Contemporary drug development for small molecules and biologics (Mabs, duobodies, proteins, cell therapy, gene therapy as well as new modalities) emphasizes strategic, program-specific pathways designed to best match the disease and the medication under evaluation. With an emphasis on quality data, informed decision-making, and speed, early- and late-stage development needs to be seamlessly integrated and, at times, combined.
NGT BioPharma Consultants, in collaboration with reputable Clinical Research Organizations (CROs), work closely with our clients to provide the strategy and oversight needed to confidently advance their early-stage clinical development candidates towards first in human and Phase 1 studies (e.g., SAD / MAD, PK, drug interaction, special population and safety studies), proof-of-concept studies, and registration trials.
NGT provides clinical support in close concert with, as needed, other NGT functional areas such as Nonclinical Sciences, CMC, Quality & Compliance, and Regulatory Strategy & Submissions