Regulatory affairs in regen med: building trust, expediting development and navigating the impact of COVID-19

Manal Morsy's extensive experience in drug development with particular focus on strategic regulatory aspects taking into account early research, clinical, commercial, and post marketing development have made her a global leader in pharmaceutical regulatory affairs. Her 30 years of successful experience in technically and managerially leading teams to successful biologics’ (vaccines and cell therapy) and new chemical entities’ key regulatory designations (RMAT, SPA, Fast Track, Priority review, Orphan) as well as multiple global marketing traditional and conditional authorization approvals have made her an asset to Athersys Inc., where she currently serves as the Senior Vice President and Head of Global Regulatory Affairs.

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