Education Program

Taking capacity expansion to the next level

Day 1
December 04, 2017
  • 0830 - 1000
    Opening Keynote Session
    In this keynote session, hear from industry leaders about innovative processes and tools to effective effectively start up a greenfield, restart an existing site, execute capital project upgrades, and plan for pipeline capacity.
    Speakers
    Vice President, Engineering, Facilities & Operations
    Gilead Sciences
    Senior Director and Head of Strategy and Business Operation
    Kite Pharma, Inc.
  • 1000 - 1030
    Networking Break in the Exhibit Hall
  • 1030 - 1200
    Key Factors in the Quest for Operational Agility
    Operational Agility - the capability of a company to rapidly change or adapt in response to changes. This session explores the role of strengthening human competency to achieve operational excellence and agility as a first step to continuous improvement. How agile is your company when natural disaster srtikes? Gain insights during a timely panel discussion about maintaininig business continuity when unforseen disruptions.
    Session Leaders
    Vice President, North America
    Commissioning Agents, Inc.
    Speakers
    Vice President, Engineering, Facilities & Operations
    Gilead Sciences
  • 1300 - 1430
    Supply Chain Challenges: Drug Substance is Easy!
    There was a time not so long ago when we all fretted about drug substance and the ocean of stainless costing hundreds of millions of dollars to get in place. Recently the marketplace and our internal businesses are pivoting to the immense questions of supply chain execution post drug substance. With dozens of markets for new products and the technicalities of getting bio products into the markets, we can see just two molecules equating to hundreds of launch activities. Additionally, the pressures of any normal business drive us to hedge our inputs and create newer more flexible supply solutions. These experts draw the parallels and give keen insight into how to process the emerging realities.
    Session Leaders
    Vice President and Site Head, Boulder Manufacturing Center
    AstraZeneca
    [Iterative Design for Biologics Cold Chain] Problem or Opportunity Statement: Designing for cold chain execution is a key enabler of delivering a lean execution and high right first time logistics execution for biologic products. Investing early in the development phase for products facilitates a robust scalable cold chain solution that mitigates risk, maintains high customer service and optimizes costs. Learning Objectives: What will delegates gain from this presentation?
    • Learning from some real examples from AZ launch portfolio
    • A possible solution specific to Cold Chain Design that can enable a more efficient and sustainable solution from launch through life cycle
    Speakers
    Head of Supply Chain, Biologics
    Astrazeneca
    Director, Operations Improvement
    CRB
  • 1300 - 1430
    Multiproduct Madness
    "I want it all…I want it now" Closure. Agility. Flexibility. Speed. Hybrid. Efficient. Clinical and Commercial products together. This is the Multi-product Madness that is the Biotech Industry in 2017. Join us in this session to hear three powerhouse discussions on how companies are putting "method to the madness" and creating the next generation of manufacturing assets.
    Session Leaders
    Managing Partner, Strategic Mfg
    NNE
    [Maximizing Facility Throughput in a CDMO Environment] How do you achieve efficient and successful scale up of a portfolio of clinical NPIs in a single facility?

    Patheon is a leading provider of Biologics contract manufacturing, and this talk will look at some of the lessons learned in building up the teams, systems and facilities to maximize the throughput and success rate of a diverse program portfolio.

    Achieving high manufacturing utilization in biologics contract manufacturing facilities is challenging due to frequent product changeovers and to remain flexible to Customer’s needs. In this presentation, methodologies for achieving high throughput manufacturing in a multiproduct suite will be presented, with an emphasis on successfully integrating single-use technology.
    Speakers
    Managing Partner, Strategic Mfg
    NNE
    Director of Manufacturing
    Patheon, Thermo Fisher Scientific
    Senior Manager Technology Pharma Bio
    Jacobs Engineering Group Inc
  • 1430 - 1530
    Networking Break in the Exhibit Hall
  • 1530 - 1700
    Caging the Tiger: Managing the Risk of Contamination
    Biopharmaceutical processes contamination risk is lurking in every process stage, whether upstream of a bioreactor or in the final filling of a sterile product. In this session learn about lessons learned and current strategies in bio manufacturing, proving process equipment closure and designs for achieving different degrees of process closure and guidance for selecting an appropriate closure method using a risk-based approach.
