DRUG SAFETY

drug safety

Pfizer’s Drug Safety R&D scientists develop and apply skills, experience, and cutting-edge tools for quantitative assessment of nonclinical safety and risk management of targets, therapeutic candidates (drugs, vaccine candidates), and marketed products across the research, discovery, development, and commercial phases of drug development. We seek to enrich our capabilities for target and therapeutic candidate safety assessment along with mechanistic understanding of toxicity findings to allow development of an efficient risk management strategy using evidence-based translation of findings between animals and humans.

Specifically, our focus areas include:

Probabilistic screening approaches, mechanistic science to understand safety risks and discovery-development of translatable biomarkers related to target organ toxicity, such as:

  • Cardiovascular and vascular injury
  • Neuropathology biomarkers (central and peripheral)
  • Liver injury, in particular immune-mediated drug-induced liver injury (DILI) and transporters
  • Immunosafety concerns including both immunosuppression and immunostimulation, such as hypersensitivity, autoimmunity, complement activation 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

Advancing regulatory science using drug development tools (computational, QSAR, etc.) to support all therapeutic areas for mono- and combination-therapy approaches (interpretation and translatability)

  • Novel data insights and applications of Artificial Intelligence (AI) to predict, understand and improve safety assessment
  • Systems toxicology approaches using genetic and multi-omics data sets to allow prediction of adverse events and develop a patient risk stratification strategy
  • High-resolution screening methodologies (single cell transcriptomics, nanoproteomics), single parameter and multiplex digital image analysis and omics approaches to discover, develop and qualify multi-parametric biomarkers for clinical safety monitoring
  • Comparative systems analysis to model responses between animals and humans

Biotherapeutics, nanoparticle drug and emerging modalities associated safety issues and mitigation strategies

  • Mechanistic and quantitative approaches to understand safety of novel modalities such as gene therapy, gene editing, and protein degrader
  • Assays to assess safety of novel biotherapeutics (e.g., bispecifics) and gene therapy for humans
  • Anti-Drug Antibodies (ADA) related with polymer-based nanoparticle formulation
  • Nanoparticle-specific toxicities and target tissues/organs