PKPD Strategies, LLC

Our Experience

Roger Toothaker holds a PhD in Pharmaceutics from UW-Madison, and has been directly involved in drug development for over 40 years. His career has focused primarily on relationships between pharmacokinetics and drug effect in both nonclinical and clinical settings. Now, as an independent drug development consultant, he champions the use of model-based drug development through appropriate pharmacokinetic and pharmacodynamic measurements, modeling/simulation, and promoting continual learning to understand the true value of potential new therapeutics under a unique business model emphasizing the value of translational clinical research.

Why Us?

PKPD Strategies works with you to help you identify appropriate model-informed drug development strategies on which to base pipeline, design, and regulatory decisions.

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OUR APPROACH

Establish Basis for Clinical Development at Pre-clinical Development Stage

Develop and apply key drug and biomarker measurement methods
Use mathematical modeling to summarize key nonclinical safety and efficacy results across studies and species to extrapolate to humans
Provide support for starting dose and escalation scheme of early safety studies
Develop rational, sequenced clinical study designs that achieve a targeted development goal

Use Established Basis to Facilitate Clinical Development Strategy

Apply and expand measurement methods to support evolving clinical strategies and needs
Use existing (and evolving!) PKPD model to:
Capture new learnings from each clinical study
Verify the design, sequencing, and need for the subsequent planned studies
Support rationale for Phase 3 study approach with regulators and clinicians
Identify and support label claims and strategies for effective product application (the right drug at the right dose at the right time for the right patient)

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