Cut Point Statistics

Clinical Immunogenicity

Adverse patient responses to a biologic resulting in the development of anti-drug antibodies (ADAs) is a phenomenon known as immunogenicity. Because this immune response can adversely affect the safety and efficacy of a drug, assessments surrounding this event are critical in the preclinical development phase. A protein laboratory with an immunological research focus, B2S Life Sciences provides comprehensive and detail-oriented services for client interested in examining immunogenicity and ADA interaction assessments. Aligning with the latest regulatory guidance, our statisticians employ the well-integrated three-tier approach to define the immunogenicity profile of a prospective therapeutic. Our meticulous analyses coupled with expert data interpretation set an industry standard, and position B2S favorably within the screening and confirmatory cut point determination landscape. As such, we offer a vast range of immunogenicity support capabilities that include:

  • Preparation of immunogenicity risk assessment plans
  • Development of bioanalytical assays for detection of binding antibodies and neutralizing antibodies
  • Generation and characterization of custom immunoanalytical reagents (conjugates and surrogate antibodies)
  • Oversight of method validation and regulated bioanalysis at CROs
  • Statistical computation of immunogenicity cut points (screening, confirmatory, titer, and neutralizing antibodies)
  • Assay troubleshooting
  • Interpretation of clinical immunogenicity and report generation
  • Specialized ADME studies to investigate immunogenicity findings

Immunogenicity Consulting Support

As part of the consulting experience, B2S Life Sciences provides comprehensive statistical analysis clinical trial support from phase I through phase IV. Possessing a wide range of experience, our statisticians have distinguished themselves as proficient data custodians at a variety of major pharmaceutical companies. This affords B2S a multi-functional malleability across the continuum of clinical trial research, providing support in areas such as initial planning and study design, protocol development, statistical analysis planning, interim analyses, final analysis and reporting, statistical support for manuscripts and presentations and statistical defense and interactions with global regulatory agencies. Finally, a synergistic collaboration between the clinical scientist, data management and medical writers allows us to generate high-quality data and results in a timely fashion. Some key capabilities include:

  • Protocol study design
  • Sample size and power calculations
  • Statistics section of the protocol
  • Creating and reviewing statistical analysis plans
  • Creating, reviewing and participating in interim analysis and assessment committees
  • Preparing materials for interim analysis and assessment committees
  • Preparing analyses for final report, manuscript and presentation
  • Multi-site clinical trials
  • Safety analyses including laboratory measures, EGC and AE measurements
  • Performance of meta-analysis by combining data from multiple studies
  • Defending protocol at protocol review committees and before the FDA or other regulatory agencies
  • Validation of all analyses and programs
  • Creating analysis datasets to be used in analysis, listings, tables and graphs
  • Providing listings, summaries and graphs for the final study report, manuscript or presentation, interim analysis or periodic safety reports
  • Providing ongoing support for special listings or summaries requested by the clinical team or the clinical scientist

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