cleaning and sterilization processes.
    State-of-the-art hybrid solutions are based on well-designed engineering concepts, combining single-use technologies with high-end stainless steel components. Therefore, benefits of both system types can be realized: low investment costs, high flexibility and shorter set-up times of single-use technology are combined with durable stainless steel components, guaranteeing the highest level of process automation, safety, integrity and reproducibility. This presentation will detail how current isolated and stand-alone assemblies can be customized and interconnected with highly sophisticated cross-functionality – from a mechanical and automation perspective – for generic bio-manufacturing plants. This involves customized technical adjustments and optimization of single-use equipment, from replacing single components, such as heating-cooling circuits, gassing stations and automation systems, to complete retrofitting of stainless steel components to the single-use facility.
    || [Quantitative ß-Globin Expression using RP-UPLC]
    Poster Presenter: Agnes Lin
    ß-hemoglobinopathies are genetic diseases that affect many patients worldwide. Transfusion-dependent ß-thalassemia (TDT) and severe sickle cell disease (SCD) result from mutations in the ß-globin gene impairing production of functional hemoglobin A (HbA). Gene therapy has the potential to alleviate complications from TDT and SCD by reconstitution of functional red blood cells. LentiGlobin gene therapy contains autologous CD34+ cells transduced ex vivo with the BB305 lentiviral vector (LVV) encoding ß-globin with a T87Q substitution, ßA-T87Q-globin. Following myeloablation and LentiGlobin infusion, transduced HSCs engraft in the bone marrow and differentiate into progenitors that express ßA-T87Q-globin. A quantitative assay for ßA-T87Q-globin protein is needed to monitor expression of gene therapy-derived Hb. Therefore, the T87Q amino acid substitution needs to be distinguished from wild type ß-globin. We developed an optimized reverse-phase ultrahigh-performance liquid chromatography (RP-UPLC) method to show clear separation of the ßA-T87Q-, ßA- and ßS (sickle)-globin chains. The method has followed ICH Q2 R1 guidelines and will be an important tool to ensure the accurate quantitation of the therapeutic protein expression.
    || [Vacuum Wastewater Conveyance In Pharmaceutical Applications]
    Poster Presenters: Brian Smith & Dan Lonergan
    Vacuum wastewater systems are a proven technology and Airvac has been installing them since the early 1970s in the USA. Not widely known as an alternative to gravity systems, the technology is especially useful in situations involving older infrastructure where existing plumbing lines may be inaccessible or too disruptive to hook into in an operating facility. In addition, the Airvac system can literally be installed anywhere with less project labor and business disruption. Airvac is the only known company that has successfully installed these negative pressure systems in FDA regulated facilities in both the US and Europe. Our system is modern, internationally available and can transform a facility into a modern structure. In Switzerland, Airvac is commissioning a brand new modern 10 story building for Roche that will be entirely negative pressure for all the wastewater generated at the site including all black, gray, autoclave and lab waters. 270 vacuum floor drains are installed that make the facility totally modular where renovations involving plumbing are totally non disruptive and simple.
    || [Comparative Assessment of Multi-use Component (Diaphragm Valves and Hygienic Gaskets) Service Life ]
    Poster Presenter: James D. Vogel
    Unlike stainless steel and single-use components which have been thoroughly defined and qualified, there has been little attention given to these overlooked components that literally hold your process together. The studies focus on true side-by-side comparisons without the application variabilities by studying different component materials, manufacturers, sizes, and configurations in controlled test conditions – giving hygienic gaskets and diaphragm valves the attention that they have deserved to help you make a more efficient process.
    || [A Risk-Based Approach to Stainless Steel Equipment Maintenance]
    Poster Presenter: Elizabeth Rivera
    Considering the risk associated with rouged surfaces, manufacturers would benefit from focusing more attention on treatments that prevent rouge from happening. Some companies take a reactive approach and wait until rouge has been detected or has impacted production before taking corrective action. Process attributes such as elevated temperature, extreme pH solutions, or surface damage (e.g., from poor quality welding) can corrode stainless-steel surfaces (4-7). If a process or surface condition is expected to lead to corrosion at some point during the life of the equipment, then an effort should be made to investigate and prevent that corrosion from occurring.
