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Monday, September 21, 2020

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BioPharm Americaabout eventkeyboard_arrow_right
AI Applications for Drug Discovery Development
Drug Delivery Partnerships
Leading Biotech Boston CEO & BD
BioPharm America: Innovation and Investing
Drug Delivery Partnerships
BioProcess Internationalabout eventkeyboard_arrow_right
Cell Line Development & Engineering
Raw Materials and Supply Chain Management
Data Science Tools for Accelerated Product Life Cycle
Single-Use Technologies for Cell & Gene Therapies
Cell Culture & Upstream Processing
Bioprocessing 4.0
Recovery & Purification
Intensified and Continuous Processing
Speed from Gene to Market
Analytical & Quality
Speed from Gene to Market
Manufacturing Strategy
Intensified and Continuous Processing
Intensified and Continuous Processing
Cell & Gene Therapy
Analytical & Quality
Analytical & Quality
Speed from Gene to Market
Recovery & Purification
Recovery & Purification
Bioprocessing 4.0
Cell & Gene Therapy Bioprocessing & Commercializationabout eventkeyboard_arrow_right
Cell & Gene Therapy Bioprocessing and Commercialization – Partnering Track
PLENARY SESSION: COMMERCIALIZATION STRATEGIES – LESSONS LEARNED & VALUABLE FUTURE OUTLOOKS
PLENARY SESSION: ALLOGENEIC CAR & T CELL THERAPIES – IPSC, GENE EDITING & UNIVERSAL CELLS
Viral Vectors in Cell & Gene Therapies
Advanced Tools for Cell and Tissue Manufacturing: 20/20 View
Single Use Applications for Cell & Gene Therapies
Characterisation for Cell and Gene Therapies
Cell Therapy
Gene Edited Ex Vivo Cell Therapy
In Vivo Gene Therapy
Workshop 1: In Vivo Gene Therapy Commercialization & Delivery Strategies
2:00pm - 2:30pm
Tissue Maturation and Bioreactor Culture
Tissue Maturation and Bioreactor Culture
3:05pm - 3:25pm
Spotlight Presentation
Spotlight Presentation
8:15am - 8:45am
Fate Therapeutic’s Off-the-shelf, iPSC-derived CAR T-Cell Cancer Immunotherapy Program
Fate Therapeutic’s Off-the-shelf, iPSC-derived CAR T-Cell Cancer Immunotherapy Program
Betsy Rezner - Director, Process & Assay Development, Fate Therapeutics Inc.
4:00pm - 4:30pm
Sensors
Sensors
1:25pm - 1:55pm
Applying Systems Biology Tools for Process Understanding and Improvements
Applying Systems Biology Tools for Process Understanding and Improvements
Michael Betenbaugh - Professor, Johns Hopkins University
10:45am - 11:15am
Risk Based Approaches to Comparability
Risk Based Approaches to Comparability
Erica Bust - Senior Process Engineer, Juno Therapeutics Inc., USA
12:00pm - 12:05pm
Changeover to Technology Workshops
Changeover to Technology Workshops
12:00pm - 12:05pm
Changeover to Technology Workshops
Changeover to Technology Workshops
2:45pm - 3:05pm
Spotlight Presentation – BioTechne
Spotlight Presentation – BioTechne
10:45am - 11:15am
Assessing the future prospects of upstream bioprocessing systems for commercial AAV production
Assessing the future prospects of upstream bioprocessing systems for commercial AAV production
Scott Jeffers - Director, UniQure
10:30am - 11:00am
Overcoming the Challenges of Implementing Continuous Processing
Overcoming the Challenges of Implementing Continuous Processing
Daryl Powers, PhD - Head US Upstream Cell Culture Development, Sanofi
10:30am - 11:00am
Overcoming the Challenges of Implementing Continuous Processing
Overcoming the Challenges of Implementing Continuous Processing
Daryl Powers, PhD - Head US Upstream Cell Culture Development, Sanofi
11:00am - 12:30pm
Data Science Tools for Accelerated Product Life Cycle
Data Science Tools for Accelerated Product Life Cycle

Course Objective 

Hands-on learning of basic principles and best practices performing data analytics and data management for integrated bioprocesses. Designed for the biopharmaceutical and industrial biotech industry.

The course topics include:

  • Best bioprocess data analytics principles
  • Design of experiments
  • Data management and contextualization of data sources of different origin
  • Basic statistics for root cause analysis, scale-up, scale-down and comparability studies
  • Process validation analytics and monitoring (CPV)

 

Course Outline 

  • Digital Bioprocess Lab/ Plant: Data Management Workflow
  • Monitoring & Trending, raw data visualization
  • Inspecting your data for outliers
  • Setting process phases


  • Bioprocess data analytics: Best practices 
  • Conversion of raw data to reliable feature-based information
  • Design of Experiments (DoE)
  • Integrated Process Analysis over multiple unit operations
  • Root Cause Analysis of process variability
  • Comparability studies: Scale-up & Scale-Down and process validation tasks


Primary Audience 

This course is designed for all individuals who are involved in bioprocess development & manufacturing as well as process validation. This includes bioprocess development scientists, engineers, manufacturing and quality supervisors, and management. No sta­tistical or mathematical background is required.


Interactive seminar 

Bring your own laptop. You will perform exercises on bioprocess data management and analytics using the web-based educational software tool inCyght®.

Christoph Herwig - Bioprocess Engineering Professor, TU Wien, Austria
10:10am - 10:40am
The Economics of Seed Train Intensification
The Economics of Seed Train Intensification

Bristol-Myers Squibb

11:00am - 11:30am
Process Intensification: Implementation of Continuous Manufacturing in Upstream Processing
Process Intensification: Implementation of Continuous Manufacturing in Upstream Processing
Gregory Hiller - Research Fellow, Pfizer
11:00am - 11:30am
Process Intensification: Implementation of Continuous Manufacturing in Upstream Processing
Process Intensification: Implementation of Continuous Manufacturing in Upstream Processing
Gregory Hiller - Research Fellow, Pfizer
11:10am - 11:40am
A Trust-Based Approach to R&D Acceleration — Ethical, Collaborative Data Research, Synthesis & Integration as a Prerequisite to Innovation
A Trust-Based Approach to R&D Acceleration — Ethical, Collaborative Data Research, Synthesis & Integration as a Prerequisite to Innovation
2:15pm - 2:45pm
Vector Characterization Optimization Techniques
Vector Characterization Optimization Techniques
Andrew Espejo - Vector Analytics Lead, CMC Gene Therapy, Vertex Pharmaceuticals (pending final confirmation)
9:00am - 9:30am
Case Study: Strategies to Evaluate and Control Raw Material Variability and its Impact on Cell Culture Quality
Case Study: Strategies to Evaluate and Control Raw Material Variability and its Impact on Cell Culture Quality

A Representative from Genentech

10:30am - 11:10am
What does precision medicine actually mean and how can AI and ML impact it?
What does precision medicine actually mean and how can AI and ML impact it?
5:00pm - 5:30pm
TFDF(Tangential Flow Depth Filtration) as a Harvest Option
TFDF(Tangential Flow Depth Filtration) as a Harvest Option
5:00pm - 5:30pm
TFDF(Tangential Flow Depth Filtration) as a Harvest Option
TFDF(Tangential Flow Depth Filtration) as a Harvest Option
10:00am - 10:30am
Novel Technologies and Analytical Strategies to Control Raw Material Variability
Novel Technologies and Analytical Strategies to Control Raw Material Variability
Andreas Unsoeld - Head of Cell Culture Media, Boehringer Ingelheim Pharma GmbH & Co KG
12:10pm - 12:40pm
Spotlight Presentation – GE Healthcare
Spotlight Presentation – GE Healthcare
11:00am - 11:30am
Towards a Digital Twin Application in Downstream Process Development for Smooth and Efficient BLAs
Towards a Digital Twin Application in Downstream Process Development for Smooth and Efficient BLAs
1:20pm - 1:25pm
Chairperson’s Opening Remarks
Chairperson’s Opening Remarks
1:20pm - 1:25pm
Chairperson’s Opening Remarks
Chairperson’s Opening Remarks
1:20pm - 1:25pm
Chairperson’s Opening Remarks
Chairperson’s Opening Remarks
10:30am - 11:00am
Exposing the content of different AAV fractions after ultracentrifugation
Exposing the content of different AAV fractions after ultracentrifugation
David Dobnik - Scientific Associate, National Institute of Biology, Slovenia
1:25pm - 1:30pm
Chairperson’s Opening Remarks
Chairperson’s Opening Remarks
1:25pm - 1:30pm
Chairperson’s Opening Remarks
Chairperson’s Opening Remarks
12:00am - 11:55pm
On demand sessions
On demand sessions
12:00am - 11:55pm
On demand sessions
On demand sessions
11:15am - 12:00pm
Panel Discussion: Investment in the CGT space: trends, technologies and early stage success
Panel Discussion: Investment in the CGT space: trends, technologies and early stage success
Mike Zhao - Senior Vice President, MSQ Ventures
Jak Knowles - VP Venture Investments, Bayer
Shinichiro (Shin) Fuse, Ph.D. - Managing Director, MPM Capital
Matt Cohen - Partner, Osage University Partners
Walter Kowtonuik - Principal, Third Rock Ventures, USA
2:30pm - 3:15pm
Creating a partnership in advanced therapies to enable seamless transition of a program
Creating a partnership in advanced therapies to enable seamless transition of a program
Janelle A. Sabo - Global Head, Clinical Supplies, Systems and Innovation, Eli Lilly Research and Development
Devyn Smith - Chief Strategy Officer and Head of Operations, Sigilon Therapeutics, USA
4:30pm - 5:00pm
Meta Data – Leveraging Data to Reduce Design Space and Speed Development
Meta Data – Leveraging Data to Reduce Design Space and Speed Development
11:00am - 11:30am
Meeting the Needs of Fast to Clinic and Fast Filing
Meeting the Needs of Fast to Clinic and Fast Filing
9:00am - 9:30am
Spotlight Presentation - Fujifilm Diosynth
Spotlight Presentation - Fujifilm Diosynth
1:45pm - 2:15pm
Media Optimization Gone Wrong: When Enhanced Metabolism Leads to Cell Death
Media Optimization Gone Wrong: When Enhanced Metabolism Leads to Cell Death
Ryan Sanford - Sr. Associate Scientist, Biogen
1:45pm - 2:15pm
Media Optimization Gone Wrong: When Enhanced Metabolism Leads to Cell Death
Media Optimization Gone Wrong: When Enhanced Metabolism Leads to Cell Death
Ryan Sanford - Sr. Associate Scientist, Biogen
1:55pm - 2:25pm
Strategies to Maximize Existing Capacity whilst Increasing Profitability and Operating Ability of Manufacturing Facilities
Strategies to Maximize Existing Capacity whilst Increasing Profitability and Operating Ability of Manufacturing Facilities
9:00am - 9:30am
What Guidance Does Economic Analysis Provide? What are the Key Targets for Intensification? Small Vs. Large Scale and USP Vs. DSP
What Guidance Does Economic Analysis Provide? What are the Key Targets for Intensification? Small Vs. Large Scale and USP Vs. DSP
Andrew Sinclair - President and Founder, BioPharm Services Ltd, United Kingdom
9:00am - 9:30am
What Guidance Does Economic Analysis Provide? What are the Key Targets for Intensification? Small Vs. Large Scale and USP Vs. DSP
What Guidance Does Economic Analysis Provide? What are the Key Targets for Intensification? Small Vs. Large Scale and USP Vs. DSP
Andrew Sinclair - President and Founder, BioPharm Services Ltd, United Kingdom
4:45pm - 5:30pm
Panel Discussion: Bridging the Gap between Academia and Commercialisation: When to spin out?
Panel Discussion: Bridging the Gap between Academia and Commercialisation: When to spin out?
Elizabeth Schwarzbach - CBO, New York Stem Cell Foundation
Sofia Braag - Business Development Principal, University of Massachusetts Medical School
Robert L. Buchanan - Co-Founder & CEO, Ambulero
1:25pm - 1:55pm
Validation Strategy and Approach
Validation Strategy and Approach

Novartis Pharma AG Representative Invited

1:35pm - 2:30pm
Panel Discussion: Pricing and Reimbursement strategies for Cell and Gene Therapies
Panel Discussion: Pricing and Reimbursement strategies for Cell and Gene Therapies
Kevin W. Mayo - Managing Partner, Venture Genome LLC
Phillip D. Carter - Head of U.S. Market Access, Orchard Therapeutics
10:30am - 11:00am
Networking Refreshment Break
Networking Refreshment Break
10:40am - 11:10am
Raman Technology For In-Line Monitoring And Control Of CHO Cell Culture Process
Raman Technology For In-Line Monitoring And Control Of CHO Cell Culture Process
Anita E.Tolouei - Scientist I, KBI Biopharma
1:30pm - 3:00pm
Data Science Tools for Accelerated Product Life Cycle
Data Science Tools for Accelerated Product Life Cycle

Course Objective 

Hands-on learning of basic principles and best practices performing data analytics and data management for integrated bioprocesses. Designed for the biopharmaceutical and industrial biotech industry.

The course topics include:

  • Best bioprocess data analytics principles
  • Design of experiments
  • Data management and contextualization of data sources of different origin
  • Basic statistics for root cause analysis, scale-up, scale-down and comparability studies
  • Process validation analytics and monitoring (CPV)

 

Course Outline 

  • Digital Bioprocess Lab/ Plant: Data Management Workflow
  • Monitoring & Trending, raw data visualization
  • Inspecting your data for outliers
  • Setting process phases


  • Bioprocess data analytics: Best practices 
  • Conversion of raw data to reliable feature-based information
  • Design of Experiments (DoE)
  • Integrated Process Analysis over multiple unit operations
  • Root Cause Analysis of process variability
  • Comparability studies: Scale-up & Scale-Down and process validation tasks


Primary Audience 

This course is designed for all individuals who are involved in bioprocess development & manufacturing as well as process validation. This includes bioprocess development scientists, engineers, manufacturing and quality supervisors, and management. No sta­tistical or mathematical background is required.


Interactive seminar 

Bring your own laptop. You will perform exercises on bioprocess data management and analytics using the web-based educational software tool inCyght®.

Christoph Herwig - Bioprocess Engineering Professor, TU Wien, Austria
2:00pm - 2:20pm
Scalable GMP Production of AAV, Lentivirus & Plasmids
Scalable GMP Production of AAV, Lentivirus & Plasmids
Jeffrey Hung - Chief Commercial Officer, Vigene Biosciences, Inc., USA
2:15pm - 2:45pm
Utilizing PAT to Improve Efficiencies, Testing, and Cycle Times in Downstream Processing
Utilizing PAT to Improve Efficiencies, Testing, and Cycle Times in Downstream Processing

Biogen Representative Invited

2:15pm - 2:45pm
Utilizing PAT to Improve Efficiencies, Testing, and Cycle Times in Downstream Processing
Utilizing PAT to Improve Efficiencies, Testing, and Cycle Times in Downstream Processing

Biogen Representative Invited

2:20pm - 2:50pm
Spotlight Presentation
Spotlight Presentation
8:30am - 9:00am
A Technical End-to-End Project Review to Ensure Commercial Viability
A Technical End-to-End Project Review to Ensure Commercial Viability
11:00am - 11:30am
Ecosystem Innovation: Synthetic biology
Ecosystem Innovation: Synthetic biology
8:45am - 9:30am
Panel Discussion: Strategies and Challenges in Manufacturing and Commercialization
Panel Discussion: Strategies and Challenges in Manufacturing and Commercialization
Thomas Bollenbach - Chief Technology Officer, Advanced Regenerative Manufacturing Institute
Loren Wagner - Head, CAR-T Manufacturing Operations, Bristol-Myers Squibb
Chris Gemmiti, Ph.D. - Head of Operations, Sentien Biotechnologies Inc.
Mahendra Rao - CEO, panCELLa
10:10am - 10:40am
Mitigation of Polysorbate Degradation
Mitigation of Polysorbate Degradation

Genentech Representative Invited

2:00pm - 2:30pm
Building the Biotech Ecosystem: Fireside chat: The mentor/mentee relationship
Keynote
Building the Biotech Ecosystem: Fireside chat: The mentor/mentee relationship
5:00pm - 5:30pm
Phase Appropriate Thinking – Microbiology and Contamination Control
Phase Appropriate Thinking – Microbiology and Contamination Control
Donald Singer - Consultant, formerly, GSK Senior Fellow, Microbiology, Biopharmaceutical GMP Operations, USA
11:40am - 12:00pm
AI in Cell and Gene Therapy Manufacturing
AI in Cell and Gene Therapy Manufacturing
Michael Roberts - Chief Technology Officer (Europe), Asklepios BioPharmaceutical, Inc.
11:40am - 12:00pm
AI in Cell and Gene Therapy Manufacturing
AI in Cell and Gene Therapy Manufacturing
Michael Roberts - Chief Technology Officer (Europe), Asklepios BioPharmaceutical, Inc.
1:45pm - 2:15pm
The case for rAAV titration by HPLC
The case for rAAV titration by HPLC
Franz Schnetzinger - Director Analytical Development, Gyroscope Therapeutics
9:00am - 10:30am
Data Science Tools for Accelerated Product Life Cycle
Keynote
Data Science Tools for Accelerated Product Life Cycle

Course Objective 

Hands-on learning of basic principles and best practices performing data analytics and data management for integrated bioprocesses. Designed for the biopharmaceutical and industrial biotech industry.

The course topics include:

  • Best bioprocess data analytics principles
  • Design of experiments
  • Data management and contextualization of data sources of different origin
  • Basic statistics for root cause analysis, scale-up, scale-down and comparability studies
  • Process validation analytics and monitoring (CPV)

 

Course Outline 

  • Digital Bioprocess Lab/ Plant: Data Management Workflow
  • Monitoring & Trending, raw data visualization
  • Inspecting your data for outliers
  • Setting process phases


  • Bioprocess data analytics: Best practices 
  • Conversion of raw data to reliable feature-based information
  • Design of Experiments (DoE)
  • Integrated Process Analysis over multiple unit operations
  • Root Cause Analysis of process variability
  • Comparability studies: Scale-up & Scale-Down and process validation tasks


Primary Audience 

This course is designed for all individuals who are involved in bioprocess development & manufacturing as well as process validation. This includes bioprocess development scientists, engineers, manufacturing and quality supervisors, and management. No sta­tistical or mathematical background is required.


Interactive seminar 

Bring your own laptop. You will perform exercises on bioprocess data management and analytics using the web-based educational software tool inCyght®.


