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Europe Online Cell & Gene Therapy Boot Camp

31 Jan - 2 Feb 2023

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Boot Camp Agenda

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Boot Camp Agenda

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Note: All times listed below reflect EST
Virtual sessions only
Day 1: Tuesday, January 31
12:00 pm - 1:00 pm
Boot Camp / Seminar

Science and Manufacturing

By the end of this session, attendees will be able to:


  • Understand the scientific principles driving cell and gene therapies

  • Explain the difference between in-vivo, ex-vivo genetic manipulation and autologous and allogeneic therapies

  • Relate how the science and manufacturing processes being used create both clinical and commercial supply chain challenges

Speakers
Paul Ingram
1:00 pm - 2:00 pm
Boot Camp / Seminar

Labeling and Regulatory

By the end of this session, attendees will be able to:


  • Identify ‘made to order’ and ‘make to stock’ portions of an autologous cell and gene therapy supply chain

  • Describe the three ecosystems of a cell and gene therapy value chain

  • Understand how traceability begins with the cell collection label and continues to the drug product label for infusion

Day 2: Wednesday, February 1
12:00 pm - 1:00 pm
Boot Camp / Seminar

Sites and Systems

By the end of this session, attendees will be able to:


  • Broadly describe the processes/best practices to be undertaken to build out the user requirements for internal and site use

  • Operate and maintain business systems for ongoing communication and supply chain management

  • Understand the different scaling of IT systems from clinical to commercialization

Speakers
Neeraj Shah , Trish Demko
1:00 pm - 2:00 pm
Boot Camp / Seminar

Clinical to Commercial

By the end of this session, attendees will be able to:


  • Describe the differences between autologous and allogenic cell therapy supply chains

  • Understand commercial regulatory & quality supply chain requirements

  • Differentiate between clinical and commercial operational requirements

  • Recognize a commercial scale up or scale out strategy

Speakers
Scott Ohanesian , Matt Yedwabnick
Day 3: Thursday, February 2
12:00 pm - 1:00 pm
Boot Camp / Seminar

Supply Chain Considerations (Temperature, Chain of Identity, Chain of Custody, Scalability, Regulations for Transport)

By the end of this session, attendees will be able to:


  • List two (2) major strategies employed for delivering a robust personalized medicine supply chain

  • Identify at least two (2) concerns in the handling of cell and gene therapy clinical materials

  • Describe potential labeling solutions appropriate to the labeling of cell and gene therapy products for transport

  • Create better outcomes for patients via the creation of a robust supply chain

Speakers
Scott Ohanesian , Sue Lee
1:00 pm - 2:00 pm
Boot Camp / Seminar

Biostorage

By the end of this session, attendees will be able to:


  • Understand the potential storage requirements for autologous and allogeneic therapies and associated materials

  • Recognize the challenges to scaling the advanced therapy supply chain

  • Describe the differences between small molecule / biologics and advanced therapy supply chains

Speakers
Rob Jones

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