    || [Viral Safety of Cleaned Surfaces Using a Risk-Based Approach]
    Poster Presenter: Paul Lopolito
    Viral cross-contamination of process equipment and small parts is a concern for biopharmaceutical and medical device industries. Viral contamination can lead to costly delays in production, product loss, and regulatory issues. Viral clearance studies focus on viral inactivation or removal steps within the process flow ensuring a theoretical viral log reduction and low viral risk. The viral clearance strategy often overlooks the potential of cross-contamination from equipment surfaces and small parts from one donor, batch or product to another. An effective clean-in-place (CIP), automated part
    Speakers
    Head of Executive Quality
    ZETA GmbH
    Head of Sales UK, Ireland, North America
    ZETA
    Sr. Associate Scientist, Analytical Development
    BlueBird Bio
    Placeholder Person Graphic
    VP, Execution and Delivery
    Airvac-Aqseptence Group
    Placeholder Person Graphic
    President and CEO
    Airvac-Aqseptence Group
    Founder/Director
    The BioProcess Institute
    Technical Services Manager
    STERIS Corp
    Placeholder Person Graphic
    Technical Services Senior Manager
    Steris Corporation
    CEO
    PTI Inspection Systems
  • 1100 - 1215
    Process Technology and Equipment Design for mAb and Single Use
    Yesterday, today and tomorrow. Learn how the manufacturing processes of monoclonal antibodies (mAbs) have changed over the past few decades, including a closer look into today's automated technology around buffer preparation.
    Session Leaders
    Senior Director, Global Quality & Compliance
    Genentech/Roche Inc
    Session Description
    [Deploying Automated Buffer Production for cGMP Use ]
    Speaker: Ioana Erlandsson
    Buffer preparation for chromatography and filtration steps in bioprocessing is a challenge in terms of providing timely buffer delivery, reproducibility and good process economics. Biopharmaceutical manufacturing often takes place in “tank farms”, facilities in which large volume tanks are used for cell culture processes, and equally sized or even larger tanks are needed for buffer preparation and storage to support downstream processing. The current downstream buffer management approach that relies on large tanks imposes constraints on operations, plant flexibility, and facility construction. In this presentation we demonstrate one possible solution for providing reproducible, automated, point-of-use buffer preparation using inline conditioning (IC) technology. Here the process buffers are formulated inline from concentrated stock solutions of acids, bases, salts and additives and diluted with water. The control strategies of the IC system are designed to prepare buffers automatically where the critical process parameters can be controlled by feedback using conductivity, pH, flow or a combination of these. The success of this approach has been demonstrated to depend on well-designed automated hardware, the associated control algorithms and proper understanding of the basic chemistry involved in buffer formulation.
    || [Traditional mAb Manufacturing and New Changes]
    Speaker: Michael Laird
    Speakers
    Process Design Manager
    GE Healthcare
    Placeholder Person Graphic
    Senior Director & Principal Scientist
    Genentech Inc
  • 1100 - 1215
    Antibody Drug Conjugates (ADCs)
    Session Leaders
    Vice President
    A/Z Corporation
    Session Description
    [Aseptic Meets High-Potent - Setting the Stage for Next Level ADC Processing]
    Speaker: Matthias Angelmaier
    The processing of HPAPI's, especially ADC's faces multiple challenges in terms of equipment design ,execution as well as handling/operation. This presentation covers besides an introduction into ADC's, several customer projects to identity the major challenges in terms of aseptic high-potent fill-finish equipment. Besides having the right Isolator and filter systems design, the focus needs to be on the filling equipment and the right cleaning and wash-in-place procedures to secure both the product as well as the operators.
    || [From DNA to IND in less than 18 Months: “How to develop and manufacture ADCs better and faster”]
    Speaker: Wenjie Cheng, PhD
    With strong synthesis, protein-production, analysis and characterization, and GMP manufacturing capabilities, WuXi Biologics’s integrated technology platform allows us to be able to handle very complicated ADC development and manufacture with speed and quality. During this presentation, we will share a few case studies on how we:
    • Meet challenges during ADC process development,
    • Make the GMP production more robust, and
    • Move from DNA to IND within 18 months on a routine basis.
