Collaborate with FDA, Industry and Others to Improve
Product Development and Review
On March 15-17, 300 people
from PhUSE, FDA, CDISC, and Industry gathered together in Silver Spring,
Maryland for the 4th annual Computational Science Symposium (CSS). This
event and ongoing collaboration is unique within our industry as it brings the
key stakeholders from across the product development and review process to
solve issues, explore new ideas and work together to improve the product
The meeting kicked off with FDA State of the Union where the FDA shared valuable information about how they
are leveraging the standards, tools and processes to improve their review
process. Lilliam Rosario and her
colleagues provided real world examples of how reviewers are using the
JumpStart program to assess the quality of their submission data, load the data
into their various tools and provide standard analyses for the reviewers. This overall process has enabled the FDA to
assess quality within two weeks of submission and put analyses in front of the
reviewer within four weeks; a significant reduction in time within their process.
After the review of the JumpStart program, Armando
Olivia provided an overview of the new and improved JANUS Clinical Trials
Repository (CTR). He shared, that as of January,
2015, the CTR is in production at FDA with over 60 trials loaded and ready for
analysis. Within the final presentation,
Steve Wilson explained that this was a different kind of conference – a
collaborative working environment. Steve Wilson asked attendees to “move beyond
their stake, roll up their sleeves and use their expertise to seek solutions”.
Throughout the event the working group projects collaborated on current projects and identified a number of new projects. These new topics included
best practices to support the new electronic
submission guidance, support the testing and implementation of Therapeutic
Area User Guides (TAUGs), development of best practices and requirements for
Statistical Computing Environments (SCEs), and the need for dynamic
visualization of clinical data.
By the end of the
Symposium, there was significant excitement about the current projects
delivering value to the product development process and new projects that were
kicking off innovative ideas. While all attendees understood that the
challenges identified are not easy to solve, everyone was eager to roll up
their sleeves and execute what could be achieved through collaboration.
new attendee said after the event:
among sponsor, CRO and the FDA was a formula for success.
all there working together to solve problems and explore new concepts. The
progress the small groups were able to make in a short
View the Presentations and Posters here.
Join a Working Group and help optimize our industry!