Optimizing vial size by tackling regulatory and manufacturing challenges
impact summary
Developed a comprehensive plan based on learnings to effectively optimize vial count at time of launch while also helping to mitigate identified manufacturing risks
Optimizing vial size by tackling regulatory & manufacturing challenges
“Great work by the team that got us to actionable recommendations!”
SITUATION
Upon launch, Brand X was anticipating to face regulatory & manufacturing challenges based on the product’s number of vials required per dose (i.e., FDA concerns, financial penalties based on updated Inflation Reduction Act, and HCP/Patient burden). Accordingly, the Team needed to develop a plan to optimize vial counts while mitigating risks
APPROACH
Using a multi-pronged approach, Luminas:
Collaborated with cross-functional teams to pressure test key modeling assumptions & decision considerations
Analyzed analogues and primary research on in-office buying processes and to understand the impact of differing vial strength options
RESULTS
Luminas was able to:
Illustrate the need for an additional vial strength
Determine the ideal additional vial size and combination of vial sizes likely to be purchased
Uncover the manufacturing implications associated with developing and producing an additional vial strength post-launch
