Collaborate with FDA, Industry and Others to Improve
Product Development and Review
The annual Computational Science Symposium (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 CSS is to continue the work initiated at the previous annual meetings by bringing regulatory agencies including the FDA, industry and academia together to provide an update on current initiatives ongoing within the FDA, explore emerging technologies and establish collaborative working groups to address current challenges related to the access and review of data to support product development. Previous work has included the creation of a Study Data Reviewer's Guide Template for submission, development of a non-clinical road map and the application of semantics technology to standards.
PhUSE CS Working Groups
Since the 2014 CSS, the projects within the PhUSE CS Working Groups have been meeting, collaborating and delivering valuable outputs as part of their objectives. The two links below provide an overview of the current working groups and a long list of the deliverables produced by the work.
• Computational Science Working Group Dashboard
• Computational Science Working Group Catalog of Deliverables
Over the past year, the projects within the CS Working Groups have successfully delivered on a number of their goals to better support industry and FDA. Below are some of those successful projects.
- Analysis Data Reviewer's Guide (ADRG) – A standardized template providing best practices and recommendations for information needed within a submission regarding the analyses and ADaM
- SEND Implementation Wiki, a knowledge base for SEND implementers including reference articles and links, modeling basics and FAQs
- Release of Multiple White Papers including Analyses and Displays Associated to Non-Compartmental Pharmacokinetics, Best Practices for Data Sizing, and Analyses Associated with Demographics, Disposition and Medications
- Delivery of CDISC Standards in RDF – Implementation of the CDISC standards within RDF, a robust model for standards development and system interoperability.
Since the beginning of the Computational Science Symposium three years FDA has played a important part in the development and ongoing support of the conference and the associated working groups. At the 2015 conference, FDA participants will once again have a prominent role. The conference will kick off with the FDA State of the Union where Dr. Lilliam Rosario will share their experiences implementing Jump Start, an award winning program within FDA to leverage tools, standards, and processes to improve the review process. In addition, FDA attendees will share how they are leveraging the work done within the CS Working Groups, updates on the new guidances, and ideas for what they would like to see tackled moving forward. At the end of the day Tuesday, their will be an open panel with FDA participants for attendees to ask their questions.
The 2015 CSS will once again feature the PhUSE Scriptathon - A hands-on opportunity to jump-start the Standard Scripts Working Group code repository! After last year's resounding success, the Scriptathon was replicated at PharmaSUG and the PhUSE Annual Conference in London this past October. Over two dozen scripts have been added to the repository as it continues to grow.
Participants will collaborate to create standard scripts for predefined targeted analyses using various code languages. The group will meet during the conference and on Monday evening to bang through some code. Join us for food, beverages and a hands-on opportunity to contribute to the PhUSE code repository! Note that participation will be limited, so sign up early.
Working Group Meet and Greet
With so many attendees arriving on Sunday evening, we will host an informal working group meet and greet with drinks, snacks and the opportunity to browse the posters. The working groups will have introductory sessions providing an overview of their history, current projects and how you can contribute. This will allow the projects to hit the ground running on Monday. Join us on Sunday evening and network with your colleagues from across industry and FDA and learn about the exciting work being done across projects.
As part of the CSS, the CS Working Group Steering Committee is 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 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 31 2014 to be included in the March 2015 meeting.
The conference registration will commence at 4pm on Sunday, March 15th followed by the opening CS Working Group Meet and Greet session at 5pm. The conference will end at 4pm on Tuesday, March 17th.
Online registration is now open and the Symposium is limited to only 300 attendees so register early before the event is sold out. Advanced onsite registration will open on Sunday, March 16th between 4pm - 5pm.