Last night over 640 SAS users from 12 countries met in Orlando for a great opening session at PharmaSUG 2015. Elizabeth Dennis from EMB Statistical Solutions and Syamala Schoemperlen from Alcon, a Novartis Company are this year’s co-chairs. They lined up a wonderful venue as well as content for the conference.

The co-chairs kicked off the evening with thanking their conference committee, section chairs and volunteers for making it all possible. Highlights include:

• 11 student scholarship winners
• 11 junior professional scholarship winners
• Charity drive for Adopt a Classroom, focusing on STEM education for the University High School in Orlando
• Over 175 papers, 22 super demos, 25 posters, 8 hands-on training sessions in the conference proceedings

SAS is a proud partner of PharmaSUG.  Matt Becker, SAS Principal Solutions Architect, thanked PharmaSUG and all the users for supporting the event and invited them to the SAS area in the Exhibit and Demo room to help guide their journey at the conference, “Our experts are here to speak with you – visit us”.

Electronic standardization will transform the review process

Keynote speaker, Lilliam Rosario, PhD, of the U.S. Food and Drug Administration (FDA) spoke on the topic of "Modernizing CDER Drug Review - OCS Technology & Support".

She started by saying that the pharmaceutical industry needs to use the data that is at its fingertips. The industry and the FDA need to modernize the review process and use data to improve it.

The review process is at a point of transformation – electronic standardization will become a requirement. This standardization allows the FDA to transform the regulatory review process. The next level is to put the tools and technology in the hands of the reviewer.

She shared a great vision of the intersection of data, tools and technology. If you look at the data, the feedback, run the analysis and then discuss before filing for review, you have a better chance at making it through review.

The FDA uses a solution called JumpStart. It uses two major pieces before delivering to the review team; data fitness and exploratory analysis. The FDA JumpStart Program includes reviewing the tool with data fitness (validator and business rules, human exploration – package).  Following all these standards in data fitness will make a big difference on how the review is conducted. Then there is exploratory analysis to help with safety signals to approach the review.

In the end, if you provide the reviewers with the useful data then can help to decide if the product is safe to put on the market.

Dr. Rosario mentioned that an electronic standardization policy is coming, including tools to support the review process. Dr. Rosario stressed to use this conference to give feedback to help move this policy along.

Follow the conference on Twitter

To read more highlights from this year’s PharmaSUG conference, follow on twitter with #PharmaSUG and @PharmaSUG through Wednesday.