Niki is a strategic regulatory affairs leader providing general regulatory affairs strategy and drug development strategy with over 15 years of experience gained from academic, sponsor and consulting settings who thrives on developing impactful strategic plans for innovative products and then executing those plans. Her expertise and leadership spans from the research and development phase to supporting and executing marketing applications for commercialization.
Through partnering with clients, Niki acts as the head of regulatory for biotech / pharma clients by becoming a hands-on strategic regulatory team lead. She provides direction and execution of strategic regulatory plans for development programs with both technical and tactical oversight of regulatory teams and submission components with forward planning towards development inflection points and milestones. Niki oversees the development and positioning of strategic messaging in regulatory documents through authoring and/or critically reviewing for content, quality, and compliance. She also routinely provides oversight of communications with FDA and leads FDA -Sponsored meetings.
Niki’s product modality expertise includes cell therapies (T cell therapies), gene therapies (gene replacement, in vivo gene editing, genetically ex vivo modified cells, and RNA therapies) vaccines, small molecules, monoclonal antibodies (mABs), proteins, and anti-sense oligonucleotides (ASOs). She is familiar with combination products (device + drug/biologic) and in vitro developed tests.
Niki has contributed to product development in the following therapeutic indications: bone regeneration, CNS (both neurologic and psychiatric indications), immune-oncology, oncology, infectious diseases such as complicated HIV, tuberculosis, intra-abdominal infection and c. difficle infection, lyme disease, ophthalmic diseases, respiratory, and rare diseases.
Prior to 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.