Providing program management support in the lead-up to NDA submission and launch

Case Study:
Program Management Support for NDA Submission and Launch Readiness

This case study showcases how Magnolia Market Access guided a biopharma company through effective launch planning and organizational alignment to prepare for a new drug application (NDA) submission and subsequent product launch.

Key highlights include:

  • Challenge: Align cross-functional teams to ensure cohesive strategies for NDA submission, label creation, and launch readiness amidst rapid organizational growth.
  • Approach:
    • Conducted a readiness assessment to identify gaps in cross-functional awareness and collaboration.
    • Developed a lifecycle plan incorporating input from Product Development, Marketing, and Medical Affairs to align strategies.
    • Created a RACI matrix to clarify roles and responsibilities across teams.
    • Planned postlaunch activities, including patient assistance programs and organizational growth strategies.
  • Outcome: The coordinated efforts enabled an on-time, within-budget launch, ensuring patient access to a new therapy.

Download the case study to learn how structured program management can streamline the path to successful drug launches.