Successful commercial launch planning requires careful coordination between multiple functional areas, triggered years in advance of the planned launch date. Whether biopharmaceutical companies are planning their first commercial launch, entering a new therapeutic area, or leveraging an existing therapeutic against a new indication, launch planning is a critical and complex exercise.
Successful launch planning often combines aspects of:
1.) Complex program management, where critical path timelines schedules and performance reports are maintained. Critical dates, inter-dependencies, risks and communications must all be carefully managed.
2.) Organizational design, ensuring activities are appropriately planned and staffed and structured. This extends well beyond identifying an optimal reporting and territory management hierarchy, and into coverage multiple critical support arenas like data management, hardware, training, and medical affairs.
3.) Systems integration, leveraging tools for compliant outreach efforts, sales force alignment and reporting.
Scimitar has helped managed a multitude of highly successful product launches, from rare indications with patient recruitment challenges to major, multi-billion dollar blockbusters. Although no two client situations are alike, as a first step the following ‘ground level’ activities are often required:
- Establish a clear launch readiness steering committee and appropriate sub-team structure.
- Engage with all stakeholders to identify and prioritize critical activities and solution potential issues/ gaps.
- Ensure critical path activities, for which delays in completion translate to overall program timeline delays, are mapped early, and that an understanding and communication of current execution steps is clear.
- Gain alignment on planned launch timing, and feet-on the street’ (FOS) dates.
- Identify planned training dates, with an emphasis on compliant physician contact system ‘go-live’ and training.
Blockbuster Commercial Launch Operations for a Top-5 Biotech Company
Situation: A top biotech leader in oncology was preparing to launch two highly complex drugs in a therapeutic area where the company had no prior market knowledge, experience or sales force. One of these products carried multi-billion dollar revenue potential.
The company required active program management across all key commercial launch arenas, from sales force structuring and data acquisition to training and management of payer coverage.
Approach & Outcomes
Drove two highly successful program launches, through:
- Defining launch governance structure and program managed critical path activitiest
- Product launches expected to be the largest in the company’s history
- Structured and program managed launch activities, training & tools for 700+ reps
- Developed an in-depth launch playbook to aid in future launch efforts, capturing process steps, roles and responsibilities activities and key risks
- Completed both highly successful launches, with clinical operations activities met on time and 20% under budget