Cell & Gene Therapy Bioprocessing & Commercialization is part of the Informa Connect Division of Informa PLC

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8:00am - 8:55am

Registration

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Showing of Streams
10:30am - 11:00am

Networking Refreshment Break

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Showing of Streams
12:30pm - 1:30pm

Networking Luncheon

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Showing of Streams
3:00pm - 3:30pm

Networking Refreshment Break

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Showing of Streams
8:00am - 8:55am 55 mins
Registration
8:55am - 9:00am 5 mins
Workshop 1: Upstream Supply Chain and Raw Material Considerations
*Workshops start at 12:00pm
8:55am - 9:00am 5 mins
Workshop 2: Next Generation Tools for Manufacturing Regenerative Medicine Products at Scale: In collaboration with ARMI
Chairperson's Remarks
8:55am - 9:00am 5 mins
Workshop 3: Clinical and Early Stage CAR T and Cell Therapy Advances – Solid Tumours, Combination Therapies and Safety Switches
*Workshops start at 12:00pm
8:55am - 9:00am 5 mins
Workshop 4: Single Use Applications for Cell & Gene Therapies
Chairperson's Opening Remarks
9:00am - 9:30am 30 mins
Workshop 2: Next Generation Tools for Manufacturing Regenerative Medicine Products at Scale: In collaboration with ARMI
Development of Tissue Therapies as compared to the Development of Cell and Gene Therapies: A Look Back, A Look Ahead
  • Jennifer Briggs Braswell, PhD - Chief Administrative Officer, ARMI, BioFab, USA
9:00am - 10:30am 90 mins
Info
Workshop 4: Single Use Applications for Cell & Gene Therapies
Single-Use Technologoes for Cell & Gene Therapies
  • James Dean Vogel - Founder and Director , The BioProcess Institute

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!

9:30am - 10:00am 30 mins
Workshop 2: Next Generation Tools for Manufacturing Regenerative Medicine Products at Scale: In collaboration with ARMI
Raw Materials/Starting Materials
  • Derek Hei - Senior VP, Manufacturing, Quality & Regulatory, BlueRock Therapeutics, USA
10:00am - 10:30am 30 mins
Workshop 2: Next Generation Tools for Manufacturing Regenerative Medicine Products at Scale: In collaboration with ARMI
Cell Culture and Expansion
  • Taby Ahsan - Director of Development, RoosterBio Inc., USA
  • Bruce A Bunnell - Professor, Director of the Tulane Center for Stem Cell Research & Regenerative Medicine, USA
10:30am - 11:00am 30 mins
Networking Refreshment Break
11:00am - 11:05am 5 mins
Workshop 1: Upstream Supply Chain and Raw Material Considerations
*Workshops start at 12:00pm
11:00am - 11:30am 30 mins
Workshop 2: Next Generation Tools for Manufacturing Regenerative Medicine Products at Scale: In collaboration with ARMI
Cell Harvest
11:00am - 11:05am 5 mins
Workshop 3: Clinical and Early Stage CAR T and Cell Therapy Advances – Solid Tumours, Combination Therapies and Safety Switches
*Workshops start at 12:00pm
11:00am - 12:30pm 90 mins
Info
Workshop 4: Single Use Applications for Cell & Gene Therapies
Single-Use Technologies for Cell & Gene Therapies
  • James Dean Vogel - Founder and Director , The BioProcess Institute

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!

11:30am - 12:00pm 30 mins
Workshop 2: Next Generation Tools for Manufacturing Regenerative Medicine Products at Scale: In collaboration with ARMI
Biomaterial Scaffold Fabrication – Additive Manufacturing Materials and Methods
  • Peter Gingras - President & CEO, Viscus Biologics LLC, USA
12:00pm - 12:30pm 30 mins
Workshop 2: Next Generation Tools for Manufacturing Regenerative Medicine Products at Scale: In collaboration with ARMI
Scaffold Fabrication
12:30pm - 1:30pm 60 mins
Networking Luncheon
1:30pm - 2:00pm 30 mins
Info
Workshop 1: Upstream Supply Chain and Raw Material Considerations
Auto vs. Allo Supply chain considerations; incorporating starting materials into your process
  • Joseph Carosi - Associate Director, Novartis, USA

Looking for one auto and one allo manufacturer to discuss how they are incorporating raw materials into their current process/chain of custody etc. 

1:30pm - 2:00pm 30 mins
Workshop 2: Next Generation Tools for Manufacturing Regenerative Medicine Products at Scale: In collaboration with ARMI
Tissue Maturation and Bioreactor Culture
  • Sarindr Bhumiratana - CSO, Co-Founder, EpiBone, USA
1:30pm - 2:00pm 30 mins
Workshop 3: Clinical and Early Stage CAR T and Cell Therapy Advances – Solid Tumours, Combination Therapies and Safety Switches
Novel Strategies to Activate, Target and Gene Modify NK Cells for Off-The-Shelf Cancer Therapy
  • Jeffrey Miller - Professor of Medicine, Deputy Director, Masonic Cancer Center, Division of Hematology, Oncology and Transplantation, University of Minnesota, Roger L. and Lynn C. Headrick Family Chair in Cancer Therapeutics, USA
1:30pm - 3:00pm 90 mins
Info
Workshop 4: Single Use Applications for Cell & Gene Therapies
Single-Use Technologies for Cell & Gene Therapies
  • James Dean Vogel - Founder and Director , The BioProcess Institute

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!

