On Demand Conferences

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

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

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.

Practical Challenges With Quality System Management

Practical Challenges with Quality System Management in Cell and Gene Therapies This session will focus on the challenges with the establishment of quality oversight and systems from the initial patient interface through manufacturing and supply for cell and gene therapies.  Experience with the application of cGMPs in the hospital setting will be discussed as well as the conflicting priorities when multiple companies are imposing different demands on the same institutions, notably as these controls are part of the approved applications. The efforts to harmonize standards globally, as well as the regulator experience in determining true compliance risks will be addressed.  

• FDA Perspective on GMPs for Cell & Gene Therapies
  Ekaterina Allen, PhD, RAC, Regulatory Project Manager & CMC Facilities Reviewer,
  FDA/CBER  
• Quality Considerations for Cell & Gene Therapy
  Luciana Mansolelli, Head Quality Strategic Planning, Cell & Gene Technical Development & Manufacturing
  Novartis
• Challenges for GMPs for ATMPs: European Perspective
  Lina Ertle, Head of External Relations EMEA &
  Japan, Roche

Increased Automation and Digitalization in Manufacturing

Increased Automation and Digitalization in Manufacturing Computer systems have continued to help manage complexity involved in biopharmaceutical manufacturing.  Such systems have evolved in ways previously not anticipated.  This session will explore some of the evolving uses of computer systems to allow a greater focus on product quality.  

• BioPhorum Plug and Play: Developing and Utilizing Standards to Enable Reduced Project Delivery Time
  Bruce Kane, P.E. Global Life Science Technical Consultant
  Rockwell  
• Automation How Digital is Transforming Quality Assurance Operations: A Focus on Real and Right Time Release
  Michael Shanno, Head of Digital and IT Biologics Quality
  Sanofi
• The Digital Twin: Integrated Engineering the Key to Cost-Effective Digitalization
  Martin Mayer, Business Development
  ZETA

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.

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.

Innovation in Technological Platforms in Biopharmaceutical

Plenary Session - Innovation in Technological Platforms in Biopharmaceutical Manufacturing 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.

• Process and Facility Innovation using PODs in Vaccine Manufacturing – Benefits and Challenges
  Maria Hoffman, Executive Director, Supply Chain Management
  Merck  
• Innovations in Sterile Manufacturing – Regulatory Considerations
  Patricia Hughes, PhD, Branch Chief, Division of Microbiology Assessment
  CDER, FDA

Opening Plenary

Opening Plenary - Challenges and Opportunities in the Manufacturing of New Treatment Modalities 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 of Biosimilars.

Regulatory and Industry Insights & Lessons Learned

Closing Plenary Session & Fireside Chat - Regulatory and Industry Insights & Lessons Learned 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. 

• Facilitating Development of Advanced Therapies
  Raj K. Puri, MD, Director, Division of Cellular & Gene Therapies
  CBER, FDA  
• Industry and Regulatory Fireside Chat
  Raj K. Puri, MD, PhD, Director, Division of Cellular & Gene Therapies
  CBER, FDA
  Patricia Hughes, PhD, Branch Chief, Division of Microbiology Assessment
  CDER, FDA
  John Balchunas, Workforce Director National Institute for
  Innovation in Manufacturing Biopharmaceuticals (NIIMBL)
  Lawrence Hill, CEO & VP Global Clinical Development
  Gan & Lee USA
  Maria Hoffman, Executive Director, Supply Chain Management
  Merck
• Closing Remarks & Adjourn
  Joseph Famulare, Conference Chair, VP Global Compliance & External Collaboration
  Genentech

Regulatory Updates on Biotechnological & Biological Products

Regulatory Updates on Biotechnological and Biologic Products 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.

• COVID-19 Pandemic Regulatory Responses
  Joseph Famulare, Vice President, Global Quality Compliance and External Relations Genentech, A Member of the
  Roche Group  
• Update on Sterile Products and Change Management
  Richard Friedman, Deputy Director, Science & Regulatory Policy
  CDER, FDA  
• Regulatory Requirement Differences Between China and US for Biologics & Biosimilars
  Lawrence A. Hill, PharmD, RPh, MBA, CEO
  Gan &Lee Pharmaceuticals USA

Automation, Robotics and Digitalization in QC Labs

Automation, Robotics and Digitalization in Biopharmaceutical QC Labs The goal of this session is to engage laboratory leaders, automation and informatics experts, regulators, and instrument/equipment/software vendors in rich discussions regarding the use of automation, robotics, and digital solutions to advance multiple dimensions of operational excellence in the pharma quality control laboratories.

