Clinical Pharmacology Consulting
Biesdorf Consulting LLC provides expert clinical pharmacology and model-informed drug development (MIDD) support to advance innovative drug development programs from First-in-Human (FIH) through late-stage development and approval.
We deliver strategic, data-driven expertise across clinical pharmacology strategy development, dose selection/optimization, clinical study design, pharmacokinetic (PK) and pharmacodynamic (PD) analysis, regulatory support and scientific communication. We integrate seamlessly with program teams to provide strong clinical pharmacology representation that drives data-driven decisions by leveraging specialized knowledge in PK, PD, and MIDD.
Our mission is to optimize benefit–risk assessment and dosing strategies, align programs with regulatory expectations and accelerate informed decision-making to advance innovative treatments for patients.
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 Selection/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.
Carla Biesdorf de Almeida, PhD, MBA
Clinical pharmacologist with 10+ years of experience in drug development and model-informed strategies across pharmaceutical industry and academia.
Proven record of designing and executing end-to-end clinical pharmacology strategies from FIH to late-stage development, authoring clinical pharmacology plan, driving dose optimization strategies and participating in regulatory interactions.
Deep expertise in the clinical pharmacology of biologics (ADCs, mAb, bispecifics) as well as small molecules, with strong knowledge in oncology drug development and dose optimization.
High proficiency in MIDD approaches including PBPK modeling, NCA, PopPK, PKPD and exposure-response analyses and leading data analysis planning, interpretation, and reporting.
Passionate about integrating quantitative science into clinical decision-making to advance innovative treatments for patients.