Christoph Herwig - Bioprocess Engineering Professor, TU Wien, Austria
4:00pm - 4:30pm
Developing Analytical Tools and Models for Continuous Manufacturing
Developing Analytical Tools and Models for Continuous Manufacturing
4:00pm - 4:30pm
Developing Analytical Tools and Models for Continuous Manufacturing
Developing Analytical Tools and Models for Continuous Manufacturing
10:30am - 11:00am
Case Study: Best Practises for Streamlining Technology Transfer Processes
Case Study: Best Practises for Streamlining Technology Transfer Processes
Jonathan Tsang - Director, Manufacturing Sciences & Technology Biotech, Technology Transfer, Bayer
11:10am - 11:40am
Comparing Dielectric and Raman Spectroscopy for Online Cell Growth Monitoring of Biotherapeutics Manufacturing
Comparing Dielectric and Raman Spectroscopy for Online Cell Growth Monitoring of Biotherapeutics Manufacturing
Feng Xu - Sr. Scientist, Merck
3:00pm - 3:30pm
Networking Refreshment Break
Networking Refreshment Break
4:30pm - 5:00pm
Results from Using a Single Use Centrifuge
Results from Using a Single Use Centrifuge

Genentech Representative Invited

4:30pm - 5:00pm
Results from Using a Single Use Centrifuge
Results from Using a Single Use Centrifuge

Genentech Representative Invited

11:00am - 11:30am
Application of Data Analytics to Raw Materials
Application of Data Analytics to Raw Materials
Patrick Gammell - Executive Director, Amgen
9:30am - 10:00am
Patients and Partnering: Fireside chat: Maximizing value in an M&A
Keynote
Patients and Partnering: Fireside chat: Maximizing value in an M&A
1:55pm - 2:25pm
BioPhorum Working Group Initiatives for Impediments to Implementation
BioPhorum Working Group Initiatives for Impediments to Implementation

BioPhorum Working Group Member

11:40am - 11:45am
Transition to Technology Workshop
Transition to Technology Workshop
11:40am - 11:45am
Transition to Technology Workshop
Transition to Technology Workshop
8:55am - 9:00am
Course Leader Opening Remarks
Course Leader Opening Remarks
James Dean Vogel - Founder and Director , The BioProcess Institute
8:55am - 9:00am
Course Leader Opening Remarks
Course Leader Opening Remarks
James Dean Vogel - Founder and Director , The BioProcess Institute
2:45pm - 3:20pm
Spotlight Presentation
Spotlight Presentation
4:00pm - 4:45pm
Panel Discussion: Partnering solutions for staffing and recruitment issues in the CGT space
Panel Discussion: Partnering solutions for staffing and recruitment issues in the CGT space
Andrew Rigoglioso - Associate Director, Talent Acquisition, Flagship Pioneering
Alison Quelch - Director, Talent Acquisition, Global Product Development & Supply, Bristol-Myers Squibb
Jennifer Royal-Fitch - Lead Recruiter, Gene Therapy Program & The Orphan Disease Center, Univeristy of Pennsylvania
2:30pm - 3:00pm
Application of AI and Machine Learning to Aid Decision Making and Maintenance in Process Development and Manufacturing
Application of AI and Machine Learning to Aid Decision Making and Maintenance in Process Development and Manufacturing
Christian Airiau, Ph.D - Global Head of Data Sciences & Biologics Development, Sanofi
1:30pm - 2:00pm
Polysorbate, The Good, The Bad and The Ugly
Polysorbate, The Good, The Bad and The Ugly
Linda Yi - Senior Scientist, Analytical Development, Biogen
12:00pm - 12:20pm
Data Foundations for Enabling AI and ML: Building a data foundation for AI and ML applications
Data Foundations for Enabling AI and ML: Building a data foundation for AI and ML applications
2:30pm - 2:50pm
GE Healthcare
GE Healthcare
8:45am - 9:00am
Opening remarks
Opening remarks
3:30pm - 5:00pm
Single Use Applications for Cell & Gene Therapies - Cont'd
Single Use Applications for Cell & Gene Therapies - Cont'd
4:00pm - 4:30pm
Emerging tools and needs for AAV vector characterization
Emerging tools and needs for AAV vector characterization
Fabien Dorange - Head of Analytical Development, Genethon
2:00pm - 2:30pm
Guard Bands: Protecting You Against Measurement Uncertainty
Guard Bands: Protecting You Against Measurement Uncertainty
Steven Walfish - Principal Scientific Liaison, USP
2:45pm - 3:15pm
Scientific & Technology Presentations
Scientific & Technology Presentations
2:45pm - 3:15pm
Scientific & Technology Presentations
Scientific & Technology Presentations
4:00pm - 4:30pm
MSc as a Source Material
MSc as a Source Material
Kathy Williams - VP of Quality and Reg Affairs, RoosterBio, Inc., USA
1:30pm - 3:00pm
Session 3 - Choosing the most appropriate vector for your application part 1
Session 3 - Choosing the most appropriate vector for your application part 1
12:00pm - 12:30pm
Spotlight Presentation
Spotlight Presentation
5:00pm - 5:30pm
Development of a Model Predictive Controller for Feedback Control of Galactosylation and Fucosylation of mAb Expressed in a Perfusion CHO Cell Culture
Development of a Model Predictive Controller for Feedback Control of Galactosylation and Fucosylation of mAb Expressed in a Perfusion CHO Cell Culture
Brandon Downey - Principal Engineer, Lonza
5:00pm - 5:30pm
Development of a Model Predictive Controller for Feedback Control of Galactosylation and Fucosylation of mAb Expressed in a Perfusion CHO Cell Culture
Development of a Model Predictive Controller for Feedback Control of Galactosylation and Fucosylation of mAb Expressed in a Perfusion CHO Cell Culture
Brandon Downey - Principal Engineer, Lonza
8:30am - 9:00am
Mechanistic Chromatography Modeling
Mechanistic Chromatography Modeling
2:15pm - 2:45pm
Bench to Bedside Harmonization – Facilitating Delivery to Clinics & Hospitals
Bench to Bedside Harmonization – Facilitating Delivery to Clinics & Hospitals
Cristina Stoyanov - CMC Lead, Orchard Therapeutics, USA
7:40am - 7:45am
Chairperson’s Opening remarks
Chairperson’s Opening remarks
1:30pm - 2:00pm
How Cell Line Development is Affected by the Adoption of Perfusion Processes
How Cell Line Development is Affected by the Adoption of Perfusion Processes
Christine DeMaria - Director, Cell Line Development, Sanofi, (pending final confirmation)
1:45pm - 2:15pm
An Organization Approach To Single-Use Standardization For Technical, Quality And Procurement Improvements
An Organization Approach To Single-Use Standardization For Technical, Quality And Procurement Improvements
Hana Sheikh - Senior Engineer, Roche-Genentech
5:00pm - 5:30pm
Final Product Release Testing Strategies
Final Product Release Testing Strategies
10:10am - 10:15am
Chairperson’s Opening Remarks
Chairperson’s Opening Remarks
12:00pm - 12:30pm
Spotlight Presentations
Spotlight Presentations
8:15am - 8:45am
Ways NMR spectroscopy illuminates the path for process development of glycoconjugate vaccines
Ways NMR spectroscopy illuminates the path for process development of glycoconjugate vaccines
Kelly Sackett - Principal Scientist, Pfizer
7:55am - 8:00am
Chairpersons Opening Remarks
Chairpersons Opening Remarks
11:30am - 12:00pm
Next Generation Cell Line & Cell Culture Process Development
Next Generation Cell Line & Cell Culture Process Development
Kitty Agarwal - Senior Scientist, Biologics Process Development, Bristol-Myers Squibb, (pending final confirmation)
10:30am - 10:55am
Quantitative Analytical Technologies for Cell & Gene Therapies
Quantitative Analytical Technologies for Cell & Gene Therapies
Barrett J. Nehila - Associate Director, Analytical Development, Torque Therapeutics
10:50am - 11:10am
Potency & Fully Characterizing your Cell Product
Potency & Fully Characterizing your Cell Product
10:50am - 11:10am
Potency & Fully Characterizing your Cell Product
Potency & Fully Characterizing your Cell Product
11:30am - 12:00pm
Ecosystem Innovation: Fireside chat: Pricing
Keynote
Ecosystem Innovation: Fireside chat: Pricing
11:00am - 11:30am
Preparing for Commercial Launch and Overcoming Pain Points – CMC
Preparing for Commercial Launch and Overcoming Pain Points – CMC
10:40am - 11:10am
Computational Methods to Simulate Antibody HCP Interactions
Computational Methods to Simulate Antibody HCP Interactions

Sanofi Representative Invited

11:00am - 11:30am
Early Engineering and Formulation Approaches to Improve Physicochemical Stability of Therapeutic Peptides
Early Engineering and Formulation Approaches to Improve Physicochemical Stability of Therapeutic Peptides
Lin Zhang, Ph.D. - Research Scientist, BioTechnology Discovery Research, Eli Lilly and Company
11:45am - 12:10pm
AI in Cell and Gene Therapy Manufacturing
AI in Cell and Gene Therapy Manufacturing
Michael Roberts - Chief Technology Officer (Europe), Asklepios BioPharmaceutical, Inc.
10:55am - 11:15am
Encapsulation Approaches – A Sigilon Case Study
Encapsulation Approaches – A Sigilon Case Study
Martha Rook - SVP, Manufacturing, Sigilon Therapeutics Inc.
3:00pm - 3:30pm
Building the Biotech Ecosystem: New players in the healthcare space
Building the Biotech Ecosystem: New players in the healthcare space
1:45pm - 2:15pm
Approaches to Speed Up Cell Line Development
Approaches to Speed Up Cell Line Development
1:30pm - 2:00pm
Large-Scale Implementation of a Continuous Multicolumn Chromatography Process
Large-Scale Implementation of a Continuous Multicolumn Chromatography Process

AstraZeneca Representative Invited

7:45am - 8:15am
Gene edited Allogeneic cells
Gene edited Allogeneic cells
Kalai Sivarajan - Team Leader, CMC, Precision Biosciences (pending final confirmation)
2:30pm - 3:00pm
Building the Biotech Ecosystem: Building your biotech from the ground up
Building the Biotech Ecosystem: Building your biotech from the ground up
11:15am - 11:45am
Process Development Considerations for Exosomes
Process Development Considerations for Exosomes
Jon A. Rowley, Ph.D. - Founder & Chief Product Officer, RoosterBio Inc.
9:00am - 9:30am
PAT System Development and Implementation for Biopharmaceutical Manufacturing Process Real-time Monitoring and Control in GMP
PAT System Development and Implementation for Biopharmaceutical Manufacturing Process Real-time Monitoring and Control in GMP
Ting-Kuo Huang, PhD - Principal Engineer, Genentech
2:30pm - 2:50pm
BIA Separations
BIA Separations
9:00am - 10:30am
Single Use Applications for Cell & Gene Therapies
Single Use Applications for Cell & Gene Therapies
8:45am - 9:15am
PANEL: Universal Cells: Is the Future for CGT Allogeneic ‘Off the Shelf’?
PANEL: Universal Cells: Is the Future for CGT Allogeneic ‘Off the Shelf’?
Lior Raviv - Vice President, Pluristem Therapeutics Inc.
Philip Lee - COO and Co-Founder, Senti Biosciences
Betsy Rezner - Director, Process & Assay Development, Fate Therapeutics Inc.
Kalai Sivarajan - Team Leader, CMC, Precision Biosciences (pending final confirmation)
Antonio Lee, Ph.D. - CEO & Managing Director, Medipost America Inc.
8:15am - 8:45am
Strategy for Preparing for the Possibility of a Breakthrough Designation
Strategy for Preparing for the Possibility of a Breakthrough Designation
10:40am - 11:10am
Emerging Fields Of Drug Therapies And Their Commercial Scale Production Challenges
Emerging Fields Of Drug Therapies And Their Commercial Scale Production Challenges
11:10am - 11:40am
Updates from Biophorum - Primary Separations and Filtration
Updates from Biophorum - Primary Separations and Filtration
10:30am - 11:00am
Meta Data – Leveraging Data to Reduce Design Space and Speed Development
Meta Data – Leveraging Data to Reduce Design Space and Speed Development
11:00am - 11:30am
Optimizing Upstream Process Development Using Modeling and Integration of Advanced Analytics
Optimizing Upstream Process Development Using Modeling and Integration of Advanced Analytics
10:10am - 10:40am
Roadmap to PAT
Roadmap to PAT
Julia Ding, PhD - Director, Process Development Analytical & Analytical Development, Bristol Myers Squibb
10:30am - 11:00am
Developability: Analytical Platform Approaches for Complex Proteins
Developability: Analytical Platform Approaches for Complex Proteins
Sarah Auclair - Scientist, Sanofi
9:30am - 10:00am
Implementation of an Integrated Approach for Fingerprinting Cell Culture Media
Implementation of an Integrated Approach for Fingerprinting Cell Culture Media
Kathryn Aron, Ph.D. - Group Leader, Cell Culture Process Development, Bristol-Myers Squibb
2:00pm - 2:40pm
Exploring partnerships and industry success in 2020 and beyond
Exploring partnerships and industry success in 2020 and beyond
10:30am - 11:00am
Application of Digitalization, Machine Learning and Artificial Intelligence in Upstream Process Development
Application of Digitalization, Machine Learning and Artificial Intelligence in Upstream Process Development
John Bowers - Senior Principal Scientist, Merck
4:00pm - 4:30pm
Utilizing Prior Knowledge Assessments of Process Characterization Cell Culture and Purification Operations to Accelerate FMEA Risk Assessments During Process Design
Utilizing Prior Knowledge Assessments of Process Characterization Cell Culture and Purification Operations to Accelerate FMEA Risk Assessments During Process Design
4:00pm - 4:30pm
Standardization in Manufacturing of Cell Therapy Products
Standardization in Manufacturing of Cell Therapy Products
8:45am - 9:15am
Getting Value from Data
Getting Value from Data
Eugene Tung - Executive Director of Manufacturing IT, Merck
1:30pm - 2:00pm
Ecosystem Innovation: Diversity and inclusion: Cultivating the next generation of biotech execs
Ecosystem Innovation: Diversity and inclusion: Cultivating the next generation of biotech execs
12:00pm - 12:30pm
Ecosystem Innovation: To go IPO or remain private?
Ecosystem Innovation: To go IPO or remain private?
5:00pm - 5:30pm
Manufacturing in the Industry 4.0 Era: How to Balance Innovation with Performance while not Being Disrupted
Manufacturing in the Industry 4.0 Era: How to Balance Innovation with Performance while not Being Disrupted
Christos Varsakelis - Senior Manager Global Data Analytics & Innovation, GSK Vaccines
9:00am - 9:30am
Scale-Down of Chromatography
Scale-Down of Chromatography

Merck Representative Invited

9:15am - 9:45am
Scientific & Technology Presentations
Scientific & Technology Presentations
3:30pm - 4:00pm
Starting Material Standardization for Cell Therapies
Starting Material Standardization for Cell Therapies
Scott Burger - Principal, Advanced Cell & Gene Therapy, USA
4:00pm - 4:30pm
Cell Line Engineering of AAV/Lentiviral Vectors
Cell Line Engineering of AAV/Lentiviral Vectors
4:30pm - 5:00pm
Data Governance and Data Integrity as a framework during Process Development
Data Governance and Data Integrity as a framework during Process Development
Sara Levy - CSV & Data integrity Manager, Pluristem Therapeutics Inc.
11:00am - 11:30am
Overcoming Downstream Challenges at New Continuous Facility in Philadelphia
Overcoming Downstream Challenges at New Continuous Facility in Philadelphia

GSK Representative invited

1:45pm - 2:15pm
Identifying Critical Quality Attribute Performance Impact During Process Characterization
Identifying Critical Quality Attribute Performance Impact During Process Characterization
1:45pm - 2:15pm
Identifying Critical Quality Attribute Performance Impact During Process Characterization
Identifying Critical Quality Attribute Performance Impact During Process Characterization
9:30am - 10:00am
Reporter Cell Line Development
Reporter Cell Line Development
Benson Li - Associate Principal Scientist, Merck
2:00pm - 2:30pm
Fujifilm Irving
Fujifilm Irving
7:55am - 8:00am
Chairperson’s Opening remarks
Chairperson’s Opening remarks
11:30am - 12:10pm
Mechanistic Understanding of Recombinant Adeno-Associated Virus Production
Mechanistic Understanding of Recombinant Adeno-Associated Virus Production
Sha Sha - Postdoc, Massachusetts Institute of Technology
1:30pm - 2:00pm
Tissue Maturation and Bioreactor Culture
Tissue Maturation and Bioreactor Culture
George Joseph Christ - Professor of Biomedical Engineering and Orthopaedic Surgery, University of Virginia
2:00pm - 2:30pm
At-Scale Demonstration of an Integrated Continuous Multi-Column Chromatography Process
At-Scale Demonstration of an Integrated Continuous Multi-Column Chromatography Process

