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7:00am - 7:55am

Registration

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

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

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

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

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
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

9:00am - 9:30am 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

9:00am - 9:30am 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

9:30am - 10:30am 60 mins
Morning Coffee & Networking
10:30am - 11:00am 30 mins
Info
Cell, Gene and CART Therapy Bioprocessing
Making changes in USP for gene therapy to improve productivity
  • What new technologies are out there?
  • Transient cell expression which is unpredictable – what is there out there in terms of more stable cell lines?
  • How are people physically making changes to get the results they need?
10:30am - 11:00am 30 mins
Info
Cell, Gene and CART Therapy Commercialization
Reinvention and Optimisation of Vector Production Platforms
  • Investment and developments in vector production platforms
  • How can we improve scalability, robustness and productivity?
  • Moving away from adherent cell culture platforms
10:30am - 11:00am 30 mins
Info
Overcoming Downstream Barriers: Supply Chain, Cryopreservation and Delivery
Regulatory issues and considerations for cryopreservation
  • What are the main regulatory concerns surrounding cryopreservation
  • Sterility testing and regulatory impacts on this
11:00am - 11:30am 30 mins
Info
Cell, Gene and CART Therapy Bioprocessing
Purification technologies: A need for innovation

Looking for 2 speakers to come and present short 15-minute tech slots on the below topics:

 

  • Innovation in purification technologies for gene therapies
  • Cell purification in cell therapy: ultrasound and microfluidics
11:00am - 11:30am 30 mins
Info
Cell, Gene and CART Therapy Commercialization
New manufacturing models for autologous cell therapies
  • 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
  • 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
  • Adherent cell case study
  • Suspension based bioreactors – assessing the process early on
  • What are the COG’s considerations?
11:30am - 12:00pm 30 mins
Info
Cell, Gene and CART Therapy Commercialization
Gene therapy productivity: Viral vector supply and demand
  • Gene therapy productivity
  • How can you ensure you are getting enough vector to meet supply and demand to run your large-scale process?
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

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
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
Bridging the gap between CMO’s and process development
  • How can industry and CMO’s work together bridge the distance between manufacturing and process development?
  • Resulting effects on both cost and time?
1:45pm - 2:15pm 30 mins
Info
Cell, Gene and CART Therapy Commercialization
Second generation T cell therapies – affordability long term manufacturing considerations
  • 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
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
Info
Cell, Gene and CART Therapy Bioprocessing
Cell processing – Creating a robust and sustainable solution
  • How can you optimize your process to give you the best CQA’s, both from a process and product standpoint?
2:15pm - 2:45pm 30 mins
Info
Cell, Gene and CART Therapy Commercialization
Scaling, manufacturing and commercialisation strategies for broader patient populations
  • Gene therapy case studies
  • Not a patient to patient scale; so, what does manufacturing look like from a financial perspective
  • What are the commercial considerations and strategies?
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
Info
Cell, Gene and CART Therapy Bioprocessing
Preparing for commercialization – Evolution in Automation Approaches
  • Manual -> modular -> integrated -> step change automation
  • COGs should reduce, and industrialization potential should increase
  • Finding platforms dedicated to your entire manufacturing process and not just a few process steps
4:00pm - 4:30pm 30 mins
Info
Cell, Gene and CART Therapy Commercialization
Strategies for Reducing Needle-to Needle time – CART centres of Excellence
  • Forward look at the potential for the development of centres of excellence
  • Cell processing becoming de-centralised to be nearby, thus reducing needle-needle time
  • Need for the manufacturing process to fit infrastructure of the point of care
  • What would this mean for the patient?
4:00pm - 4:30pm 30 mins
Info
Overcoming Downstream Barriers: Supply Chain, Cryopreservation and Delivery
Cryo considerations for emerging next generation cell types
  • 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
Info
Cell, Gene and CART Therapy Bioprocessing
The Role of QC in the Development of a Fully Automated Process
  • Release controls
  • CQA’s and technologies associated with understanding these
  • What are the possibilities in terms of the full automation of QC analysis
  • Could we get so far as automated release of the product?
4:30pm - 5:30pm 60 mins
Info
Cell, Gene and CART Therapy Commercialization
Dual Dialogue: Designing a fully flexible cell therapy facility
  • Case study
  • How best to design a facility that can be fully flexible to meet the needs of R&D and manufacturing
  • How can it be put in place, so changes can be made as hoc to labs, clean rooms etc?
4:30pm - 5:30pm 60 mins
Info
Overcoming Downstream Barriers: Supply Chain, Cryopreservation and Delivery
Dual Dialogue: 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?
5:00pm - 5:30pm 30 mins
Info
Cell, Gene and CART Therapy Bioprocessing
Creation of Fit-for Purpose Devices and an All-in-One Automated Platform
  • What needs to be done to allow for flexible development?
  • Do all in one platforms offer the future – still gaps in closed upstream and downstream
  • COGs considerations
5:30pm - 6:30pm 60 mins
Cocktail Reception & BWB Party
6:30pm - 7:30pm 60 mins
Woman’s Leadership Programme and Dinner