Dr. Gavin Liu
Consultant
Gavin Liu, PhD, is a CMC and technical development leader with extensive experience supporting the development of complex biologics, with a strong focus on cell and gene therapy. He brings deep expertise across CAR-T, CAR-NK, TIL, and stem cell–derived platforms, with a proven track record of advancing programs from early development through IND-enabling readiness and early clinical stages. His strengths include building robust control strategies, translating technical data into regulator-ready narratives, and identifying CMC risks early to support efficient regulatory interactions.
He has led cross-functional teams across process development, analytical development, GMP manufacturing support, and QC release for clinical-stage programs. He has hands-on experience in assay strategy and implementation, including flow cytometry, qPCR, potency, sterility, and stability programs, as well as tech transfer to internal GMP facilities and external CDMOs. His work bridges discovery and development functions, enabling practical, phase-appropriate CMC solutions aligned with regulatory expectations.
Dr. Liu earned his PhD from Peking University and completed postdoctoral training at UCSF. He has held leadership roles at AffyImmune Therapeutics (Head of CMC), uBriGene Biosciences (Head of QC), Simcere Pharmaceutical Group (Associate Director, Cell Therapy), and Mustang Bio (Process Development Lead), and previously conducted cancer and immuno-oncology research at the University of Washington.
At Arc Nouvel, Dr. Liu brings his depth of experience to support sponsors with practical CMC and regulatory guidance across cell and gene therapies, viral vectors, and biologics.
