Overcoming The ‘Valley Of Death' For Cell And Gene Therapy Manufacturing

Any organization that has ever worked to bring a drug to market is familiar with the “valley of death” – for many nascent therapies, meeting clinical outcomes in time for the next funding cycle is the difference between progress and that so-called “death.” A therapy may have huge potential to address unmet need or improve on existing treatments, but without the money needed to support development, this potential is never realized.

Avoiding the valley of death requires an early understanding of a drug’s proposed development process, as well as the potential pitfalls that could stall that development. One of the most important decisions an organization can make early on relates to partnering. Selecting the right contract development and manufacturing organization (CDMO) to perform preclinical, clinical, and commercialization work can represent one of the most important decisions an organization can make in circumventing the valley of death and shepherding a therapy successfully to market.