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7:00am - 7:55am

Registration

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Showing of Streams
9:30am - 10:25am

Morning Coffee & Networking

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Showing of Streams
12:30pm - 1:45pm

Networking Luncheon in the Poster & Exhibition Hall

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Showing of Streams
3:15pm - 4:00pm

Refreshment Break in the Poster & Exhibit Hall

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Showing of Streams
5:30pm - 6:30pm

Cocktail Reception & BWB Party

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6:30pm - 7:30pm

Woman’s Leadership Programme and Dinner

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7:00am - 7:55am 55 mins
Registration
7:55am - 8:00am 5 mins
Cell, Gene and CART Therapy Bioprocessing
Chairperson's Opening Remarks
7:55am - 8:00am 5 mins
Cell, Gene and CART Therapy Commercialization
Chairperson's Opening Remarks
7:55am - 8:00am 5 mins
Overcoming Downstream Barriers: Supply Chain, Cryopreservation and Delivery
Chairperson's Opening Remarks
8:00am - 9:00am 60 mins
Info
Cell, Gene and CART Therapy Bioprocessing
Breakfast Surgery – FDA, EMA and PMDA Pinch Points
  • Francesco Cicirello - Chairman of the PIC/S Working Group on the revision of Annex 2, and Deputy Chairman of the PIC/S Sub-Committee on the Harmonisation of GMDP / Pharmaceutical Inspection Co-operation Scheme, Australia
  • Ginette Michaud - Director, Office of Biological Products Operations, FDA, USA

Knect365 is looking for 5-6 panellists, comprised of suppliers, manufacturers and regulators to join this breakfast surgery. Attendees will have the opportunity to submit their ‘pinch’ points anonymously to the panel in advance and this session will provide the perfect opportunity to hear from the experts on expectations


Topics to be covered include:

  • Classification and clearance of equipment for manufacturing
  • Raw materials and starting materials
  • Trial landscape
  • Key performance indicators
  • Cryopreservation
  • Stability and visible particles in ATMPs
  • GMP inspections
  • Tech transfer and different global manufacturing requirements
  • Comparability testing
  • Designations
8:00am - 9:00am 60 mins
Info
Cell, Gene and CART Therapy Commercialization
Breakfast Surgery – FDA, EMA and PMDA Pinch Points
  • Francesco Cicirello - Chairman of the PIC/S Working Group on the revision of Annex 2, and Deputy Chairman of the PIC/S Sub-Committee on the Harmonisation of GMDP / Pharmaceutical Inspection Co-operation Scheme, Australia
  • Ginette Michaud - Director, Office of Biological Products Operations, FDA, USA

Knect365 is looking for 5-6 panellists, comprised of suppliers, manufacturers and regulators to join this breakfast surgery. Attendees will have the opportunity to submit their ‘pinch’ points anonymously to the panel in advance and this session will provide the perfect opportunity to hear from the experts on expectations


Topics to be covered include:

  • Classification and clearance of equipment for manufacturing
  • Raw materials and starting materials
  • Trial landscape
  • Key performance indicators
  • Cryopreservation
  • Stability and visible particles in ATMPs
  • GMP inspections
  • Tech transfer and different global manufacturing requirements
  • Comparability testing
  • Designations
8:00am - 9:00am 60 mins
Info
Overcoming Downstream Barriers: Supply Chain, Cryopreservation and Delivery
Breakfast Surgery – FDA, EMA and PMDA Pinch Points
  • Francesco Cicirello - Chairman of the PIC/S Working Group on the revision of Annex 2, and Deputy Chairman of the PIC/S Sub-Committee on the Harmonisation of GMDP / Pharmaceutical Inspection Co-operation Scheme, Australia
  • Ginette Michaud - Director, Office of Biological Products Operations, FDA, USA

Knect365 is looking for 5-6 panellists, comprised of suppliers, manufacturers and regulators to join this breakfast surgery. Attendees will have the opportunity to submit their ‘pinch’ points anonymously to the panel in advance and this session will provide the perfect opportunity to hear from the experts on expectations


Topics to be covered include:

  • Classification and clearance of equipment for manufacturing
  • Raw materials and starting materials
  • Trial landscape
  • Key performance indicators
  • Cryopreservation
  • Stability and visible particles in ATMPs
  • GMP inspections
  • Tech transfer and different global manufacturing requirements
  • Comparability testing
  • Designations
9:00am - 9:30am 30 mins
Cell, Gene and CART Therapy Bioprocessing
Spotlight Presentation - Be The Match Biotherapies
9:00am - 9:30am 30 mins
Cell, Gene and CART Therapy Commercialization
Spotlight Presentation - Be The Match Biotherapies
9:00am - 9:30am 30 mins
Overcoming Downstream Barriers: Supply Chain, Cryopreservation and Delivery
Spotlight Presentation - Be The Match Biotherapies
9:30am - 10:25am 55 mins
Morning Coffee & Networking
10:25am - 10:30am 5 mins
Cell, Gene and CART Therapy Bioprocessing
Chairperson's Opening Remarks
  • Lior Raviv - Vice President, Pluristem Therapeutics Inc.
10:25am - 10:30am 5 mins
Cell, Gene and CART Therapy Commercialization
Chairperson's Opening Remarks
  • Dan Gincel - VP University Partnerships, TEDCO Executive Director, MD Stem Cell Research Fund, Maryland Stem Cell Research Fund, USA
10:25am - 10:30am 5 mins
Overcoming Downstream Barriers: Supply Chain, Cryopreservation and Delivery
Chairperson's Opening Remarks
10:30am - 11:00am 30 mins
Info
Cell, Gene and CART Therapy Bioprocessing
Development of CAR T cell Manufacturing
  • Xiuyan Wang - Assistant Director, Memorial Sloan Kettering Cancer Center, USA

