Jose Roman

Associate Director, Oncology North America Regulatory Lead @Johnson & Johnson Innovative Medicine

Conducted the regulatory strategy for Phase 3 clinical studies for a novel drug-device combination product to determine the contribution of components and study design- Initiated regulatory IND application strategy and preparation for a First in Human early development bispecific antibody and a novel-novel bispecific antibody program- Contributed to the regulatory background preparation for an FDA Oncologic Drug Advisory Committee meeting- Managed a regulatory postdoctoral fellow throughout their 2-year fellowship