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08:25 - 08:30
Chairperson’s Opening Remarks

Chairperson’s Opening Remarks

  • Anthony Davies - Executive Chairman, Dark Horse Consulting Inc, USA
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Showing of Streams
10:20 - 11:05

Morning Coffee

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Showing of Streams
12:50 - 14:00

Lunch and Networking

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Showing of Streams
15:30 - 16:00

Afternoon Coffee

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Showing of Streams
17:10 - 17:15
End of Day Two

End of Day Two

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08:25 - 08:30 5 mins
Chairperson’s Opening Remarks
  • Anthony Davies - Executive Chairman, Dark Horse Consulting Inc, USA
08:30 - 08:50 20 mins
Joint Plenary Session
Title TBC
  • Jean-Luc Golnez - Health & Safety Inspector, FAMHP, Belgium
08:50 - 09:10 20 mins
Joint Plenary Session
International standardization efforts for accelerating the development and commercialization of cell and gene therapy products
  • Sheng Lin-Gibson - Deputy Chief, National Institutes of Standards & Technology, USA
09:10 - 09:45 35 mins
Info
Joint Plenary Session
Breakfast Surgery – FDA, EMA and PMDA Pinch Points
  • Andreea Barbu - Assessor, Farmacy & Biotechnology Department, Pharmaceutics and Biotechnology, MPA, Sweden
  • Jean-Luc Golnez - Health & Safety Inspector, FAMHP, Belgium
  • Catherine Cancian - VP Pharmaceutical Operations, Gensight Biologics, France
  • Sheng Lin-Gibson - Deputy Chief, National Institutes of Standards & Technology, USA
  • Francesco Cicirello - Chairperson PIC/S Working Group on Annex 2 Revision, Inspector, Australia

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:

  • Statistical tools for data assessments
  • GMP for ATMP’s – the new guideline and what it means for industry
  • Raw materials and viral safety considerations
  • Analytics and CMC – Potency assays, comparability etc.
  • Interactions with competent authorities for drugs, tissues & cells
  • Compendial testing – safety testing, and sterility


09:45 - 10:05 20 mins
Info
Joint Plenary Session
Evaluation of Poros AAVX Pan-Affinity Resin for rAAV Purification and cGMP Manufacturing
  • Daniel Hurwit - Senior Associate Engineer, Voyager Therapeutics, USA

Affinity interaction based resins are the foundation for the platform purification of many different biological molecules. While some AAV affinity resins have existed for more than a decade, the growth in the AAV field now demands a true pan-affinity workhorse, analogous to Protein A for mAbs.  In this work we investigate POROS CaptureSelect AAVX (AAVX) for the purification of various serotypes from both crude and pure feed streams.  Performance of AAVX is directly compared against other commercially available AAV affinity resins.  We evaluate binding capacities, binding kinetics, product recovery, impurity clearance, washing and elution strategies, cleanability, cyclability, regeneration as well as the scalability and suitability of the new resin for commercial manufacturing. The results demonstrate that the new AAVX resin is a robust option for the scalable, platform purification of various rAAV capsids from crude feed streams.

10:05 - 10:20 15 mins
Info
Joint Plenary Session
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: Michael Dunnet, Tel:  +44 (0)20 7017 7870; Email: michael.dunnet@knect365.com

