Clinical Modeling and Simulation
Optimizing dose and therapeutic regimen, and improving your probability of success
A critical approach to precise dosing
Outsourcing clinical and nonclinical (translational) Modeling and Simulation (M&S) to experts like Allucent allows you to remain agile and competitive, while focusing on your core competencies of drug development, commercialization, and product innovation. Among the many benefits of conducting M&S is to optimize your dose and regimen improving the probability of success throughout development and at approval, and ensuring ideal labelling, prescribing, and an optimal patient experience.
Optimizing the Dose
Optimizing dose and regimen is essential to developing safe and effective medicines. Allucent’s Modeling and Simulation expertise helps you:
- Select the right dose for the right patient. We leverage pharmacokinetic (PK), pharmacodynamic (PD), efficacy and safety data to ensure the right dose is selected throughout development
- Reduce development time and cost. We optimise starting dose, dose escalation, dose finding, sampling, trial design and duration to significantly reduce trial time, cost, and patient burden.
- Enhance regulatory interactions and labelling. Modeling and Simulation is central to dose justification at submission and for drug labelling.
Why Allucent?
- Full breadth of services. We are an integrated team of quantitative pharmacologists, pharmacometricians, and data programmers and analysts who deliver end-to-end modeling and simulation services from preclinical to post-marketing across all modalities and therapeutic areas
- Translational pharmacology. Pre-clinical to clinical translation, phase I design, drug-drug interaction risk, formulation, or route of administration changes
- Pharmacometrics. Population PK and PK/PD modelling, exposure-response analysis, clinical trial simulation and cQT analysis
- Data Programming and analytics. Modeling dataset preparation, exploratory data analysis and PK/PD reporting
Areas of Expertise
- Project Optimus. Dose optimization is the new challenge in oncology and hematology. We are experts in using Modeling and Simulation to support dose designs and decision making.
- Patient diversity & special populations. We help with diverse patient inclusion in trials, submissions, and labelling. We have specialized expertise in modelling different patient populations across different ethnic groups or those with co-morbidities, (e.g. obesity or renal or liver impairment.)
- Pediatrics and Rare Disease. Many pediatric indications are considered rare diseases requiring specific dosing and trial design. We’re specialists in pediatric M&S, extrapolating from adults or developing medicines solely for children.
“The depth of expertise we bring to modeling and simulation is evident in the success stories of our clients. We excel in translating complex data into actionable insights through sophisticated models that predict outcomes with exceptional accuracy. This capability is a testament to our team’s dedication and innovation in this field.”
Alex MacDonald, PhD
VP, Global Head of Model-Informed Drug Development
You have questions. We have answers.
How does Allucent deliver on time with high quality?
We have experienced, integrated teams of scientists using state of art software, with rigorous quality systems to ensure success. Our team of skilled project managers oversee budgets, timelines, and maintain optimal relationships with our clients.
Why should I incorporate Modeling and Simulation when my traditional empirical approach works perfectly well?
Traditional empirical approaches have not worked well across the sector, with technical probability of success from phase I transition through drug approval still at low levels. Inadequate dose optimization in oncology, leading to post-marketing dose ranging requirements or dose adjustments, as well as non-approvals, have led FDA to initiate Project Optimus. This is in recognition that historical, largely empirical drug development paradigms are no longer fit for the types of medicines being developed in oncology or hematology.
How will Allucent’s Modeling and Simulation help me satisfy our regulatory requirements?
From pre-clinical, initial clinical trial application, or regulatory interaction stage, to the conduct of pivotal trials, regulatory submission and approval, Modeling and Simulation has been widely adopted by industry and accepted by regulatory agencies. Such analysis can be supportive, or in certain cases, be the primary evidence for regulatory agency assessment, approval, and labeling.
For solutions to your specific needs, contact us. We’re happy to set up a free 30-minute consultation.
