Spirit of Collaboration at PhUSE CSS 2017

PhUSE CSS 2017 - Conference Review

The USA hosted for the 6th consecutive year the PhUSE CSS (Computational Science Symposium) at Silver Spring with 325 attendees coming from many pharmaceutical companies, CROs, FDA and CDER. The CSS is an FDA/CDER and PhUSE co-sponsored meeting - the agency officially support the projects and recognise the successes the working groups every year. The CSS is a great opportunity to connect, share thoughts and ideas freely with a focus on sharing accomplished work publicly in order to help the industry and organise the next collaborations and actions. 

The keynote presentations were really interesting and discussed a wide range of topics from new eCTD rules and standards to improving FDA Non-clinical review capabilities for CDISC-SEND submission to how analytical tools are used for a NDA/BLA . It was also very interesting to hear how clinicians from the FDA review submissions and the different steps they go through during their review period and the hurdles they face during this process. The conference also had 2 hands-on workshops and 33 posters were presented.

PhUSE CSS has 5 active working groups and during the conference each project lead presented accomplishments from the last CSS and topic of interests for this year:

  • Standard analyses and code sharing
  • Optimizing the use of data standards
  • Linked data and graph databases
  • Emerging trends and technologies
  • Non-clinical Topics

The link below details the different projects under each working group and the fantastic work done so far (Many SAS and R scripts are available for use from the Standard Analysis and code sharing working group!)

http://www.phusewiki.org/wiki/index.php?title=FDA_Working_Groups

I was amazed to see this great collaboration between Pharma/CROs/CDER/FDA. It's fantastic to see all of us working very hard toward the same goals: to improve standards and processes and look at new technology for the benefit of the industry and the patients.