1. Phoenix 1.3 supports working with data formatted in SDTM, the CDISC-defined format for study data tabulation by providing an import and export feature. For the next release of Phoenix, we are working on some improvements for these features, but more importantly on adding a workflow object that will allow users to create analysis-ready datasets from the imported SDTM domain files.

    In this Webinar, we will demonstrate the currently available features and present the planned new features to give interested Phoenix users an early chance for discussion and feedback on how the use of CDISC data.

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  2. Effective medications are a mainstay of modern pediatric medicine. Yet, ethical concerns about conducting clinical trials in pediatric patients are a major challenge in pediatric drug development. Learn how Dr. Samer Mouksassi and his team at Pharsight Consulting Services have overcome these challenges through the use of pharmacometrics.

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  3. This webinar will demonstrate a simulation of a case study using the prototype of Phoenix Trial Designer, which is actively being developed by Certara. The webinar will update interested users on the progress of the software, show the proposed design of the tool, discuss its dependencies, and outline intended capabilities for the first version of this product. Future plans for the tool following the first release will also be discussed. To help guide decisions on the development of this product, we will gather feedback from M&S scientists attending this webinar in a Q&A session. The intended audience is scientists familiar with Pharsight Trial Simulator who are interested in the successor software, Phoenix Trial Designer.

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  4. Why do so many cancer drugs fail in clinical trials? Optimal dose and dosing regimen selection in oncology remains empirical. Early clinical studies (Phase 2) are often not adequately designed and analyzed to maximize learning and decisions are often based on limited information (overall response rate, ORR) resulting in a high failure rate in Phase 3 trials.

    A drug-disease modeling approach has been successfully applied to predict expected clinical responses and overall survival (OS) in cancer patients in a number of clinical settings. This modeling framework focuses on efficacy, and the core of this framework tumor growth inhibition (TGI) models that makes use of the full longitudinal tumor size data as opposed to categorizing them as in the calculation of overall response rate (ORR). Tumor size response metrics e.g. change from baseline at an early visit, time to tumor to regrowth are used as biomarkers of drug effect to predict OS in drug-independent models.

    This modeling framework (drug-specific TGI model coupled with drug-independent OS models) can enhance learning from early clinical studies compared to the traditional approach of estimating ORR and progression free survival (PFS). Simulations support the use of tumor size response metrics as endpoints in Phase 2 studies as opposed to ORR or PFS. Recent prospective simulations of Phase 2 and Phase III clinical trials will be presented. Drug-disease models and clinical trial simulation offer a powerful science-based quantitative approach to predict expected drug profile, support end-of-phase 2 decisions, and design of phase 3 studies in oncology.

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  5. Do you face project roadblocks due to gaps between computer aided drug design and the medicinal chemistry lab? In this session, we will describe Muse Invent, a "reaction driven" evolutionary algorithm approach to de novo molecular design. Structures generated by Muse Invent include a proposed synthesis path intended to aid the medicinal chemist in assessing the synthetic feasibility of the ideas that are generated. Our methodology for reaction driven molecular evolution is independent of how the design ideas are scores. Results and validation studies with a variety of common CADD scoring methods will be presented.

    # vimeo.com/114069913 Uploaded 22 Plays 0 Comments

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Certara is the global biosimulation technology-enabled drug development and drug safety consulting company. Its customers include hundreds of biopharmaceutical companies around the globe, together with several regulatory agencies. Certara’s solutions,…

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Certara is the global biosimulation technology-enabled drug development and drug safety consulting company. Its customers include hundreds of biopharmaceutical companies around the globe, together with several regulatory agencies. Certara’s solutions, which span the discovery, preclinical and clinical stages of drug development, enable data-driven decisions, leading to more precisely designed trials with a reduced risk of failure and improved subject safety. For more information, visit http://www.certara.com.

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