Just Biotherapuetics Representative Invited

2:00pm - 2:30pm
Intertek
Intertek
11:10am - 11:40am
Microchip electrophoresis with high pressure mass spectrometry detection for at-line nutrient monitoring
Microchip electrophoresis with high pressure mass spectrometry detection for at-line nutrient monitoring
Seth Madren - Scientist II, Biogen
11:10am - 11:40am
Process-Related Impurities: Case Studies on Risk Assessment
Process-Related Impurities: Case Studies on Risk Assessment
4:00pm - 4:30pm
Implementation of Next Generation Clarification Technologies
Implementation of Next Generation Clarification Technologies
4:00pm - 4:30pm
Implementation of Next Generation Clarification Technologies
Implementation of Next Generation Clarification Technologies
9:00am - 9:30am
Application of CRISPR Cas9 To Enhance Host Cell Lines
Application of CRISPR Cas9 To Enhance Host Cell Lines
Anke Mayer-Bartschmid, - Cell and Protein Sciences, Pharmaceuticals Division, , Bayer Pharma
2:30pm - 3:00pm
Immunogenicity/ Bioanalytical strategy of complex molecules/ regulatory submissions
Immunogenicity/ Bioanalytical strategy of complex molecules/ regulatory submissions
Boris Gorovits - Bioanalytical Sciences Lead, Senior Director, Pfizer BioMedicine Design, USA
2:15pm - 2:45pm
Adapting Media Development and Workflows to Support Continuous Processing
Adapting Media Development and Workflows to Support Continuous Processing
2:15pm - 2:45pm
Adapting Media Development and Workflows to Support Continuous Processing
Adapting Media Development and Workflows to Support Continuous Processing
10:00am - 10:30am
Cell Culture and Expansion
Cell Culture and Expansion
Jan Jensen - CEO and Founder, Trailhead Biosystems Inc.
11:30am - 11:35am
Changeover to Technology Workshops
Changeover to Technology Workshops
5:00pm - 5:30pm
PANEL: The Future of Adeno and Lenti Viral Vector Production & Other Production Platforms
PANEL: The Future of Adeno and Lenti Viral Vector Production & Other Production Platforms
2:15pm - 2:45pm
Product Dependent Cryopreservation Protocols
Product Dependent Cryopreservation Protocols
David McKenna - Professor and American Red Cross Chair in Transfusion Medicine, Department of Laboratory Medicine and Pathology, University of Minnesota
10:25am - 10:30am
Chairperson’s Opening Remarks
Chairperson’s Opening Remarks
8:15am - 8:45am
Building a Fully Integrated Continuous Bioprocessing cGMP Plant: Promises It Holds and Lessons Learned from It
Building a Fully Integrated Continuous Bioprocessing cGMP Plant: Promises It Holds and Lessons Learned from It
4:30pm - 5:00pm
A Case Study in Applying PAT to the Continuous Biomanufacturing of Monoclonal Antibodies
A Case Study in Applying PAT to the Continuous Biomanufacturing of Monoclonal Antibodies
Moo Sun Hong - Postdoc, MIT
4:30pm - 5:00pm
A Case Study in Applying PAT to the Continuous Biomanufacturing of Monoclonal Antibodies
A Case Study in Applying PAT to the Continuous Biomanufacturing of Monoclonal Antibodies
Moo Sun Hong - Postdoc, MIT
2:00pm - 2:30pm
Multi-Faceted Approach To Ensure Clonality Assurance and Clonal Stability
Multi-Faceted Approach To Ensure Clonality Assurance and Clonal Stability
Lina Chakrabarti - Senior Manager, R & D, Astrazeneca
1:40pm - 1:45pm
Chairperson’s Opening Remarks
Chairperson’s Opening Remarks
1:40pm - 1:45pm
Chairperson’s Opening Remarks
Chairperson’s Opening Remarks
12:10pm - 12:40pm
Spotlight Presentation
Spotlight Presentation
10:10am - 10:40am
How to Verify You've Chosen the Right Candidate? Overcoming Pain Points in Target Identification, Target Characterization, and Target Validation
How to Verify You've Chosen the Right Candidate? Overcoming Pain Points in Target Identification, Target Characterization, and Target Validation
11:15am - 11:35am
Instrumentation and Mechanisms to Drive Efficient therapies
Instrumentation and Mechanisms to Drive Efficient therapies
Alan Smith, Ph.D. - Executive Vice President, Technical Operations, Bellicum Pharmaceuticals
10:55am - 11:20am
Manufacturing and Quality Control of Immunotherapies
Manufacturing and Quality Control of Immunotherapies
Steve Oh - Director Stem Cell Bioprocessing & Institute Professor,, Bioprocessing Technology Institute
1:40pm - 1:45pm
Chairpersons Opening Remarks
Chairpersons Opening Remarks
Ran Zheng - Chief Technical Officer, Orchard Therapeutics
10:15am - 10:45am
Adherent Cell Manufacturing & Process Development
Adherent Cell Manufacturing & Process Development
Lior Raviv - Vice President, Pluristem Therapeutics Inc.
8:10am - 8:15am
Chairperson’s Opening Remarks
Chairperson’s Opening Remarks
8:15am - 8:45am
Panel Discussion: Steps Toward Digital Transformation – Overcoming Setup, Data Management, Integration Solution and Security Challenges
Panel Discussion: Steps Toward Digital Transformation – Overcoming Setup, Data Management, Integration Solution and Security Challenges
Christoph Herwig - Bioprocess Engineering Professor, TU Wien, Austria
11:45am - 12:20pm
Spotlight Presentation
Spotlight Presentation

Use this event to raise your corporate profile and demonstrate your products and services to our targeted, multidisciplinary audience. By joining us in sponsoring and exhibiting at this event, you will be able to:

  • Use an exhibition stand to meet new clients in the main networking area
  • Raise your corporate profile and shape your corporate image with logo placement
  • Ensure market presence as a thought leader with a speaking position


For sponsorship and exhibition opportunities please contact: Kristin Skahan; Email: kristin.skahan@knect365.com

11:45am - 12:20pm
Spotlight Presentation
Spotlight Presentation

Use this event to raise your corporate profile and demonstrate your products and services to our targeted, multidisciplinary audience. By joining us in sponsoring and exhibiting at this event, you will be able to:

  • Use an exhibition stand to meet new clients in the main networking area
  • Raise your corporate profile and shape your corporate image with logo placement
  • Ensure market presence as a thought leader with a speaking position


For sponsorship and exhibition opportunities please contact: Kristin Skahan; Email: kristin.skahan@knect365.com

11:35am - 12:05pm
Technology Workshops
Technology Workshops
10:10am - 10:40am
High-Resolution Optical and Dielectric Methods for Monitoring Cells in Bioprocesses
High-Resolution Optical and Dielectric Methods for Monitoring Cells in Bioprocesses
Michael Butler - Principal Investigator in Cell Technology, National Institute of Bioprocessing Research & Training (NIBRT), Ireland
1:25pm - 1:55pm
High throughput Developability Assessments To Reduce Timelines
High throughput Developability Assessments To Reduce Timelines
Alejandro Carpy - Group Leader, Roche
10:10am - 10:40am
Manufacturing Strategies and Novel Technologies to Accelerate New Modalities
Manufacturing Strategies and Novel Technologies to Accelerate New Modalities
Sally Alkass - Associate Director, Biogen
4:30pm - 5:00pm
Digital Transformation and Smart Biomanufacturing: Case Study from Bayer
Digital Transformation and Smart Biomanufacturing: Case Study from Bayer
Oliver Hesse - Director, Lab Automation and Data Management, Biological Development, Bayer Healthcare LLC
3:25pm - 3:30pm
Chairperson’s Opening Remarks
Chairperson’s Opening Remarks
David Smith - Chief Commercial Officer, Healios
11:00am - 11:30am
Digital Twins and Data Science for Robust Control Strategies
Digital Twins and Data Science for Robust Control Strategies
Christoph Herwig - Bioprocess Engineering Professor, TU Wien, Austria
4:00pm - 5:30pm
Session 5 – Purification Requirements
Session 5 – Purification Requirements
4:30pm - 5:00pm
Data Management and the Use of AI
Data Management and the Use of AI
4:55pm - 5:00pm
Chairperson’s Opening Remarks
Chairperson’s Opening Remarks
12:00pm - 12:30pm
Scaffold Fabrication
Scaffold Fabrication
8:00am - 8:45am
State of the Industry
State of the Industry
Michael Lehmicke - Director, Science and Industry Affairs, Alliance for Regenerative Medicine
3:30pm - 5:00pm
Data Science Tools for Accelerated Product Life Cycle
Data Science Tools for Accelerated Product Life Cycle

Course Objective 

Hands-on learning of basic principles and best practices performing data analytics and data management for integrated bioprocesses. Designed for the biopharmaceutical and industrial biotech industry.

The course topics include:

  • Best bioprocess data analytics principles
  • Design of experiments
  • Data management and contextualization of data sources of different origin
  • Basic statistics for root cause analysis, scale-up, scale-down and comparability studies
  • Process validation analytics and monitoring (CPV)

 

Course Outline 

  • Digital Bioprocess Lab/ Plant: Data Management Workflow
  • Monitoring & Trending, raw data visualization
  • Inspecting your data for outliers
  • Setting process phases


  • Bioprocess data analytics: Best practices 
  • Conversion of raw data to reliable feature-based information
  • Design of Experiments (DoE)
  • Integrated Process Analysis over multiple unit operations
  • Root Cause Analysis of process variability
  • Comparability studies: Scale-up & Scale-Down and process validation tasks


Primary Audience 

This course is designed for all individuals who are involved in bioprocess development & manufacturing as well as process validation. This includes bioprocess development scientists, engineers, manufacturing and quality supervisors, and management. No sta­tistical or mathematical background is required.


Interactive seminar 

Bring your own laptop. You will perform exercises on bioprocess data management and analytics using the web-based educational software tool inCyght®.

Christoph Herwig - Bioprocess Engineering Professor, TU Wien, Austria
2:15pm - 2:45pm
Transposon-Mediated Gene Integration for Future GMP Production
Transposon-Mediated Gene Integration for Future GMP Production
8:45am - 9:15am
Regulations For Interchangeability Studies for Biosimilars
Regulations For Interchangeability Studies for Biosimilars
Renata Varga, Ph.D. - Scientist - Characterization, Analytical Sciences, Global Biological CMC, Teva Pharmaceuticals
11:30am - 11:40am
Analytical Method Development and Validation – Building the Characterization Testing Foundation & Toolkit
Analytical Method Development and Validation – Building the Characterization Testing Foundation & Toolkit
11:30am - 11:40am
Analytical Method Development and Validation – Building the Characterization Testing Foundation & Toolkit
Analytical Method Development and Validation – Building the Characterization Testing Foundation & Toolkit
8:10am - 8:15am
Chairperson's Opening Remarks
Chairperson's Opening Remarks
4:25pm - 4:55pm
Re- Dosing: Is Gene Therapy Really a Cure?
Re- Dosing: Is Gene Therapy Really a Cure?
Kei Kishimoto - CSO, Selecta Biosciences
1:55pm - 2:25pm
Application of Metabolomics in A Legacy Process
Application of Metabolomics in A Legacy Process
Brendan Bishop - Associate Engineer/Scientist, Bristol-Myers Squibb
9:00am - 9:30am
Patients and Partnering: The role of patient advocacy groups and disease foundations in our ecosystem
Patients and Partnering: The role of patient advocacy groups and disease foundations in our ecosystem
11:45am - 12:15pm
Technology Workshop
Technology Workshop
11:45am - 12:15pm
Technology Workshop
Technology Workshop
9:00am - 10:30am
Single-Use Technologies for Cell & Gene Therapies
Single-Use Technologies for Cell & Gene Therapies

Overview:

An Introduction to Single-Use Technologies and the specific attributes and quality needs when implementing Single-Use Technologies in Cell and Gene Therapy Manufacturing. BPI’s training workshop will focus on the importance and the implementation of Single-Use technologies in production of manufacturing facilities. The format of the course includes valuable and unbiased classroom instruction by industry expert James Dean Vogel, P.E. With Mr. Vogel’s assistance, course participants will experience the latest Single-Use products first hand during the lab portion of the course.

Topics include:

Brief Review of Cell and Gene Production Methods and Regulatory Considerations

Single-Use Bioprocess Equipment - Materials of Construction

Single-Use Advantages and Disadvantages

Single-Use Requirements for Cell and Gene Therapies and Risks

Single-Use Components available for Hands-On Demonstration

Attendees range from end-users, suppliers, sales and regulatory personnel who have a general understanding of the SUT industry and want to experience Single-Use products hands on!

James Dean Vogel - Founder and Director , The BioProcess Institute
1:55pm - 2:25pm
Automated High throughput Chromatography Screening Platform for Virus Purification
Automated High throughput Chromatography Screening Platform for Virus Purification

Merck Representative Invited

10:15am - 10:35am
Will Allogeneic Cell Therapies Replace the Current Autologous Models?
Will Allogeneic Cell Therapies Replace the Current Autologous Models?
Geoffrey Hodge - Chief Technical Officer, Unum Therapeutics
10:35am - 10:55am
Senti Bio Case Study – Gene Edited MSc
Senti Bio Case Study – Gene Edited MSc
Philip Lee - COO and Co-Founder, Senti Biosciences
8:45am - 9:15am
Overcoming Downstream Development Problems with Multimeric Proteins
Overcoming Downstream Development Problems with Multimeric Proteins

Presenter to be Determined

11:00am - 11:30am
Challenges of New Modality Molecule Formats on Productivity and Product Quality
Challenges of New Modality Molecule Formats on Productivity and Product Quality
Lianchun Fan, Ph D. - Director of Cellular & Molecular Biology Science, Process Science, Abbvie Bioresearch Center, (pending final confirmation)
10:40am - 11:10am
Noninvasive Analytics for Product Inspection and Process Monitoring
Noninvasive Analytics for Product Inspection and Process Monitoring
Bruce Yu - Professor, Maryland University
1:30pm - 3:00pm
Single Use Applications for Cell & Gene Therapies - Cont'd
Single Use Applications for Cell & Gene Therapies - Cont'd
11:20am - 11:45am
Analytical Method Development and Validation – Building the Characterization Testing Foundation & Toolkit
Analytical Method Development and Validation – Building the Characterization Testing Foundation & Toolkit
Lara Ionescu Silverman - Senior Director, Research and Development, DiscGenics
11:00am - 11:30am
Cell Harvest
Cell Harvest
8:55am - 9:00am
Chairperson's Opening Remarks
Chairperson's Opening Remarks
Christoph Herwig - Bioprocess Engineering Professor, TU Wien, Austria
8:55am - 9:00am
Chairperson's Opening Remarks
Chairperson's Opening Remarks
Christoph Herwig - Bioprocess Engineering Professor, TU Wien, Austria
4:00pm - 4:30pm
Advanced Automation of Single-Use Systems – Implementation of the Flexible Plug-and-Play Approach
Advanced Automation of Single-Use Systems – Implementation of the Flexible Plug-and-Play Approach
Pietro Perrone - Automation Process Engineer, GE Healthcare
1:25pm - 1:55pm
Manufacturing of Novel Immuno-Oncology Biologics at the Right Scale
Manufacturing of Novel Immuno-Oncology Biologics at the Right Scale
Rizwan Manzer - Director of CMC and Manufacturing, Verseau Therapeutics
12:20pm - 1:00pm
Data Foundations for Enabling AI and ML: Responsible AI and machine learning for drug discovery and development
Data Foundations for Enabling AI and ML: Responsible AI and machine learning for drug discovery and development
12:05pm - 12:35pm
Technology Workshop
Technology Workshop
12:05pm - 12:35pm
Technology Workshop
Technology Workshop
2:00pm - 2:30pm
Artificial Intelligence, Machine Learning and Data Science: How to Utilise in Bioprocessing?
Artificial Intelligence, Machine Learning and Data Science: How to Utilise in Bioprocessing?
Michael Sokolov - COO and Co-founder, Datahow AG
8:15am - 8:45am
A Robust Platform Design For Both Antibody And Bispecific Production
A Robust Platform Design For Both Antibody And Bispecific Production
Yang Wu - Scientist II, Macrogenics
10:00am - 10:30am
Analysis of Cell Lines
Analysis of Cell Lines
James Lambropoulos - Engineer, Biogen
4:00pm - 4:30pm
Cryopreservation & Storage of Viral Vectors
Cryopreservation & Storage of Viral Vectors
Erik Woods - Co-Founder and Chief Science Officer, Ossium Health, Inc., USA
1:30pm - 2:00pm
PANEL: Autologous Manufacturing – What will Autologous Manufacturing of the Future Look Like?
PANEL: Autologous Manufacturing – What will Autologous Manufacturing of the Future Look Like?
Jennifer Adrian - Manager, Cellular Therapy Manufacturing Operations, bluebird bio
Adam Haskett - Associate Director, External Manufacturing, Kite Pharma
10:30am - 11:15am
Partnering and Collaborations among Investors, Incubators and Biotechnology Companies
Partnering and Collaborations among Investors, Incubators and Biotechnology Companies
Jennifer Griffin - VP Industrial Strategy & Investments, Massachusetts Life Science Center
Paul Lammers - President & CEO, Triumvira Immunologics
3:30pm - 4:00pm
Sensors
Sensors
2:25pm - 2:55pm
Scientific & Technology Presentations
Scientific & Technology Presentations
2:25pm - 2:55pm
Scientific & Technology Presentations
Scientific & Technology Presentations
9:00am - 9:30am
Implementation of Real Time, Online Monitoring Methods for Performance and Product Quality in Cell Culture Bioreactors
Implementation of Real Time, Online Monitoring Methods for Performance and Product Quality in Cell Culture Bioreactors
George Zhou, PhD - Research Fellow, Merck & Co., Inc.
1:25pm - 1:55pm
Fully Automated Platform Approach to FIH Purification Development: mAbs and Beyond
Fully Automated Platform Approach to FIH Purification Development: mAbs and Beyond

Sanofi Representative Invited

3:30pm - 5:00pm
Panel Discussion: Best Practices and Quality Control Strategies to Ensure Raw Materials Supply Chain Security
Panel Discussion: Best Practices and Quality Control Strategies to Ensure Raw Materials Supply Chain Security
  • Best practices to monitor and control raw material variability: Industry and Supplier perspectives
  • What risk-based approaches are industry taking to manage quality control for suppliers and raw material changes from suppliers?
  • How are industry working together with vendors to ensure quality control of raw materials?
  • Sourcing strategies – Feedback on how to conduct quality audits
  • Supplier controls to ensure attributes are in a state of control
  • Supply chain security: Lessons learnt on supply chain agreements
  • Supply chain management strategies for single use supply chains
8:00am - 9:00am
PANEL: Commercial Trailblazers: Valuable Lessons Learnt on the Path to Commercialization
PANEL: Commercial Trailblazers: Valuable Lessons Learnt on the Path to Commercialization
4:30pm - 5:00pm
Formulation & Freezing Process Optimization from Small to Large Scale
Formulation & Freezing Process Optimization from Small to Large Scale
11:30am - 12:00pm
Using Prior Knowledge to Move Quickly Through Development
Using Prior Knowledge to Move Quickly Through Development

Genentech Representative Invited

11:30am - 12:00pm
Digitalisation of Raw Material Data and Application of Data Analytics to Increase Understanding and Control Variation
Digitalisation of Raw Material Data and Application of Data Analytics to Increase Understanding and Control Variation

A Representative from Genentech

11:00am - 12:30pm
Single-Use Technologies for Cell & Gene Therapies
Single-Use Technologies for Cell & Gene Therapies

Overview:

An Introduction to Single-Use Technologies and the specific attributes and quality needs when implementing Single-Use Technologies in Cell and Gene Therapy Manufacturing. BPI’s training workshop will focus on the importance and the implementation of Single-Use technologies in production of manufacturing facilities. The format of the course includes valuable and unbiased classroom instruction by industry expert James Dean Vogel, P.E. With Mr. Vogel’s assistance, course participants will experience the latest Single-Use products first hand during the lab portion of the course.

Topics include:

Brief Review of Cell and Gene Production Methods and Regulatory Considerations

Single-Use Bioprocess Equipment - Materials of Construction

Single-Use Advantages and Disadvantages

Single-Use Requirements for Cell and Gene Therapies and Risks

Single-Use Components available for Hands-On Demonstration

Attendees range from end-users, suppliers, sales and regulatory personnel who have a general understanding of the SUT industry and want to experience Single-Use products hands on!

James Dean Vogel - Founder and Director , The BioProcess Institute
10:40am - 11:10am
The Different Focus of COGs in Continuous Manufacturing Process Compared to Fed Batch – Medium, Perfusion Columns, and Continuous Chromatography
The Different Focus of COGs in Continuous Manufacturing Process Compared to Fed Batch – Medium, Perfusion Columns, and Continuous Chromatography

Bayer Representative Invited

4:30pm - 5:00pm
Spotlight Presentation
Spotlight Presentation
3:30pm - 5:00pm
Single-Use Technologies for Cell & Gene Therapies
Single-Use Technologies for Cell & Gene Therapies

Overview:

An Introduction to Single-Use Technologies and the specific attributes and quality needs when implementing Single-Use Technologies in Cell and Gene Therapy Manufacturing. BPI’s training workshop will focus on the importance and the implementation of Single-Use technologies in production of manufacturing facilities. The format of the course includes valuable and unbiased classroom instruction by industry expert James Dean Vogel, P.E. With Mr. Vogel’s assistance, course participants will experience the latest Single-Use products first hand during the lab portion of the course.