10:20 - 11:05 45 mins
Morning Coffee
11:05 - 11:40 35 mins
Info
Stream 1: Manufacturing and Process Development – Analytical Strategies, Design Space, QbD and Cost of Goods Considerations
Enabling commercial scale-out of T-cell manufacturing
  • Smaragda Angelidou - Cell & Gene Therapy Medicine & Process Delivery Leader, Glaxosmithkline, UK
  • What are the key challenges in scaling an autologous process for commercial?
  • The role of closed systems in scalability
  • Understanding and controlling Key Quality Attributes
11:05 - 11:40 35 mins
Stream 2: Facility Design, Manufacturing Networks and End to End Solutions for Commercial Success
Revision of PIC/S Annex 2 for ATMP, challenges with automation and facilitation of cross-border manufacturing
  • Francesco Cicirello - Chairperson PIC/S Working Group on Annex 2 Revision, Inspector, Australia
11:40 - 12:15 35 mins
Info
Stream 1: Manufacturing and Process Development – Analytical Strategies, Design Space, QbD and Cost of Goods Considerations
Adopting Various Manufacturing Closed Systems to Gene Modified T Cell Therapies
  • Ali Mohamed - CMC Vice President, Immatics US Inc,
  • Immatics developed a proprietary tumor antigen targets discovery
  • platform, XPRESIDENT®
  • The platform identifies novel tumor-specific targets and TCR candidate.
  • It also screens TCR candidates based on these targets against off-target
  • toxicities in absence of reliable in vivo models
  • Natural and engineered TCRs against these tumor targets have been used
  • in various Immatics’ Adoptive Cellular Therapy programs in “First In Man”
  • clinical trials
  • Extensive process development was carried out using primary T cells
  • derived from multiple healthy donors and cancer patients to optimize
  • each step in the manufacturing of TCR T cells for 3 clinical trials (IMA101,
  • IMA201, IMA202, and IMA203)
  • Manufacturing for engineered TCR T cell therapies has been adapted into
  • 3 different closed systems with for future phases of clinical trials with
  • excellent results
11:40 - 12:15 35 mins
Info
Stream 2: Facility Design, Manufacturing Networks and End to End Solutions for Commercial Success
Adopting Various Manufacturing Closed Systems to Gene Modified T Cell Therapies
  • Ali Mohamed - CMC Vice President, Immatics US Inc,
  • Immatics developed a proprietary tumor antigen targets discovery
  • platform, XPRESIDENT®
  • The platform identifies novel tumor-specific targets and TCR candidate.
  • It also screens TCR candidates based on these targets against off-target
  • toxicities in absence of reliable in vivo models
  • Natural and engineered TCRs against these tumor targets have been used
  • in various Immatics’ Adoptive Cellular Therapy programs in “First In Man”
  • clinical trials
  • Extensive process development was carried out using primary T cells
  • derived from multiple healthy donors and cancer patients to optimize
  • each step in the manufacturing of TCR T cells for 3 clinical trials (IMA101,
  • IMA201, IMA202, and IMA203)
  • Manufacturing for engineered TCR T cell therapies has been adapted into
  • 3 different closed systems with for future phases of clinical trials with
  • excellent results
11:40 - 12:15 35 mins
Stream 3: Clinical Development for Cell, Gene and Immunotherapies
Ensuring enough supply and magnitude in terms of patient and dose increases
12:15 - 12:30 15 mins
Stream 1: Manufacturing and Process Development – Analytical Strategies, Design Space, QbD and Cost of Goods Considerations
A presentation from Vivabiocell
12:15 - 12:30 15 mins
Info
Stream 2: Facility Design, Manufacturing Networks and End to End Solutions for Commercial Success
Characterization of viral vector samples at different process steps; morphology, integrity, purity and percentage full
  • Vanessa Carvalho - Senior Scientist, Vironova, AB
12:15 - 12:45 30 mins
Stream 3: Clinical Development for Cell, Gene and Immunotherapies
Spotlight presentation
  • A Representative from Miltenyi Biotec, Miltenyi Biotec, Germany
12:30 - 12:45 15 mins
Info
Stream 1: Manufacturing and Process Development – Analytical Strategies, Design Space, QbD and Cost of Goods Considerations
Enhancing economic reality for cell based medicine through manufacturing optimization
  • Benjamin Le Quéré - Business Manager, Bioprocessing Solutions, Saint-Gobain, France
12:30 - 12:50 20 mins
Info
Stream 2: Facility Design, Manufacturing Networks and End to End Solutions for Commercial Success
Spinning Membrane Filtration: Applications in Washing, Concentrating, and Fill/Finish Manufacturing for Cell and Gene Therapies
  • Steven Binninger - EU Cell Therapy Leader, Fresenius Kabi, Germany
12:50 - 14:00 70 mins
Lunch and Networking
14:00 - 14:35 35 mins
Info
Stream 1: Manufacturing and Process Development – Analytical Strategies, Design Space, QbD and Cost of Goods Considerations
Designing a manufacturing facility to meet scaling up requirements
  • Amanda Skulte - Cell & Gene Therapy Product Steward, Novartis, Switzerland