    Speakers
    Product Manager, Isolator Technology
    Robert Bosch GmbH
    Executive Director
    Wuxi Biologics
  • 1215 - 1315
    Lunch- Exhibits and Poster Presentations
  • 1315 - 1445
    From Lab to Patient: A Start-up Company's Manufacturing Journey
    With nearly a thousand entities pursuing cell and gene therapies, the road to stardom is littered with tales and frustrations. Learn from accomplished professionals who have beaten the gauntlet and are taking their startup to maturity. Discover the resources unknown to many through university-based incubation and mentoring while understanding the timelines and financial resources needed.
    Session Leaders
    Bio Executive
    In Transition
    Session Description
    [Navigating the Cultural Change from Development to Commercial Manufacturing]
    Speaker: Greg Anthos
    || [The Hitchhiker's Guide to Entrepreneurial Biotech - What to Anticipate on the Journey]
    Speaker: Louise Hall
    By drawing upon past experiences supporting start-ups and emerging companies, and presenting a biotech case study, this presentation will provide an insider perspective on lessons learned from a start-up biotech company on the journey from initial concept to an emerging biotech. Pillars of a start-up will be highlighted along with the importance of using established principles as a guide. Insight will be given to various interconnecting and overlapping pathways such as walking the fine financial line, navigating the regulatory drug development process, and pacing the growth of facilities and resources. Finally, we will consider critical key attributes essential for embarking on a venture; namely, grit and a little bit of "craziness".
    Speakers
    Placeholder Person Graphic
    Principal
    Tunnell Consulting
    Placeholder Person Graphic
    VP, CMC & Program Management
    Locus Bioscience, Inc.
    Chairman & Founder
    Hyde Engineering + Consulting Inc
  • 1315 - 1445
    Science + Data = Results
    Advances in manufacturing control strategy, new tools for process control, and the goal of maximizing operational productivity are at the heart of efforts to integrate science and data to achieve higher levels of operational productivity. This session will focus on three examples of how companies are using advanced manufacturing tools to achieve higher productivity output.
    Session Leaders
    Head of Design, Technology & Standards, Biologics Engineering
    Sanofi
    Session Description
    [Opening the "Black Box": Novel Characterization Methodology of Bioreactors]
    Speaker: Thomas Maischberger
    Today, in line with the evolution of bioprocessing techniques to satisfy the concepts on Pharma 4.0, there is a heavy emphasis on strain and expression system improvements. Against this background, the demands on bioreactors have become ever more exacting over recent years, requiring paradigm shifts in manufacturing efficiencies. Continuous optimization, design improvements and characterization of bioreactors are crucial factors placing high demands for innovation in pharmaceutical manufacturing. Therefore, it is inevitable that a focus is placed on new approaches in plant engineering to keep pace with the technological developments of the biopharmaceutical industry.
    || [Real-time Control Executed by in-line Sensors]
    Speaker: Helena Ohrvik
    Productivity and flexibility increases when the right tools for hardware, automation, process design, in-line sensors, and in-line process control are combined. In this work we combined several of these factors to accomplish enhanced process control. Real time techniques have the advantage of being in-line analytics and are therefore in accordance with Process Analytical Technology (PAT) initiatives. Through real-time monitoring and prediction of specific components as nutrients or metabolites, a cell culture process can be closely monitored and controlled. Feedback loops can be used to further reduce manual handling of cultures, therefore reducing contamination risk and free operator time. Here, we demonstrate the feasibility and flexibility of capacitance and Near-Infrared (N-IR) in-line sensors integrated for real-time monitoring and automated in-process control in two different process options; steady state perfusion and fed batch culture.
    || [Biotech 4.0 Use Case: Machine Learning in UPB Pooling Strategy]
    Speaker: Robert Dimitri
    A practical example of utilizing Machine Learning in Biopharma.
    Learn about how Takeda is creating the ability to predict and improve productivity by optimizing the pooling of unpurified bulk bags when planning campaigns of multiple downstream process runs. A broad range of material, batch record, LIMS and upstream process parameters are ingested to feed machine learning (ML) models, and predict the total drug substance protein yield.
    Speakers
    Process Engineer
    Zeta GmbH
    Scientist
    GE Healthcare
    Associate Director, Process Analytics Lead
    Takeda Pharmaceutical Co. Ltd.