Topics include:

Brief Review of Cell and Gene Production Methods and Regulatory Considerations

Single-Use Bioprocess Equipment - Materials of Construction

Single-Use Advantages and Disadvantages

Single-Use Requirements for Cell and Gene Therapies and Risks

Single-Use Components available for Hands-On Demonstration

Attendees range from end-users, suppliers, sales and regulatory personnel who have a general understanding of the SUT industry and want to experience Single-Use products hands on!

James Dean Vogel - Founder and Director , The BioProcess Institute
9:30am - 10:00am
Raw Materials/Starting Materials
Raw Materials/Starting Materials
11:30am - 11:50am
Innovation in Drug Delivery and Formulation Technology: Drawing the parallels of innovation from design firms to pharma - An IDEO perspective
Keynote
Innovation in Drug Delivery and Formulation Technology: Drawing the parallels of innovation from design firms to pharma - An IDEO perspective
2:00pm - 2:30pm
Case Study: Advancement in Raw Material Management and Control to Reduce Raw Material Variability in Clinical and Commercial Manufacturing
Case Study: Advancement in Raw Material Management and Control to Reduce Raw Material Variability in Clinical and Commercial Manufacturing

A Representative from Genentech

3:25pm - 3:55pm
Raw Materials: BOMs, Risks & Securing Supply
Raw Materials: BOMs, Risks & Securing Supply
Tom Walls - Associate Director Supply Chain, bluebirdbio
8:45am - 9:15am
CMC Development (Shortcuts?) for Breakthrough Therapies
CMC Development (Shortcuts?) for Breakthrough Therapies
5:00pm - 5:30pm
Towards a Digital Twin Application in Downstream Process Development for Smooth and Efficient BLAs
Towards a Digital Twin Application in Downstream Process Development for Smooth and Efficient BLAs
1:45pm - 2:15pm
Fresh vs. Cryopreserved: Tightening up Supply Chains
Fresh vs. Cryopreserved: Tightening up Supply Chains
Jason Acker - Professor, Laboratory Medicine and Pathology, University of Alberta, Canada
11:10am - 11:30am
Manufacturing and Quality Control of Immunotherapies
Manufacturing and Quality Control of Immunotherapies
Steve Oh - Director Stem Cell Bioprocessing & Institute Professor,, A*Star, Singapore
11:10am - 11:30am
Manufacturing and Quality Control of Immunotherapies
Manufacturing and Quality Control of Immunotherapies
Steve Oh - Director Stem Cell Bioprocessing & Institute Professor,, A*Star, Singapore
3:30pm - 4:00pm
Automation in Cell Line Generation
Automation in Cell Line Generation
10:30am - 11:00am
Speed to BLA for Accelerated Programs
Speed to BLA for Accelerated Programs
1:55pm - 2:25pm
Multi-Attribute Methods (MS) for in process monitoring and rapid testing of mAbs and non-mAbs in upstream and downstream process development
Multi-Attribute Methods (MS) for in process monitoring and rapid testing of mAbs and non-mAbs in upstream and downstream process development
Yaping Sun - Senior Scientist, Takeda
8:30am - 9:00am
Smart Strategies to Enhance Productivity, Improve Titres, Cell Culture Performance and Product Quality
Smart Strategies to Enhance Productivity, Improve Titres, Cell Culture Performance and Product Quality
11:35am - 12:05pm
Sartorius
Sartorius
10:00am - 10:20am
What will AI actually solve in the next 5–10 years?
Keynote
What will AI actually solve in the next 5–10 years?
8:30am - 9:00am
Improving Process Understanding and Speed with Raman Spectroscopy
Improving Process Understanding and Speed with Raman Spectroscopy
David Chiu - Scientist, Seattle Genetics
11:00am - 11:30am
Data Science and Digitalization Is The Perceived Enabler For Accelerating Technology Transfer And Process Validation
Data Science and Digitalization Is The Perceived Enabler For Accelerating Technology Transfer And Process Validation
Christoph Herwig - Bioprocess Engineering Professor, TU Wien, Austria
11:10am - 11:40am
Manufacturing Technologies, Facility Design and Industrialised Supply Chains for Cell and Gene Therapies
Manufacturing Technologies, Facility Design and Industrialised Supply Chains for Cell and Gene Therapies
Justin Horvath - Director of Manufacturing Sciences, REGENXBIO Inc
2:30pm - 3:00pm
Systems thinking for you manufacturing process or Developing Your Manufacturing Process from A->Z
Systems thinking for you manufacturing process or Developing Your Manufacturing Process from A->Z
Priya Baraniak - Scientist, RoosterBio
10:00am - 10:30am
Patients and Partnering: Top considerations when engaging a potential strategic partnership
Patients and Partnering: Top considerations when engaging a potential strategic partnership
3:55pm - 4:25pm
Efficiency Challenges as a Result of Viral Vectors
Efficiency Challenges as a Result of Viral Vectors
Adam Haskett - Associate Director, External Manufacturing, Kite Pharma
12:00pm - 12:20pm
Healthcare Delivery, Hospitals and Precision Medicine: AI and genomic approaches to diagnostics in the rare-disease space
Healthcare Delivery, Hospitals and Precision Medicine: AI and genomic approaches to diagnostics in the rare-disease space
1:30pm - 2:00pm
Case Study from Biogen: Manufacturing Intelligence and Control Strategies
Case Study from Biogen: Manufacturing Intelligence and Control Strategies
Rob Guenard, PhD - Senior Director, Global Manufacturing Science, Biogen
11:30am - 12:00pm
Interactive Panel Discussion – Proven Strategies for Increasing Speed to IND
Interactive Panel Discussion – Proven Strategies for Increasing Speed to IND
11:00am - 11:30am
Pathogen Safety Margins for Gene Therapy Manufacturing
Pathogen Safety Margins for Gene Therapy Manufacturing
Thomas Kreil - Vice President, Global Pathogen Safety, Takeda
11:15am - 11:45am
Suspension Systems in Continuous Viral Vector Production Processes
Suspension Systems in Continuous Viral Vector Production Processes
Felipe Tapia - Postdoctoral Researcher, Bioprocess Engineering, Max Planck Institute
3:30pm - 4:00pm
Session 4 – Choosing the most appropriate viral vector for your application – part 2
Session 4 – Choosing the most appropriate viral vector for your application – part 2
10:40am - 11:10am
Aligning with R&D and Marketing TPP to Achieve R&D and Commercial Success
Aligning with R&D and Marketing TPP to Achieve R&D and Commercial Success
10:15am - 10:45am
Next Generation cell lines & large-scale bioprocessing technology
Next Generation cell lines & large-scale bioprocessing technology
Sam Wandsworth - Chief Scientific Officer, Ultragenyx Gene Therapy
11:30am - 12:00pm
Improving Product Quality Through Cell Culture Process Intensification
Improving Product Quality Through Cell Culture Process Intensification
Yan Wang - Senior Scientist, Amgen
11:30am - 12:00pm
Improving Product Quality Through Cell Culture Process Intensification
Improving Product Quality Through Cell Culture Process Intensification
Yan Wang - Senior Scientist, Amgen
11:30am - 12:00pm
Panel Discussion: Best Practises for Working with CMOs and Overcoming Technology Transfer Challenges
Panel Discussion: Best Practises for Working with CMOs and Overcoming Technology Transfer Challenges
1:30pm - 3:00pm
Single-Use Technologies for Cell & Gene Therapies
Single-Use Technologies for Cell & Gene Therapies

Overview:

An Introduction to Single-Use Technologies and the specific attributes and quality needs when implementing Single-Use Technologies in Cell and Gene Therapy Manufacturing. BPI’s training workshop will focus on the importance and the implementation of Single-Use technologies in production of manufacturing facilities. The format of the course includes valuable and unbiased classroom instruction by industry expert James Dean Vogel, P.E. With Mr. Vogel’s assistance, course participants will experience the latest Single-Use products first hand during the lab portion of the course.

Topics include:

Brief Review of Cell and Gene Production Methods and Regulatory Considerations

Single-Use Bioprocess Equipment - Materials of Construction

Single-Use Advantages and Disadvantages

Single-Use Requirements for Cell and Gene Therapies and Risks

Single-Use Components available for Hands-On Demonstration

Attendees range from end-users, suppliers, sales and regulatory personnel who have a general understanding of the SUT industry and want to experience Single-Use products hands on!

James Dean Vogel - Founder and Director , The BioProcess Institute
1:45pm - 2:15pm
Tracking from Donor to Patient
Tracking from Donor to Patient
Sarah Nikiforow - Asst. Professor, Stem Cell Transplantation Program, Asst. Medical Director, Cell Manipulation Core Facility, Dana-Farber Cancer Institute
10:30am - 11:00am
Development and Validation of a Continuous Capture Skid for GMP (OR) MRNA synthesis and purification
Development and Validation of a Continuous Capture Skid for GMP (OR) MRNA synthesis and purification

Sanofi Representative invited

8:45am - 9:15am
Strategic Approach for Upstream Process Development of Glycosylated Fusion Proteins
Strategic Approach for Upstream Process Development of Glycosylated Fusion Proteins
Kiran Andra - Scientist, Alexion Pharmaceuticals Inc
9:00am - 10:30am
Session 1 – Understanding underlying virology
Session 1 – Understanding underlying virology
2:15pm - 2:45pm
Utilising Single Use Technologies in Commercial Manufacturing
Utilising Single Use Technologies in Commercial Manufacturing
Weibing Ding - Director, GSK
1:30pm - 2:00pm
The Art of Raw: Strategies and Tactics for Efficient Raw Materials Testing, Management, and Logistics
The Art of Raw: Strategies and Tactics for Efficient Raw Materials Testing, Management, and Logistics
Monika Heydt - Associate Director, Merck & Co., Inc.
11:30am - 12:00pm
Scaffold Fabrication
Scaffold Fabrication
Michael Francis - Chief Science Officer & Founder, Embody Inc.
1:30pm - 2:00pm
Towards Continuous Bioprocessing of Lentiviral Vectors
Towards Continuous Bioprocessing of Lentiviral Vectors
Sven Ansorge - Director of Manufacturing, ExCellThera Inc.
1:20pm - 1:25pm
Chairperson's Opening Remarks
Chairperson's Opening Remarks
2:30pm - 3:00pm
Spotlight Presentation
Spotlight Presentation
1:25pm - 1:30pm
Chairperson's Opening Remarks
Chairperson's Opening Remarks
10:30am - 11:00am
Accelerating Upstream Process Development to First in Human Products
Accelerating Upstream Process Development to First in Human Products
12:05pm - 12:35pm
Technology Workshops
Technology Workshops
2:45pm - 3:20pm
Spotlight Presentation - CPC
Spotlight Presentation - CPC
9:15am - 9:45am
Spotlight Presentation: Pall
Spotlight Presentation: Pall
11:00am - 12:30pm
Single Use Applications for Cell & Gene Therapies - Cont'd
Single Use Applications for Cell & Gene Therapies - Cont'd
9:00am - 9:30am
ARMI | BioFabUSA Technology Update
ARMI | BioFabUSA Technology Update
Mary Clare McCorry - Director, Technology and Process Development, Advanced Regenerative Manufacturing Institute (ARMI)
1:00pm - 1:20pm
Patient-focused drug delivery - the view from a new player
Keynote
Patient-focused drug delivery - the view from a new player
8:55am - 9:00am
Chairperson’s Opening Remarks
Chairperson’s Opening Remarks
8:55am - 9:00am
Chairperson’s Opening Remarks
Chairperson’s Opening Remarks
11:00am - 12:30pm
Session 2 - Viral Vector manufacturing principles part 1
Session 2 - Viral Vector manufacturing principles part 1
10:30am - 11:00am
Manufacturing Intelligence: Developing a Holistic Control Strategy
Manufacturing Intelligence: Developing a Holistic Control Strategy
Marianthi Ierapetritou - Bob and Jane Gore Centennial Chair of Chemical & Biomolecular Engineering, University of Delaware
9:00am - 9:30am
Innovative Approaches to Accelerate Speed to Market
Innovative Approaches to Accelerate Speed to Market

Amgen Representative Invited

4:30pm - 5:00pm
Emerging upstream bioprocessing and analytical tools for vector manufacture
Emerging upstream bioprocessing and analytical tools for vector manufacture
Michael J. DiBiasio-White, Sr. - Scientist: BioProcess Development/Protein Sciences, Ring Therapeutics
12:30pm - 1:30pm
Networking Luncheon
Networking Luncheon
8:15am - 8:45am
Is Technology the Limitation or Are We? - Simple Evolution of Current Technologies Can Enable Revolutionary Change in Biopharmaceutical Drug Development
Is Technology the Limitation or Are We? - Simple Evolution of Current Technologies Can Enable Revolutionary Change in Biopharmaceutical Drug Development

Bayer Representative Invited  

8:30am - 9:00am
Keynote Address - Overview of Recent Achievements and What’s Next for Continuous Processing
Keynote Address - Overview of Recent Achievements and What’s Next for Continuous Processing

Merck Representative Invited

8:30am - 9:00am
Keynote Address - Overview of Recent Achievements and What’s Next for Continuous Processing
Keynote Address - Overview of Recent Achievements and What’s Next for Continuous Processing

Merck Representative Invited

1:20pm - 1:40pm
Innovations in drug delivery that are shaping the future of drug product science and manufacturing
Keynote
Innovations in drug delivery that are shaping the future of drug product science and manufacturing
2:30pm - 3:00pm
Intensification Projects – Case Studies and Lessons learned
Intensification Projects – Case Studies and Lessons learned

Roche Representative Invited

10:30am - 10:50am
Quantitative Analytical Technologies For Cell & Gene Therapies
Quantitative Analytical Technologies For Cell & Gene Therapies
Barrett J. Nehila - Associate Director, Analytical Development, Torque Therapeutics
10:30am - 10:50am
Quantitative Analytical Technologies For Cell & Gene Therapies
Quantitative Analytical Technologies For Cell & Gene Therapies
Barrett J. Nehila - Associate Director, Analytical Development, Torque Therapeutics
BioPharm America - AI Applications for Drug Discovery Development
10:00am - 10:20am
Keynote
What will AI actually solve in the next 5–10 years?
  • Landscape, regulatory and business overview
  • High-level summary of use cases 
  • Where should investment be made and what could be the best strategic decisions?
Emir Roach - Global Head of Emerging Technologies and Digital Health Partnerships, Takeda
10:30am - 11:10am
What does precision medicine actually mean and how can AI and ML impact it?

Precision medicine is a medical model that can customize healthcare, treatments, practices or products for the individual patient. In this discussion our experts will explore AI and ML’s impact on Precision medicine and what the industry needs to do to prepare for it, tackle challenges as they evolve and develop appropriate solutions. 

  • how this industry is using AI and ML for Precision medicine 
  • what can we really use it for 
  • what problems we are trying to solve using these tools, and what impacts they will have on those problem
Monique Levy - Chief Strategy Officer, BlackThorn Therapeutics, USA
Colin Hill - Chairman, CEO and Co-Founder, GNS Healthcare
12:00pm - 12:20pm
Data Foundations for Enabling AI and ML: Building a data foundation for AI and ML applications
  • •How a strategy/foundation can be built to enable AI
  • •What can be built to determine models needed
  • •What data can drive
Patrick Combes - WW Technical Leader - Healthcare & Life Sciences, Amazon Web Services
12:00pm - 12:20pm
Healthcare Delivery, Hospitals and Precision Medicine: AI and genomic approaches to diagnostics in the rare-disease space
John Reynders - VP, Data Sciences, Genomics, and Bioinformatics, Alexion Pharmaceuticals
12:20pm - 1:00pm
Data Foundations for Enabling AI and ML: Responsible AI and machine learning for drug discovery and development
  • What credibility and assessments for an AI system
  • Data exploration as it feeds into AI and Machine Learning systems
  • Oversight of the data, algorithms and overall systems
Arvind Rao - Associate Professor, Department of Computational Medicine & Bioinformatics, Associate Professor, Radiation Oncology, University of Michigan Medical School
Nirmal Keshava - VP, Data Analytics and Innovation Science, Cerevel Therapeutics
Ashwini Ghogare - Manager, AI-Enabled Drug Discovery, Global Strategy Group, MilliporeSigma
Abe Heifets - CEO and Co-Founder, Atomwise
BioPharm America - Drug Delivery Partnerships
12:00am - 11:55pm
On demand sessions
  • Master Class A: Alliance management - concepts and tools to make the best out of your partnerships
  • Master Class B: Negotiation for drug delivery innovation

  • Plenary Presentation: What will it take to succeed in drug delivery - A look into what's coming

Case Studies - New Innovation from Start-Ups to Big Pharma

  • Presentation: Case study: Alleviating challenges of oral peptide delivery 
  • Presentation: Partnering to create a smart injection pen ready to scale to high volume production 
  • Presentation: Update: Development of dual-chamber reconstitution systems and fill-finish capabilities 
  • Panel Discussion: Connectivity in drug delivery – strategies from the leaders of the pack 

Formulation Development and Technology

  • Presentation: Ionic liquids for drug delivery 
  • Presentation: Brain delivery of biologics – VIA cerebrospinal fluid 
  • Presentation: Challenges and opportunities to improving the subcutaneous delivery of biologics 
  • Presentation: Learning and challenges: Release testing and simulations for long acting parenteral products 

Innovation in Drug Delivery and Formulation Technology 

  • Panel: De-risking partnerships – Best practices to working with start-ups, pharma, and novel technologies

Drug Delivery and Formulations Technologies to Advance New Therapeutic Development 

  • Presentation: Pandemic prevention through gene therapy delivery
  • Presentation: Technological advances to address oral delivery of challenging molecules 
  • Presentation: 3ml patchpump platform: Adaptations for simple and complex therapies 
  • Drug delivery's impact on the $135 billion over the counter (OTC) pharma market

Strategies for Patient-Centric Design and Development 

  • Linking the device to the patient

Regulatory Considerations 

  • USP 800 - How it will affect drug delivery and formulations
  • Regulatory and scientific justifications for CMC Changes - Case studies of modified release products
  • EU/MDR/IVDR combination product and companion product considerations


11:30am - 11:50am
Keynote
Innovation in Drug Delivery and Formulation Technology: Drawing the parallels of innovation from design firms to pharma - An IDEO perspective
Prat Ganapathy - Design Director, IDEO
Jesse Fourt - Design Director, IDEO
1:00pm - 1:20pm
Keynote
Patient-focused drug delivery - the view from a new player
1:20pm - 1:40pm
Keynote
Innovations in drug delivery that are shaping the future of drug product science and manufacturing
Ronald Smith - Scientific AVP, Pharmaceutical Sciences, Merck Research Laboratories
2:00pm - 2:40pm
Exploring partnerships and industry success in 2020 and beyond
BioPharm America - Leading Biotech Boston CEO & BD
8:45am - 9:00am
Opening remarks
Wendy Nelson - CEO, Leading Biotech
Robert Perez - Founder and Chairperson, Life Science Cares
9:00am - 9:30am
Patients and Partnering: The role of patient advocacy groups and disease foundations in our ecosystem
Chris Garabedian - CEO, Xontogeny, and former CEO, Sarepta
Jenn McNary - Founder, One Rare, Beauhawks
Michele Rhee - Patient Affairs, Enzyvant
9:30am - 10:00am
Keynote
Patients and Partnering: Fireside chat: Maximizing value in an M&A
Gary Glick - Founder and Executive Chair, IFM
Lina Gugucheva - CBO, Northern Biologics
10:00am - 10:30am
Patients and Partnering: Top considerations when engaging a potential strategic partnership
Chandra Ramanathan - VP and Head, East Coast Innovation Center, Bayer
Steve Tregay - ., BioInnovation Capital
Patrick Tricoli - CEO, Nanobiotix USA
11:00am - 11:30am
Ecosystem Innovation: Synthetic biology
Reshma Shetty - Co-Founder, Ginkgo Bioworks
Ron Weiss - Professor, MIT Synthetic Biology Lab
11:30am - 12:00pm
Keynote
Ecosystem Innovation: Fireside chat: Pricing
Bruce Booth - Partner, Atlas Venture
Andy Plump - President, R&D, Takeda Pharmaceuticals
12:00pm - 12:30pm
Ecosystem Innovation: To go IPO or remain private?
Ankit Mahadevia - Founder and CEO, Spero Therapeutics
Brian McVeigh - CBO, Zafgen
Donald Nicholson - former CEO, Nimbus Therapeutics
1:30pm - 2:00pm
Ecosystem Innovation: Diversity and inclusion: Cultivating the next generation of biotech execs

What can we do as an industry to cultivate the next generation of leaders and innovators and encourage diversity (beyond just gender diversity) while doing so?

