Day 1
7 February 2019
  • 0700 - 1800
    Registration Open
  • 0830 - 1015
    Opening Plenary & Keynote
    Session Leaders
    VP Project Lead Biologics Expansion
    Janssen Pharmaceuticals
    [J&J’s Manufacturing for the Future Journey]
    Speaker: Bart Talloen
    || [Design Considerations for Viral Vector Gene Therapy Facilities]
    Speaker: Christopher Murphy
    || [San Francisco Bay Area Chapter Introduction ]
    Speaker: Brian Vaughn
    || [Facilities of the Future: Past, present and future]
    Speaker: Andy Ramelmeier
    || [Welcome and Opening Remarks ]
    Speaker: John Bournas
    Speakers
    VP, Supply Chain Strategy & Deployment
    J&J Corporate
    Chief Operating Officer
    Brammer Bio
    President, ISPE San Francisco Bay Area Chapter
    CRB
    Senior Vice President, Chief Manufacturing and Quality Officer
    Sangamo Therapeutics, Inc.
    President and CEO
    ISPE
  • 1015 - 1100
    Networking Break in Expo Hall
  • 1100 - 1230
    Combination Product Manufacturing
    This session explores the challenges of designing, manufacturing, and navigating regulatory approval for combination products. Speakers will provide case studies around the human element of combination product use and the associated design considerations. Speakers will discuss the various regulatory expectations focusing on US FDA and EU regulations. Speakers will discuss the challenges of combination device manufacturing, especially the aseptic filling challenges.
    Session Leaders
    President/CEO
    CAI
    [Combination Product Design ]
    Speaker: Arjit Narang
    || [Regulatory Expectations and Approaches for Combination Products ]
    Speaker: Chin-Wei Soo & Karl Saldanha
    || [Challenges in Manufacturing Parenteral Combination Products ]
    Speaker: Maximilian Simm
    Speakers
    Sr.Scientist
    Genentech Inc
    Global Regulatory Head, PTR Combination Products/Devices
    Genentech Inc
    Placeholder Person Graphic
    Associate Regulatory Program Director
    Genentech Inc
    Placeholder Person Graphic
    Head of Production
    Vetter Pharma-Fertigung GmbH & Co KG
  • 1100 - 1230
    Flexibility in the Design of Cell & Gene Therapy Facilities
    Facility of the future (FoF) aspects range from the design and construction of the building itself to specific technologies that positively impact operation. Biopharma companies are demanding that the design of new manufacturing facilities is based on both modular design and construction techniques to deliver faster facility deployment and reduced CAPEX through standardization of design modules. Additionally companies are seeking to reduce OPEX through the introduction of technologies that enable optimization of working practices and even shift patterns. This session will explore some of these FoF aspects and the benefits they provide with presentations on the flexible design of a cell and gene therapy facility and the use of robotics application in a GMP manufacturing
    Session Leaders
    Technical Director Pharma Sector
    PM Group
    [Factory of the Future for Cell and Gene Therapy Facilities]
    Speaker: Jordaan Kemp
    || [Plug and Play ]
    Speaker: Rex Polly
    Speakers
    Placeholder Person Graphic
    Principal Architect
    PM Group
    Placeholder Person Graphic
    Principal Process Lead, Automation
    Lonza Biologics Inc
  • 1230 - 1330
    Networking Lunch in Expo Hall
  • 1330 - 1500
    Innovation in Biopharmaceutical Facilities
    Hear how to improve and promote innovation on the biopharmaceuticals manufacturing arena and case studies of innovation in some important biopharmaceuticals manufacturers.
