• Adam Manhi (chair)

• Emma Salib (programme manager)

• Jennifer McCaffery (lay)

• Hayley Hall (lay)

• Sonia Patton (patient)

• Trishna Bharadia (patient)

• Yanrong Jiang (clinical)

No conflicts declared by panel

Approved

• Lay summary provides strong explanation of disease background and unmet need.

• Good and concise description of data that will be analysed, type of analysis, objectives and outputs.

• Clear distinction between this data access request (fit-for-purpose assessment) and potential downstream analyses to support a wider set of use cases.

• Clear that J&J will only receive outputs of Flatiron’s analysis and no access to data.

• The panel raised several comments on other aspects of the application including:
  
  

  • The content could have been written in more lay terms.

  • Further detail could have been provided on what patient demographic and clinical characteristics would be analysed.

  • Overall the panel felt this approach of assessing the database was likely to lead to a more focused future data access request from J&J.