    Session Leaders
    Director of Engineering and Facilities
    Emergent BioSolutions
    [Contamination Prevention and Response: An Operational Mindset] There is no such thing as an acceptable contamination rate. I reject the notion that contamination is part of the business of doing cell culture. If you continue to learn the lessons of contamination, yours and others, by driving actions against a definitive root cause then eventually you will eliminate the risk from the operation. Strict controls and adherence to conservative decision making ensure a high success rate. I will talk through some of my tried and true prevention elements as well as how to manage the on-going risks. We will also discuss how the risks and recovery differ for a viral contamination and how that might impact your prevention controls.
    Speakers
    Director of Manufacturing
    AstraZeneca, PLP
    Unit Head, PTD Biologics
    Bayer- US LLC
    Principal
    Andre Walker Consulting
  • 1530 - 1700
    Taking a Chance on New Technologies
    New technologies emerge faster than ever. In this session, learn about "intelligent valve" technology comprising pneumatics, electronics and software that allows simple directional control valve functions to complex motion tasks… all done via apps. The session then moves to a focus on enzyme indicators in engineering project delivery and decontamination process monitoring.
    Session Leaders
    Vice Provost
    University of Maryland, Baltimore County
    Deputy Director, Office of Biotechnology Products
    FDA/CDER/OPQ/OBP
    [Future Pneumatics!: Digital and Intelligent] For the first time ever, valve functions can be controlled & changed via software – without the need to change the hardware. This revolutionary “intelligent valve” technology comprising pneumatics, electronics and software allows the realization of a wide range of functions, from simple directional control valve functions to complex motion tasks… all done via apps! Let Festo help you realize functions such as status monitoring, reduced energy consumption and overall equipment effectiveness with far fewer components than ever before. That’s what we call Digital Simplicity!
    Speakers
    Scientific Leader - Healthcare Biotechnology At Health Protection Agency
    Public Health England
    Product Manager
    Festo
    Managing Director
    Protak Scientific Limited
  • 1700 - 1800
    Welcome Reception in the Exhibit Hall
Day 2
December 05, 2017
  • 0800 - 1015
    Keynote Session
    As future technologies in biologics become more and more time sensitive, CDMOs provide operational agility for just-in-time patient dosing. Whether manufacturing a monoclonal antibody or tolling up to commercialize CAR T therapy, the ability to be nimble and flexible becomes increasingly important in the face of uncertain demands, challenges, and regulatory requirements.
    Session Leaders
    Executive Director, Strategic Development
    Commissioning Agents, Inc
    [The Kymriah® Story – Unique Aspects in CAR T Therapy Launch]
    Speaker: Arvind Natarajan, PhD
    The presentation will cover the development, manufacturing, and launch of Kymriah, the first CAR-T therapy, a personalized medicine for the treatment of pediatric and young adult acute lymphoblastic leukemia. Delegates will gain an understanding of how manufacturing and supplying product for autologous (personalized) therapy is significantly different from traditional biopharmaceutical manufacturing.
    Speakers
    Head, Program Management Office and Strategy
    Novartis
    Deputy Director, Office of Biotechnology Products
    FDA/CDER/OPQ/OBP
    Chairman and CEO
    Avara Pharmaceutical Services
  • 1015 - 1100
    Networking Break in the Exhibit Hall
  • 1100 - 1230
    Molecule To Market: Overcoming the Pinch Points
    Time is money in getting a new molecule to market. Join us to learn how companies are working to make timelines more predictable when dealing with the regulatory challenges of more novel products and dynamic clinical schedules.
    Session Leaders
    Principal
    Andre Walker Consulting
    Speakers
    Associate Director, Engineering, Drug Substance
    Versartis
    Manufacturing Tech Transfer Lead
    Biogen
    Process & Technology Director
    DPS Group
  • 1100 - 1230
    Control Strategy- The Foundation of Success
    Learn from companies who have achieved refined processes to utilize Quality by Design (QBD) and Process Analytical Technology (PAT) to reduce uncertainty in development and speed post-approval changes.
    Session Leaders
    Professor
    Institute of Chemical Engineering
    [Process Analytical Technology (PAT) in Continuous Bioprocessing] In recent years biotech companies have been emphasizing on the implementation and utilization of process analytical technology (PAT) in continuous bioprocessing. An overview of PAT concepts for biotech processes with emphasis on integrated continuous bioprocessing and production of monoclonal antibodies will be presented. || [Leveraging Platform Knowledge to Streamline and Improve Process Parameter Control and Classification] Leveraging historical understanding of the process via platform knowledge can aid in streamlining process parameter risk assessments, design of process studies, the classification of process parameters, and the determination of PARs. This presentation will share ways to incorporate platform knowledge in the development of a process control strategy.

