Value-based drug development
Promising science does not always translate into a blockbuster
In-house state-of-the-art whole body PBPK platform to conduct early value assessments
PHARMAECONOMICA has developed a strategic quantitative framework aimed at providing highly specialized early human simulation, progression pathway optimization, and commercial feasibility evaluation. We achieve this through a unique blend of available molecule-specific information and target-specific information, combined with early economic modeling. Our approach is built on a flexible modular design able to identify the drug market potential/liability as early as possible in the discovery/development process.
Our strong expertise in Physiological pharmacokinetic modeling (PBPK) provides a wide range of possibilities to speed up your research by making informed decisions and creating better clinical designs. These solutions provide significant cost advantages as well as allow early regulatory acceptance of your research. Regulatory agencies already acknowledge PBPK-based mechanistic model-driven assessments as a valid method for crucial decisions in areas like dose selection, evaluation of interaction potential with deciding on the optimum number of studies or study waivers, as well as studies in special populations, etc.
Innovative Biotech, MedTech, and Pharma companies need to develop an accurate assessment of the probability of scientific, regulatory, and commercial success of their assets, in order to advance the assets from bench to bedside. A comprehensive, data-driven, and objective understanding of the potential value of the asset is key to securing the successful commercialization of promising science initiatives. It really requires specialist expertise to move a candidate through development, clinical testing, formulation, regulatory submission, marketing approval, manufacturing certification, and market launch. Indeed, advancing a candidate from “bench to bedside” requires massive financial resources, as well as deep technical and commercial knowledge.
Benefits of early human simulation
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Target identification and mechanistic understanding
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Early projection of optimal dose to select clinical candidates
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Determining the minimum anticipated biological effect level
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Assessing the clinical viability of a new compound
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Study design optimization & internal “go/no-go” decisions
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Predicting clinical outcome measures based on biomarkers
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Dose and schedule selection and label recommendations
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Differentiation and commercialization strategies
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Selection of patient population and bridging between populations (such as pediatrics, elderly, and obese patients)
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Characterizing and extrapolating the PK properties across species and patient populations
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Estimating the potential impact of the new drug on therapeutic compliance
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Estimating absolute and relative clinical utility index
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Estimating the potential impact of the drug on resource utilization and on quality of life
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Estimating early justifiable pricing range
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Estimating early cost-effectiveness
Early value assessment
Innovative Biotech, MedTech, and Pharma companies need to develop an accurate assessment of the probability of scientific, regulatory, and commercial success of their assets, in order to advance the assets from bench to bedside. A comprehensive, data-driven, and objective understanding of the value of the asset is key to securing the successful commercialization of promising science initiatives.
It really requires specialist expertise to move a candidate through development, clinical testing, formulation, regulatory submission, marketing approval, manufacturing certification, and market launch. Indeed, advancing a candidate from “bench to bedside” requires massive financial resources, as well as deep technical and commercial knowledge.
PHARMAECONOMICA helps your Organization produce development programs with the ability to secure superior outcomes in the treated population of patients will determine competitive differentiation and sustainable advantage for the early-stage asset.
Benefits of early value assessment
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Make the most use of available data, increasing data quality and allowing more reliable predictions
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Increase the probability of success at portfolio, program, and trial level
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Integrate a value-based approach to support your value story
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Define the real value of your asset to convince potential investors
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Align your organization on what really matters to support future launch activities
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Reduce uncertainty regarding the data and assumptions informing forecasting- and valuation models
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Integrate a data-driven approach to your decision-making process to reduce human cognitive biases
