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A New Blueprint for Commercializing Cell and Gene Therapies

How advanced medicines commercial readiness differs from traditional drug launches.

Cell and gene therapies represent tremendous potential advancement for patient care, with the first therapy approved in 2017 they have only recently become available. As we enter 2023, a half-decade after the first FDA approved Cell and Gene Therapy (CGT), some of the few pioneers of these therapies with curative intent are not meeting commercial expectations. While reasons for underperformance vary, the common thread that weaves throughout is the degree of commercial and/or launch planning readiness established prior to anticipated approval.

Four Key Elements of Successful Drug Launch Planning

Commercial Readiness

Looking into the future, with thousands of cell and gene therapies in development, manufacturers are paving a new path for launching their products into the marketplace. Cell and gene therapies have changed how we treat diseases, now, as more of these treatments are commercializing, manufacturers have to learn from these pioneers and start to recognize the importance of evolving the go-to-market model.  This starts much earlier now, and if done right, more patients can have access to these treatments at scale.


In this paper, we share a few insights related to unlocking non-clinical barriers to demand generation and enabling a runway for a CGT launch:

  1. Map patient navigation by treatment center and its network facilities
  2. Identify and prioritize treatment center sites of care
  3. Establish a process for treatment center certification/qualification

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Herspiegel is a leading professional services firm helping biotech start-ups and the world’s largest pharmaceutical companies navigate the path from science to brand performance and change patients’ lives. We are committed to using strategic insights from medical to commercial to market access to solve critical problems.