    Session Leaders
    President, North America Facilities
    Grifols Therapeutic Inc
    [Innovation A Flexible, Multi-Modality Research and Development Facility Designed for the Future]
    Speaker: Daniel Iampietro
    Our pipeline has undergone dramatic change over the past 25 years becoming more diverse in the types and modalities of the compounds in development. This will drive the need for new and innovative technologies and approaches to successfully develop these compounds into the therapies that will drive future growth. To best position the company for future success, we are developing plans a new research center. The center will consist of a new 120,000 square foot formulation development facility and the renovation of 50,000 square feet in an existing building for associated laboratory support. Through the center's reconfigurable modular and podular design, it will provide state of the art equipment and technology to develop new products for both human health and animal health in a flexible, collaborative and innovative way. || [Continous Downstreaming Processing ]
    Speaker: Jean-Luc Beulay
    || [Continuous Coating Expansion of the PCMM ( Portable Continuous Miniature Manufacturing) Operation)]
    Speaker: Valentin Tarasenko
    Pfizer has expanded the current PCMM operation ( Portable Continuous Miniture Manufacturing ) to enable continuous coating via GEA OMEGA technology and GCON POD modules. The extsing POD design was modifed and a new coating wing was added to enable continuous manufacturing at 5 to 30 kg/hr of powders to coated tablets. || [Latest Evolution on NIIMBL]
    Speaker: Ruben Carbonell, PhD
    Speakers
    Director, Operations and Capital Project Team Leader
    Merck & Co Inc
    Director, Marketing & Product Development
    Novasep SAS
    Placeholder Person Graphic
    Head of Technology & Innovation
    Merck & Co Inc
    Director, Global Technology & Engineering
    Pfizer Inc
    Cheif Technology Officer
    NIIMBL - Natl. Inst. for Innovation in Manufacturing Biopharmaceuticals
  • 1330 - 1500
    Case Studies in Cell and Gene Therapy
    This session will discuss the science behind Cell and Gene Therapy and then thru a case study on a recent project look into Facilities, Equipment and Regulatory impacts driving these types of facilities.
    Session Leaders
    President and Managing Director
    IPS
    [Filling Considerations for Cell Therapy ]
    Speaker: Josh Russell
    || [Regulatory compliance implacations for Cell Therapy]
    Speakers: Vince Cebular
    || [Cleanroom Design for Cell Therapy Facilities ]
    Speakers: George Wiker
    || [Novartis Cell Therapy Program]
    Speaker: Nick Casale
    Speakers
    Dir. Technical Sales and Marketing
    Automated Systems of Tacoma (AST)
    Senior Vice President, Compliance Services
    IPS
    Executive Director
    AES Clean Technology, Inc.
    Placeholder Person Graphic
    Regional Engineering Head
    Novartis Pharmaceuticals
  • 1500 - 1545
    Networking Break in Expo Hall
  • 1545 - 1715
    Single Use Facility
    This session will examine new technologies, new design approaches, and new operating strategies associated with Single Use Technologies. This session will include several speakers on facility design and SUT project delivery. It will also examine how SUT was selected and implemented for complex cell and gene therapy manufacturing involving primarily manual aseptic manipulations.
    Session Leaders
    President/CEO
    CAI
    [SUT Facility Concept for Brazil: A New Adaptable Paradigm]
    Speaker: Doug DeVeny
    || [SUF Phase 2 Project ]
    Speakers: Robert Wheeler & Madhumitha Ravikumar & Richard Martel
    The BMS presentation for the facility of the future conference will cover the drivers for the facility design, basic requirements, desired outcome and rationale for selecting a hybrid design layout. We will walk through the design evolution starting from a copy of our existing in operation manufacturing suite to a full ballroom design and ultimately discussing where we landed with a Hybrid design that meet our existing design standards and risk assessment criteria.
    The second half of the presentation will bring you through upstream and downstream technologies focusing on next generation manufacturing, single use technologies and process economics. Upstream will discuss the use of isolator technology and perfusion utilizing an alternate tangential flow (ATF) skid and dynamic control of perfusion flowrates. Downstream will discuss process intensification using multicolumn continuous capture chromatography, integrated pool-less batch processing and automated viral inactivation. Throughout the presentation, we will discuss new technologies we used, challenges we faced and how we overcame them.