Barbara Fox - CEO, Rheos Medicines
Daniel Lynch - Chairperson of the Board, Surface Oncology
Adelene Perkins - CEO, Infinity Pharmaceuticals
Jennifer Petter - Founder and CSO, Arrakis Therapeutics
2:00pm - 2:30pm
Keynote
Building the Biotech Ecosystem: Fireside chat: The mentor/mentee relationship

How does an entrepreneur find a mentor? What does such a relationship look like and how to ensure each party gets the most out of it?

Michael Bonney - Executive Chair, Kaleido Biosciences
Carrie Bourdow - CEO, Trevena
2:30pm - 3:00pm
Building the Biotech Ecosystem: Building your biotech from the ground up

What does it take to get your company up and running? What pitfalls do you want to avoid? Lessons learned from those that have done it!

Carolyn Morgan - CEO, Precision Effect
PJ Anand - Founder and CEO, Alcyone Lifesciences
Jodie Morrison - CEO, Cadent Therapeutics
Bernat Olle - CEO, Vedanta Biosciences
3:00pm - 3:30pm
Building the Biotech Ecosystem: New players in the healthcare space
Imran Eba - Partner, Action Potential Venture Capital
BioProcess International - Cell Line Development & Engineering
9:00am - 9:30am
Application of CRISPR Cas9 To Enhance Host Cell Lines
  • Carrying out knock in instead of knock-out
  • What functional assays are needed to see what the impact on the cell is?
Anke Mayer-Bartschmid, - Cell and Protein Sciences, Pharmaceuticals Division, , Bayer Pharma
9:30am - 10:00am
Reporter Cell Line Development
Benson Li - Associate Principal Scientist, Merck
10:00am - 10:30am
Analysis of Cell Lines
James Lambropoulos - Engineer, Biogen
10:30am - 11:00am
Networking Refreshment Break
11:00am - 11:30am
Challenges of New Modality Molecule Formats on Productivity and Product Quality
Lianchun Fan, Ph D. - Director of Cellular & Molecular Biology Science, Process Science, Abbvie Bioresearch Center, (pending final confirmation)
11:30am - 12:00pm
Next Generation Cell Line & Cell Culture Process Development
Kitty Agarwal - Senior Scientist, Biologics Process Development, Bristol-Myers Squibb, (pending final confirmation)
1:30pm - 2:00pm
How Cell Line Development is Affected by the Adoption of Perfusion Processes
Christine DeMaria - Director, Cell Line Development, Sanofi, (pending final confirmation)
2:00pm - 2:30pm
Multi-Faceted Approach To Ensure Clonality Assurance and Clonal Stability
Lina Chakrabarti - Senior Manager, R & D, Astrazeneca
2:30pm - 3:00pm
Spotlight Presentation
3:00pm - 3:30pm
Networking Refreshment Break
3:30pm - 4:00pm
Automation in Cell Line Generation
4:00pm - 4:30pm
Cell Line Engineering of AAV/Lentiviral Vectors
BioProcess International - Raw Materials and Supply Chain Management
9:00am - 9:30am
Case Study: Strategies to Evaluate and Control Raw Material Variability and its Impact on Cell Culture Quality

A Representative from Genentech

9:30am - 10:00am
Implementation of an Integrated Approach for Fingerprinting Cell Culture Media

In this talk, we will describe implementation of liquid media fingerprinting in process development to provide increased understanding of impacts of raw material variability on process performance and protein quality throughout scale-up, technology transfer, and media stability characterization. Case studies will illustrate some of the media characteristics and differences detected due to storage conditions, preparation errors, and lot-to-lot variation in raw materials.

Kathryn Aron, Ph.D. - Group Leader, Cell Culture Process Development, Bristol-Myers Squibb
10:00am - 10:30am
Novel Technologies and Analytical Strategies to Control Raw Material Variability
Andreas Unsoeld - Head of Cell Culture Media, Boehringer Ingelheim Pharma GmbH & Co KG
11:00am - 11:30am
Application of Data Analytics to Raw Materials
Patrick Gammell - Executive Director, Amgen
11:30am - 12:00pm
Digitalisation of Raw Material Data and Application of Data Analytics to Increase Understanding and Control Variation

A Representative from Genentech

12:00pm - 12:30pm
Spotlight Presentation
12:30pm - 1:30pm
Networking Luncheon
1:30pm - 2:00pm
The Art of Raw: Strategies and Tactics for Efficient Raw Materials Testing, Management, and Logistics

Maximizing efficiencies in incoming raw material management as a means to support swift expansion of manufacturing capability as vaccines go through significant increases. These efficiencies include 1). Fit for Use Testing 2). Same Supplier Lot Acceptance Program 3). Reduced Testing Vendor Qualification. 4). Logistics Consolidation

Monika Heydt - Associate Director, Merck & Co., Inc.
2:00pm - 2:30pm
Case Study: Advancement in Raw Material Management and Control to Reduce Raw Material Variability in Clinical and Commercial Manufacturing

A Representative from Genentech

3:30pm - 5:00pm
Panel Discussion: Best Practices and Quality Control Strategies to Ensure Raw Materials Supply Chain Security
  • Best practices to monitor and control raw material variability: Industry and Supplier perspectives
  • What risk-based approaches are industry taking to manage quality control for suppliers and raw material changes from suppliers?
  • How are industry working together with vendors to ensure quality control of raw materials?
  • Sourcing strategies – Feedback on how to conduct quality audits
  • Supplier controls to ensure attributes are in a state of control
  • Supply chain security: Lessons learnt on supply chain agreements
  • Supply chain management strategies for single use supply chains
BioProcess International - Data Science Tools for Accelerated Product Life Cycle
8:55am - 9:00am
Chairperson's Opening Remarks
Christoph Herwig - Bioprocess Engineering Professor, TU Wien, Austria
9:00am - 10:30am
Keynote
Data Science Tools for Accelerated Product Life Cycle

Course Objective 

Hands-on learning of basic principles and best practices performing data analytics and data management for integrated bioprocesses. Designed for the biopharmaceutical and industrial biotech industry.

The course topics include:

  • Best bioprocess data analytics principles
  • Design of experiments
  • Data management and contextualization of data sources of different origin
  • Basic statistics for root cause analysis, scale-up, scale-down and comparability studies
  • Process validation analytics and monitoring (CPV)

 

Course Outline 

  • Digital Bioprocess Lab/ Plant: Data Management Workflow
  • Monitoring & Trending, raw data visualization
  • Inspecting your data for outliers
  • Setting process phases


  • Bioprocess data analytics: Best practices 
  • Conversion of raw data to reliable feature-based information
  • Design of Experiments (DoE)
  • Integrated Process Analysis over multiple unit operations
  • Root Cause Analysis of process variability
  • Comparability studies: Scale-up & Scale-Down and process validation tasks


Primary Audience 

This course is designed for all individuals who are involved in bioprocess development & manufacturing as well as process validation. This includes bioprocess development scientists, engineers, manufacturing and quality supervisors, and management. No sta­tistical or mathematical background is required.


Interactive seminar 

Bring your own laptop. You will perform exercises on bioprocess data management and analytics using the web-based educational software tool inCyght®.


Christoph Herwig - Bioprocess Engineering Professor, TU Wien, Austria
11:00am - 12:30pm
Data Science Tools for Accelerated Product Life Cycle

Course Objective 

Hands-on learning of basic principles and best practices performing data analytics and data management for integrated bioprocesses. Designed for the biopharmaceutical and industrial biotech industry.

The course topics include:

  • Best bioprocess data analytics principles
  • Design of experiments
  • Data management and contextualization of data sources of different origin
  • Basic statistics for root cause analysis, scale-up, scale-down and comparability studies
  • Process validation analytics and monitoring (CPV)

 

Course Outline 

  • Digital Bioprocess Lab/ Plant: Data Management Workflow
  • Monitoring & Trending, raw data visualization
  • Inspecting your data for outliers
  • Setting process phases


  • Bioprocess data analytics: Best practices 
  • Conversion of raw data to reliable feature-based information
  • Design of Experiments (DoE)
  • Integrated Process Analysis over multiple unit operations
  • Root Cause Analysis of process variability
  • Comparability studies: Scale-up & Scale-Down and process validation tasks


Primary Audience 

This course is designed for all individuals who are involved in bioprocess development & manufacturing as well as process validation. This includes bioprocess development scientists, engineers, manufacturing and quality supervisors, and management. No sta­tistical or mathematical background is required.


Interactive seminar 

Bring your own laptop. You will perform exercises on bioprocess data management and analytics using the web-based educational software tool inCyght®.

Christoph Herwig - Bioprocess Engineering Professor, TU Wien, Austria
1:30pm - 3:00pm
Data Science Tools for Accelerated Product Life Cycle

Course Objective 

Hands-on learning of basic principles and best practices performing data analytics and data management for integrated bioprocesses. Designed for the biopharmaceutical and industrial biotech industry.

The course topics include:

  • Best bioprocess data analytics principles
  • Design of experiments
  • Data management and contextualization of data sources of different origin
  • Basic statistics for root cause analysis, scale-up, scale-down and comparability studies
  • Process validation analytics and monitoring (CPV)

 

Course Outline 

  • Digital Bioprocess Lab/ Plant: Data Management Workflow
  • Monitoring & Trending, raw data visualization
  • Inspecting your data for outliers
  • Setting process phases


  • Bioprocess data analytics: Best practices 
  • Conversion of raw data to reliable feature-based information
  • Design of Experiments (DoE)
  • Integrated Process Analysis over multiple unit operations
  • Root Cause Analysis of process variability
  • Comparability studies: Scale-up & Scale-Down and process validation tasks


Primary Audience 

This course is designed for all individuals who are involved in bioprocess development & manufacturing as well as process validation. This includes bioprocess development scientists, engineers, manufacturing and quality supervisors, and management. No sta­tistical or mathematical background is required.


Interactive seminar 

Bring your own laptop. You will perform exercises on bioprocess data management and analytics using the web-based educational software tool inCyght®.

Christoph Herwig - Bioprocess Engineering Professor, TU Wien, Austria
3:30pm - 5:00pm
Data Science Tools for Accelerated Product Life Cycle

Course Objective 

Hands-on learning of basic principles and best practices performing data analytics and data management for integrated bioprocesses. Designed for the biopharmaceutical and industrial biotech industry.

The course topics include:

  • Best bioprocess data analytics principles
  • Design of experiments
  • Data management and contextualization of data sources of different origin
  • Basic statistics for root cause analysis, scale-up, scale-down and comparability studies
  • Process validation analytics and monitoring (CPV)

 

Course Outline 

  • Digital Bioprocess Lab/ Plant: Data Management Workflow
  • Monitoring & Trending, raw data visualization
  • Inspecting your data for outliers
  • Setting process phases


  • Bioprocess data analytics: Best practices 
  • Conversion of raw data to reliable feature-based information
  • Design of Experiments (DoE)
  • Integrated Process Analysis over multiple unit operations
  • Root Cause Analysis of process variability
  • Comparability studies: Scale-up & Scale-Down and process validation tasks


Primary Audience 

This course is designed for all individuals who are involved in bioprocess development & manufacturing as well as process validation. This includes bioprocess development scientists, engineers, manufacturing and quality supervisors, and management. No sta­tistical or mathematical background is required.


Interactive seminar 

Bring your own laptop. You will perform exercises on bioprocess data management and analytics using the web-based educational software tool inCyght®.

Christoph Herwig - Bioprocess Engineering Professor, TU Wien, Austria
BioProcess International - Single-Use Technologies for Cell & Gene Therapies
9:00am - 10:30am
Single-Use Technologies for Cell & Gene Therapies

Overview:

An Introduction to Single-Use Technologies and the specific attributes and quality needs when implementing Single-Use Technologies in Cell and Gene Therapy Manufacturing. BPI’s training workshop will focus on the importance and the implementation of Single-Use technologies in production of manufacturing facilities. The format of the course includes valuable and unbiased classroom instruction by industry expert James Dean Vogel, P.E. With Mr. Vogel’s assistance, course participants will experience the latest Single-Use products first hand during the lab portion of the course.

Topics include:

Brief Review of Cell and Gene Production Methods and Regulatory Considerations

Single-Use Bioprocess Equipment - Materials of Construction

Single-Use Advantages and Disadvantages

Single-Use Requirements for Cell and Gene Therapies and Risks

Single-Use Components available for Hands-On Demonstration

Attendees range from end-users, suppliers, sales and regulatory personnel who have a general understanding of the SUT industry and want to experience Single-Use products hands on!

James Dean Vogel - Founder and Director , The BioProcess Institute
11:00am - 12:30pm
Single-Use Technologies for Cell & Gene Therapies

Overview:

An Introduction to Single-Use Technologies and the specific attributes and quality needs when implementing Single-Use Technologies in Cell and Gene Therapy Manufacturing. BPI’s training workshop will focus on the importance and the implementation of Single-Use technologies in production of manufacturing facilities. The format of the course includes valuable and unbiased classroom instruction by industry expert James Dean Vogel, P.E. With Mr. Vogel’s assistance, course participants will experience the latest Single-Use products first hand during the lab portion of the course.

Topics include:

Brief Review of Cell and Gene Production Methods and Regulatory Considerations

Single-Use Bioprocess Equipment - Materials of Construction

Single-Use Advantages and Disadvantages

Single-Use Requirements for Cell and Gene Therapies and Risks

Single-Use Components available for Hands-On Demonstration

Attendees range from end-users, suppliers, sales and regulatory personnel who have a general understanding of the SUT industry and want to experience Single-Use products hands on!

James Dean Vogel - Founder and Director , The BioProcess Institute
1:30pm - 3:00pm
Single-Use Technologies for Cell & Gene Therapies

Overview:

An Introduction to Single-Use Technologies and the specific attributes and quality needs when implementing Single-Use Technologies in Cell and Gene Therapy Manufacturing. BPI’s training workshop will focus on the importance and the implementation of Single-Use technologies in production of manufacturing facilities. The format of the course includes valuable and unbiased classroom instruction by industry expert James Dean Vogel, P.E. With Mr. Vogel’s assistance, course participants will experience the latest Single-Use products first hand during the lab portion of the course.

Topics include:

Brief Review of Cell and Gene Production Methods and Regulatory Considerations

Single-Use Bioprocess Equipment - Materials of Construction

Single-Use Advantages and Disadvantages

Single-Use Requirements for Cell and Gene Therapies and Risks

Single-Use Components available for Hands-On Demonstration

Attendees range from end-users, suppliers, sales and regulatory personnel who have a general understanding of the SUT industry and want to experience Single-Use products hands on!

James Dean Vogel - Founder and Director , The BioProcess Institute
3:30pm - 5:00pm
Single-Use Technologies for Cell & Gene Therapies

Overview:

An Introduction to Single-Use Technologies and the specific attributes and quality needs when implementing Single-Use Technologies in Cell and Gene Therapy Manufacturing. BPI’s training workshop will focus on the importance and the implementation of Single-Use technologies in production of manufacturing facilities. The format of the course includes valuable and unbiased classroom instruction by industry expert James Dean Vogel, P.E. With Mr. Vogel’s assistance, course participants will experience the latest Single-Use products first hand during the lab portion of the course.

Topics include:

Brief Review of Cell and Gene Production Methods and Regulatory Considerations

Single-Use Bioprocess Equipment - Materials of Construction

Single-Use Advantages and Disadvantages

Single-Use Requirements for Cell and Gene Therapies and Risks

Single-Use Components available for Hands-On Demonstration

Attendees range from end-users, suppliers, sales and regulatory personnel who have a general understanding of the SUT industry and want to experience Single-Use products hands on!

James Dean Vogel - Founder and Director , The BioProcess Institute
BioProcess International - Cell Culture & Upstream Processing
8:15am - 8:45am
A Robust Platform Design For Both Antibody And Bispecific Production

This presentation covers how we design a platform process for both antibody and bispecific production. A robust production platform significantly reduces the timeline for process development and validation.

Yang Wu - Scientist II, Macrogenics
8:30am - 9:00am
Smart Strategies to Enhance Productivity, Improve Titres, Cell Culture Performance and Product Quality
8:45am - 9:15am
Strategic Approach for Upstream Process Development of Glycosylated Fusion Proteins

Glycosylated fusion proteins are gaining more attention in the current biologics market. Early stage process development for druggable fusion proteins often includes challenges from productivity and product quality attributes. Platform process usually needs to be drastically revised to meet the target product profiles for glycosylated fusion proteins. Employing a strategic and systematic approach is crucial to satisfy the critical project timelines. Our approach was to assess the upstream related challenges based on critical product quality attributes identified in preliminary experiments and prioritize the parameters during the process development. This approach showed that reducing the quantity of experiments and meets the desired productivity and product quality.

