Developing the First EMEA Cross-Functional Strategic Plan for an Autologous CAR T-Cell Therapy Asset with a Newly-Formed Launch Commercialization Team (T-30 months)

Building an EMEA strategic brand plan for an autologous chimeric antigen receptor (CAR) T-cell therapy asset launch in multiple myeloma that effectively conveyed the unique considerations related to the product and the process aspects of launch strategy commercialization

Situation

The client’s key objective was to develop the first strategic brand plan for senior leadership that bridged the asset transition from clinical development to early launch planning commercialization and critical strategy ‘must dos’, working with their newly-established regional, cross-functional commercialization team

Approach

We consolidated extensive internal data across multiple regional and global functions, secondary market research, and internal stakeholder engagement, to develop a situational overview anchored to key business questions that needed to be addressed

We communicated the triad of complexities needing to be navigated that made the launching of an autologous CAR T-cell therapy for the organization different to all other brand launches:

1. ‘Process is the product’ considerations (manufacturing; quality control; product journey; site certification and training; administration and patient monitoring requirements)
2. The clinical promise represented by the target product profile (TPP) and potential step change in patient care
3. Market access challenges associated with the pricing and budget impact of a one-time treatment versus existing life-long therapy treatment options