    Speakers
    Global Technical Lead, Architecture / HVAC
    Genentech Inc
    Placeholder Person Graphic
    Upstream Manager
    Bristol Myers Squibb
    Placeholder Person Graphic
    Manager, Manufacturing Support
    Bristol Myers Squibb
    Senior Project Engineer
    Bristol Myers Squibb
  • 1545 - 1715
    Emerging Technologies
    Session Leaders
    CEO and Chairman of the Board
    CRB
    [Utilization of New Technologies in the Factory Floor of the Future ]
    Speaker: Trevor Vandermeer
    || [Building a Native Digital Manufacturing Site ]
    Speaker: Roland Smith
    || [3D Printing- Additive Manufacturing]
    Speaker: John Dulchinos
    || []
    Speaker: Timo Simmen
    Speakers
    Placeholder Person Graphic
    Lead Process Controls Engineer, Life Sciences
    Rockwell Automation
    Sr. Director, Digital GxP Systems
    Moderna Therapeutics
    Vice President, Digital Manufacturing
    Jabil, Inc.
    Director Parenteral Technology Innovation & Standardisation
    Cilag AG, Janssen Supply Chain
  • 1715 - 1800
    Wine Tasting & Reception in Expo Hall
  • 1800 - 1915
    Dinner With Session: Automation Systems Impact on Gilead's Operations
    Hear how computers and automation systems are impacting Gilead's operational strategy with a focus on data and analytics and some disruptive technologies.
    Session Leaders
    VP Project Lead Biologics Expansion
    Janssen Pharmaceuticals
    [Emerging Trends in Operations]
    Speaker: Joydeep Ganguly
    Speakers
    Vice President, CFO Operations
    Gilead Sciences
Day 2
8 February 2019
  • 0700 - 1230
    Registration Open
  • 0730 - 0830
    Women in Pharma
    Speakers
    Chief Technical Officer
    Allogen Therapeutics
    Principal Engineer
    CRB
  • 0830 - 1030
    Impact of Automation and Industry 4.0 on Future Facilities
    This session will present a broad range of thoughts and experiences related to the impact of automation along with a  broad range of challenges and opportunities.  Discussion will range from cyber security  to advances in process automation, robotics, artificial intelligence (AI), data management and potential of cloud based data and open protocols enhancing flexibility.
    Session Leaders
    CEO and Chairman of the Board
    CRB
    [Operationalizing for COGM in different biotechnology production scenarios]
    Speaker: Alison Moore, PhD
    Biotechnology production facilities have evolved over the last 4 decades and with the expansion of biotechnology modalities, we have further heterogeneity in plant infrastructure. While some principles of production efficiency are constant in any scenario, other opportunities to optimize COGM can be associated with plant design and intent, and require the convergence of operations’ disciplines in new ways to maximize performance. || [Industry 4.0]
    Speaker: Thomas Burke
    Mr. Burke will share his vast experiences from over 20 years with Rockwell Automation and 13 years leading the OPC Foundation. The objective of the OPC Foundation is to promote Open Protocols in automation which will enable substantial advances in flexibility for future manufacturing and processing operations. Mr. Burke’s experience crosses manufacturing and process controls for all industries. He will talk about what he is seeing in forward looking industries and share his ideas on how those advances might benefit the Pharma and Biotech industries. He will focus on the challenges in Cyber Security and what he is observing in his recent work with various industry leaders. || [Robots and the Future of Manufacturing ]
    Speaker: Jay Douglass
    Robots have many benefits for manufacturing, but also some limitations. In general, robots are under-employed by small and medium-sized manufacturers who are vital to the overall supply chain and global competitiveness. Large manufacturers desire advances in collaborate robots and logistics in order to further automate their environment. Advanced Robotics for Manufacturing (ARM), one of 14 ManufacturingUSA® Institutes nationwide, is working to solve this problem by bringing together industry, academic and government partners to advance the use of robotics in manufacturing. Attend this session to learn how. || [The Convergence of Science and Engineering in Future Pharmaceutical Manufacturing]
    Speaker: Sam Guhan, PhD
    Dr. Sam Guhan, VP of Global Engineering at Amgen will share his thoughts on challenges of future pharmaceutical manufacturing. Dr. Guhan will comment on miniaturization, modularization and integration of manufacturing steps, and why proactive communication and collaboration between scientists and engineers will be so important.