  • 1445 - 1530
    Networking Break- Exhibits and Poster Presentations
  • 1530 - 1700
    Contract Manufacturing and Supply Chain - New Modalities
    Contracting for CMO services in new modalities like Gene Therapy open up new service expectations, relationship issues and expand the field of third-party manufacture supporting viral vectors. Spark Therapeutics is a pioneer in this field marking the first gene therapy approval in our industry for retinal blindness. As such the use of a contract manufacturing base has to be thought out carefully for terms and conditions, specifications and timelines acceptable to the emerging business. The volumes will stun many people as well.
    Session Leaders
    Bio Executive
    In Transition
    Session Description
    [New Adventures in the Supply Chain: The New Manufacturing Modalities and Critical Supply Chain Pinch Points]
    Speaker: Dave Macdonald
    It has taken 40 years of work to get comfortable with the biologics supply chain (animal-free, chemically defined, single use, downstream capacity crunch etc.). Now we have a host of new modalities; gene therapy, genetic engineering, cell therapy, oligonucleotides and antibody-drug conjugates – each with its own new supply chain challenges. These include new equipment vendors, new complex raw materials and their vendors, extended and complex supply chains, and immature pre-clinical vendors discovering the rigors of commercial GMPs. And these new modalities are on the fast track, moving from pre-clinical to product launch at an unprecedented speed. This presentation will discuss case studies of supply chain issues in these modalities and potential paths to resolve them.
    || [Contracting for Gene Therapy]
    Speakers: Chris Stevens & Chris Klem
    Emerging therapeutic modalities such as gene therapy have many challenges in order to successfully commercialize them. Successfully balancing investment in internal and external manufacturing capacity is critical to enabling this commercialization if your company is pursuing one of these new modalities. This presentation will explore some of the thinking and planning that has been executed for Spark's commercial and clinical gene therapy manufacturing footprint
    Speakers
    Placeholder Person Graphic
    Director, External Manufacturing
    Spark Therapeutics, Inc.
    Principal Engineer
    Hyde Engineering and Consulting
    Head of Manufacturing
    Spark Therapeutics
  • 1530 - 1700
    The Goal: Integrated Platforms and Seamless Data
    Biopharmaceutical operations often consist of complex arrays of stand-alone skids that require manual activities. There are tangible benefits to integrating the equipment in the manufacturing facility into one continuous network of systems and data. Key considerations include redundancy, flexibility, multi-product operation, communication network choice, customized versus standard equipment, and alignment among multiple sites. Lessons learned from experiences in integrating different equipment into a single solution have helped identify key elements for success.
    Session Leaders
    Head of Design, Technology & Standards, Biologics Engineering
    Sanofi
    Session Description
    [A Pragmatic Approach to facility Layout and Automation Strategy]
    Speaker: Peter Genest
    || [Implementing Open Protocols and Connectivity to Empower Operations and Maximize Capacity]
    Speaker: David Sharpe
    || [Plug & Play for Single Use Technology ]
    Speaker: Christoph Lebl
    || [Efficiency Gained in Manufacturing with Single-Use Technology]
    Speaker: Pietro Perrone
    Speakers
    Director of Offering and Strategy, BioProcess Automation & Digital
    GE Healthcare
    Global Industry Director
    Rockwell Automation
    Director, Global Automation Control
    Lonza AG
    Automation Process Engineer
    GE Healthcare
  • 1700 - 1800
    Welcome Reception
  • 1800 - 2000
    Boston Chapter Social Event
Day 2
19 June 2019
  • 0700 - 0830
    Women in Pharma: Balance for Better in Biopharmaceutical Manufacturing
    Join the conversation! This WIP panel of biopharmaceutical leaders will share their insights on achieving and the value of gender balance in biopharmaceutical manufacturing. In addition, the event will include audience participation in breakout group discussions. We hope you can join us, and all are welcome to take a seat at the table! This session is included with full conference registration.
