Supporting a Global Indication Launch for a Biotech
Clarkston Consulting supported a global indication launch for a biotech, managing the strategy, planning, and execution of the launch. Read a synopsis of the project below or download the full case study.
Download the Global Indication Launch for a Biotech Case Study Here
An international biotech company was expecting health authority approvals of a new indication for an existing drug across many markets. The new indication was suspected to have a global market value of ~$10B, which significantly increased the value of their existing target patient population, making it a company-wide corporate goal to launch this indication as fast as possible. The biotech engaged Clarkston Consulting to manage the strategy, planning, and execution of the new indication launch within the pack and label space for 10+ markets.
In order to accomplish this, Clarkston needed to map out the shortest possible packaging and labeling timelines for the new indication, both internally and with contract manufacturers, to accelerate time to market while still maintaining a high level of confidence for success. Clarkston met with 20+ stakeholders and facilitated multi-hour workshops to develop the most streamlined plan and launch strategy across the 14 markets. Additionally, Clarkston created contingency plans in case situations like health authority approval delays or mishaps with contract manufacturers occurred and aligned on all plans with senior leadership.
Once the plan was created and communicated, Clarkston developed 14 project plans (one for each market) as well as three dashboards (for various audiences) to ensure all overdue and upcoming activities were being tracked. Additionally, Clarkston introduced risk, issue, and decision management tools to drive transparency and mitigation. Clarkston also set up and facilitated a weekly meeting of 20+ cross-functional stakeholders (e.g., regulatory, quality, external manufacturing, planning and artwork) to encourage open lines of communication, conduct issue resolution where needed, and ensure all activities stayed on track.
By partnering closely with key stakeholders both internally and externally, maintaining detailed oversight of on-time completion of key activities, and escalating risks early with leadership, Clarkston was able to ensure all markets with new indication launches for 2025 successfully packed on time.
