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Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products Proceedings of a Workshop (2019) / Chapter Skim
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7 Potential Next Steps to Consider for Addressing Variability
Pages 79-84

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From page 79...
... Following the discussion, Tsokas summarized and shared ideas for moving the field forward with regard to the development of regenerative products based on presentations and discussions held throughout the day. CROSSCUTTING TOPIC DISCUSSION Getting the Most from the Available Data on Variability Tsokas asked the panelists to comment on using the volumes of available data to inform discussions and decisions about variability.
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From page 80...
... Participants discussed sharing indication-specific or target-specific data that might inform the selection of clinical endpoints, for example, or the identification of critical attributes. It is possible that sharing data might help identify quality attributes for CAR T cell products, Marks said, but he added that different constructs can have different characteristics (e.g., adverse event profiles)
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From page 81...
... Using Functional Assays to Assess Products Participants offered a range of views and concerns regarding the use of functional assays to address variability of products. Siegel reiterated a theme from the morning discussion that addressing the variability of cell products would require moving beyond phenotypic assays to using functional assays.
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From page 82...
... The location where the patient is treated with the regenerative medicine product is a variable. The number of sites for clinical trials is currently small, but as products reach the market, providers will handle multiple patient populations and multiple products, each with different administration and handling protocols.
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From page 83...
... Three successive panels had then considered patient sources of variability, variability in donor tissues and cells, and variability in the manufacturing process. Across these panels there was discussion of the role of the immune system in tissue regeneration, the unique supply chain for regenerative medicine products, and the importance of designing quality into the processes from start to finish.
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From page 84...
... (Marks) •  orge strong vendor partnerships, including process controls, because F they are critical to controlling variability in the raw materials used for cell and gene therapies.
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Key Terms

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  • cell therapy
  • joint replacement
  • raised concerns
  • medicine products

  • therapy registry
  • cell products
  • help identify
  • shared data
  • data sharing

  • morning discussion
  • multiple products
  • improving whatever
  • emerging field
  • sharing precompetitive

  • process standards
  • american joint
  • precompetitive data
  • issues surrounding
  • discussion getting


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