Our conversation with Philogen CEO, CSO, and Cofounder Prof. Dario Neri reveals his company’s metered emergence from academia, its avoidance of venture capital, and its rapid realization of revenue through pre-pipeline collaboration.
Developing innovative treatments for patients with orphan and rare diseases offers substantial challenges. This article shares the author's tips for recruiting from small patient populations, collaborating with the FDA, choosing to work with a CRO or not, and determining a patient-centric approach.
The European Union Clinical Trial Regulation No. 536/2014, which went into effect in January, introduced the most significant changes to the processes for clinical trial applications in at least the past 15 years. Learn how it impacts the trial master file and consider three key functions that an electronic TMF must have to achieve compliance and maintain organizational success.