• Technology Solutions & Business Drivers for Moving from Manual to Automated Solutions in the Pharmaceutical QC Lab
  Jacqueline Larew, Senior Advisor-Global Quality
  Eli Lilly and Company
  Mark G. Schweitzer, Global AS&T and Scientific Initiatives
  Novartis  
• QC Today and QC in the Future
  Vinny Browning III, Executive Director Commercial Attributes Sciences
  Amgen  
• Case Study: Automation of Stability Data Reporting and Trend Analysis
  Janine Kuratli, Manager Data Analytics
  CSL Behring  
• Case Study: Automated Technology Platform for Real-Time PCR-based Adventitious Agent Detection
  Sven M. Deutschmann, PhD, Head of Global ASAT
  Adventitious Agents    
• Testing & Alternative Microbiological Methods, Global QC
  Sven M. Deutschmann, PhD, Head of Global ASAT
  Roche Diagnostics GmbH

Single Use Technology Strategies

Single Use Technology Strategies The approach to manufacture is never simple and now more and more hybridized. In this session experts share their latest findings and recommendations in SUT.  Given the movement toward personalized medicine even if you are not a single use proponent, getting ready for the future is important to your business.

• Going from N-1 to Purified Product in a Closed and Connected Single-use Solution
  Pietro Perrone, PE Cytiva, Formerly GE Healthcare Life Hande Özgen, PhD,
  Scientist Cytiva, Formerly GE Healthcare Life  
• Single-use Versus Stainless Steel Biomanufacturing Facilities: Are Hybrid Facilities the Best of Both Worlds?
  Lindsay Smart
  ZETA

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

Analytics Considerations for Continuous Manufacturing

Analytics Considerations for Continuous Manufacturing This session will be a series of presentations related to analytics and release assays critical to successful implementation of CM. The session will include perspectives on emerging approaches for assessment of quality attributes, on release testing, and on the importance of process control and PAT.

• Quality Considerations for the Multi-Attribute Method (MAM)
  Sarah Rogstad, Staff Fellow, Chemist
  FDA
• Modern Microbiological Monitoring of Continuous Processing
  Cheryl Essex, Head of Microbiological Control for Biologic Drugs
  Sanofi
• Integrating Analysis with Process Control for the Continuous Bioprocessing: Extending the Lifecycle Concept to Process Analytical Technologies
  Jose C. Menezes, PhD, President and CEO
  4Tune Engineering Ltd

Current Status on CM for Biologics: Development to Clinical

Speakers will provide insights on the current stage of deployment of CM for biological molecule clinical manufacturing from the point of view of process technologies, facility assets, and manufacturing operations. Examples of successes as well as challenges encountered will be shared.

• The Biopharmaceutical Industry Emerging Continuous and Integrated Platform for Recombinant Protein Jon Coffman, PhD, Senior Director of Bioprocess Technology and Engineering AstraZeneca
• Perspectives on the Development of Continuous Manufacturing for Biological Products
  Mark Brower, Principal Scientist
  Merck
• Novel Technologies to Enable Continuous Manufacturing of Biologics
  Govind Rao, PhD, Director, Center for Advanced Sensor Technology
  University of Maryland, Baltimore County

Implementation Approaches for Large Molecule

Implementation Approaches for Large Molecule Continuous Manufacturing This session will focus on the integrated and continuous biomanufacturing process applied in the production of large molecules with experience shared by Sanofi, Pfizer and BI. Several areas will be discussed including leveraging the at-scale data to support comparability studies, as well as pre PPQ campaigns, and lifecycle process validation considerations.

• Lifecycle Process Validation Considerations for Large Molecule Continuous Manufacturing
  Katherine Giacoletti, Partner
  SynoloStats LLC  
• Leveraging ICB Technology for Novel Approaches to Process Performance Qualification
  Kevin Brower, Head of Purification Development
  US Sanofi
• Development of an Integrated Manufacturing Process: The iSKID™
  Michael Jankowski, associate Research Fellow, Analytical R&D
  Pfizer Biotx Pharm Sci

Perspectives on the Adoption and Implementation

Perspectives on the Adoption and Implementation of Continuous ManufacturingThis session will include 3 highly regarded experts in the CM for biological molecules. These experts will share perspectives and experiences on the development and potential adoption of CM for large molecules.

• Integrated Approach to Semi-Continuous Drug Substance Manufacturing
  Mehdi Ghodbane, PhD, Downstream Process Development, Medicinal Science & Technology
  GlaxoSmithKline  
• N-1 Perfusion from Development through GMP Implementation
  Gene Schaefer, Senior Director Large Molecule API Development
  Janssen
• Sanofi’s MA Digitalized Facility, an Ecosystem of the Future
  Navin Tiwari, Director, Head of Digital Shop Floor & Automation
  Sanofi

Advances in Continuous Manufacturing for Small Molecule

Advances in Continuous Manufacturing for Small Molecule While continuous processes started with a few continuous steps, the maximal value of continuous manufacturing will be gained from increased integration. Several recent processes demonstrate this value. This session will focus on actual industrial processes, emphasizing the technical and business advantages of integration. Advances in the integration of unit operations, independently for API and drug product as well as the end-to-end integration of the two will be discussed over the course of the session.