There has been a drastic increase of academic and industrial interest in CAR T cell therapy after its approval for the treatment of ALL and NHL by FDA. The success of this promising therapy relies on reproducible manufacturing of high-quality clinical-grade CAR T cells. Over a decade ago we established a robust modular CAR-T production platform, which has allowed us to successfully manufacture hundreds of CAR-T cell products and to support 12 phase I CAR-T cell clinical trials at our center. In order to further increase the throughput in CAR T cell production and to enable reproducible manufacturing between multiple point of care for multi-center trials, we evaluated the CliniMACS Prodigy system, which incorporates all steps of the manufacturing process from T cell selection to end of process CAR T cell formulation.

We have successfully performed Prodigy runs to generate T cells expressing CARs encoded by gammaretroviral vectors starting from either healthy donors or cryopreserved patient apheresis products. Moreover, we performed multiple side by side comparison runs using either the modular platform or the Prodigy platform. We further evaluated the in vivo anti-tumor activity of CAR-T cells generated with both manufacturing platforms using either PC3 or NALM6 tumor models and correlated their anti-tumor activities with the effector/central memory phenotype of the CAR-T cells.

10:30am - 11:00am 30 mins
Cell, Gene and CART Therapy Commercialization
Viral Vector Process and Analytics For Allogeneic Cell Therapy
  • Christoph Kahl - Associate Director, Viral Vector Process and Analytics, Atara Biotherapeutics, USA
10:30am - 11:00am 30 mins
Info
Overcoming Downstream Barriers: Supply Chain, Cryopreservation and Delivery
Regulatory issues and considerations for cryopreservation
  • Scott Burger - Principal, Advanced Cell & Gene Therapy, USA
  • What are the main regulatory concerns surrounding cryopreservation
  • Sterility testing and regulatory impacts on this
11:00am - 11:30am 30 mins
Cell, Gene and CART Therapy Bioprocessing
Sorting potent stem cells and purification of cells with inertial microfluidics
  • Steve Oh - Director Stem Cell Bioprocessing & Institute Professor,, A*Star, Singapore
11:00am - 11:30am 30 mins
Info
Cell, Gene and CART Therapy Commercialization
New manufacturing models for autologous cell therapies
  • Knut Niss - Chief Technology Officer, Mustang Bio, USA
  • Device based approaches
  • What are the key challenges in upscaling
  • Creating robust and reproducible processes
11:00am - 11:30am 30 mins
Info
Overcoming Downstream Barriers: Supply Chain, Cryopreservation and Delivery
Cryobiology – effects of freezing and thawing on cell viability
  • Jason Acker - Professor, University of Alberta, Canada
  • Case study on the effect freezing and thawing has on cell viability
  • how do you measure viability and what is the most reliable value?
11:30am - 12:00pm 30 mins
Info
Cell, Gene and CART Therapy Bioprocessing
Sustainable, scalable adherent cell manufacturing
  • Shashi Murthy, PhD - Professor of Chemical Engineering & Sherman Center Director, Northeastern University
  • Adherent cell case study
  • Suspension based bioreactors – assessing the process early on
  • What are the COG’s considerations?
11:30am - 12:00pm 30 mins
Cell, Gene and CART Therapy Commercialization
A Case Study from Caribou Biosciences, Inc.
  • Graham Lilley - Process Development Engineer, Caribou Biosciences, Inc., USA
11:30am - 12:00pm 30 mins
Info
Overcoming Downstream Barriers: Supply Chain, Cryopreservation and Delivery
Importance of a temperature - controlled supply chain for therapeutic cells prior to their cryopreservation
  • Case Study
12:00pm - 12:30pm 30 mins
Info
Cell, Gene and CART Therapy Bioprocessing
Spotlight Presentation - PBS Biotech
12:00pm - 12:30pm 30 mins
Info
Cell, Gene and CART Therapy Commercialization
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

12:00pm - 12:30pm 30 mins
Info
Overcoming Downstream Barriers: Supply Chain, Cryopreservation and Delivery
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