Kiran Andra - Scientist, Alexion Pharmaceuticals Inc
9:00am - 9:30am
Implementation of Real Time, Online Monitoring Methods for Performance and Product Quality in Cell Culture Bioreactors
  • Systematic assessment of PAT tools for upstream process development and manufacturing
  • Implementation of PAT in upstream processing to characterise cell culture processes
  • Real time monitoring methods for cell culture performance
  • Evaluating online real-time monitoring methods to monitor the physiological state of CHO cells in bioreactors, control cell density and culture traceability in bioreactors
George Zhou, PhD - Research Fellow, Merck & Co., Inc.
9:15am - 9:45am
Scientific & Technology Presentations
10:10am - 10:40am
High-Resolution Optical and Dielectric Methods for Monitoring Cells in Bioprocesses

The metabolic state of mammalian cells in a bioprocess can be monitored by high-resolution optical systems or by changes in dielectric properties. Each method can determine a metabolic inflection points just prior to loss of cell viability. Such changes can be observed up to 20h before cells stain with trypan blue. We have established a threshold of cytoplasmic conductivity below which cells cannot be recovered from apoptosis. This point occurs at a time when there are observable changes in the cell membrane that can be detected by high-resolution optics. This early detection of metabolic changes allows dielectrics and high-resolution optics to be offered as a means of monitoring a bioprocess and maintaining cell viability over prolonged time periods.

Michael Butler - Principal Investigator in Cell Technology, National Institute of Bioprocessing Research & Training (NIBRT), Ireland
10:30am - 11:00am
Application of Digitalization, Machine Learning and Artificial Intelligence in Upstream Process Development
John Bowers - Senior Principal Scientist, Merck
10:40am - 11:10am
Raman Technology For In-Line Monitoring And Control Of CHO Cell Culture Process

Process analytical technology (PAT) is FDA’s initiative to persuade biopharmaceutical manufacturing companies to improve real-time process monitoring and control. Raman spectroscopy coupled with chemometric analysis and predictive PLS models is a part of PAT initiative that is growing rapidly in the biopharma industry. We have evaluated the capability of Raman technique for monitoring as well as controlling the glucose level for mammalian CHO cell culture processes in bench-scale 3 L bioreactors. We developed predictive models for important nutrients and metabolites in the culture such as glucose, lactate, glutamine, glutamate, ammonia, LDH, and osmolality. Our research showed, in-line Raman probe coupled with a calibration model for glucose and lactate, enabled glucose to be maintained at 2.5 g/L and 4 g/L. Well controlled glucose level showed 20% improvement in titer. For another process, lactate level was maintained at 4 g/L instead of rising to 14 g/L using Raman technology. This improved lactate profile resulted in significant increase in the cell-specific productivity. Raman technology combined with good predictive models showed promise as a reliable tool for on-line monitoring and developing feedback nutrient feeding strategy for important culture components.

Anita E.Tolouei - Scientist I, KBI Biopharma
11:00am - 11:30am
Optimizing Upstream Process Development Using Modeling and Integration of Advanced Analytics
11:10am - 11:40am
Comparing Dielectric and Raman Spectroscopy for Online Cell Growth Monitoring of Biotherapeutics Manufacturing

Cell growth is routinely monitored during production of monoclonal antibodies. We will present development approaches, including both Raman and Dielectric spectroscopies, for demonstrating a successful continuous monitoring of cell growth. Advanced multivariate modeling was employed for method performance evaluation in terms of accuracy, precision, and robustness. Certain industrial applications such as probe unifying will also be discussed in this work.

Feng Xu - Sr. Scientist, Merck
11:30am - 11:35am
Changeover to Technology Workshops
11:30am - 12:00pm
Improving Product Quality Through Cell Culture Process Intensification

Cell culture process intensification mostly focuses on biomass and productivity, however, the impact on product quality is not much discussed. Productivity and product quality can be a trade-off situation for bioprocessing professionals. This is especially true when we are dealing with complex biologic molecules which are generally difficult to express. Efficiency of end-to-end biomanufacturing processes will be improved when we focus on reducing the production of product-related impurities, such as aggregates or fragmented species, during cell culture process. This presentation highlights two strategies through cell culture intensification which benefits biologic product quality, increases process efficiency, and provides cell culture manufacturing flexibility.

Yan Wang - Senior Scientist, Amgen
11:35am - 12:05pm
Technology Workshops
12:05pm - 12:35pm
Technology Workshop
1:25pm - 1:55pm
Applying Systems Biology Tools for Process Understanding and Improvements
Michael Betenbaugh - Professor, Johns Hopkins University
1:30pm - 2:00pm
Case Study from Biogen: Manufacturing Intelligence and Control Strategies
Rob Guenard, PhD - Senior Director, Global Manufacturing Science, Biogen
1:55pm - 2:25pm
Application of Metabolomics in A Legacy Process
Brendan Bishop - Associate Engineer/Scientist, Bristol-Myers Squibb
2:00pm - 2:30pm
Artificial Intelligence, Machine Learning and Data Science: How to Utilise in Bioprocessing?
Michael Sokolov - COO and Co-founder, Datahow AG
2:15pm - 2:45pm
Adapting Media Development and Workflows to Support Continuous Processing
4:00pm - 4:30pm
Implementation of Next Generation Clarification Technologies
BioProcess International - Bioprocessing 4.0
8:15am - 8:45am
Panel Discussion: Steps Toward Digital Transformation – Overcoming Setup, Data Management, Integration Solution and Security Challenges
  • How to setup ecosystems for digital transformation to analyse data more effectively?
  • Digital tech transfer: How to manage all processing documents in digital formats?
  • Data management and connectivity for smart facilities: How to define processes, which signals to control and how to connect all equipment across an organisation in a common language?
  • Data management and information architecture systems required within organisation frameworks: Standardizing data naming conventions, functionalities, formats and access for effective data flow
  • Data visualisation and data integrity solutions – How to translate to digital transformation?
  • What are the concepts of data lakes and native environments for data visualisation?
  • Data security: How to secure platforms in terms of access?
  • Technology management and overcoming mindset changes in organisation (technical and cultural)
Christoph Herwig - Bioprocess Engineering Professor, TU Wien, Austria
8:45am - 9:15am
Getting Value from Data

This talk will cover the development of an analytics platform for manufacturing data and how to extract value from the platform. Several use cases will be presented.

Eugene Tung - Executive Director of Manufacturing IT, Merck
10:30am - 11:00am
Manufacturing Intelligence: Developing a Holistic Control Strategy
Marianthi Ierapetritou - Bob and Jane Gore Centennial Chair of Chemical & Biomolecular Engineering, University of Delaware
11:00am - 11:30am
Digital Twins and Data Science for Robust Control Strategies
  • How can digital twins and data science supplement or substitute for PAT in quality control strategies?
  • Data science ornamented PAT solutions for process control
  • Validation of digital twins
  • How to calibrate and deploy digital twin models in bioprocessing?
Christoph Herwig - Bioprocess Engineering Professor, TU Wien, Austria
2:30pm - 3:00pm
Application of AI and Machine Learning to Aid Decision Making and Maintenance in Process Development and Manufacturing
Christian Airiau, Ph.D - Global Head of Data Sciences & Biologics Development, Sanofi
4:00pm - 4:30pm
Advanced Automation of Single-Use Systems – Implementation of the Flexible Plug-and-Play Approach

The biopharmaceutical industry’s movement away from large scale, fixed facilities to the more flexible, single-use technologies has demonstrated a desire to move toward modular and agile process designs and equipment. To align with this movement, automation systems need to be comparably flexible. Process systems need to be adaptable to allow facilities and process flows to be built and reconfigured without costly automation development efforts. Modular automation is seen as the key enabler to achieve low cost and flexible automation. The presentation describes the benefits, development, and implementation of an interface standard that allows a supervisory control system to interface to an intelligent process skid on the ISA-88 phase level. The interface standard is being developed through a BioPhorum Operations Group collaboration. The collaboration represents a new approach for bringing together the entire ecosystem (end users, equipment vendors, system integrators) to create a Plug-and-Play interface standard for automated systems that will benefit all members of the ecosystem. A case study on tests results of the operational model and structure of the bioreactor unit operation will be discussed in detail. The standard allows the batch engine of a supervisory system to execute standard functions within the equipment based on a predefined set of process parameters and generate a defined set of report data. Automation increases operational consistency and product quality. Getting a facility ready-to-go with minimal cost and time reduces the both cost of goods (CoG) and time to market. Flexible automation is an important contributor to an efficient operation for the biopharmaceutical manufacturers.

Pietro Perrone - Automation Process Engineer, GE Healthcare
4:30pm - 5:00pm
Digital Transformation and Smart Biomanufacturing: Case Study from Bayer
Oliver Hesse - Director, Lab Automation and Data Management, Biological Development, Bayer Healthcare LLC
5:00pm - 5:30pm
Manufacturing in the Industry 4.0 Era: How to Balance Innovation with Performance while not Being Disrupted

The manufacturing status quo reflects a compromise between innovation and performance. But the battle between these values is perpetual and, in the dawn of Industry 4.0 era, a new compromise between technological progress and the need for stationarity is being crafted. Being able to successfully harvest the benefits of the fourth industrial revolution requires a) separating facts from fiction and b) getting acquainted with the never-before-encountered bottlenecks that will have to be deal with. In this talk, we will go through the unique opportunities and the unprecedented challenges accompanying the fourth industrial revolution. The point of view, however, is not that of the salesman, which is frequently encountered online, but rather of the buyer, i.e. manufacturing. The objective, therefore, is simple, albeit arduous: transform the buyer of this negotiation table into an informed investor that no-longer faces a competitive disadvantage.

Christos Varsakelis - Senior Manager Global Data Analytics & Innovation, GSK Vaccines
BioProcess International - Recovery & Purification
8:15am - 8:45am
Is Technology the Limitation or Are We? - Simple Evolution of Current Technologies Can Enable Revolutionary Change in Biopharmaceutical Drug Development

Bayer Representative Invited  

8:30am - 9:00am
Mechanistic Chromatography Modeling

Genentech Representative Invited

8:45am - 9:15am
Overcoming Downstream Development Problems with Multimeric Proteins

Presenter to be Determined

9:00am - 9:30am
Scale-Down of Chromatography

Merck Representative Invited

10:10am - 10:40am
Mitigation of Polysorbate Degradation

Genentech Representative Invited

10:30am - 11:00am
Meta Data – Leveraging Data to Reduce Design Space and Speed Development
10:40am - 11:10am
Computational Methods to Simulate Antibody HCP Interactions

Sanofi Representative Invited

11:00am - 11:30am
Towards a Digital Twin Application in Downstream Process Development for Smooth and Efficient BLAs
11:00am - 11:30am
Overcoming Downstream Challenges at New Continuous Facility in Philadelphia

GSK Representative invited

11:10am - 11:40am
Process-Related Impurities: Case Studies on Risk Assessment
11:30am - 12:00pm
Using Prior Knowledge to Move Quickly Through Development

Genentech Representative Invited

12:05pm - 12:35pm
Technology Workshops
1:25pm - 1:55pm
Fully Automated Platform Approach to FIH Purification Development: mAbs and Beyond

Sanofi Representative Invited

1:55pm - 2:25pm
Automated High throughput Chromatography Screening Platform for Virus Purification

Merck Representative Invited

2:00pm - 2:30pm
At-Scale Demonstration of an Integrated Continuous Multi-Column Chromatography Process

Just Biotherapuetics Representative Invited

2:15pm - 2:45pm
Utilizing PAT to Improve Efficiencies, Testing, and Cycle Times in Downstream Processing

Biogen Representative Invited

4:30pm - 5:00pm
Results from Using a Single Use Centrifuge

Genentech Representative Invited

5:00pm - 5:30pm
TFDF(Tangential Flow Depth Filtration) as a Harvest Option
BioProcess International - Intensified and Continuous Processing
8:10am - 8:15am
Chairperson’s Opening Remarks
8:15am - 8:45am
Building a Fully Integrated Continuous Bioprocessing cGMP Plant: Promises It Holds and Lessons Learned from It
10:10am - 10:40am
The Economics of Seed Train Intensification

Bristol-Myers Squibb

10:30am - 11:00am
Overcoming the Challenges of Implementing Continuous Processing
Daryl Powers, PhD - Head US Upstream Cell Culture Development, Sanofi
10:30am - 11:00am
Development and Validation of a Continuous Capture Skid for GMP (OR) MRNA synthesis and purification

Sanofi Representative invited

10:40am - 11:10am
The Different Focus of COGs in Continuous Manufacturing Process Compared to Fed Batch – Medium, Perfusion Columns, and Continuous Chromatography

Bayer Representative Invited

11:00am - 11:30am
Process Intensification: Implementation of Continuous Manufacturing in Upstream Processing
Gregory Hiller - Research Fellow, Pfizer
11:10am - 11:40am
Updates from Biophorum - Primary Separations and Filtration
11:45am - 12:15pm
Technology Workshop
1:20pm - 1:25pm
Chairperson’s Opening Remarks
1:25pm - 1:55pm
Validation Strategy and Approach

Novartis Pharma AG Representative Invited

1:30pm - 2:00pm
Large-Scale Implementation of a Continuous Multicolumn Chromatography Process

AstraZeneca Representative Invited

1:45pm - 2:15pm
Media Optimization Gone Wrong: When Enhanced Metabolism Leads to Cell Death

Media optimization is complex. Levers and components that are commonly used to improve growth can at time accelerate metabolism to a point of process failure. Here we present a case study where a cell line selected in one media was unable to support growth in a second due to an interaction of two metabolites.

Ryan Sanford - Sr. Associate Scientist, Biogen
1:55pm - 2:25pm
BioPhorum Working Group Initiatives for Impediments to Implementation

BioPhorum Working Group Member

2:30pm - 3:00pm
Intensification Projects – Case Studies and Lessons learned

Roche Representative Invited

2:45pm - 3:15pm
Scientific & Technology Presentations
4:00pm - 4:30pm
Developing Analytical Tools and Models for Continuous Manufacturing

Merck Representative Invited

5:00pm - 5:30pm
Development of a Model Predictive Controller for Feedback Control of Galactosylation and Fucosylation of mAb Expressed in a Perfusion CHO Cell Culture
Brandon Downey - Principal Engineer, Lonza
BioProcess International - Speed from Gene to Market
8:15am - 8:45am
Strategy for Preparing for the Possibility of a Breakthrough Designation
8:30am - 9:00am
A Technical End-to-End Project Review to Ensure Commercial Viability
8:45am - 9:15am
CMC Development (Shortcuts?) for Breakthrough Therapies

Merck Representative Invited

9:00am - 9:30am
Innovative Approaches to Accelerate Speed to Market

Amgen Representative Invited

10:10am - 10:40am
How to Verify You've Chosen the Right Candidate? Overcoming Pain Points in Target Identification, Target Characterization, and Target Validation
10:30am - 11:00am
Speed to BLA for Accelerated Programs

AbbVie Representative Invited

10:30am - 11:00am
Accelerating Upstream Process Development to First in Human Products

Bristol-Myers Squibb Representative Invited

10:40am - 11:10am
Aligning with R&D and Marketing TPP to Achieve R&D and Commercial Success
11:00am - 11:30am
Meeting the Needs of Fast to Clinic and Fast Filing

Shire Representative Invited

11:00am - 11:30am
Preparing for Commercial Launch and Overcoming Pain Points – CMC
11:10am - 11:40am
A Trust-Based Approach to R&D Acceleration — Ethical, Collaborative Data Research, Synthesis & Integration as a Prerequisite to Innovation
11:30am - 12:00pm
Interactive Panel Discussion – Proven Strategies for Increasing Speed to IND

Discussion Moderator and Panelists to be Determined

11:40am - 11:45am
Transition to Technology Workshop
1:20pm - 1:25pm
Chairperson's Opening Remarks
1:45pm - 2:15pm
Approaches to Speed Up Cell Line Development

Biogen Representative Invited

2:15pm - 2:45pm
Transposon-Mediated Gene Integration for Future GMP Production

Janssen Representative Invited

4:00pm - 4:30pm
Utilizing Prior Knowledge Assessments of Process Characterization Cell Culture and Purification Operations to Accelerate FMEA Risk Assessments During Process Design
4:30pm - 5:00pm
Meta Data – Leveraging Data to Reduce Design Space and Speed Development
5:00pm - 5:30pm
Towards a Digital Twin Application in Downstream Process Development for Smooth and Efficient BLAs
BioProcess International - Analytical & Quality
8:10am - 8:15am
Chairperson's Opening Remarks
8:15am - 8:45am
Ways NMR spectroscopy illuminates the path for process development of glycoconjugate vaccines
Kelly Sackett - Principal Scientist, Pfizer
8:30am - 9:00am
Improving Process Understanding and Speed with Raman Spectroscopy
David Chiu - Scientist, Seattle Genetics
8:45am - 9:15am
Regulations For Interchangeability Studies for Biosimilars

Interchangeability can be a somewhat confusing term in the US biosimilar development arena, raising similar questions and hesitance as was the whole biosimilars in general, a few years ago. The FDA has finalized its guidance document about interchangeability in May 2019, but the necessity and requirements of switching clinical studies are still not completely clear and there are many misinterpretations across pharmaceutical industry and health care practitioners. However, there is light at the end of this tunnel: thru data collection, collaboration and education, as it was done for biosimilars in the past, interchangeability will be better understood and handled appropriately. This presentation will go through the definition of interchangeability, general requirements and supportive information collected so far.

Renata Varga, Ph.D. - Scientist - Characterization, Analytical Sciences, Global Biological CMC, Teva Pharmaceuticals
9:00am - 9:30am
PAT System Development and Implementation for Biopharmaceutical Manufacturing Process Real-time Monitoring and Control in GMP
Ting-Kuo Huang, PhD - Principal Engineer, Genentech
10:10am - 10:40am
Roadmap to PAT
Julia Ding, PhD - Director, Process Development Analytical & Analytical Development, Bristol Myers Squibb
10:30am - 11:00am
Developability: Analytical Platform Approaches for Complex Proteins
Sarah Auclair - Scientist, Sanofi
10:30am - 10:50am
Quantitative Analytical Technologies For Cell & Gene Therapies
  • Quantitative tools for cell and gene molecules  
  • Not using flow cytometry
Barrett J. Nehila - Associate Director, Analytical Development, Torque Therapeutics
10:40am - 11:10am
Noninvasive Analytics for Product Inspection and Process Monitoring

Water is the dominant component of most pharmaceutical solutions.  Water proton NMR (wNMR) can be used to quantitatively inspect drug products (DP) without compromising DP integrity.  Examples of applying wNMR to inspect FDA-approved biologic and non-biologic complex drugs will be presented.  wNMR is also being developed as noninvasive in-line process analytical technology for uninterrupted continuous biomanufacturing.  