    Session Leaders
    Director of Technical Services, External Manufacturing
    Alexion
    Speakers
    Site Head / Senior Director, Vector Manufacturing
    Bluebird Bio
    VP Operations
    Valsource Inc
    Director, Contract Manufacturing
    Ultragenyx Pharmaceutical Inc
    Director of Plasmids and Small Molecules
    Vector Manufacturing Group, Bluebird Bio
  • 0700 - 1700
    Registration Open
  • 0845 - 1015
    The Next Wave of Biologic Therapies
    Innovation in technological platforms are under development to reduce the complexity and variability associated with the manufacturing and delivery of cell and gene therapies. These advances strive to achieve the development of gene therapies with drug-like properties that can be globally scaled out. This session will provide insight on the visionary work underway and share experiences on how this transformative approach can expand access to therapies that treat multiple cancers all, as well as provide avenues for treatment in other therapeutic areas.
    Session Leaders
    Independent Consultant
    Arencibia Quality Compliance Associates
    Session Description
    [Developing Platforms for NexGen Biotherapeutics]
    Speaker: Charles Cooney, PhD
    The rapid advance of biotherapeutics over the past two decades has been enabled by a platform molecular scaffold for monoclonal antibodies and a platform process for their manufacture. We now face one of the most exciting times in biotherapeutic development with diverse novel modalities that offer exciting opportunities to address unmet medical needs but lack the benefit of a common platform for product and process development. The lessons learned from MABs can provide insight into strategies and principles for new platform development.
    || [Pace and Sequence, Why and Why Not : Implementation of New Technology in Real World Biopharmaceutical Manufacturing]
    Speaker: Jeffrey Baker, PhD
    The pace and sequence of changes in the biopharmaceutical product portfolio has exploded in recent years, presenting new health care solutions and new challenges in process control and economics. Frequently the implementation of new, innovative, manufacturing equipment, process schemes, analytics, and process controls on the manufacturing floor lag these developments by many years. Today biopharmaceutical processes looking very similar to those launched two decades ago and frequently process changes are incremental. This is not in and of itself a bad thing, sometimes known, refined technology is most appropriate and preferred in a low volume, high value enterprise. Nevertheless, it is important to reflect upon why new analytics and manufacturing technologies move to real world manufacturing so slowly in order to assure that innovation is being fully leveraged to the patient’s benefit. This talk will examine possible hurdles to the implementation of new control schemes and processing approaches in biopharmaceutical manufacturing .
    Speakers
    Robert T. Haslam (1911) Professor of Chemical Engineering, Emeritus
    MIT Chemical Engineering
    Deputy Director, Office of Biotechnology Products
    FDA/CDER/OPQ/OBP
  • 1015 - 1100
    Networking Break- Exhibits and Poster Presentations
  • 1100 - 1230
    Strategies for Achieving Product Success
    Successful product development requires careful attention to all steps involved in end-to-end manufacturing. This session will present case studies of technologies successfully used in late stage manufacturing steps that were critical to product quality.
    Session Leaders
    Vice Provost, Academic Affairs
    University of Maryland, Baltimore County
    Session Description
    [How to Use Nanovectors to Improve Your Bioavailability]
    Speaker: Franck Pavan
    New molecules in biotech are difficult to manage and to design in order to fit the target cells and therapies. One of the key aspects can be to use special technologies to enhance the bioavailability of the molecule by vectorization of the drug substance. The audience will be able to understand nanovectorisation issues and challenges and will benefit from the vectorization approach through case studies. The case studies will provide the audience with different aspects of the technology and key elements to help overcome potential pitfalls. This presentation willl aim to clarify the technologies and show key projects and products which are providing real improvement to cell and gene therapy.
    || [High Concentration Antibody Formulations for Optimal Delivery]
    Speaker: Indu Javeri, PhD
    The importance of a robust formulation, especially high concentration formulations, is often left until late in the clinical approval process. When dosage form considerations are not planned into the contract manufacturing process, often it can derail the development process and cause problems in final formulation at a contract manufacturing site. This presentation will include a case study demonstrating the process to achieve a high concentration antibody formulation needed for a sub cutaneous injection (low volume, highly concentrated) for at-home patient use in order to avoid delivery by infusion. The content will include data on antibody pre-formulation characterization and a detailed description of the data driven process for establishing a stable, highly concentrated antibody dosage form. High concentration formulations also pose challenges for analytical methods and in particular monitoring possible aggregation events. As a result of this session, attendees will gain an appreciation of how the correct final dosage form may be linked to the success of the product, how to plan for this and how to use a data driven iterative process in formulation and dosage form development. Considerations for technology transfer from R& D to cGMP manufacturing, including strategies to maintain stability and decrease aggregation will also be covered.