Case study

14:00 - 14:35 35 mins
Info
Stream 2: Facility Design, Manufacturing Networks and End to End Solutions for Commercial Success
Designing a manufacturing facility to meet scaling up requirements
  • Amanda Skulte - Cell & Gene Therapy Product Steward, Novartis, Switzerland

Case study

14:00 - 14:35 35 mins
Info
Stream 3: Clinical Development for Cell, Gene and Immunotherapies
Low Cost Automation to Drive Efficiency and Reproducibility: Case Studies
  • Shashi Murthy, PhD - Professor of Chemical Engineering, Northeastern University, USA
  • When should investments into automation be made?
  • Early in POC for long term process?
14:35 - 15:10 35 mins
Stream 1: Manufacturing and Process Development – Analytical Strategies, Design Space, QbD and Cost of Goods Considerations
Scale Up Case Study: VSV-GP
  • Dethardt Mueller - Head of CMC, Viratherapeutics GmbH, Austria
14:35 - 15:10 35 mins
Stream 2: Facility Design, Manufacturing Networks and End to End Solutions for Commercial Success
Solving challenges in development, manufacture and delivery of cell and gene therapies
  • Lisa Fox-Craig - Vice President, Cell Therapy Operations, Orchard Therapeutics, USA
14:35 - 15:10 35 mins
Stream 3: Clinical Development for Cell, Gene and Immunotherapies
Solving challenges in development, manufacture and delivery of cell and gene therapies
  • Lisa Fox-Craig - Vice President, Cell Therapy Operations, Orchard Therapeutics, USA
15:10 - 15:30 20 mins
Info
Stream 1: Manufacturing and Process Development – Analytical Strategies, Design Space, QbD and Cost of Goods Considerations
Spotlight presentation: IMEC
15:10 - 15:30 20 mins
Info
Stream 2: Facility Design, Manufacturing Networks and End to End Solutions for Commercial Success
Spotlight presentation: Comecer

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: Michael Dunnet, Tel:  +44 (0)20 7017 7870; Email: michael.dunnet@knect365.com

15:10 - 15:30 20 mins
Stream 3: Clinical Development for Cell, Gene and Immunotherapies
Spotlight Presentation
15:30 - 16:00 30 mins
Afternoon Coffee
16:00 - 16:35 35 mins
Info
Stream 1: Manufacturing and Process Development – Analytical Strategies, Design Space, QbD and Cost of Goods Considerations
Meeting the challenge of delivering allogeneic therapies in the commercial sector
  • Robert Leach - Quality Control Manager, Cellectis, France
  • What is the future for autologous therapies?
  • Are they commercially viable
  • What are the strategies for ensuring that they are?
16:00 - 16:35 35 mins
Info
Stream 2: Facility Design, Manufacturing Networks and End to End Solutions for Commercial Success
Industry expectations and management at collection centres
  • A Representative from Be The Match BioTherapies, Be The Match BioTherapies, USA
  • What expectations do manufacturers have for their sites?
  • What resource challenges does this pose?
  • What would make it easier from a facility perspective for the site?

 

16:00 - 16:35 35 mins
Stream 3: Clinical Development for Cell, Gene and Immunotherapies
Current state of play for the cell therapy industry in the clinic – stats and facts
  • Tijana Ignjatovic - Senior Director, Trends and Market Access, Datamonitor, UK
16:35 - 17:10 35 mins
Stream 1: Manufacturing and Process Development – Analytical Strategies, Design Space, QbD and Cost of Goods Considerations
Creating sustainable process development strategies for Gene Therapy products
  • Juan Bort Hernandez - Head of Early Stage Development, Shire, Austria
16:35 - 17:10 35 mins
Info
Stream 2: Facility Design, Manufacturing Networks and End to End Solutions for Commercial Success
Capabilities of blood centres and banks – Could they be CMO’s of the future?
  • Veronica Albertini - Chief Scientific Officer, Swiss Stem Cells Bank SA
  • What are the capabilities of blood centres and the blood banking industries?
  • What is the leverage for them to become CMO’s?
  • What changes need to be made to infrastructure to make this happen?
16:35 - 17:10 35 mins
Stream 3: Clinical Development for Cell, Gene and Immunotherapies
Please more to another track
17:10 - 17:15 5 mins
End of Day Two