NGT BioPharma Consultants understand the scientific and regulatory challenges companies face when evaluating small molecules and/or biologics candidates (Mabs, duobodies, proteins, cell therapy, gene therapy, and other new modalities) while advancing through nonclinical (preclinical) and clinic development.

We work collaboratively with our clients to efficiently support and integrate the multidisciplinary scientific evaluations required to characterize the new molecular entity’s properties which will be needed to enable progression into the clinic and the initiation of first-in-human (FIH) trials. These assessments include pharmacology for safety and efficacy, toxicology, pharmacokinetics, and the CMC attributes that thoroughly characterize the manufacturing processes. We understand these critical interdependencies and will leverage our collective knowledge and experience to develop nonclinical plans to support a drug candidate’s proposed clinical indication and clinical development plan.