2:00pm - 2:30pm 30 mins
Workshop 1: Upstream Supply Chain and Raw Material Considerations
Feedback from the ISIA on the use of serum in manufacturing
  • Rosemary Versteegen, PhD - CEO, International Serum Industry Association
2:00pm - 2:30pm 30 mins
Workshop 2: Next Generation Tools for Manufacturing Regenerative Medicine Products at Scale: In collaboration with ARMI
Tissue Maturation and Bioreactor Culture
  • Stuart Jacobson - ARMI Tissue Foundry Project Manager, DEKA, USA
2:00pm - 2:30pm 30 mins
Workshop 3: Clinical and Early Stage CAR T and Cell Therapy Advances – Solid Tumours, Combination Therapies and Safety Switches
Signal 3 Modified T Cells
  • Bilal Omer - Assistant Professor, Baylor College of Medicine, USA
2:30pm - 3:00pm 30 mins
Workshop 1: Upstream Supply Chain and Raw Material Considerations
Collection of starting product before cell processing and production
  • Eileen Galvin Karr - Apheresis Site Manager, Key Biologics LLC, USA
2:30pm - 3:00pm 30 mins
Workshop 2: Next Generation Tools for Manufacturing Regenerative Medicine Products at Scale: In collaboration with ARMI
Preservation and Transport
2:30pm - 3:00pm 30 mins
Info
Workshop 3: Clinical and Early Stage CAR T and Cell Therapy Advances – Solid Tumours, Combination Therapies and Safety Switches
Off-the shelf, TCR-transduced T cells for solid cancers
  • Ali Mohamed - VP, CMC, Immatics, USA
  • Immatics utilizes a proprietary tumor antigen targets discovery platform, XPRESIDENT® which identifies tumor targets and screen cognate TCRs for off-target toxicities
  • These targets and cognate TCRs against their cognate TCRs are used as the basis of various Immatics’ Adoptive Immunotherapy programs
  • Autologous and allogeneic T cell products are developed for solid cancers using Immatics targets & TCRs:
    • ACTolog®, endogenous (non-engineered) autologous multi-product T cells against a warehouse of tumor targets
    • ACTengine®, TCR engineered autologous T cells against a specific tumor target
    • ACTallo®, TCR engineered allogeneic, non-gene edited gd T cells against a specific tumor target
  • Products have been developed and manufactured under cGMP conditions to meet preset safety & efficacy release criteria for patient infusion for the various clinical trials
3:00pm - 3:30pm 30 mins
Networking Refreshment Break
3:30pm - 4:00pm 30 mins
Workshop 1: Upstream Supply Chain and Raw Material Considerations
Regulatory considerations concerning continuous supply of raw materials
  • Jakub Cierny - Senior Quality Compliance Manager, Sotio AS, Czech Republic
3:30pm - 4:00pm 30 mins
Workshop 2: Next Generation Tools for Manufacturing Regenerative Medicine Products at Scale: In collaboration with ARMI
Quality Systems
3:30pm - 4:00pm 30 mins
Workshop 3: Clinical and Early Stage CAR T and Cell Therapy Advances – Solid Tumours, Combination Therapies and Safety Switches
CAR Macrophage Immunotherapy to target Solid Tumors
  • Michael Klichinsky - Co-Founder, Carisma Therapeutics
3:30pm - 5:00pm 90 mins
Info
Workshop 4: Single Use Applications for Cell & Gene Therapies
Single-Use Technologies for Cell & Gene Therapies
  • James Dean Vogel - Founder and Director , The BioProcess Institute

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!

4:00pm - 4:30pm 30 mins
Workshop 1: Upstream Supply Chain and Raw Material Considerations
Raw material sourcing and qualification
  • Scott Burger - Principal, Advanced Cell & Gene Therapy, USA
4:00pm - 4:30pm 30 mins
Workshop 2: Next Generation Tools for Manufacturing Regenerative Medicine Products at Scale: In collaboration with ARMI
Process Development Through multiomic platform
  • Carolyn Yeago - Associate Director of Research, Marcus Center for Therapeutic Cell Characterization and Manufacturing, Georgia Institute of Technology, USA
4:00pm - 4:30pm 30 mins
Workshop 3: Clinical and Early Stage CAR T and Cell Therapy Advances – Solid Tumours, Combination Therapies and Safety Switches
Pre-clinical and Early Clinical Development of ORBCEL Immunotherapy
  • Steve Elliman - Chief Scientific Officer, Orbsen Therapeutics, USA
4:30pm - 5:00pm 30 mins
Workshop 1: Upstream Supply Chain and Raw Material Considerations
Management and Control of Raw Materials Used in the Manufacture of Biological Medicinal Products
  • Sergio Fracchia - Global regCMC Director, Cell and Gene Therapy, Novartis, Switzerland
4:30pm - 5:00pm 30 mins
Workshop 2: Next Generation Tools for Manufacturing Regenerative Medicine Products at Scale: In collaboration with ARMI
Data Management and Process Optimization Software
4:30pm - 5:00pm 30 mins
Workshop 3: Clinical and Early Stage CAR T and Cell Therapy Advances – Solid Tumours, Combination Therapies and Safety Switches
Gamma Delta T cells for the treatment of Cancer
  • Michael Leek - Chief Executive, TC BioPharm
5:00pm - 5:30pm 30 mins
Workshop 1: Upstream Supply Chain and Raw Material Considerations
Discussion panel: Supplier qualification and considerations
  • Scott Burger - Principal, Advanced Cell & Gene Therapy, USA
  • Jakub Cierny - Senior Quality Compliance Manager, Sotio AS, Czech Republic
  • James Brown - VP Corporate Development, Aldevron, USA