    || [Hybrid Model Identification for Bioreactor Performance Optimization via Supervisory Control - A Digital Twin]
    Speaker: Syed Kaschif Ahmed, PhD
    Current production bioreactor processes rely on traditional feedback loops for set-point control (parameter based approaches). At Biogen, we are exploring the utilization of more advanced model-based control approaches to enable performance-based controls. During this talk, we will discuss our efforts around the development of a hybrid model (digital twin) for the bioreactor. This simulator can potentially become the heart of a more advanced control strategy that includes a model predictive control (MPC) and a real-time performance optimizer (RTO).
    Speakers
    Placeholder Person Graphic
    Chief Executive Officer
    Eurocom
    Placeholder Person Graphic
    President & CEO
    CuriRx
    Placeholder Person Graphic
    Advanced Process Control Engineer
    Biogen
    Placeholder Person Graphic
    Industrial Partnership Manager
    LETI Health, CEA TECH
  • 1100 - 1230
    Viral Vector Manufacturing: Challenges and Insights
    Cell and gene therapies promise truly transformational medicine, correcting the genetic origins of disease, or transforming the functionality of tissues. Viral vectors are the key to this technology, but production methods and scale are lagging industry's needs driving leading firms to investing in development and infrastructure projects.
    Session Leaders
    Senior Director, Global Quality & Compliance
    Genentech/Roche Inc
    Speakers
    Placeholder Person Graphic
    Scientist I, Vector Process Development
    Bluebird Bio
  • 1230 - 1330
    Lunch- Exhibits and Poster Presentations
  • 1330 - 1500
    Biomanufacturing the Future: Strategies to Reduce Early Clinical Timelines through Continuous Implementation
    Continuous biopharmaceutical processing is proven in the lab and promises significant benefits in commercial operations. This session will explore the technical, regulatory, and organizational challenges to adopting this transformative manufacturing paradigm, and how they might be overcome.
    Session Leaders
    Principal
    Walker BioPharm Consulting
    Session Description
    [Biomanufacturing the Future: Strategies to Reduce Early Clinical Timelines through Continuous Implementation ]
    Speaker: Lynne Frick
    || [The Future is Now: Informing the Business Decision for Continuous Processing]
    Speaker: Greg Zarbis-Papstoitsis
    || [Drive to Implementation: A Community of Practice to Support Continuous Bioprocessing]
    Speaker: Tom Ransohoff
    Speakers
    Co-Founder
    4th Dimension Bioprocess
    VP, Process and Manufacturing
    Compass Therapeutics
    VP & Principal Consultant
    BioProcess Technical Consultants Inc
  • 1330 - 1500
    Viral Vectors Roundtable Discussion
    Learning is almost never comprehended without hands-on immersive exposure. In this session experts with industry hands-on experience take the audience through an exercise to design the facility centered on a gene therapy need. You will work as a table among folks you may have just met illustrating the diversity of thought in our real world home bases. You will also have direct facilitation from the experts to help you create a robust conceptual design. When it's done you will have designed your first gene therapy facility which you can take as an example back to your host.
    Session Leaders
    Bio Executive
    In Transition
    Speakers
    Process Engineer
    CRB
    Placeholder Person Graphic
    Managing Partner
    42 Degrees North Solutions
    Process Architect
    CRB
    Process Engineer
    CRB
  • 1500 - 1545
    Networking Break- Exhibits and Poster Presentations
  • 1545 - 1715
    Practical Considerations and Implementation of Continuous Processing Roundtable Discussion
    Building on the previous session, this workshop will delve into the various challenges, drawing upon the experiences of successful small molecule continuous operations to map biopharm's path forward. Discussion topics will include: Regulatory framework and cGMP considerations in continuous processing; Practical operational considerations when running continuous processes; Single use and continuous processing; Understanding non-technical hurdles to continuous processing; The role of process control and automation in continuous processing; and "Product Attribute" monitoring and continuous processing.
