Biopharma R&D

Clinical Pharmacology
Clinical Pharmacology is a discipline that aspires to maximize the therapeutic’s efficacy without leading to adverse events and in certain scenarios aids in identification of the appropriate patient population where the therapeutic will have maximal effect. Clinical pharmacologists work towards enhancing patient care by identifying the optimal use of a certain therapeutic, while developing a more comprehensive understanding of the intended efficacy and adverse events both short term and long term.
At Vantage, our M&S approach towards Clin Pharm have focused on the following aspects
- Establish Proof of Mechanism
- Connecting the mechanistic model to the clinical PD outcomes
- Identify optimal Recommended Phase 2 Dose (RP2D)
Keys Questions that M&S can address
- Explore hypotheses that explain observed data
- Map known mechanism of action to measured biomarkers and support proof of mechanism
- Simulate dose regimens and optimize the recommended Phase 2 dose
- Dosing regimen recommendation for dose fractionation studies
- Clinical PK-PD prediction
Case Studies

Target prioritization pipeline for an auto-immune disease
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Physiologically-based Ocular PKPD platform model for translational R&D
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Vaccine Dose Prediction for seasonal Viral Infection
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Predicting efficacy of combination therapy in auto-immune disease
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Vantage RA Model integrates mechanistic pathways & disease scores to aid Clinical Trial design
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Hypoglycemia exacerbation in T2Ds who exhibit weight loss on insulin Rx
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Leveraging Single Arm Trial to inform late-stage Clinical Trial decision making
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