Mission

 

Helping clients achieve effective and efficient drug development and clinical

pharmacology programs using model informed drug development
 

 

Objective-Driven

  • Streamline drug development by improving the efficiency of the Pre-IND phase to the Proof-of-Concept study

 

  • Strategic drug development planning, specifically in clinical pharmacology plans

 

 

Resourceful

  • Maximize information - the right data at the right time

 

  • Make timely data-driven decisions

 

  • Minimize waste - plans and studies designed to target specific program, business and regulatory goals while avoiding superfluous studies or assessments

 

 

Efficient

  • Partners with experts possessing a broad range of experience from other disciplines to optimize strategies and study designs

 

  • Meets project goals and development objectives through an expansive, reliable approach

 

 

 

Skillful

  • Standard non-compartment PK analysis for non-clinical and human PK/PD studies

 

  • Phase 1 study designs and dose selection for first-in-human, multiple dose tolerance, drug-drug interaction, dose response, and proof of concept studies

 

  • In-licensing opportunity preparation and evaluation - experience in first-pass review and full due diligence of the pharmacokinetic and clinical pharmacology aspects of drug candidates

 

 

Deliberate

  • IND option selection for streamlining development and decision making

 

  • Phase 1 study design option selection to maximize information and minimizing cost

 

  • Proof of concept study design optimization to enhance learning and decision making

 

  • Develop quantitative decision making criteria through comparison of marketing profile to market place competition

 

 

Evidence-Based

  • Development plans, study designs and analysis based on:

 

- the body of drug and disease state literature

 

- the understanding of PK, dose-response, disease progression, and time course of drug effect.

 

  • PK/PD and dose-response analysis

 

  • Phase 2/3 population PK and PK/PD study design and analysis

 

 

 

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