Strategic advisory: Label expansion

Situation

• Biotech company in rare disease space seeking label expansion through FDA Emergency Use Authorization (EUA) in COVID-19

• Current treatment options limited to use of antivirals through EUA with vaccine rollout on the horizon creating a narrow window of opportunity for the client

• Understand the treatment landscape and validate/align on data to be submitted for EUA application outstanding

Task

• Identify and engage with key multidisciplinary stakeholders to discuss and understand the COVID-19 therapeutic landscape

Action

• Deployed a KOL identification initiative to identify and better understand the various disciplines involved in patient care

• Created an advisory engagement plan which consisted of 2 advisory boards

• Each advisory board included clinician representation from different parts of the country to account for variations in protocols and treatment algorithms

• Developed content to garner further insight for future clinical trial development

Result

• Through advisory boards client was able to proceed with and pursue EUA for label expansion

• Insights gathered from advisors allowed for refinement and creation of efficiencies within current clinical trials