The Computational Sciences Symposium (CSS) will be celebrating its 6th annual event and has established itself as the premier collaboration within the clinical trial environment. The collaboration has continued to grow hosting the first inaugural event in Europe this past June and engaging other regulatory agencies including EMA and PMDA.
This year’s event will once again be co-sponsored by FDA and PhUSE and take place in March of 2017. The annual CSS brings together Academia, Regulators, Industry, and technology providers to address computational science needs in support of regulatory review and ultimately bring safe and effective products to those who need them.
The focus of the Annual Computational Science Symposium is to continue the work initiated at the previous annual meeting and throughout the year. The event will provide an update on current initiatives ongoing within the FDA, explore emerging technologies, and establish collaborative projects to address current challenges related to the access and review of data to support product development.
Since the 2016 CSS, the projects within the Working groups have been meeting, collaborating, and delivering valuable outputs as part of their objectives. Click here to read further information on all Working Groups, describing their projects with links to information about each one.
Over the past year, the Working Group projects have successfully delivered on their objectives to support the overall mission of the collaboration. Below are samples of those successful projects and the great work being done by many volunteers.
- Non Clinical Study Data Reviewer’s Guide: Extension of the SDRG, a standardized template providing best practices and recommendations for non clinical information needed within a submissions
- Analysis of Alternative Transport Formats: Survey to evaluate the requirements and needs for a more robust delivery format to regulatory agencies
- Study Data Standardization Plan (SDSP): Development of a recommended study data standardization plan early in the development cycle to optimize implementation of data standards is the focus of this new project
In addition to the regularly scheduled activities including an opening session by the FDA, working group collaboration, poster session, and networking, other exciting activities are being planned.
Prototyping Next Generation Transport Formats
The Linked Data and Graph Databases Working Group (formerly the Semantic Technology Working Group) will be running a breakout session which will differ from previous symposiums. In addition to the project breakout sessions, the Working Group will host a separate breakout session that will build upon the Alternative Transport Format project in the Emerging Trends and Technologies Working Group and prototype next generation transport formats. This hands-on sessions will represent data in different formats including CDISC Dataset XML, the Resource Description Framework (RDF) and Neo4j property graphs. The wrap-up session will include a debrief and attempt to draw conclusions from the prototyping activity.
The Working Group welcomes anyone with CDISC business knowledge or data modeling knowledge to join the prototyping activities (i.e. you don’t need to be a technology expert). Registration for these sessions will be limited. Please indicate your interest by selecting Linked Data and Graph Databases Working Group during the registration. If you have any questions in advance, please contact Tim Williams or Scott Bahlavooni.
The Working Group Steering Committee are accepting proposals for new projects. A proposal will address problems of significant relevance to computational science related to drug, biologic and device development and must meet all of the guidelines for projects within the FDA/PhUSE collaboration.
Click here for more information and to download the New Project Request Form. New projects can be submitted at any time but there is a deadline of 31st December to be included in the 2017 meeting.
The conference will commence at 4 pm on Sunday, March 19th with the opening networking session and end at 5pm on Tuesday, March 21st.
Online registration will open on November 1st. The Symposium is limited to only 300 attendees so register early before the event sells out.