Model Informed Drug Development

"We are clinical pharmacologists and drug developers with innate ability to aid in solving drug development challenges and developing straight forward strategies for successful therapies."

Our Model Informed Drug Development (MIDD) team uses quantitative modeling and data-informed simulations to help make clinical development decisions on the dose and dosing regimen. The Vanadro team has been aiding sponsors and our collaborators with MIDD for years. We guide our collaborators through the associated clinical development decisions as well as regulatory interactions using the MIDD. We primarily use MIDD to assist our collaborators in developing pharmacokinetic and pharmacodynamic models to leverage all of the available pre-clinical and clinical data to help with drug development decisions using modeling and simulation (M&S) methodologies.

PK/PD Modeling

Our MIDD team has experience with standard and complex pharmacokinetic evaluations as well as with all forms of pharmacodynamic evaluations.

Modeling and Simulation methodologies aid in decision making in drug development

Utilizing M&S methods is a valuable decision-making tool across the wide variety of industries and in particular in the pharmaceutical industry.  Pharmaceutical industry collaborators and regulatory agencies are increasingly utilizing the M&S to optimize the drug development.

The MIDD is used to predict the dose, the dosing regimen,  populations, including differences across the disease states, optimize making more efficient clinical trials, help with changing the indications, extrapolate exposures/safety and efficacy to special populations, utilize preclinical, public domain, competitors, placebo data to integrate and translate to human or support human development, simulate clinical trials and finally help with the interactions with Regulatory Agencies.

 

Our Drug Development Experience

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Preclinical Development

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Clinical Development

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Immuno-oncology Development & Strategy

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Clinical Pharmacology Strategy & Development

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FDA & Global Regulatory

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Strategic Due Diligence

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Pharmacometrics

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Pharmacokinetics

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Project Optimus Services

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Model Informed Drug Development

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