Marinka Tellier provides technical and scientific support for clients on global regulatory affairs and drug development. She has extensive regulatory and scientific experience in early stage clinical development of biologics and drugs, including clinical protocol development and regulatory management of clinical trial conduct. Dr. Tellier also has expertise in the preparation and review of numerous FDA regulatory submissions (including pre-IND meeting packages and original INDs/NDA/ANDA/BLA), as well as scientific and medical writing (e.g. informed consent, investigator’s brochures, final clinical study reports, clinical and non-clinical review sections, etc.). She is trained as an immunologist and microbiologist and prior to joining NSF she provided regulatory and clinical trial support to the Division of Microbiology and Infectious Diseases at NIAID/NIH for more than 10 years.