CONSULTINGAssess the impact of a manufacturing issue on launch success: Vial strength and the associated # of vials required to achieve dose
Great work by the team that got us to actionable recommendations!”
– Executive Director of Global Marketing
SITUATION
Our client was preparing to launch a medication with a vial strength (# of milligrams) that could require as many as 15 vials to achieve the target dose. This issue could have a significant impact on various stakeholders who impact launch success including HCPs/practices, regulators, payors. Therefore, the client needed to determine if it needed to address the issue.
APPROACH
In order to provide a holistic situation assessment to inform a vial strength decisions, Luminas:
Analyzed how several recent analogous launch scenarios played out in the real world
Incorporated qualitative and quantitative research that assessed in-office buying processes
Gathered internal feedback via workshops among cross-functional stakeholders
RESULTS
Luminas was able to illustrate the impact of a vial strength on:
HCP/practice burden
FDA approval – the relevancy of inflation reduction act (IRA) guidelines that seek to minimize medication errors
Access esp. in markets that have policies to minimize discarded units/waste
IMPACT
Client used the research to:
Finetune forecast assumptions for current launch
Outline pros and cons of an addition vial strength option and ultimately make recommendations on how to move forward