• Full Integration of Continuous Manufacturing
  Sal Mascia, PhD, President and CEO
  CONTINUUS
• Mighty Machines; Integrating Design of Chemical Processes and Flow Reactor Systems
  Matthew M. Bio, PhD, President and CEO
  Snapdragon Chemistry
• Enabling End to End Continuous Manufacturing: FDA Perspective
  Sharmista Chatterjee, PhD, Division Director
  OPMA, OPQ/CDER

Emerging Technologies

Emerging Technologies The session brings together industrial case studies from practitioners who have delivered innovative solutions to enable the adoption of continuous processing within their companies.

• Commercializing New Chemical Technologies in Flow
  Moiz Diwan, PhD, Director, Head of Enabling Technology Group
  AbbVie  
• Continuous Processing for the Manufacture of Active Pharmaceutical Ingredients
  Martin Johnson, PhD, Sr. Engineering Advisor
  Eli Lilly & Company
• The Use of Kinetic Modelling to Define a Design Space for a Continuous Process
  Peter Shapland, PhD, Scientific Leader, R&D Medicinal Science & Technology
  GSK Stevenage

Expert Roundtable

Expert Roundtable: How do we realize the full potential for Small Molecule in the new decade? Panel discussion with experts in the area of small molecule continuous manufacturing will discuss the technical, regulatory, and business hurdles for continuous manufacturing. This session will highlight CM as a continuum from E2E to hybrid approaches, including the need for "batch steps" for some products, requirement differences which can be a hindrance to global implementation of advanced technologies enabled by CM such as PAT, RTRT, and modeling; and why E2E CM may or may not be the optimal solution.        

• Malcolm Berry, PhD, CEO & Founder MB
  Chemistry Consulting, Ltd.    
• Sharmista Chatterjee, PhD, Division Director OPMA,
  OPQ/CDER  
• Gabriella Dahlgren, PhD, Manager, Strategy Deployment
  Janssen Supply Group LLC      
• Elizabeth Grieco, Director Vertex  
• Michael O’Brien, PhD, Founder and President NGT
  BioPharma Consultants

Success Stories From Small Molecule Drug Product

Success Stories From Small Molecule Drug Product Significant progress in CM implementation has been made over the last ten years. From fundamental studies within academia to global drug product CM approvals, CM represents a paradigm shift within the industry that will continue to grow with time. In this session, success stories from some of the early adopters and implementers will be shared which include regulatory, technical, and business-related achievements in the hope that it will encourage others to join the CM movement!

• Leveraging Continuous Manufacturing to Enable Real Time Release Testing
  Joseph Medendorp, Senior Director, Technical Operations
  Vertex  
• Particle Design and Engineering to Enable Continuous Direct Compression Manufacturing Processes
  Jeremy Merritt, PhD, Principal Research Scientist, Particle Design Lab – Small Molecule Design & Development
  Eli Lilly and Company Janssen
• CM-strategy: A Story of Multiple Platforms From R&D to Commercial
  Jeroen Geens, Engineering Technical Director – New Platforms
  Janssen

A New Decade for Continuous Manufacturing

A New Decade for Continuous Manufacturing Continuous manufacturing for pharmaceutical and biopharmaceutical manufacturing is still in its infancy with only a limited number of products approved within the past 5 years. As we begin the third decade of the third millennium, we anticipate that bio/pharmaceutical manufacturing will continue to get smaller, faster, and smarter. In this opening conference session, a broad array of speakers from industry, academia, and regulatory agencies will provide their views on the state of continuous bio/pharmaceutical manufacturing today and predictions for its future.

• Welcome and Opening Remarks
  Christine M. V. Moore, PhD, Conference Chair; Global Head and Executive Director, GRACS CMC Policy
  Merck  
• Speaker Introductions
  Sharmista Chatterjee, PhD, Division Director
  OPMA, OPQ/CDER
• ICH Q13 Guidance – Continuous Manufacturing of Drug Substance and Drug Product
  JRapti Madurawe, PhD, Division Director
  FDA/CDER/OPQ/OPPQ
• End to End Collaboration to Transform Biopharmaceutical Development & Manufacturing
  John Erickson, PhD, Senior Fellow,
  National Institute for Innovation in Manufacturing Biopharmaceuticals NIIMBL
• Perspectives on the Implementation of Continuous Manufacturing 
  Sarah O’Keefe, PhD, VP Small Molecule Design and Development
  Eli Lilly and Company