Darlene Noci

Darlene Noci has over 20 years of experience as an accomplished global product development leader specializing in global regulatory affairs and strategic oversight of early and late-stage programs.

Throughout her career, Darlene contributed to several successful drug approvals, including Fabrazyme®, Mozobil®, Clolar®/Evoltra®, and Bavencio®. Prior to founding her own regulatory consulting firm in 2018, Darlene served as Vice President, Regulatory Affairs and Quality Assurance at X4 Pharmaceuticals. Prior to X4, Darlene served as Global Regulatory Lead Strategist, Immuno-Oncology at EMD Serono, the North America biopharma business of Merck KgaA, Darmstadt, Germany where she led the global regulatory strategy and portfolio for Bavencio®, the company’s anti-programmed death-ligand 1 (PDL-1) antibody. In this role, she was instrumental in the global clinical development in record time to a proof of concept spanning more than 10 solid tumor indications, including non-small cell lung cancer and urothelial carcinoma. Darlene drove the team responsible for securing Bavencio’s Orphan Drug Designation, Fast Track Designation, and Breakthrough Therapy Designation, which led to accelerated approval for the treatment of patients with Merkel Cell Carcinoma. Darlene also served on the joint steering committee with Pfizer. Prior to EMD Serono, she held various regulatory and team leadership positions with increasing responsibility in oncology and rare disease at several companies including Infinity, Sanofi, and Genzyme. She gives credit to her mentors at Genzyme, where she spent 14 years, inspired by leaders driven by science and passion for bringing much needed therapies to patients.

Darlene earned her Master’s degree in Government from Harvard University.