Dr. Maria Zimina, Business Development Manager at SOM Biotech, attended “Hard Reg Café” of Regulatory Affairs meeting that took place on June 5 at the Barcelona Science Park (www.pcb.ub.edu). The event was organized by the CataloniaBio & HealthTech Regulatory Affairs Workgroup with the support of ACCIÓ (Government of Catalonia).
The main objective of the meeting was to share the key steps which biomedical companies and start-ups have to follow to gain Food and Drug Administration (FDA) approval for new drugs. During the meeting, specialists in Regulatory affairs from Reguliance (US) not only explained about particular requirements of FDA but also about specifics of Orphan Drug Designation (ODD), as well as covered the Comparison of Regulatory process in EU vs. the USA.
SOM Biotech is a European clinical-stage biopharmaceutical company with a strong pipeline of products focused on Orphan diseases at preclinical and clinical stages. One of the main assets of SOM Biotech – SOM3355 for treatment of the chorea movements associated with Huntington’s disease, is currently under Clinical Phase 2a. Additionally, one of the programs of SOM Biotech is almost ready to enter to Clinical Phase. Therefore, it is strategically important for SOM Biotech to have a deeper understanding of the FDA approval process so that it can open opportunities for development and approval of its products in the United States.