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This year, the 2020 ISPE Biopharmaceutical Manufacturing Conference will focus on advances in manufacturing, facilities, and analytics important to bring new therapies to patients. Now more than ever, manufacturing is on the critical path as many new treatments in the area of personalized medicines and individualized batch production present the challenge to bring these medicines through rapid development, reliable manufacturing, and availability to patients a pace with the advances clinical research is bringing to address unmet needs. At the same time, biosimilars are advancing with the opportunity to provide more access to medicines. In this opening session, we will hear an important regulatory perspective from FDA on gene therapy drug development and a reflection from industry on 10 years on Biosimilars.


Monday

Monday

Monday

Monday

Regulatory expectations related to biotechnology and biological products are continually evolving both within mature and emerging regulatory agencies. This session will provide a snapshot of recent regulatory changes across the global landscape. Invited speakers will provide a sampling of some of the recent regulatory responses related to the ongoing COVID-19 pandemic, discuss the rapidly evolving regulatory landscape in China, and highlight some of the recent trends related to sterile products in the United States.


Tuesday

Tuesday

As described in the morning session, regulatory expectations continue to evolve given the complexities associated with new products and innovation. This session will provide an opportunity to hear more about this topic in the context of an innovative vaccine facility and related sterile manufacturing requirements.


Tuesday

Wrapping up the conference it is important to hear from regulatory leaders to help frame the strategy for the era ahead. Lessons learned from organizations around the world will give individuals the most current insights for those difficult discussion back at your home base.


Tuesday

Tuesday

Tuesday

Tuesday

Planning, Building and Operating Cell and Gene Therapy

Planning, Building and Operating Cell and Gene Therapy Facilities (Part I) Many cell and gene therapy facilities are in different phases of planning, construction, and expansion.  Learn from experts in engineering and manufacturing about how these facilities are progressing. This two-session track will explore various designs as we move from lab scale to higher volume production; control for single use to allow for multiple manufacturing trains. These sessions will examine going from manual to automated processing to meet the demand and the various technologies and layouts being utilized to supply patient needs and meet regulatory GMP requirements.  

  • Building Flexibility for Multiple Cell Therapy Processes
    Daniel Swanson, Senior Project Engineer Biopharmaceutical Pilot Plant
    GlaxoSmithKline  
  • Leveraging Operational Simulations for Gene Therapy Facilities
    Niranjan Kulkarni, PhD, Director, Operations Improvement
    CRB

Monday

Pharma 4.0: What it is, What it isn’t

Pharma 4.0: What it is, What it isn’t and How to Implement itTrying to figure out what Pharma 4.0 is and what it means to your business? This session will clarify what Pharma 4.0 is and offer practical aspects of how it has been implemented in the plant and what it means to your workforce.

  • Why Pharma 4.0? Did We Advance?
    Christian Woelbeling, Senior Director Global Accounts
    Werum IT Solutions  
  • Enabling Automation and Pharma 4.0 in Cell Therapy
    Laura Moody, PhD, Product Manager – Primary Packaging
    Shin Kawamata, Director of R&D Centre for Cell Therapy
    Foundation for Biomedical Research and Innovation (FBRI)
    David Margetts, CEO
    Factorytalk, Co. Ltd.
  • Pharma 4.0 Meets Operator 4.0: Facing Knowledge Challenges of Manufacturing in the 4.0
    Era Patrick Boyle, President
    SkillPad Canada Inc.

Monday

Monday

Planning, Building and Operating Cell and Gene Therapy

Planning, Building and Operating Cell and Gene Therapy Facilities (Part II) Many cell and gene therapy facilities are in different phases of planning, construction, and expansion.  Learn from experts in engineering and manufacturing about how these facilities are progressing.   This two-session track will explore various designs as we move from lab scale to higher volume production; control for single use to allow for multiple manufacturing trains. These sessions will examine going from manual to automated processing to meet the demand and the various technologies and layouts being utilized to supply patient needs and meet regulatory GMP requirements.  

  • ATMP Facility Scale-up to Production using Isolator Technology
    Michael Hennessy Head of Global Sales
    ProSys Group  
  • The Impact of Innovation on Building the Facilities of the Future
    John Khoury, Principal Engineer
    ProjectFarma
    Alexis Melendez, Director of Engineering and Facilities Kite
    Pharma, Inc.

Monday

Application of ICH Q12 Principles in Modern CMC Submissions

Application of ICH Q12 Principles in Modern CMC Submissions This session brings together industry and regulatory agency representatives to discuss case studies involving the implementation of ICH Q12 principles in regulatory submissions to facilitate post-approval CMC changes in an efficient and predictable manner.

  • FDA Perspective on the Implementation of ICH Q12
    Pietro Perrone, PE Terrance Ocheltree, PhD, President
    PharmTree Consultants  
  • ICH Q12 and Beyond: The Journey Towards Regulatory Convergence in Product Life Cycle Management
    Nina Cauchon, PhD, Director, Regulatory Affairs – CMC
    Amgen Inc.
  • Application of ICH Q12, Established Conditions, and a Product Life Cycle Management Document to the Analytical Aspects of the 2019 FDA Q12 Pilot Program
    Michael Cohen, PhD, Research Fellow – Global CMC
    Pfizer  
  • Extended Panel Q&A/Discussion
    Nina Cauchon, PhD, Director, Regulatory Affairs – CMC
    Amgen Inc.
    Michael Cohen, PhD, Research Fellow – Global CMC
    Pfizer
    Andrew Chang, PhD, Vice President, Quality and Regulatory Compliance, Product Supply Quality
    Novo Nordisk

Monday

Cell and Gene Therapy CMC and Manufacturing

Cell and Gene Therapy CMC and Manufacturing: Ensuring the Analysis, Production and Quality Robust and cost-effective characterization and manufacturing presents a core challenge in the commercialization of gene and cell therapies with pressure mounting on CMC, analytical and manufacturing teams to keep up with accelerated development times and cost pressures. Gene and Cell Therapy CMC and Manufacturing examines the critical challenges facing the production, characterization and quality control of gene and cell therapies, with dedicated presentations on rapid CMC development, product and process characterization, upstream and downstream bioprocessing and considerations for personalized and large-scale manufacturing.

  • Transformation from R&D to Manufacturing
    James Warren, PhD, Vice President Pharmaceutical Development
    Ultragenyx
  • Re-thinking Comparability Assessments for Individualized Therapeutics?
    Kathy Francissen, PhD, Senior Director, Pharma Technical Regulatory
    Genentech, A Member of the Roche Group
  • Virtual Inspections: Navigating the New Paradigm
    Monica M. Commerford, PhD, Manager of Regulatory Affairs
    Brammer Bio

Monday

Monday

Technology Advancements for Drug Product Manufacturing

Technology Advancements for Drug Product ManufacturingThis session will discuss technology advances related to the manufacturing of biologic drug products of different dosage forms.  Technologies and case studies to be discussed include low temperature sealing of container closures and continuous aseptic spray freeze-drying. 

  • Dynamic Challenge Sealing Performance for Biologic Container Systems at Low Temperature
    Qingyu Zeng, PhD, Fellow, Technical Director
    West Pharmaceutical Services, Inc.  
  • Single-Use Technology for Final Fill: An Overview
    Laura Moody, PhD, Product Manager – Primary Packaging Pharma Liquid Packaging, North America,
    Syntegon Pharma Technology LLC
  • Vial Visualization Using AI
    Joshua Stauffer, Staff Engineer
    Merck & Co., Inc.

Monday

Monday