In the rush to get an IND filed and issue that all-important “Phase I trial initiated” press release,
many small to mid-size firms end up patching together their clinical and regulatory value story from multiple sources. The result? A collection of development data and information that may lack coherence and, consequently, credibility.
By investing in a coherent value story before and even after filing for an IND, sponsors can take advantage of what may be viewed as a dry run before market. This lays the foundation for greater commercial success whether you intend to develop, out-license, or sell your product.
Integrating clinical and regulatory functions from an early stage adds value to your product, reduces costs (sometimes just by getting to “no” faster), and ultimately produces a sharper, more compelling value story. Here are three strategies we advise clients with early-stage assets to keep in mind.