Bruce Yu - Professor, Maryland University
11:00am - 11:30am
Early Engineering and Formulation Approaches to Improve Physicochemical Stability of Therapeutic Peptides
Lin Zhang, Ph.D. - Research Scientist, BioTechnology Discovery Research, Eli Lilly and Company
11:10am - 11:40am
Microchip electrophoresis with high pressure mass spectrometry detection for at-line nutrient monitoring
Seth Madren - Scientist II, Biogen
11:30am - 11:40am
Analytical Method Development and Validation – Building the Characterization Testing Foundation & Toolkit
Lara Ionescu Silverman - Senior Director, Research and Development, DiscGenics
11:40am - 12:00pm
AI in Cell and Gene Therapy Manufacturing
Michael Roberts - Chief Technology Officer (Europe), Asklepios BioPharmaceutical, Inc.
12:00pm - 12:05pm
Changeover to Technology Workshops
1:25pm - 1:55pm
High throughput Developability Assessments To Reduce Timelines
  • High-throughput quick approaches to quickly reduce the number of molecules you are looking at down to the key players
Alejandro Carpy - Group Leader, Roche
1:25pm - 1:30pm
Chairperson's Opening Remarks
1:30pm - 2:00pm
Polysorbate, The Good, The Bad and The Ugly
Linda Yi - Senior Scientist, Analytical Development, Biogen
1:45pm - 2:15pm
Identifying Critical Quality Attribute Performance Impact During Process Characterization
1:55pm - 2:25pm
Multi-Attribute Methods (MS) for in process monitoring and rapid testing of mAbs and non-mAbs in upstream and downstream process development
Yaping Sun - Senior Scientist, Takeda
2:00pm - 2:30pm
Guard Bands: Protecting You Against Measurement Uncertainty
Steven Walfish - Principal Scientific Liaison, USP
2:30pm - 3:00pm
Immunogenicity/ Bioanalytical strategy of complex molecules/ regulatory submissions

Recently updated FDA guideline for immunogenicity assessment of protein based biotherapeutics suggests added complexity of immunogenicity assessment, type of data reported and the need for additional characterization of the immune response in the clinic. The exact nature of the characterization would significantly depend on the biotherapeutic modality, treatment indication and regiment. Better understanding of the timing for additional assessment of immune responses may involve detection of immune responses to domains or elements of the therapeutics and more. Many questions are still remain unanswered. Some will be discussed during presentation

Boris Gorovits - Bioanalytical Sciences Lead, Senior Director, Pfizer BioMedicine Design, USA
4:30pm - 5:00pm
A Case Study in Applying PAT to the Continuous Biomanufacturing of Monoclonal Antibodies
Moo Sun Hong - Postdoc, MIT
BioProcess International - Manufacturing Strategy
8:30am - 9:00am
Keynote Address - Overview of Recent Achievements and What’s Next for Continuous Processing

Merck Representative Invited

9:00am - 9:30am
What Guidance Does Economic Analysis Provide? What are the Key Targets for Intensification? Small Vs. Large Scale and USP Vs. DSP
Andrew Sinclair - President and Founder, BioPharm Services Ltd, United Kingdom
10:10am - 10:40am
Manufacturing Strategies and Novel Technologies to Accelerate New Modalities
Sally Alkass - Associate Director, Biogen
10:30am - 11:00am
Case Study: Best Practises for Streamlining Technology Transfer Processes
Jonathan Tsang - Director, Manufacturing Sciences & Technology Biotech, Technology Transfer, Bayer
10:40am - 11:10am
Emerging Fields Of Drug Therapies And Their Commercial Scale Production Challenges

Over the past year and a half, EHS & Biosafety (EHS&B) subject matter experts from over 15 global biopharmaceutical industries have partnered to share and discuss emerging trends and challenges facing their industry, in particular the rapidly expanding field of Cell & Gene Therapy (CGT).  The EHS&B group discussed opportunities to aid those involved in the CGT arena, in particular those working with commercial scale volumes within the manufacturing area, in particular developing drug substances for human trials for the ultimate use as therapeutic drugs.   “Commercial Scale” was defined as not only the production of CGT products using processes described as large scale (>10 Liters), but also where the commercial production is less than 10 Liters. The scale of production does not necessarily mean high risk.

The aim of this presentation is to identify, share, and enhance best practices and standards from other modalities, improve risk controls, increase the speed of learning, and ultimately influence and/or aid regulatory agencies in developing guidance or policies around CGT development and manufacturing. The scope of this guidance is strictly limited to the occupational health and safety risks associated with facilities and distribution sites in the clinical and commercial supply chain and does not attempt to address risks associated with clinical trials or patient safety.  The end goal is to create partnerships across the industry and supply chain that provide the quickest route to implementation, so that the industry shares, learns and builds the best solutions together.

11:00am - 11:30am
Data Science and Digitalization Is The Perceived Enabler For Accelerating Technology Transfer And Process Validation
  • How data science can be beneficial for successful tech transfer
  • How to focus on critical unknowns for data science assisted risk assessment and data science for proving comparability.
  • Novel data science tools, such as comparability analysis, power analysis and integrated process modelling
  • How to validate models in a GxP life cycle context
  • Its application along the product lifecycle as emphasized in ICH Q12
Christoph Herwig - Bioprocess Engineering Professor, TU Wien, Austria
11:10am - 11:40am
Manufacturing Technologies, Facility Design and Industrialised Supply Chains for Cell and Gene Therapies
Justin Horvath - Director of Manufacturing Sciences, REGENXBIO Inc
11:30am - 12:00pm
Panel Discussion: Best Practises for Working with CMOs and Overcoming Technology Transfer Challenges
  • Understanding CMO capacities
  • Best practises for working with CMOs
  • Setting expectations for tech transfers
  • Lessons learnt from transferring to CMO and vice versa
  • Electronic communication: How to exchange information in a safe and convenient manner
  • Using Cloud and Amazon Web Services for document sharing in GMP compliant environments
  • Case studies from CMO and end user perspectives
1:25pm - 1:55pm
Manufacturing of Novel Immuno-Oncology Biologics at the Right Scale

Verseau Therapeutics is developing the first-in-class macrophage checkpoint modulators that can potentially induce an anti-tumor immune response in patients, who are not benefitting from the current therapies.

One of the challenges associated with accelerated biologics development for a novel pharmacological target is the correct assessment of the clinical manufacturing scale. To address this challenge, Verseau is simultaneously monitoring the cell line productivity and the projected dose required to cover the target to adjust manufacturing to scale that delivers drug products in the shortest time and in the most economical way possible.

Rizwan Manzer - Director of CMC and Manufacturing, Verseau Therapeutics
1:40pm - 1:45pm
Chairperson’s Opening Remarks
1:45pm - 2:15pm
An Organization Approach To Single-Use Standardization For Technical, Quality And Procurement Improvements

The biologics market is changing: pressure from biosimilars, more potent medicines, more productive processes, new treatment modalities, market volatility, and regulatory changes. How can we meet shrinking development times, lower cost, and improve quality for single-use facilities? The short answer: with standardization of single-use. Here we discuss our pathway to single-use standardization and review the impact of our policies for a future single-use facility.

Hana Sheikh - Senior Engineer, Roche-Genentech
1:55pm - 2:25pm
Strategies to Maximize Existing Capacity whilst Increasing Profitability and Operating Ability of Manufacturing Facilities
2:15pm - 2:45pm
Utilising Single Use Technologies in Commercial Manufacturing
Weibing Ding - Director, GSK
2:25pm - 2:55pm
Scientific & Technology Presentations
BioProcess International - Cell & Gene Therapy
10:50am - 11:10am
Potency & Fully Characterizing your Cell Product
  • What does potency really mean?
  • And how do you quantify it?
  • How is this rolled into your CQA’s Impact on release assays Potency testing development & progressive implementation
  • Characterization of potency of reprogramming stem cells
11:10am - 11:30am
Manufacturing and Quality Control of Immunotherapies
Steve Oh - Director Stem Cell Bioprocessing & Institute Professor,, A*Star, Singapore
Cell & Gene Therapy Bioprocessing & Commercialization - Cell & Gene Therapy Bioprocessing and Commercialization – Partnering Track
7:55am - 8:00am
Chairpersons Opening Remarks
8:00am - 8:45am
State of the Industry
Michael Lehmicke - Director, Science and Industry Affairs, Alliance for Regenerative Medicine
8:45am - 9:30am
Panel Discussion: Strategies and Challenges in Manufacturing and Commercialization
  • What are the challenges presented by constantly changing technologies; how can partnering and collaboration held effectively address them?
  • What is the impact of industry M&As on manufacturing capacity?
  • What’s driving the increase? Will it last? What is the impact on the investment landscape?
  • Is the focus just on Pure Cell Therapy and Gene Edited Cell Therapy? Will we see a future shift towards pure Gene Therapies?
  • AI and Machine Learning: what’s the impact on data management for manufacturing?

 


Thomas Bollenbach - Chief Technology Officer, Advanced Regenerative Manufacturing Institute
Loren Wagner - Head, CAR-T Manufacturing Operations, Bristol-Myers Squibb
Chris Gemmiti, Ph.D. - Head of Operations, Sentien Biotechnologies Inc.
Mahendra Rao - CEO, panCELLa
10:30am - 11:15am
Partnering and Collaborations among Investors, Incubators and Biotechnology Companies
  • Key challenges to commercialize CGT: addressing challenges from a range of perspectives: e.g. Tech transfer, scalability, regulatory considerations 
  • Unpacking the collaboration between investors, incubators and biotechnology companies: where is value added, what milestones are investors looking for?
  • Trends in manufacturing, changing capabilities, standards and practices 
Jennifer Griffin - VP Industrial Strategy & Investments, Massachusetts Life Science Center
Paul Lammers - President & CEO, Triumvira Immunologics
11:15am - 12:00pm
Panel Discussion: Investment in the CGT space: trends, technologies and early stage success
  • What are the latest investment trends; where is the money going; where is it not going?
  • Investors perspective on novel technologies; balancing risk vs investment
  • What can early stage companies do to stand out and attract investment?
  • AI and Diagnostics – what is the impact of new players in the field?
  • What are investors looking for?



Mike Zhao - Senior Vice President, MSQ Ventures
Jak Knowles - VP Venture Investments, Bayer
Shinichiro (Shin) Fuse, Ph.D. - Managing Director, MPM Capital
Matt Cohen - Partner, Osage University Partners
Walter Kowtonuik - Principal, Third Rock Ventures, USA
12:00pm - 12:30pm
Spotlight Presentations

Use this event to raise your corporate profile and demonstrate your products and services to our targeted, multidisciplinary audience. By joining us in sponsoring and exhibiting at this event, you will be able to;


  • Use and exhibition stand to meet new clients in the main networking area
  • Raise your corporate profile and shape your corporate image with logo placement
  • Ensure market presence as a thought leader with a speaking position

 

For sponsorship and exhibition opportunities please contact Kristin Shakan; Email: kristin.shakan@informa.com

1:35pm - 2:30pm
Panel Discussion: Pricing and Reimbursement strategies for Cell and Gene Therapies
  • What unique challenges do the one-time administration nature of gene therapies throw up for traditional buy-and-bill models?
  • How do we balance performance risk; redefining a cure?
  • Partnerships to resolve complex financing and risk issues
  • Evaluating payment models; Value based agreements, Amortized Payment models, Carve-outs and Risk Pools.

Kevin W. Mayo - Managing Partner, Venture Genome LLC
Phillip D. Carter - Head of U.S. Market Access, Orchard Therapeutics
2:30pm - 3:15pm
Creating a partnership in advanced therapies to enable seamless transition of a program
  • How to build an integrated team across organizations
  • Keys to success for partnership
  • Maximizing speed to the clinic without impacting quality
  • Transferring CMC successfully without lost time or effort
Janelle A. Sabo - Global Head, Clinical Supplies, Systems and Innovation, Eli Lilly Research and Development
Devyn Smith - Chief Strategy Officer and Head of Operations, Sigilon Therapeutics, USA
4:00pm - 4:45pm
Panel Discussion: Partnering solutions for staffing and recruitment issues in the CGT space
  • What are the key challenges faced in meeting staffing capability in novel therapeutic spaces?
  • What is the role of universities and bio incubators in this?
  • The trade-off between Experience vs Training
  • What are pharma doing to address this problem?
  • The small company perspective: what are we doing to address these challenges?



Andrew Rigoglioso - Associate Director, Talent Acquisition, Flagship Pioneering
Alison Quelch - Director, Talent Acquisition, Global Product Development & Supply, Bristol-Myers Squibb
Jennifer Royal-Fitch - Lead Recruiter, Gene Therapy Program & The Orphan Disease Center, Univeristy of Pennsylvania
4:45pm - 5:30pm
Panel Discussion: Bridging the Gap between Academia and Commercialisation: When to spin out?
  • What are the trends; product & technology out licensing or founding a company
  • Best Practice when working with Pharma
  • Finding the best partners to suit your asset
  • Partnering strategies to de-risk the investment



Elizabeth Schwarzbach - CBO, New York Stem Cell Foundation
Sofia Braag - Business Development Principal, University of Massachusetts Medical School
Robert L. Buchanan - Co-Founder & CEO, Ambulero
Cell & Gene Therapy Bioprocessing & Commercialization - PLENARY SESSION: COMMERCIALIZATION STRATEGIES – LESSONS LEARNED & VALUABLE FUTURE OUTLOOKS
7:55am - 8:00am
Chairperson’s Opening remarks
8:00am - 9:00am
PANEL: Commercial Trailblazers: Valuable Lessons Learnt on the Path to Commercialization
  • Strategies and pitfalls
  • Pricing and reimbursement
9:00am - 9:30am
Spotlight Presentation - Fujifilm Diosynth
Cell & Gene Therapy Bioprocessing & Commercialization - PLENARY SESSION: ALLOGENEIC CAR & T CELL THERAPIES – IPSC, GENE EDITING & UNIVERSAL CELLS
7:40am - 7:45am
Chairperson’s Opening remarks
7:45am - 8:15am
Gene edited Allogeneic cells
  • How can gene editing result in better allogeneic cells?
  • Immunotolerance, reducing rejection etc.
Kalai Sivarajan - Team Leader, CMC, Precision Biosciences (pending final confirmation)
8:15am - 8:45am
Fate Therapeutic’s Off-the-shelf, iPSC-derived CAR T-Cell Cancer Immunotherapy Program
Betsy Rezner - Director, Process & Assay Development, Fate Therapeutics Inc.
8:45am - 9:15am
PANEL: Universal Cells: Is the Future for CGT Allogeneic ‘Off the Shelf’?
  • What would be the right cocktail of edits to get the perfect universal allogeneic cell?
  • For those opposed to gene edited allo, what are the alternatives – should we re-visit embryonic stem cells?
  • How can we push Allo to become the future of treatment – through editing, encapsulation or through better cell sourcing?
  • What makes a ‘good’ allogeneic cell?
  • What are the potential pitfalls of this strategy?
  • How is best to navigate this from a reg perspective?
  • Haplobanking
Lior Raviv - Vice President, Pluristem Therapeutics Inc.
Philip Lee - COO and Co-Founder, Senti Biosciences
Betsy Rezner - Director, Process & Assay Development, Fate Therapeutics Inc.
Kalai Sivarajan - Team Leader, CMC, Precision Biosciences (pending final confirmation)
Antonio Lee, Ph.D. - CEO & Managing Director, Medipost America Inc.
9:15am - 9:45am
Spotlight Presentation: Pall
Cell & Gene Therapy Bioprocessing & Commercialization - Viral Vectors in Cell & Gene Therapies
9:00am - 10:30am
Session 1 – Understanding underlying virology

Explain the wide variety of virus types and how this can be utilized to choose the best virus for the application and also the ability to use the native targeting ability for some virus types. Describe the development of the different GT viruses that has been and are used today. What virus is good for some and not for other applications with details on the genetics and infectious cycle of example virus types to illustrate the reasons. The following will be considered:


  • The ability of viruses to integrate with the host genome and insert viral DNA
  • Engineering of viruses so they become integrative but non-replicative in order to ensure patient safety
  • What are the viruses we use for CGT applications: some strand of the HIV virus which has been modified over time, lentivirus, adenovirus etc
11:00am - 12:30pm
Session 2 - Viral Vector manufacturing principles part 1

Elimination of bacterial DNA sequences from plasmids and how different DNA sequences can cause immune reactions and cell death plus other considerations of plasmid design. Considerations of scaling up from the lab to the clinical scale plus media composition and cell line considerations due to potential contaminations causing immune reactions when injected into patient.

Design of production facilities with positive pressure and strict protocols for manufacturing etc.


  • Plasmid design
  • Growth in HEK293 Cells and expansion to reach desired titration, 50l, 200l
  • Understanding the different technologies available and when to use what.

Facility requirements – operating in closed systems saves time and money as you can operate in a grade C/D facility

Cell & Gene Therapy Bioprocessing & Commercialization - Advanced Tools for Cell and Tissue Manufacturing: 20/20 View
8:55am - 9:00am
Chairperson’s Opening Remarks
9:00am - 9:30am
ARMI | BioFabUSA Technology Update
Mary Clare McCorry - Director, Technology and Process Development, Advanced Regenerative Manufacturing Institute (ARMI)
9:30am - 10:00am
Raw Materials/Starting Materials
10:00am - 10:30am
Cell Culture and Expansion
Jan Jensen - CEO and Founder, Trailhead Biosystems Inc.
11:00am - 11:30am
Cell Harvest
11:30am - 12:00pm
Scaffold Fabrication
Michael Francis - Chief Science Officer & Founder, Embody Inc.
12:00pm - 12:30pm
Scaffold Fabrication
1:30pm - 2:00pm
Tissue Maturation and Bioreactor Culture
George Joseph Christ - Professor of Biomedical Engineering and Orthopaedic Surgery, University of Virginia
2:00pm - 2:30pm
Tissue Maturation and Bioreactor Culture
2:30pm - 3:00pm
Systems thinking for you manufacturing process or Developing Your Manufacturing Process from A->Z
Priya Baraniak - Scientist, RoosterBio
3:30pm - 4:00pm
Sensors
4:00pm - 4:30pm
Sensors
4:30pm - 5:00pm
Data Management and the Use of AI
Cell & Gene Therapy Bioprocessing & Commercialization - Single Use Applications for Cell & Gene Therapies
8:55am - 9:00am
Course Leader Opening Remarks
James Dean Vogel - Founder and Director , The BioProcess Institute
9:00am - 10:30am
Single Use Applications for Cell & Gene Therapies

An Introduction to Single-Use Technologies and the specific attributes and quality needs when implementing Single-Use Technologies in Cell and Gene Therapy Manufacturing. BPI’s training workshop will focus on the importance and the implementation of Single-Use technologies in production of manufacturing facilities. The format of the course includes valuable and unbiased classroom instruction by industry expert James Dean Vogel, P.E. With Mr. Vogel’s assistance, course participants will experience the latest Single-Use products first-hand during the lab portion of the course.


Topics include:


  • Brief Review of Cell and Gene Production Methods and Regulatory Considerations
  • Single-Use Bioprocess Equipment - Materials of Construction
  • Single-Use Advantages and Disadvantages
  • Single-Use Requirements for Cell and Gene Therapies and Risks
  • Single-Use Components available for Hands-On Demonstration

Attendees range from end-users, suppliers, sales and regulatory personnel who have a general understanding of the SUT industry and want to experience Single-Use products hands on!