12:30pm - 1:45pm 75 mins
Networking Luncheon in the Poster & Exhibition Hall
1:45pm - 2:15pm 30 mins
Info
Cell, Gene and CART Therapy Bioprocessing
Second generation T cell therapies – affordability long term manufacturing considerations
  • Angela Scott - Founder & Chief Operating Officer at TC Biopharm, UK, TC Biopharm, UK
  • Allo vs. auto
  • New emergence of new therapies – what does this mean in terms of how manufacturing will look?
  • How can we ensure that manufacturing will be financially viable?
1:45pm - 2:15pm 30 mins
Cell, Gene and CART Therapy Commercialization
A facility concept for the production of viral vectors for gene therapy
  • Jørgen Magnus - Head of Bio-Process Technology, Bayer, AG, Germany
1:45pm - 2:15pm 30 mins
Info
Overcoming Downstream Barriers: Supply Chain, Cryopreservation and Delivery
Digital control and visibility of your cryo-chain
  • Digital cryo-chain case study
2:15pm - 2:45pm 30 mins
Cell, Gene and CART Therapy Bioprocessing
Semma Therapeutics – Developing a scaled process for manufacturing stem cell derived islets
  • Austin Thiel - Senior Principal Scientist, Semma Therapeutics, USA
2:15pm - 2:45pm 30 mins
Cell, Gene and CART Therapy Commercialization
Semma Therapeutics – Developing a scaled process for manufacturing stem cell derived islets
  • Austin Thiel - Senior Principal Scientist, Semma Therapeutics, USA
2:15pm - 2:45pm 30 mins
Info
Overcoming Downstream Barriers: Supply Chain, Cryopreservation and Delivery
End to end digital solutions for localized facilities and delivery clinics
  • What happens currently when localized facilities and delivery clinics receive cryopreserved product?
  • Can this part of the process move more towards closed digital solutions?
  • What would this mean for the process a whole?
2:45pm - 3:15pm 30 mins
Info
Cell, Gene and CART Therapy Bioprocessing
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

2:45pm - 3:15pm 30 mins
Info
Cell, Gene and CART Therapy Commercialization
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

2:45pm - 3:15pm 30 mins
Info
Overcoming Downstream Barriers: Supply Chain, Cryopreservation and Delivery
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

3:15pm - 4:00pm 45 mins
Refreshment Break in the Poster & Exhibit Hall
4:00pm - 4:30pm 30 mins
Cell, Gene and CART Therapy Bioprocessing
Scale up Process Development for iPSC Derived Immune Cell Therapies
  • Wen Bo Wang - Senior Vice President, Technical Operations, Fate Therapeutics, USA
4:00pm - 4:30pm 30 mins
Cell, Gene and CART Therapy Commercialization
Scale up Process Development for iPSC Derived Immune Cell Therapies
  • Wen Bo Wang - Senior Vice President, Technical Operations, Fate Therapeutics, USA
4:00pm - 4:30pm 30 mins
Info
Overcoming Downstream Barriers: Supply Chain, Cryopreservation and Delivery
Cryo considerations for emerging next generation cell types
  • Erik Woods - Co-Founder and Chief Science Officer, Ossium Health, Inc., USA
  • What will be the role of cryopreservation in next generation 3.0 cell and gene therapies?
  • Will it be required?
4:30pm - 5:00pm 30 mins
Cell, Gene and CART Therapy Bioprocessing
UCL: Manufacturing Research Activity and Automation Case Studies
  • Qasim Rafik - Senior Lecturer in Bioprocessing of Regenerative, Cellular and Gene, UCL, UK
4:30pm - 5:00pm 30 mins
Cell, Gene and CART Therapy Commercialization
UCL: Manufacturing Research Activity and Automation Case Studies
  • Qasim Rafik - Senior Lecturer in Bioprocessing of Regenerative, Cellular and Gene, UCL, UK
4:30pm - 5:00pm 30 mins
Overcoming Downstream Barriers: Supply Chain, Cryopreservation and Delivery
Process Considerations for Cryogenic Shipping
  • Craig Vermeyen - Senior Manager, Packaging Engineering, Kite, a Gilead Company, USA
5:00pm - 5:30pm 30 mins
Cell, Gene and CART Therapy Bioprocessing
Augmenting Automated Analytics for Cell and Gene Therapy Manufacture
  • Veeren Chauhan - Research Fellow, University of Nottingham, USA
5:00pm - 5:30pm 30 mins
Cell, Gene and CART Therapy Commercialization
Augmenting Automated Analytics for Cell and Gene Therapy Manufacture
  • Veeren Chauhan - Research Fellow, University of Nottingham, USA
5:00pm - 5:30pm 30 mins
Info
Overcoming Downstream Barriers: Supply Chain, Cryopreservation and Delivery
Cryopreservation considerations when moving from clinical phase to commercial phase manufacturing

Knect365 is looking for 2 speakers to present one after another on cryopreservation considerations:

 

  • What is required when reaching marketing/commercial stage with regards to cryopreservation?
  • Small amount of doses vs. commercial scale amount
  • What considerations must be made?
  • Challenges and opportunities?
5:30pm - 6:30pm 60 mins
Cocktail Reception & BWB Party
6:30pm - 7:30pm 60 mins
Woman’s Leadership Programme and Dinner