    Delegates will gain:
    • Ideas for utilizing platform knowledge for the improvement of future control strategies
    • Process parameter classification metric and PAR approach that align closely with ICH
    • An approach to link manufacturing control/flexibility into the design of process studies
    Speakers
    Sr. Principal R&D Scientist
    Pall Corporation
    Senior Research Advisor
    Eli Lilly & Co
    Pharma Technical Regulatory Policy
    F. Hoffmann-La Roche Ltd
  • 1330 - 1500
    Continuous Bio Manufacturing- Not if, but When and Where?
    Move manufacturing from batch to integrated continuous operations with minimal holdup in between. Continuous flow enables higher process flexibility, consistency, and volumetric capacity, lower equipment cost and operational complexity, tighter specifications on product quality.
    Session Leaders
    Principal
    HDR Company LLC
    [Multi-Parametric Control Strategies for Enabling Continuous Biomanufacturing] Problem or Opportunity Statement:The goal of bioprocessing is to optimize process variables, such as product quantity and quality in a reproducible, scalable and transferable manner. However, bioprocesses are highly complex. A large number of process parameters and raw material attributes exist, which are highly interactive and may vary from batch to batch. Those interactions need to be understood, and source of variance must be identified and controlled. Learning Objectives:At the end of this presentation, attendees will:
    • Workflows how mechanistic models can be developed and calibrated in terms of identifiability, sensitivity and observability
    • Models as PAT tool: Demonstration of cases in which models are solution to measure less
    • Observer solutions for real-time parameter optimization
    • Multiparametric control and event prediction
    || [Continuous Biopharmaceutical Manufacturing: Modeling, Design, and Fully Automated Control] This presentation describes some recent directions in the design and operation of continuous biopharmaceutical manufacturing, including the construction of process models and their application to the design and control of biologic drug production. The approaches are demonstrated for a fully automated high-speed small-footprint biomanufacturing platform developed by researchers at Massachusetts Institute of Technology, Rensselaer Polytechnic Institute, and Northeastern University.
    Speakers
    Professor
    Institute of Chemical Engineering
    Edwin R. Gilliland Prof of Chemical Engineering
    Novartis-MIT Center
  • 1330 - 1500
    Balancing CMO vs. Internal Capabilities
    Is a CMO or internal manufacturing site better for your business? Is there a proper balance between the two? Come join the discussion on the differences between the two as the speakers share their experiences!
    Session Leaders
    Director Engineering and PM
    Takeda Oncology
    Speakers
    Global Director, Technology Transfer
    Patheon, Thermo Fisher Scientific
  • 1500 - 1600
    Networking Break in the Exhibit Hall
  • 1600 - 1730
    Developing & Commercializing a Biosimilar
    In this session, you will learn what makes a biosimilar similar and the importance of analytics in making that determination. In addition, the session will look at the role of pharmacopeia standards from USP and industry. Chemical drugs have established and appropriate monographs. This session explores the question of appropriate compendial standards for complex biologics molecules.
    Session Leaders
    Vice President and Site Head, Boulder Manufacturing Center
    AstraZeneca
    [The United States Pharmacopeia Approaches to Standards for Biologics] USP is currently focusing on a paradigm that will primarily emphasize development of performance standards applicable to biopharmaceuticals manufacturing, characterization and testing methods. This presentation will provide an overview of the USP biologics program with some case studies for performance standards. || [Biosimilar Development: Approaches for Analytical Similarity] FDA recommends a risk- and tiered-based statistical analysis for analytical similarity. We will share our approaches to evaluate analytical similarity for biosimilar development. Major mechanism of action (MoA)-reflective Tier 1 bioassays are key to demonstrating statistical equivalence and biosimilarity. Biosimilar development begins with thorough analytical characterization of reference products. Analytical similarity assessment is the foundation for biosimilar development.
    Speakers
    Vice President, Global Biologics United States Pharmacopeia
    US Pharmacopeial Convention
    Director
    AstraZeneca
    Senior Scientist
    Novartis Austria
    Director, CMC Regulatory Policy
    Genentech Inc
  • 1600 - 1730
    Biopharmaceutical Research Developments
    Innovation in manufacturing of biological products has as one of its underpinnings the new ideas and technologies being advanced in academic laboratories. This session will highlight contributions from various academic centers to biomanufacturing processes and to the education of a well-prepared workforce.
