NonClinical Development Strategy
- Integrated nonclinical program strategy from candidate selection to first-in-human studies
- Optimal design to support early go/no-go decision points, risk minimisation and investment decisions
- Optimal design to generate the right data to support rationale for dose determination for first-in-human studies
- Design of individual in vitro and in vivo studies supported by the right PK-PD-ADA assays in line with the integrated strategic plan
- Outsourcing and execution of studies with interpretation and communication of data to support successful regulatory approvals and seamless clinical development
Bioanalysis
- Integrated non-clinical and clinical bioanalytical strategy in support of the PK/PD, Biomarker & Immunogenicity strategies
- Appropriate assay formats & technologies to measure PK, PD, Biomarker and immunogenicity
- Performance characteristics & quality levels depending on development phase (right assay at the right time)
- Assay development, validation, sample analysis & integrated data interpretation
- Ligand binding, LC-MS/MS, PCR and cell-based assays
- Reagent selection
- Assay design, management, trouble shooting and sourcing
PK/PD, Biomarkers & Immunogenicity
- Integrated non-clinical and clinical PK/PD, Biomarker & Immunogenicity strategies
- Understanding exposure-response relationships
- Immunogenicity risk assessment
- Design, management, interpretation and sourcing of studies to assess immunogenicity potential such as dendritic cell assays, MAPPs assay, T cell assay, in silico algorithms.
- Integrated PK/PD, Biomarker & immunogenicity interpretation
- Integrated Summary of Immunogenicity (ISI)
Toxicology / Safety Pharmacology
- Early target safety profiling assessment (de-risking)
- Species selection
- Design, manage, interpret and source relevant safety assessment studies (in vitro & in vivo)
- Investigative studies
- Regulatory toxicology studies
- Primate Reproductive, developmental & juvenile toxicity assessments (ePPND studies for example)
- Immunotoxicology / immuno-oncology evaluation expertise
- Immunology assays
- Cytokine release Assays
- ADCC & CDC assays
- Bone physiology / pharmacology assessment expertise
- Safety pharmacology assessment for biotherapeutics expertise
- Product specific carcinogenicity risk assessment documents
Pathology
- Pathology support for animal models of disease
- Histopathology (primary read and peer review)
- Integrated interpretation of data
- Immunohistochemistry method validation and interpretation
- Target validation (on-target binding)
- Off-target interactions (e.g. tissue cross-reactivity study)
- Investigative study support – evaluating unexpected findings
Integrated risk assessment & communication
- Full integration of all available data
- First in human starting dose / dose escalation justification, based on pharmacology & toxicology data (in vitro & in vivo)
- Assist in the preparation (writing and review) of non-clinical sections of submission documents including NDA/MAA/JNDA, IMPD, IB, IND, CTA and other expert reports
- Provide support for non-clinical regulatory agency meetings worldwide
Additional Activities
- Due Diligence
- Training in Toxicology, Pathology, PK/PD & Bioanalytics etc..
- CRO selection / auditing
- Study monitoring
- Scientific advisory board support