Medical Affairs Services - Project Examples

Review of Company Pre-market Planning Activities

A major global pharma company engaged Capital K to review their existing procedures with regards to Australian pre-launch investment in development compounds. Following the review, Capital K was required to improve the Australian process to increase their ability to obtain meaningful insights into the local treatment paradigms and ensure that the global development programs meet the local company needs. Following optimisation of the process, Capital K created a tailored program with supporting materials and systems, and managed the roll-out of the associated cross-functional training programs. The Australian program received excellent feedback from the local and global organization and was used as the basis for amendments to the global pre-market operations.


Medical Support for a New Biological Entity

Capital K was commissioned to support the Australian arm of a global company in developing the local medical affairs plan for the market entry of a new biological medicine. The project included engaging with local key opinion leaders and study investigators to determine the product's positioning within the local treatment paradigm, development of Phase IIIb and Phase IV clinical study plans, and working with the regulatory and market access teams to develop the market entry plan.


Competitor War Games

Capital K was commissioned to execute a 2-day "war games" session with an international cross-functional team to identify the strengths and weaknesses of each competitor's position and use these insights to develop an in-market defence strategy for the innovator medicine. Capital K prepared all pre-work and in-session materials, facilitated the two workshop days, and provided a summary report on the ensuing strategic insights and potential defense opportunities. The project outcomes led to the development of a robust and successful defence of the commercial position, despite the entrance of major new competitors.


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Medical Affairs Services