Case study

Industry and stakeholder
consensus building

Challenge

A cutting-edge innovator in the cell and gene therapy space was experiencing high levels of patient non-compliance when conforming to the significant FDA long-term follow-up requirements. Catalyst was first asked to pressure test patient familiarity and perspective of current long-term follow-up processes. Catalyst then was asked to work with providers, data managers, industry sponsors, non-profits, and other experts to identify both barriers and modern solutions to address patient-perceived hurdles, increase compliance, and improve the long-term follow-up process for sponsors.

Strategy

  • Built the strategy and forged partnerships to collect sufficient data to drive policy discussions.
  • Worked with survey professionals, patient advocacy groups, and industry experts to launch a first-of-its-kind patient survey to assess patient familiarity and perspective of current long-term follow-up processes.
  • Analyzed survey data to identify patient-perceived hurdles within follow-up processes.
  • Organized and hosted an informal group of impacted sponsors, patient groups and interested parties to better understand barriers and brainstorm innovative solutions.
  • Crafted a white paper, drawing on group discussions and survey data, to inform on-going policy discussions and assist regulators on their mission to create patient-centric regulatory policy.

Impact

  • Goal: Intended to advance conversations with regulators around long-term follow-up and modernizing the process.

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