Niki joined Halloran Consulting Group in 2015 bringing over 11 years of experience in the healthcare and pharmaceutical industries with emphasis in CNS and oncology. Her experience spans multiple stages of drug development from pre-IND/CTA planning and execution through Phase 3 execution for NDA/MAA submission. Niki provides development strategy, management, and operational support to clients. Niki has supported regulatory submissions for small molecules, biologics (both cell and gene therapy products), mABs, and combination products in the disease areas of solid tumor/hematology oncology, immuno-oncology, infectious disease, microbiome disease space and CNS diseases such as depression, schizophrenia, and Alzheimer’s disease.
Before joining Halloran, Niki was the regulatory lead for a global Phase 3 program focused on cognitive impairment in Schizophrenia for FORUM Pharmaceuticals. Prior to FORUM, Niki worked at Dana Farber Cancer Institute where she provided clinical and regulatory support for industry and investigator sponsored clinical studies in hematology oncology.
Niki has a Regulatory Affairs Certification (RAC), with a U.S.-focus and a Bachelor’s of Science (BS) specializing in molecular, cellular, and developmental biology from the University of New Hampshire.