Two weeks ago SAS hosted over 20 users group leaders from across the US and Canada for our annual Users Group Summit. The purpose of the summit is to plan for 2013 conferences, and one of those in attendance was Craig Brelage, academic co-chair for PharmaSUG. It was a great opportunity for me to talk with Craig and his operations co-chair, Nancy Brucken, about PharmaSUG 2013, which is scheduled for May 12-15, 2013 in Chicago.
Q: May 2013 seems so far away, particularly with the holidays coming up in just a few days. What are you working on now?
A: With the help of a team of 24 wonderful volunteer section chairs, we are working - now - to select the content for the conference. That includes building the master schedule of the paper presentations, posters and hands-on training. If a user has an idea he/she would like to share, they can submit it to our Call for Papers system. We have extended the deadline for submitting papers to January 7, 2013.
Q: Where there any changes from the sections you had last year to the ones you have this year?
A: Yes. We are increasing the in-conference training opportunities by introducing the “Hands on Training” section. This section is held in a room equipped with 20+ computers, in a classroom setting, where attendees interact directly with SAS. All of these sessions are taught by invited, nationally-known instructors, at no extra cost to the attendees. We are also providing a range of papers for beginning (Techniques & Tutorials: Foundations) to advanced programmers (Beyond the Basics).
Q. What are one or two overall traits that you look for in a good presentation, regardless of the section that it’s in?
A: Anything that has proven itself useful to you and your organization! If you have a topic that you’ve presented at your company, and you received good feedback, then it’s likely to make a great presentation for the conference because other attendees will be looking for ways to address a similar situation. The topic could range from a coding tip in Coder Corner to a complex analysis method share in Health Outcomes & Epidemiology or Statistics & Pharmacokinetics.
Q: Is it true that you already have your keynote speaker selected?!
A: Yes. We are very excited to have Wayne Kubick, Chief Technical Officer of CDISC (Clinical Data Interchange Standards Consortium). Wayne will present our technical keynote on Monday morning. It will address the current state and future strategic direction of CDISC standards, and how they are evolving to meet the challenge of FDA's PDUFA-V mandate for defining therapeutic area data standards.
Q. OK. Most readers in the Pharma industry are going to know what PDUFA-V means. But I don’t. What does is stand for?
A: Reauthorizing the Prescription Drug User Fee Act (PDUFA V), was signed into law on July 9, 2012. This new law includes the reauthorization of PDUFA that provides FDA with the necessary resources to maintain a predictable and efficient review process for human drug and biologic products. With-in the law, it requires the use of therapeutic area data standards.