Over the last few years, more than two dozen cell and gene therapies (CGT) have launched in the US. Many of these CGTs have faced unique challenges post-approval. With increased interest and development of such therapies, manufacturers need to understand the specific hurdles associated with different treatments. The complexity in manufacturing and distribution has received considerable attention in expert circles and the media. In contrast, commercial challenges in bringing these therapies to the market get relatively little attention–but companies at the forefront of CGTs are learning and evolving as they navigate these difficult straits.
This report examines cell and gene therapies and the commercial challenges that accompany them, and offer recommendations that can help manufacturers reach their commercial goals.
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