Innovative model-based strategies to streamline drug-development and to optimize the “cost-to-decision”
PharmacoMetrica is a global provider of consulting services in Pharmacometrics. Our areas of expertise include population PK and PK-PD modelling, exposure-response modelling, rationale for dose selection, disease progression, model-based meta analysis of therapeutic area data, optimal study design for PK-PD, Bayesian modelling, Clinical Trial Simulation to support decision making and trial design evaluation, and physiologically-based modelling
To help Pharmaceutical and Biotechnology organizations to implement more innovative and efficient drug development processes.
Apply population model-based approach and clinical trial simulations to enhance clinical development plans
Use leading edge statistical techniques, including adaptive learning and confirming approaches, to implement resource-efficient trial design methodologies
Use a pharmacometrics approach to characterize the inherent risks of a given clinical development plan or a protocol design and to support early discontinuation of less promising compounds
Use model-based approach to enable the rational assessment of dose selection, clinical trial design, in-licensing drug opportunities and labeling requirements
Use a model-based approach to differentiate a product from competitors increasing the value of the franchise program
PharmacoMetrica services and solutions will reduce time, cost and risk of drug development activities.
The gain in efficiency (cost to decision) associated with implementing innovative model-based drug development strategies can be measured by:
the time saved in the conduct of a well designed study,
the ratio between the amount of information gathered and the cost of the trial (including the optimization of the number of patients to enroll necessary to detect a signal),
the early detection of signal of efficacy or lack of efficacy which can trigger the decision to speed up or terminate the product development (redirecting resources),
the reduction of overall time needed for filing new drug applications
PharmacoMetrica is composed by talented and highly-trained scientists with exceptional expertise and experience in pharmacometrics and clinical pharmacology.
Our track record includes numerous publications in peer-reviewed journals and invited presentations on Model-Based Drug Development delivered at international symposia and meetings.
The staff of PharmacoMetrica has the depth and breadth of skills and expertise in applying Model-Based Drug Development to overcome the challenges articulated in the Critical Path initiative.