SERVICES
Nonclinical Sciences
NGT BioPharma Consultants understand the scientific and regulatory challenges companies face when evaluating drug candidates from final compound selection to advancing those drug candidates through nonclinical and clinic development. NGT will work collaboratively with our clients to create regulatory strategies that efficiently integrate the multidisciplinary evaluations required to characterize key drug properties, including pharmacology, safety, pharmacokinetic, and CMC characteristics that allow progression into the clinic and ultimate market approval. We understand these critical interdependencies and will leverage our collective expertise and extensive experience to develop nonclinical plans that will support a drug candidate’s proposed clinical indication and clinical development plan.
Preclinical and Early-Stage Development
To address the scientific and regulatory complexities of early drug development, NGT brings a robust team of highly experienced subject experts to counsel and often lead the strategies and experimental approaches of advancing a drug candidate through preclinical and early clinical evaluations. The core scientific and technology foundations supporting early development include:
- Nonclinical pharmacology and translational assessment
- Pharmacokinetic and metabolism profiling
- Exploratory and investigative toxicology
- PK/PD evaluation, preliminary human dose/exposure projections and safety margins
- Pharmaceutical developability assessment
- Physicochemical characterization
- API synthesis & formulation, and DP supply
- Development of full CMC development plans, including production networks
- Develop Clinical Development Plans
- Non-clinical and regulatory strategies & study oversight
- IND-enabling toxicology studies –interpretation and integration, including pathology, PK/PD, etc. along with long-term and specialty toxicology evaluations
- Project management and study oversight
- Quality assurance and compliance assurance
- Regulatory submission support
Clients often engage NGT teams in a variety of ways to meet their business and scientific needs. Drawing on NGT’s scientific leadership, we have supported many of the following activities:
- Assess data packages for risks and gaps and develop mitigation strategies
- Devise nonclinical strategies that support clinical development plans and proposed indication
- Provide PK/PD modeling support and evaluate predictive models
- Advise on IND-enabling toxicology studies and analyze/interpret data · Prepare regulatory documents while leading agency interactions (See Regulatory)
- Coordinate and oversee outsourcing of nonclinical studies, CMC laboratory activities and API/drug product manufacturing (See CMC)
- Support potential investments in due diligence evaluations
- Analyze financing strategies
- Review and evaluate Intellectual Property
- Prepare business plans, investment solicitation pitch decks, and investor letters of introduction
- Identify optimal clinical indications (Target Product Profile)
- Generate Product Development Plans
- Evaluate market and competitor landscapes, and formulate commercialization strategies
- Conduct due diligence efforts
Although NGT is neither a laboratory or manufacturing services provider, we can serve as your single point of contact to our network of reputable CRO’s and CDMO ’s.
