Strategic advisory: Consensus statement development

Situation

• Biotech company in endocrine space seeking to understand the benefit and clinical relevance of delaying the onset of clinical type 1 disease (T1D)

• European guidelines and practices considered most advanced in this therapeutic area–with the
  highest level of adoption

• Limited data exists on disease-modifying therapies in T1D

Task

• Engage KOLs in Europe to understand the clinical relevance and impact of
  disease-modifying therapy on clinical T1D

Action

• An advisory panel was convened to garner feedback on draft statements describing the clinical relevance of delaying T1D

• Once there was alignment on clinical relevance, the supporting statements were used to draft a consensus statement

Result

• The consensus statement drafted was taken to the EMA in support of their conditional
  marketing authorization