Clinical Pharmacology Consulting

Advancing drug development through strategic clinical pharmacology and model-informed drug development (MIDD) expertise

How I can help

Providing scientific consultation for clinical pharmacology strategy development, dose selection/optimization, clinical study design, data analysis, regulatory support and scientific communication

Advancing drug development and supporting data-driven decisions by leveraging specialized knowledge in pharmacokinetics (PK), pharmacodynamics (PD), and MIDD

Integrating with program team to provide clinical pharmacology representation

Services we offer

Strategic Planning

  • Development of clinical pharmacology plan to support drug development programs from First-in-Human (FIH) through approval

Study Design

  • Providing clinical pharmacology support to the design and protocol development of clinical studies from FIH to late-stage development

Data Analysis & Interpretation

  • Development of analysis plan, review of analysis report, interpretation and presentation of data analysis including PK (NCA), PopPK, PBPK, PK/PD and exposure-response (efficacy and safety) analysis

Dose Optimization

  • Supporting the design of dose optimization studies and the assessment of benefit-risk for optimal dose selection and justification according to FDA's Project Optimus

Regulatory Support

  • Authoring and reviewing clinical pharmacology sections of regulatory documents (briefing books, IB, IND, NDA, BLA, and others) and supporting interactions with health authority agencies (FDA, EMA, PMDA, etc)

Scientific Communication

  • Authoring clinical pharmacology publications and presentations, providing clinical pharmacology representation for due diligence and scientific advisory services

Team

Clinical pharmacologist with 10+ years of experience in drug development across pharmaceutical industry and academia.

Proven record of designing and executing end-to-end clinical pharmacology strategies from FIH to late-stage development.

Extensive knowledge of clinical pharmacology of biologics (ADC, mAb) and drug development in oncology.

Contact us

info@biesdorfconsulting.com