How an emerging manufacturer was able to launch their first drug on-time with relatively few issues, given a short runway and resource constraints.

A pharmaceutical manufacturer needed commercial launch support before launching their first drug. The manufacturer approached Archbow five months before FDA approval and launch. They had resource constraints and an earlier PDUFA date than anticipated. They faced outstanding agreements and pending implementations with their specialty distribution, third-party logistics, dispensing, and patient/provider support service partners.

They needed immediate resources with relevant experience to complete contracts, implement programs, and provide continued support after launch to help mitigate any potential issues. Archbow was hired to provide critical launch support and hypercare after the launch.

Archbow Consulting’s approach included:

Subject Matter Expertise: Created a team of experts, including a project manager, to track key milestones and issues within a single database.

Consistent Meetings: Scheduled weekly meetings with all stakeholders
to align on open tasks and project updates and reviewed a dashboard highlighting key milestones.

Vendor Engagement: Assisted with vendor contracts and expedited new vendor partner and product documentation on behalf of the manufacturer.

The manufacturer launched on time within five months with relatively few problems.

All agreements were expeditiously signed, and critical programs were implemented prior to the scheduled launch.

Archbow provided strategic guidance, program hypercare, and issue log maintenance to help mitigate post-launch concerns.