    Session Leaders
    Vice Provost
    University of Maryland, Baltimore County
    Speakers
    Professor, Chemical-Biomolecular Engineering, Bioengineering, Neuroscience
    University of California-Berkeley
    Professor of Chemical Engineering and Bioengineering
    Stanford University
    Professor
    University of California-Davis
Day 3
December 06, 2017
  • 0700 - 0815
    Women in Pharma Sponsored Breakfast
    Empowering yourself and accepting responsibility for your own career - these are the hallmarks of professional development. This session brings together key industry leaders to discuss the challenges of mentoring and sponsorship. Please join us in sharing your personal story and learning how our professional perspectives shaped the way we navigate our careers as Women in Pharma.
    Session Leaders
    Executive Director, Strategic Development
    Commissioning Agents, Inc
  • 0830 - 1115
    Advanced Therapeutics Keynote Session
    Explore the challenges and opportunities in bringing Advanced Therapeutics to market. Understand the regulatory requirements, unique patient safety issues and assurance of quality for truly personalized medicines. This session will explore unique supply chain manufacturing and testing issues bringing these novel treatments to patients.
    Session Leaders
    Vice Provost
    University of Maryland, Baltimore County
    [Keynote Presentation: Manufacturing Considerations for Late Stage Product Development of Cell and Gene Therapy Products] Cell and Gene therapies are reviewed within FDA in the Office of Tissues and Advanced Therapies at CBER. Cell and gene therapies have tremendous potential for treating a wide range of medical conditions, including very rare diseases, and clinical indications difficult to treat by other means. These advanced therapies can be highly customized to individual patients, and have the potential to be curative. However, they also have some unique manufacturing challenges that vary greatly by product type. Challenges include supply chain issues, lack of available standards, limitations in how products can be tested, and limited source material. Despite being “advanced therapies”, they are often much less well characterized than other biologics- making risk assessment more difficult. There are also important source material collection and product administration considerations that are not traditionally encountered for other types of products. Deciding how best to meet regulatory expectations may not always be intuitive. For example, identifying critical quality attributes and establishing specifications can often be much less straightforward. Some cell therapies have a high degree of lot-to-lot variability that can pose challenges for demonstrating manufacturing consistency, or for showing comparability after a manufacturing change. Scaling patient-specific cell therapies to meet clinical trial needs and commercial demand may involve a scale-out rather than scale-up approach. Replicating manufacturing as part of scale-out can pose challenging logistical issues, and present product segregation, line clearance, and product tracking concerns. In this presentation, I will discuss some of these challenges, with a focus on late stage manufacturing considerations, including scale-out and automation.
    Speakers
    Executive Vice President Technical Operations
    BioMarin Pharmaceutical
    CMC Reviewer, Office of Tissues and Advanced Therapies
    FDA/CBER
    Senior Director, CMC Regulatory
    Genentech Inc
  • 0950 - 1020
    Networking Break
  • 1120 - 1230
    Industry & Regulatory Discussion Panel
    What are the opportunities and hurdles to get products to patients? Increasing new therapies approved in Biotech comprise a higher percentage of the pipeline each year, biosimilars coming on line, and more and new therapeutic modalities approved each year present new challenges. This panel discussion explores the challenges to industry to be agile and quick while still delivering quality products with reliable supply. For regulators, it is important to understand the challenges of the regulatory frameworks that ensure quality, safety and efficacy for new treatment modalities and technologies, and the logistics required to manufacture and deliver these to patients.
    Session Leaders
    Vice Provost
    University of Maryland, Baltimore County
    Vice President, Global Quality Compliance and External Relations
    Genentech, Inc.
    Speakers
    Vice President, Global Biologics United States Pharmacopeia
    US Pharmacopeial Convention
    Executive Vice President Technical Operations
    BioMarin Pharmaceutical
    Professor, Chemical-Biomolecular Engineering, Bioengineering, Neuroscience
    University of California-Berkeley
    CMC Reviewer, Office of Tissues and Advanced Therapies
    FDA/CBER
    Senior Director, CMC Regulatory
    Genentech Inc
    Deputy Director, Office of Biotechnology Products
    FDA/CDER/OPQ/OBP
  • 1245 - 1730
    BioMarin Research Center Facility Tour
    The BioMarin Research Center opened in 2016, and is the newest research laboratory located at the company’s San Rafael, CA headquarters. The 85,000 square-foot facility is central to the fast-growing company's pipeline of treatments for rare diseases and disorders. While on the tour, guests can see several pre-clinical labs ranging from Bioanalytical development to the general research functions and research stage bioprocess. -- Tour, transportation and lunch included