PhUSE Computational Science

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Presentation transcript:

PhUSE Computational Science Working Groups Solutions Through Collaboration

What is PhUSE? Pharmaceutical Users Software Exchange Mission: Provide a platform for creating and sharing ideas, implementing tools and standards around data, and exploring innovative methods and technologies

Paradigm Shift FDA Sponsors EMA Vendors PMDA CROs SDOs Academia

Computational Science Collaboration Mission: To provide an open, transparent, and collaborative forum in a non-competitive environment in which Academia, Regulators, Industry, and Technology providers can address computational science needs in support of product development and regulatory review, ultimately bringing safe and effective products to those who need them.

CS Collaboration Framework Working Groups Symposium Computational Science Collaboration

CS Working Groups Over 30 active projects Steering Committee Optimizing the Use of Data Standards Emerging Trends & Technologies Standard Analyses & Code Sharing Nonclinical Topics Linked Data & Graph Databases Over 30 active projects

CS Working Group Objectives Nonclinical Topics: Improve nonclinical assessments and regulatory science by identifying key needs and challenges in the field and then establishing an innovative framework for addressing them in a collaborative manner. Optimizing the Use of Data Standards: Identify specific gaps that prevent FDA and industry from optimizing the use of data standards by collaborating to close these gaps. Linked Data & Graph Databases: Investigate how formal semantic standards can support the clinical and non-clinical trial data life cycle from protocol to submission.

CS Working Group Objectives Standard Analyses & Code Sharing: Establish a platform for the collaborative development of program code to be used as analytical tools for clinical trial research, reporting, and analysis. Emerging Trends & Technologies: Provide a form identifying new opportunities for recognizing and leveraging new or emerging technologies and computational tools or under-utilized existing technologies.

CS Collaboration Activities Computational Science Symposium: Annual working meetings USA CSS Silver Spring: 19th – 21st March 2017 European CSS London: 19th – 20th June 2017 PhUSE CS Working Groups: Overview of the groups PhUSE Deliverables Under Review: Draft work packages PhUSE CS Deliverables: Finalized work packages PhUSE New Projects: Call for volunteers & leaders

Get Involved and join the Collaboration Need more information? Visit the PhUSE Wiki to find all the latest project information Visit the PhUSE Website Have a project idea? Submit a New Project Request Join a team: email css@phuse.eu