    Speakers
    Chief Technical Officer
    Allogen Therapeutics
    President & Executive Director
    OPC Foundation
    Chief Operating Officer
    Advanced Robotics for Manufacturing
    Vice President, Drug Product Development
    Amgen
  • 1030 - 1100
    Networking Break in Expo Hall
  • 1100 - 1230
    Autologous vs Allogenic Cell Therapies
    This session will look at the differences between Autologous vs Allogenic Cell Therapies and the impact it has on Facilities, Equipment, delivery.
    Session Leaders
    President and Managing Director
    IPS
    [Facility Considerations for Autologous VS Allogenic Processing]
    Speaker: Tom Piombino
    || [Manufacturing and Facility Design Challenges for Autologous Therapies]
    Speaker: Dennis Powers
    Speakers
    Vice President, Process Architect
    IPS
    Vice President, Business Development & Sales Engineering
    G-CON Manufacturing Inc.
  • 1100 - 1230
    Emerging Technologies
    There are many types of single use instruments which will allow for a very flexible operating environment. Our first presenter will discuss the benefits and good applications for single use instrumentation from a design perspective. The session will include discussion on automation systems integration and Cyber Security.
    Session Leaders
    CEO and Chairman of the Board
    CRB
    [Smart Manufacturing: Opportunities for the Connected, Integrated Enterprise]
    Speaker: Christian Monchinski
    || [Advanced & Highly Adaptive Automation Technology integrated with Industry 4.0 Trends and their Impact on Facilities of the Future]
    Speaker: Yvonne Duckworth
    This presentation will address advanced and highly adaptive automation technology as well as Industry 4.0 trends and how they are integrated in automation technology.
    Some key design concepts for Facilities of the Future include the increasing use of single use instrumentation. There are many types of single use instruments which allow for a very flexible operating environment. This presentation will discuss the benefits and good applications for single use instrumentation from a design perspective. There are design aspects to be considered when incorporating single use instrumentation on a project.
    Wireless infrastructure is another key concept for Facilities of the Future. There are many benefits to a wireless infrastructure, but there are also drawbacks as well which need to be considered when implementing the design of these systems.
    Industry 4.0 is a new trend that is making its way into the pharmaceutical industry. The pharmaceutical industry is generally more conservative than other industries, such as the automotive industry. However, there are a number of Industry 4.0 concepts that are a good fit for pharma at this point in time. This presentation will discuss the following Industry 4.0 concepts and how they are having an impact on the pharmaceutical industry:
    -How Virtual Reality and Augmented reality are being used both on the design side as well as the construction side
    -Open Communication and the benefits of OPC UA (next generation of OPC)
    -Security aspects of OPC UA and how security has been implemented to meet the needs and concerns of the pharmaceutical industry
    -System Integration combined with Smart Manufacturing
    -Cloud Storage
    -The use of wearables (smart glasses, etc)
    Speakers
    Vice President, CFO Operations
    Gilead Sciences
    President & Executive Director
    OPC Foundation
    Vice President of Manufacturing Intelligence
    Automated Control Concepts, Inc
    Principal Engineer
    CRB
  • 1235 - 1330
    Closing Plenary
    Session Leaders
    VP Project Lead Biologics Expansion
    Janssen Pharmaceuticals
    Speakers
    Managing Director
    Accenture
  • 1330 - 1430
    Networking Lunch in Expo Hall

IMIS Description Character Cleanup