Nonclinical Sciences
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.
To help your team navigate the scientific complexities of drug development, NGT has broad and deep capabilities to contribute a strong team of highly experienced subject matter experts to advise and often lead the strategies and experimental approaches of advancing a drug candidate through nonclinical (preclinical) and early clinical evaluations. Example services include:
- Devise nonclinical strategies that support clinical development plans and the proposed indication
- Exploratory and investigative toxicology strategies
- PK/PD evaluation, preliminary human dose/exposure projections and safety margins
- Non-clinical and regulatory strategies and study oversight
- Nonclinical pharmacology and translational assessment
- Pharmacokinetic and metabolism profiling
- IND-enabling toxicology studies – interpretation and integration, including pathology, PK/PD, etc. along with long-term and specialty toxicology evaluations
- Provide PK/PD modeling support and evaluate predictive models
- Coordinate and oversee the outsourcing of laboratory nonclinical studies
Although NGT is neither a laboratory or manufacturing services provider, we can serve as your single point of contact when working with our network of reputable CRO’s and CDMO’s.
