The Computational Sciences Symposium (CSS) will be celebrating its 7th annual event and has established itself as the premier collaboration within the clinical trial environment. The collaboration has continued to grow with over 40 projects across multiple working groups, over 50 regulatory attending the 2017 CSS, and engagement of other regulatory agencies including EMA and PMDA.
This year’s event will once again be co-sponsored by the FDA and PhUSE and will take place in March 2018. 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 2017 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 the Working Groups and 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 standardised 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 optimise 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.
NEW WG: Educating for the Future:
Since the 2017 CSS, a new working group was formed out of the Emerging Trends and Technologies group called “Educating for the Future”. Methodologies and technologies utilised in the clinical development process have been largely unchanged since for the last 20 years. External to our industry, there have been immense advancements in technology and mindsets related to working with data that have had little impact in our industry. This Working Group sees this as a risk to our work and the goal of this Working Group is to develop frameworks to educate the PhUSE community at large. The frameworks will be designed to educate the community on the importance of topics where we feel we have gaps, the details of the topics themselves, and how they can be used to drive innovation in the industry.
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 December 31st to potentially be included in the 2018 meeting.