Accelerate Product Approval Using In Silico Modeling & Simulation

Presented by

Premier Consulting

About this talk

In clinical research and development, comparison to a control is highly recommended by regulatory agencies for the purpose of demonstrating evidence of clinical efficacy of a drug or device. The control could be a placebo, a known standard-of-care or an available market-approved drug or device. With some diseases or certain classes of devices, a viable control (prospective or retrospective) may not be feasible for ethical or pragmatic reasons. In addition, this problem is not uncommon in the biotech and medtech industries. This creates the need for alternative approaches for carrying out comparative evaluation. Computational Modeling and Simulation (CM&S) has been identified by the US Food and Drug Administration (FDA) as a necessary component for developing in silico trial designs, in which the comparator arm is generated using CM&S techniques. The FDA encourages the use of in silico clinical trials in which a drug or device is tested against a cohort of virtual patients, therefore providing an empirical basis for appropriate comparative assessment. Understanding clinical outcomes, safety, effectiveness and developmental challenges early can impact the investment sponsors put forth towards a new compound or device. Innovative trial designs are needed to maximize existing outcomes data and to leverage advanced computational techniques for making increasingly better decisions, accelerate product development and decision making, while reducing overall R&D costs. Join Premier Research and InSilicoTrials Technologies for this joint webinar and explore the potential for including in silico modeling & simulation as an integral part of the product development plan. Please note: If we do not attend to your questions, we may follow up afterwards. Questions? Contact
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Premier Research is a clinical research company, dedicated to helping biotech, specialty pharma, and device innovators transform life-changing ideas and breakthrough science into new medical treatments. As a global company, Premier specializes in the use of innovative technologies for smart study design and trial management to deliver clean, conclusive data to sponsors. Whether it’s developing product lifecycle strategies, reducing clinical development cycle times, securing access to patients, navigating global regulations, maximizing the impact of limited rare disease data, or providing expertise in specific therapeutic areas, Premier is committed to helping its customers answer the unmet needs of patients across a broad range of medical conditions.