Getting Innovative Therapies Faster to Patients at the Right Dose: Impact of Quantitative Pharmacology Towards First Registration and Expanding Therapeutic Use

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Excerpt

Quantitative pharmacology (QP) discovers and confirms the key drug characteristics to provide clear, reproducible, and predictive evidence for optimizing drug development plans, enabling critical decision‐making, and eventually bringing safe and effective medicines to patients.1 These modeling approaches include empirical, semimechanistic, or quantitative systems pharmacology modeling techniques with the aim to integrate current knowledge regarding the drug, disease, and mechanism, and then to predict (interpolate or extrapolate) outcomes under new conditions such as untested doses and regimens, populations, or diseases.2 As part of the model‐informed drug discovery and development paradigm, QP methods can be employed in all phases of the drug development process from biomarker selection in translational medicine to dose/regimen selection, evidence generation for regulatory approval, and for extrapolation or pharmacoeconomic assessment during therapeutic use.2
Application of QP has been advocated to play an important role in delivering new therapies to patients faster by increasing confidence in decision‐making during drug development and by increasing efficiency through eliminating costs or reducing cycle times. However, most reports to date have summarized the return on investment of using QP approaches primarily in the domain of cost savings and efficiency gains.2 Here, we describe the potential of QP approaches to accelerate patient access to innovative therapies.
Although QP approaches are ardently supported by QP practitioners and their department heads, widespread and consistent appreciation of the value of QP in bringing novel therapies quicker to patients at the right dose is still lacking in the wider community of the pharmaceutical industry and healthcare providers. We think that this gap in appreciation and adoption by the wider community of stakeholders and decision‐makers can be bridged through better communication designed to convey the value of such QP approaches from a patient access and healthcare perspective,2 coupled with wider adoption of good practices among the communities of practitioners.
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