Navigating The Turbulent Waters From Discovery To Clinical

By Ed Miseta, Chief Editor, Clinical Leader

Keystone Nano recently advanced from the discovery phase to a clinical-stage firm, developing nanoparticles that target solid tumors by going after cancer cells and leaving the normal cells intact. But as company CEO Jeff Davidson found, making that transition presents challenges that are difficult to anticipate and can cause disruptions to a development timeline.

"Being a spin-out from academia [i.e., Penn State], we were familiar with early-stage research, and we had access to university resources that permitted us to perform work in discovery, original product development, and analytical testing,” explains Davidson. “What was much less available was the knowledge or experience of taking something from the research phase through to preclinical studies and into an IND (investigational new drug). We learned a lot, but that learning curve forced the process to take longer than anticipated.”