DRUG SAFETY

drug safety

Pfizer’s Drug Safety R&D scientists develop and apply skills, experience and cutting-edge tools for quantitative assessment of safety and risk management of targets and compounds across the research, discovery, development and commercial phases of drug development. We seek to enrich our capabilities for target safety assessment, selection of safer compounds, mechanistically understand toxicity for efficient risk management and translation as well as reverse translation of findings between preclinical models and humans.

We are interested in establishing alliances to develop and access:

  • Mechanisms, translatable and monitorable biomarkers, and probabilistic screening approaches related to target organ toxicity, such as:
    • Cardiovascular safety, vascular injury
    • Neuropathology biomarkers (central and peripheral)
    • Liver injury, in particular immune-mediated drug-induced liver injury (DILI) and transporters
    • Immunostimulation, including hypersensitivity, autoimmunity, and cytokine release
    • Kidney toxicity – glomerular and tubular
    • Ocular toxicity – retina and cornea
    • Bone Marrow toxicity—hematopoietic and myelopoietic (in vitro assay)
    • Gastrointestinal toxicity—characterization, mechanistic and translational relevance
  • Computational toxicology
    • Novel data insights and applications of AI to improve safety assessment
    • Predictive computational models and mechanistic understanding
    • Genetic, genomic and proteomic approaches for patient stratification, human translation of toxicology findings or monitorable biomarkers and disease pathogenesis, and high-resolution screening methodologies (single cell transcriptomics, nanoproteomics)
  • Animal models, biomarkers and screening approaches for preclinical immuno-oncology investigation, supporting mono- and combination-therapy approaches (interpretation and translatability)
    • Comparison of immune system components and responses between preclinical species and human
    • Single parameter and multiplex digital image analysis of immunohistochemical and in situ hybridization based biomarkers
  • Biotherapeutics-related analytical technologies
    • Assays to assess safety of novel biotherapeutics (e.g., bispecifics) and gene therapy for humans
  • Nanoparticle drug associated safety issues and risk improvement
    • ADA related with polymer-based nanoparticle formulation
    • Nanoparticle specific toxicities and target tissues/organs
  • Advancing Regulatory Science
    • Systems pharmacology approaches for prediction of adverse events
    • Mechanistic and quantitative approaches to understand safety of novel modalities such as gene therapy, gene editing, protein degraders