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.
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
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