Niki has over 12 years of experience in regulatory affairs and drug development. Her drug development experience covers cell and gene therapies, small molecules, and therapeutic biologics with an emphasis on the disease areas of CNS, immuno-oncology and oncology. Her experience spans multiple stages of drug development from executing early development strategies to supporting and executing marketing applications. Through partnering with clients, Niki leads early key milestone development activities such as, generating the overall program development strategy, initial interactions with the U.S FDA (INTERACT and Pre-IND Meetings), original IND applications and subsequent FDA milestone meetings and expedited pathways discussions following the generation of clinical data.
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.