The Business Problem
A Fortune 100 Global Pharmaceutical Company sought to bring to market the 1st Oral Antiviral pill to treat High-Risk Adults with Mild to Moderate COVID-19 during the 1st year of the pandemic.
Prior to the pandemic, Emergency Use Authorization (EUA) had rarely been executed in the US. EUA’s carry a high degree of complexity and require a number of considerations for launch to be considered including high public scrutiny, expedited timeline, limited external promotional and communication avenues, negotiating Advanced Purchase Agreement and distribution.
The product was set to launch under an (EUA), during the newly virtual world of the Covid-19 pandemic. In order to achieve this goal, it was essential for there to be a close partnership between the client organization and the US government.
The company turned to Magic Hat Consulting to create an execute an optimized & agile Launch Plan that was considerate of this uncertain environment. Magic Hat leveraged the Launch Excellence Playbook which they previously developed for the client.
Addressing the Issues: Expediency, Collaboration and Expertise in a Virtual World
- Magic Hat leveraged their “Launch Guide Star Approach” to create an expedited, flexible launch plan and governance to ensure a successful launch under extreme circumstances.
- This shifting from in-person to virtual, presented several challenges when it came to alignment and connectivity. Magic Hat quickly established a collaborative channel to effectively communicate EUA developments & understandings with FDA ensuring necessary team continuity.
- Magic Hat utilized innovative approaches to explore options for creative messaging, across a variety of functional areas, while staying within the confines of the EUA promotional guidance.
- Magic Hat managed, modified & cascaded multiple launch scenarios to key workstreams as pricing, supply amounts, distribution services and fees, manufacturing process sites and capacity were negotiated with Client Operations & US Government.
Delivering Successful Outcomes
- FDA granted Emergency Use Authorization (EUA) for company’s product to treat mild to moderate COVID-19 on December 23, 2021.
- Launch Team delivered all requested product to USG within their deadlines and before the end of December 2021.
- Established new, more effective ways of working, leveraging agile concepts enabling for quicker and more efficient pivots in the future.
- Optimized the Standard client Launch Excellence Playbook to reflect EUA and expedited launches.
- Built the subsequent full approval launch plan from the accomplishments of the EUA.