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.
Biotech leaders highlight how to perform critical activities leveraging process and analytical development resources from early-stage clinical to commercialization.
Understand the advantages of unit/bi-dose nasal delivery technology, application of QbD process for inhaled product development, and why to outsource inhalation development and manufacturing.
Mayo Pujols, CEO of Andelyn Biosciences, discusses how companies are focusing on reliability and predictability to further advance this innovative therapy.
Understand how to manage impurities in drug development with swift isolation, synthesis, and analysis. A client discovered an impurity during ongoing stability studies that exceeded ICH guidelines.
In a recent episode of The Business of Biotech, Philogen CEO Dr. Dario Neri sat down to explore his journey from academia to startups, as well as Philogen's own trajectory.
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.
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