11:00am - 12:30pm
Single Use Applications for Cell & Gene Therapies - Cont'd

An Introduction to Single-Use Technologies and the specific attributes and quality needs when implementing Single-Use Technologies in Cell and Gene Therapy Manufacturing. BPI’s training workshop will focus on the importance and the implementation of Single-Use technologies in production of manufacturing facilities. The format of the course includes valuable and unbiased classroom instruction by industry expert James Dean Vogel, P.E. With Mr. Vogel’s assistance, course participants will experience the latest Single-Use products first-hand during the lab portion of the course. 

 

Topics include:

 

  • Brief Review of Cell and Gene Production Methods and Regulatory Considerations 

  • Single-Use Bioprocess Equipment - Materials of Construction 

  • Single-Use Advantages and Disadvantages 

  • Single-Use Requirements for Cell and Gene Therapies and Risks 

  • Single-Use Components available for Hands-On Demonstration 

 

Attendees range from end-users, suppliers, sales and regulatory personnel who have a general understanding of the SUT industry and want to experience Single-Use products hands on! 

1:30pm - 3:00pm
Single Use Applications for Cell & Gene Therapies - Cont'd

An Introduction to Single-Use Technologies and the specific attributes and quality needs when implementing Single-Use Technologies in Cell and Gene Therapy Manufacturing. BPI’s training workshop will focus on the importance and the implementation of Single-Use technologies in production of manufacturing facilities. The format of the course includes valuable and unbiased classroom instruction by industry expert James Dean Vogel, P.E. With Mr. Vogel’s assistance, course participants will experience the latest Single-Use products first-hand during the lab portion of the course. 

 

Topics include:

 

  • Brief Review of Cell and Gene Production Methods and Regulatory Considerations 

  • Single-Use Bioprocess Equipment - Materials of Construction 

  • Single-Use Advantages and Disadvantages 

  • Single-Use Requirements for Cell and Gene Therapies and Risks 

  • Single-Use Components available for Hands-On Demonstration 

 

Attendees range from end-users, suppliers, sales and regulatory personnel who have a general understanding of the SUT industry and want to experience Single-Use products hands on! 

3:30pm - 5:00pm
Single Use Applications for Cell & Gene Therapies - Cont'd

An Introduction to Single-Use Technologies and the specific attributes and quality needs when implementing Single-Use Technologies in Cell and Gene Therapy Manufacturing. BPI’s training workshop will focus on the importance and the implementation of Single-Use technologies in production of manufacturing facilities. The format of the course includes valuable and unbiased classroom instruction by industry expert James Dean Vogel, P.E. With Mr. Vogel’s assistance, course participants will experience the latest Single-Use products first-hand during the lab portion of the course. 

Topics include: 

  • Brief Review of Cell and Gene Production Methods and Regulatory Considerations 

  • Single-Use Bioprocess Equipment - Materials of Construction 

  • Single-Use Advantages and Disadvantages 

  • Single-Use Requirements for Cell and Gene Therapies and Risks 

  • Single-Use Components available for Hands-On Demonstration 

 

Attendees range from end-users, suppliers, sales and regulatory personnel who have a general understanding of the SUT industry and want to experience Single-Use products hands on! 

Cell & Gene Therapy Bioprocessing & Commercialization - Cell Therapy
10:15am - 10:45am
Adherent Cell Manufacturing & Process Development
  • Consistent, simple, and cost-effective incorporation into products
  • What does it mean for product development?
  • What are the quality specifications?
Lior Raviv - Vice President, Pluristem Therapeutics Inc.
10:30am - 10:55am
Quantitative Analytical Technologies for Cell & Gene Therapies
Barrett J. Nehila - Associate Director, Analytical Development, Torque Therapeutics
10:45am - 11:15am
Risk Based Approaches to Comparability
Erica Bust - Senior Process Engineer, Juno Therapeutics Inc., USA
10:55am - 11:20am
Manufacturing and Quality Control of Immunotherapies
Steve Oh - Director Stem Cell Bioprocessing & Institute Professor,, Bioprocessing Technology Institute
11:15am - 11:45am
Process Development Considerations for Exosomes
  • What challenges do this next gen product bring?
  • Productivity & Cost considerations
Jon A. Rowley, Ph.D. - Founder & Chief Product Officer, RoosterBio Inc.
11:45am - 12:20pm
Spotlight Presentation

Use this event to raise your corporate profile and demonstrate your products and services to our targeted, multidisciplinary audience. By joining us in sponsoring and exhibiting at this event, you will be able to:

  • Use an exhibition stand to meet new clients in the main networking area
  • Raise your corporate profile and shape your corporate image with logo placement
  • Ensure market presence as a thought leader with a speaking position


For sponsorship and exhibition opportunities please contact: Kristin Skahan; Email: kristin.skahan@knect365.com

12:10pm - 12:40pm
Spotlight Presentation – GE Healthcare
1:25pm - 1:30pm
Chairperson’s Opening Remarks
1:45pm - 2:15pm
Fresh vs. Cryopreserved: Tightening up Supply Chains
  • What is best, not only for the source material but for the final product?
  • What do efforts on tightening up the supply chain mean with regards to this?
Jason Acker - Professor, Laboratory Medicine and Pathology, University of Alberta, Canada
2:00pm - 2:30pm
Fujifilm Irving
2:15pm - 2:45pm
Product Dependent Cryopreservation Protocols
  • Case studies and feedback on experience working with multiple product types and what cryopreservation protocols are best for each.
David McKenna - Professor and American Red Cross Chair in Transfusion Medicine, Department of Laboratory Medicine and Pathology, University of Minnesota
2:30pm - 2:50pm
BIA Separations
2:45pm - 3:05pm
Spotlight Presentation – BioTechne
3:05pm - 3:25pm
Spotlight Presentation
3:25pm - 3:30pm
Chairperson’s Opening Remarks
David Smith - Chief Commercial Officer, Healios
3:30pm - 4:00pm
Starting Material Standardization for Cell Therapies
  • What directions/ moves is the industry making towards the standardization of starting materials? 

  • Quality of starting material and how best to collect this  

  • How can you limit variation as much as possible? And how will this facilitate/ help a better understanding of what is working in process development vs. what is failing? 

  • Selection & Qualification  

  • Selection/screening, material acquisition/consent, banking, release testing, iPSC/ESC vs later progenitors 

Scott Burger - Principal, Advanced Cell & Gene Therapy, USA
4:00pm - 4:30pm
MSc as a Source Material
  • Cord blood as your stem cell source
  • What challenges would this then create from a manufacturing standpoint
Kathy Williams - VP of Quality and Reg Affairs, RoosterBio, Inc., USA
4:00pm - 4:30pm
Standardization in Manufacturing of Cell Therapy Products
  • The need for universal standards
  • What should be standardized and what will this mean for the industry?
4:30pm - 5:00pm
Data Governance and Data Integrity as a framework during Process Development
  • Data Process Mapping 
  • Data Criticality 
  • Data Quality

Sara Levy - CSV & Data integrity Manager, Pluristem Therapeutics Inc.
4:30pm - 5:00pm
Spotlight Presentation

For sponsorship and exhibition opportunities please contact: Kristin Skahan; Email: kristin.skahan@informa.com

5:00pm - 5:30pm
Final Product Release Testing Strategies
  • What improvements are being made to improve testing time?
  • Control strategies and control strategy development
  • Particulate and sub visible particulates – what is the status of testing for these?
Cell & Gene Therapy Bioprocessing & Commercialization - Gene Edited Ex Vivo Cell Therapy
10:15am - 10:35am
Will Allogeneic Cell Therapies Replace the Current Autologous Models?

Cost effectiveness of auto vs. allo

Geoffrey Hodge - Chief Technical Officer, Unum Therapeutics
10:25am - 10:30am
Chairperson’s Opening Remarks
10:35am - 10:55am
Senti Bio Case Study – Gene Edited MSc
  • Case study with modified MSc’s 


Philip Lee - COO and Co-Founder, Senti Biosciences
10:55am - 11:15am
Encapsulation Approaches – A Sigilon Case Study
  • Case study from Sigilon
Martha Rook - SVP, Manufacturing, Sigilon Therapeutics Inc.
11:15am - 11:35am
Instrumentation and Mechanisms to Drive Efficient therapies
Alan Smith, Ph.D. - Executive Vice President, Technical Operations, Bellicum Pharmaceuticals
11:20am - 11:45am
Analytical Method Development and Validation – Building the Characterization Testing Foundation & Toolkit
Lara Ionescu Silverman - Senior Director, Research and Development, DiscGenics
11:35am - 12:05pm
Sartorius
11:45am - 12:10pm
AI in Cell and Gene Therapy Manufacturing
  • What is the role of AI in CGT manufacturing?
  • Where can AI and machine learning be applied?
Michael Roberts - Chief Technology Officer (Europe), Asklepios BioPharmaceutical, Inc.
1:30pm - 2:00pm
PANEL: Autologous Manufacturing – What will Autologous Manufacturing of the Future Look Like?
  • Where do the biggest bottlenecks currently lie in auto manufacturing? Vector supply? In house or CDMO capabilities?  

  • Why is everyone looking towards Allo?  

  • Is outsourcing the way forward or should the model be acquisition, to achieve desired capability? 

  • Is automation still a good way to reduce COGs and drive a faster more hand’s off approach? 

Jennifer Adrian - Manager, Cellular Therapy Manufacturing Operations, bluebird bio
Adam Haskett - Associate Director, External Manufacturing, Kite Pharma
1:40pm - 1:45pm
Chairpersons Opening Remarks
Ran Zheng - Chief Technical Officer, Orchard Therapeutics
1:45pm - 2:15pm
Tracking from Donor to Patient
Sarah Nikiforow - Asst. Professor, Stem Cell Transplantation Program, Asst. Medical Director, Cell Manipulation Core Facility, Dana-Farber Cancer Institute
2:00pm - 2:20pm
Scalable GMP Production of AAV, Lentivirus & Plasmids
Jeffrey Hung - Chief Commercial Officer, Vigene Biosciences, Inc., USA
2:15pm - 2:45pm
Bench to Bedside Harmonization – Facilitating Delivery to Clinics & Hospitals
  • Need for protocol & audit standardization
  • What does the future look like in terms of getting the product from clean rooms to clinics/hospitals?


Cristina Stoyanov - CMC Lead, Orchard Therapeutics, USA
2:20pm - 2:50pm
Spotlight Presentation
2:45pm - 3:20pm
Spotlight Presentation

Use this event to raise your corporate profile and demonstrate your products and services to our targeted, multidisciplinary audience. By joining us in sponsoring and exhibiting at this event, you will be able to:

  • Use an exhibition stand to meet new clients in the main networking area
  • Raise your corporate profile and shape your corporate image with logo placement
  • Ensure market presence as a thought leader with a speaking position


For sponsorship and exhibition opportunities please contact: Kristin Skahan; Email: kristin.skahan@knect365.com

3:55pm - 4:25pm
Efficiency Challenges as a Result of Viral Vectors
  • Industrialization of the Viral Vector Supply Chain
Adam Haskett - Associate Director, External Manufacturing, Kite Pharma
4:00pm - 4:30pm
Cryopreservation & Storage of Viral Vectors
  • Stability issues and concerns
  • What protocols should be followed
Erik Woods - Co-Founder and Chief Science Officer, Ossium Health, Inc., USA
4:30pm - 5:00pm
Formulation & Freezing Process Optimization from Small to Large Scale
  • Best practice building your supply chain from starting cell product to delivery to the patient
  • Logistics management
  • Reg considerations
  • What technologies can facilitate this?
4:55pm - 5:00pm
Chairperson’s Opening Remarks
5:00pm - 5:30pm
Phase Appropriate Thinking – Microbiology and Contamination Control

The unique differences in cell therapy manufacturing provide both opportunity and awareness of the potential for building a microbiological quality foundation while making modifications to processes during clinical development. The importance of contamination control to the patient is utmost for safety and compliance. The ability to modify the process to ensure therapeutic consistency and adequate supply for the patient(s) is also critical. A balance is paramount. This presentation will discuss the key areas in a contamination control strategy and how it fits into a phase-appropriate approach for compliance and product (therapy) development.

Donald Singer - Consultant, formerly, GSK Senior Fellow, Microbiology, Biopharmaceutical GMP Operations, USA
Cell & Gene Therapy Bioprocessing & Commercialization - In Vivo Gene Therapy
10:10am - 10:15am
Chairperson’s Opening Remarks
10:15am - 10:45am
Next Generation cell lines & large-scale bioprocessing technology
  • Transient vs. Producer cell lines
  • Flexibility and efficiency of transient cell lines vs. need for GMP plasmids
  • Could stable cell lines improve the current challenges associated with producing viral vectors at scale?
  • How are cell lines changing?
Sam Wandsworth - Chief Scientific Officer, Ultragenyx Gene Therapy
10:30am - 11:00am
Exposing the content of different AAV fractions after ultracentrifugation

Recent developments in the biomedical fields have enabled that viruses can also be used to help us fight against numerous diseases. Even though, the production of recombinant viral vectors began 40 year ago, the established technologies still haven’t reached the optimal level. Different product and process related impurities affect the efficiency of the production. To improve the overall production process, advanced analytical techniques are needed to accurately follow presence of desired product and possible impurities in various production steps. Non-related analytical techniques usually also produce non-comparable results. We have used different analytical techniques (Quantitative PCR (qPCR), digital droplet PCR (ddPCR), high throughput sequencing (HTS), Enzyme-linked immunosorbent assay (ELISA) and transmission electron microscopy (TEM)) to thoroughly characterize four fractions of AAVs (empty, intermediate, full and heavy particles) coming from CsCl gradient ultracentrifugation purification. The results offer an interesting insight into the presence of impurities, vector genomes and viral particles in different fractions. Those results will be presented and discussed in view of selection of appropriate analytical methods, their correlations and importance for creating a wider picture of the virus vector sample.

David Dobnik - Scientific Associate, National Institute of Biology, Slovenia
10:45am - 11:15am
Assessing the future prospects of upstream bioprocessing systems for commercial AAV production
Scott Jeffers - Director, UniQure
11:00am - 11:30am
Pathogen Safety Margins for Gene Therapy Manufacturing
Thomas Kreil - Vice President, Global Pathogen Safety, Takeda
11:15am - 11:45am
Suspension Systems in Continuous Viral Vector Production Processes
Felipe Tapia - Postdoctoral Researcher, Bioprocess Engineering, Max Planck Institute
11:30am - 12:10pm
Mechanistic Understanding of Recombinant Adeno-Associated Virus Production

Recombinant adeno-associated viruses (rAAVs) are increasingly exploited as a vector for gene therapy. To keep pace with the needs ofrAAVs in various development stages of gene therapies, manufacturing capability needs to be improved. This presentation reviews the cellular pathways of rAAVproduction and the potential barriers to achieving high viral productivity. Strategies for improving productivity are discussed based on understanding the rAAVproduction pathways and targeting the bottlenecks from the standpoint of the underlying mechanisms. Part of this understanding comes from drawing connections to wild-type AAV replication.

Sha Sha - Postdoc, Massachusetts Institute of Technology
12:10pm - 12:40pm
Spotlight Presentation

Use this event to raise your corporate profile and demonstrate your products and services to our targeted, multidisciplinary audience. By joining us in sponsoring and exhibiting at this event, you will be able to:

  • Use an exhibition stand to meet new clients in the main networking area
  • Raise your corporate profile and shape your corporate image with logo placement
  • Ensure market presence as a thought leader with a speaking position


For sponsorship and exhibition opportunities please contact: Kristin Skahan; Email: kristin.skahan@knect365.com

1:30pm - 2:00pm
Towards Continuous Bioprocessing of Lentiviral Vectors
Sven Ansorge - Director of Manufacturing, ExCellThera Inc.
1:45pm - 2:15pm
The case for rAAV titration by HPLC

For genomic and capsid titre determination PCR and ELISA based assays are the method of choice for rAAV characterisation, respectively. While these are widely accepted they pose a challenge for R&D labs, however – limited throughput due to fixed times for sample preparation, digest, incubation, and amplification. A platform shift is required to free up resources and rapidly provide answers to development studies. In this talk we will discuss the implementation of HPLC assays in support of Gyroscope’s development programmes.

Franz Schnetzinger - Director Analytical Development, Gyroscope Therapeutics
2:00pm - 2:30pm
Intertek
2:15pm - 2:45pm
Vector Characterization Optimization Techniques
Andrew Espejo - Vector Analytics Lead, CMC Gene Therapy, Vertex Pharmaceuticals (pending final confirmation)
2:30pm - 2:50pm
GE Healthcare
2:45pm - 3:20pm
Spotlight Presentation - CPC
3:25pm - 3:55pm
Raw Materials: BOMs, Risks & Securing Supply
Tom Walls - Associate Director Supply Chain, bluebirdbio
4:00pm - 4:30pm
Emerging tools and needs for AAV vector characterization
Fabien Dorange - Head of Analytical Development, Genethon
4:25pm - 4:55pm
Re- Dosing: Is Gene Therapy Really a Cure?
  • If these are meant to be one-time treatments, then what does re-dosing mean? 

  • What strategies are being taken by companies – i.e. next generation vectors for re-dosing  

  • What re-treatment options are there? 

Kei Kishimoto - CSO, Selecta Biosciences
4:30pm - 5:00pm
Emerging upstream bioprocessing and analytical tools for vector manufacture
Michael J. DiBiasio-White, Sr. - Scientist: BioProcess Development/Protein Sciences, Ring Therapeutics
5:00pm - 5:30pm
PANEL: The Future of Adeno and Lenti Viral Vector Production & Other Production Platforms
  • Movement from surface to suspension culture and what this means for yields? 

  • What are the pros and cons of the different platform

Cell & Gene Therapy Bioprocessing & Commercialization - Workshop 1: In Vivo Gene Therapy Commercialization & Delivery Strategies
1:30pm - 3:00pm
Session 3 - Choosing the most appropriate vector for your application part 1
  • Importance of deep knowledge of the disease to be able to design the best therapy ie choose the right vector system and genetic control systems for the therapeutic genetic elements.

    Explain the difference in ex vivo and in vivo GT and the design of the different approaches plus discussing the use of naked nucleic acid therapies v/s vector-based therapies.


    The difference in how VV are used in gene-modified cell therapy and gene therapy – GMCT – vector is the raw material whereas in gene therapy the vector is the final product.
3:30pm - 4:00pm
Session 4 – Choosing the most appropriate viral vector for your application – part 2

Problems with large genes and also how the distant enhancers can cause issues in vector design. The target cells might have a low level of available receptors for the infection and how this can affect the design of the therapy and overall design.

4:00pm - 5:30pm
Session 5 – Purification Requirements

Importance of use of optimal culture media and certified producer cells. How it can be good and bad to “push” a producer cell line to high titters as it can be causing an issue with empty v/s full capsids. Discuss how bacterial and producer cell DNA can cause negative effects as well as other impurities from manufacturing.


  • Host cell protein requirements
  • Residual empty capsid 
  • Residual host cell DNA
  • How these purification requirements differ between gene therapy and gene-modified cell therapy.
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