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Case Study: Clinician TPP testing for an orphan drug in US and EU5

Problem

Our client, a biotech start-up focused on Orphan Diseases needed feedback from clinicians on a product in Phase II. The product treated a condition that is well recognized in children, but not consistently treated in adults.

Solution

  • Working with the client, we developed staged TPPs (for conditional and full approval) in both pediatric and adult indications
  • We recruited a mix of KOLs of interest to the client and clinicians in the US and EU5 that treat this rare disease
  • We conducted 60 minute web-enabled telephone interviews (W-TDIs) with 35 clinicians, including local language moderation and translation.

Outcome

  • We provided insight on the overall treatment and unmet needs for this disease, highlighting the differences between pediatric and adult treatment in the US and EU5.
  • We uncovered key areas of strategic need, including the transition of treatment from childhood to adulthood and reasons for discontinuing or re-initiating treatment.