Darlene Noci currently serves as AVEO’s Interim Head of Regulatory Affairs. Ms. Noci brings to AVEO over 20 years of leadership experience in global regulatory affairs and strategic drug development at several leading biotechnology and pharmaceutical companies. She has contributed to several successful drug approvals, including Fabrazyme®, Mozobil®, Clolar®/Evoltra®, and BAVENCIO®. Prior to founding her own regulatory consulting firm in 2018, she served as Vice President, Regulatory Affairs and Quality Assurance at X4 Pharmaceuticals. Prior to X4, she served as Global Regulatory Lead Strategist, Immuno-Oncology, at EMD Serono, the North America biopharma business of Merck KGaA, Darmstadt, Germany. In this position, she was the lead regulatory strategist for BAVENCIO®, the company’s anti-programmed death-ligand 1 (PD-L1) antibody, where she led the team responsible for securing its Breakthrough Therapy Designation, which subsequently led to the drug’s Accelerated Approval for the treatment of patients with Merkel cell carcinoma. Ms. Noci was also instrumental in the global clinical development plan of BAVENCIO® in various solid tumors, including urothelial carcinoma and renal cell carcinoma. Prior to EMD Serono, Ms. Noci served as an oncology and rare disease-focused regulatory lead at several companies, including Infinity Pharmaceuticals, Sanofi, and Genzyme. She received a Bachelor’s degree in Political Science from Adelphi University and a Master’s degree in Government from Harvard University.