    Session Leaders
    Principal
    Walker BioPharm Consulting
    Session Description
    [Biomanufacturing the Future: Strategies to Reduce Early Clinical Timelines through Continuous Implementation ]
    Speaker: Lynne Frick, Tom Ransohoff & Greg Zarbis-Papstoitsis
    Speakers
    Co-Founder
    4th Dimension Bioprocess
    VP, Process and Manufacturing
    Compass Therapeutics
    VP & Principal Consultant
    BioProcess Technical Consultants Inc
  • 1545 - 1715
    Future Facility Design and Operations - New Modalities & New Technologies
    The focus on development of new treatment modalities for advanced therapies has driven the adoption of newer technology and concepts in manufacturing facilities. Traditional designs are yielding to more flexible design concepts involving a smaller footprint, shorter cycle times, high degree of automation, digitalization, and improved process control. The newer technologies can enable companies to commercially manufacture advanced therapies or to enhance the quality and efficiency of existing products. Speakers who have experience integrating these future technologies into present day manufacturing facilities will share the challenges and opportunities associated with this approach.
    Session Leaders
    Compliance Head for Biologics Quality Operations
    Sanofi
    Session Description
    [An Innovative Approach to Gene and Cell Therapy Facility Builds]
    Speakers: Tony Khoury & Scott Bertch
    Many of the challenges faced revolve around mitigation of risks while building an innovative and modern facility under accelerated timelines. gene and cell therapy companies to discuss the challenges faced when creating a cutting-edge gene and cell therapy facility. The presentation will provide key takeaways from high-level individuals who worked closely on the creation of new facilities in the emerging cell and gene therapy space - from build-out to operational readiness. Attendees will understanding the site selection process, utilization of modular and single use technologies, creating proper project work streams, as well as other considerations, such as phased implementation, commissioning and qualification strategies, and change management
    || [Future Facility Design: Enabling Flexible Second Generation Manufacturing]
    Speaker: Dean Morris
    "Facility of the Future" has become a popular term in recent years and is used to describe a variety of changes in the design of pharmaceutical and biologics manufacturing facilities. This presentation will share the key elements of facility and process design employed by the Sanofi Biologics team to achieve a vision for a "Digital Factory of the Future" in Sanofi's newest manufacturing facility in Framingham, MA. Attendees with have the opportunity to share lessons-learned and best practices from the recent Sanofi experience as the industry moves to newer, more flexible facility designs.
    || [Novel Therapeutic Facilities & Design Challenges]
    Speaker: Jeffrey Kent
    The concept of a “facility of the future” refers to the increasing trend of drug manufacturers leveraging new innovations such as single use technology to maintain closed processes and challenge typical segregation strategies. While these facilities benefit from modularity and flexibility, they must operate within the limits of commercially available single use equipment. The facility of the future concept can be tied with novel drug product innovations such as cell therapy, gene therapy, personalized medicine, and intensified cell culture processes which value multiproduct flexibility and product protection over scale of operation. This presentation explores trends in novel therapeutics and process technology from a facility design perspective.
    Speakers
    Placeholder Person Graphic
    Vice President
    Project Farma
    Sr. Director of Technical Operations
    AveXis
    Director of Process Engineering/Development
    Sanofi
    Process Engineer
    DPS Engineering
Day 3
20 June 2019
  • 0700 - 1200
    Registration Open
  • 0830 - 0930
    Cell and Gene Therapies from Research to Clinical to Production - Adapting to the Challenges of Personalized Medicine
    Exciting clinical results are emerging from small innovative Cell and Gene therapy organizations, yet these must be matched by a compliant manufacturing and supply chain in order to bring Cell and Gene therapies to patients. Success requires finding and coordinating the necessary development, regulatory, manufacturing, and supply chain talent, all within a space where regulatory path norms are emerging. Two industry leaders present their experience adapting their organizations to this challenge.
