What We Do

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

• Early Research and Discovery
  • Morphological characterisation of animal models
  • Histopathology of efficacy and early safety studies

• GLP and Non-GLP Regulatory Toxicology Studies
  • Histopathology primary read, peer review & pathology working group
  • Integrated interpretation in the context of all study data

• GLP and Non-GLP Investigative and Molecular Pathology
  • Target validation
  • Off-target interactions: Tissue Cross-Reactivity (TCR) studies
  • Investigation of unexpected findings in regulatory toxicology studies

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