Label Scenario Planning Workshop

Less than four months prior to launch, a leading US biotech company received word from the FDA that recent safety incidents occurring in patients taking a related medication could adversely impact the warnings section of their label. MCAworks was approached to help the launch team prepare for the various outcomes of label negotiations.

Approach:

After working with the medical and regulatory teams to develop three potential label outcomes and characterizing market impact through industry analogs, MCAworks led a series of cross-functional workshop to prepare for the spectrum of best to worst case scenarios. Through moderated breakouts, functional teams identified specific market strategies for each scenario before coming together to refine integrated plans.

Results:

Within two weeks of being made aware of new safety concerns, the MCAworks team provided detailed contingency plans that would increase transparency with the HCP community and better prepare for launch. As a result, once the final label was received the team was able to finalize messaging, marketing materials and risk mitigation strategies within days instead of weeks.