    Session Leaders
    Independent Consultant
    Arencibia Quality Compliance Associates
    Session Description
    [Viral Vectors for Cell & Gene Therapies: from Research to Commercial Production]
    Speaker: Richard Snyder, PhD
    Viral gene transfer vector manufacturing for in vivo and ex vivo applications has largely been in support of early phase clinical trials, but as product candidates move to later development stages, demand is rapidly increasing for commercial grade vectors at a variety of scales. Decisions regarding vector design, manufacturing platform, product configuration, and regulatory strategy have an impact on timelines and resources, raw materials sourcing, and analytical testing. Developing a strategy that supports an efficient path to commercialization while reducing risk helps to bring these cutting edge cell and gene therapies to patients in need.
    || [The Transformation of Bioprocessing -- Past, Present, and Future]
    Speaker: John Cox
    This presentation is on the transformation of biotechnology manufacturing: past, present, and future. Since the beginning of the commercialization of biotechnology products, engineering and process sciences have been key to enabling the delivery of life change medicines. This transformation has resulted in logarithmic improvements in productivity, particularly with recombinant proteins and monoclonal antibodies. These productivity gains continue as the industry is challenged to deliver on ever more promising therapies to ever larger patient populations. More recently, a revolution in scientific and medical advances has resulted in new therapeutic modalities -- such as gene therapy, RNA treatments, gene editing, and cell therapy – each of which present new challenges and opportunities for bioprocessing engineers. The talk will highlight these next generation therapies, and the transformation in productivity that our industry must achieve for their commercialization.
    Speakers
    Vice President, Science and Technology, Pharma Services, Viral Vector Service
    Thermo Fisher Scientific
    Executive Chairman
    Torque Therapeutics
  • 1000 - 1030
    Networking Break
  • 1000 - 1200
    Regulatory and Industry Closing Plenary and Panel Discussion
    There are challenges and opportunities related to manufacturing of new treatment modalities. Hear the views from individuals who have direct involvement in this cutting-edge topic and learn about the practical and regulatory issues that should be considered when developing a facility and process for manufacturing such advanced products. The audience will have the opportunity to pose questions to the panelists about their most current thinking in this area.
    Session Leaders
    Compliance Head for Biologics Quality Operations
    Sanofi
    Session Description
    [Navigating Your Way from Route 361 to Route 351]
    Speaker: Keith Webber, PhD
    In December 2017, the FDA published the final Guidance for Industry and Administrative Staff on Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). This guidance provides the FDA's interpretation of the terms "minimal manipulation" and "homologous use" as they pertain to these classes of therapeutic products and whether a product will be regulated solely under Section 361 of the Public Health Service Act (PHSA) or regulated under both Section 361 and Section 351 as a drug product. With the publication of this guidance document, the FDA notified many manufacturers that their cellular or tissue-based product is considered to be a drug and that they will need to submit a Biologics License Application (BLA) to gain FDA approval to market their product. This presentation will provide an overview of the guidance as well as an understanding of its impact on HCT/P manufacturers and how to prepare for this transition.
    || [The Critical Role of Manufacturing for Advanced Therapy Medicinal Products]
    Speaker: Peter Marks, MD
    || [Industry & Regulatory Panel Discussion ]
    Panelists: Peter Marks, Richard Snyder, Jeffrey Baker, John McShane & Keith Webber
    Speakers
    Placeholder Person Graphic
    Managing Partner
    Validant
    Placeholder Person Graphic
    VP, Biotechnology
    Lachman Consultant Services
    Director, Center for Biologics Evaluation and Research (CBER)
    FDA
    Principal
    Walker BioPharm Consulting
    Deputy Director, Office of Biotechnology Products
    FDA/CDER/OPQ/OBP
  • 1200 - 1700
    Moderna, Inc Facility Tour
    Cost: $55 including lunch and transportation ---- Location: 100 Tech Drive Norwood, MA  02062  ---- General Tour Schedule: 1200 Last conference session ends --- 1230-1300 Load bus and depart hotel --- 1300-1345 Lunch and transportation --- 1345-1400 Arrival / Security / Sign In --- 1400-1515 Welcome / Tour / Q&A --- 1530  Buses load and depart for hotel --- Return to hotel by 1700
  • 1200 - 1700
    Takeda Pharmaceuticals Facility Tour
    Cost: $55 including lunch and transportation ---- Location: 400 Shire Way Lexington, MA 02421 ---- General Tour Schedule: 1200 Last conference session ends --- 1230-1300 Load bus and depart hotel --- 1300-1345 Lunch and transportation --- 1345-1400 Arrival / Security / Sign In --- 1400-1515 Welcome / Tour / Q&A --- 1530  Buses load and depart for hotel --- Return to hotel by 1700