Monday, May 23, 2005
Opening Session
I flew into Phoenix Arizona this afternoon to attend PharmaSUG 2005. The Southwest captain said it was 104 degrees and climbing. We just happen to be catching Phoenix at record temperatures. The Pointe South Mountain Resort is quite a nice resort where the conference is being held. The opening session opened today at 6:30 and was presented by Nancy Brucken, Academic Chair and Susan Fehrer, Operations Chair. They shared the fact that PharmaSUG had a record number of registrations this year at 635 attendees. Andrew Fagan gave the key note speech tonight referencing a paper that was publishing on the FDA website regarding the FDA’s critical path initiatives. The paper is available on the FDA’s website published March of 2004. It outlined some of the problems which the FDA is seeing. It tried to identify solutions by changing both the process and technologies. There were no specific instructions on how things can should be fixed but it did recommend that vendors work together to come up with solutions.
One of the problems that the FDA has identified is that there was a dip in the number of drugs in the pipeline in recent years. It then identifies some of the potential causes to this problem. New technologies such as Genomics are too new and have not yet fully met its potential. The recent mergers and business developments also has an effect the number of drugs being developed. All the easy target for disease is taken and has been developed. The chronic diseases are harder to implement. There is also a focus on drugs that are block busters. The failure rate of drugs has not improved. Only 8% of drugs being developed ever reach to market. For Phase III trials, the failure rate is now at 50%. Andrew also stressed the point that standards are lacking and this is having an affect on the success of drug development. The FDA realizes that even they themselves are lacking standards within their own organization. This is internal to the FDA, not to mention throughout the industry. The FDA still does not have the ability to look across all studies they have reviewed. This is referred to as lack of “institutional memory”.
SAS is trying to address some of these challenges that the FDA has identified. They have solutions in the areas such as Micro arrays, involvement in standards such as CDISC. SAS is a corporate sponsor and is on the board of director. SAS is also involved in working with the ODM, AdaM and define.xml. SAS views that standards groups such as CDISC and HL7 to be critical to the re-engineering push at the FDA. Among some of the other tools that SAS is working on includes: PROC CDISC, CDISC Viewer, XML Engine, XML Map Extension, new SAS formats, CDISC SDTM metadata templates for ETL studio and SAS Drug development. SAS Drug development forms a frame work to provide a solution for a compliant environment.
Most of the problems which the FDA has identified can not be solved by technology alone. There has to be corporation between vendors and FDA. Other solutions involve further development and evolution of technology.
Nancy and Susan concluded the opening session by pointing out some themes for this year’s conference. Validation is a definite theme. Other themes include CDISC, standards and electronic submissions. It was a great opening session with lots of interesting information. It is getting late so I will sign off and will report more tomorrow… actually it is already Monday morning… later today.
One of the problems that the FDA has identified is that there was a dip in the number of drugs in the pipeline in recent years. It then identifies some of the potential causes to this problem. New technologies such as Genomics are too new and have not yet fully met its potential. The recent mergers and business developments also has an effect the number of drugs being developed. All the easy target for disease is taken and has been developed. The chronic diseases are harder to implement. There is also a focus on drugs that are block busters. The failure rate of drugs has not improved. Only 8% of drugs being developed ever reach to market. For Phase III trials, the failure rate is now at 50%. Andrew also stressed the point that standards are lacking and this is having an affect on the success of drug development. The FDA realizes that even they themselves are lacking standards within their own organization. This is internal to the FDA, not to mention throughout the industry. The FDA still does not have the ability to look across all studies they have reviewed. This is referred to as lack of “institutional memory”.
SAS is trying to address some of these challenges that the FDA has identified. They have solutions in the areas such as Micro arrays, involvement in standards such as CDISC. SAS is a corporate sponsor and is on the board of director. SAS is also involved in working with the ODM, AdaM and define.xml. SAS views that standards groups such as CDISC and HL7 to be critical to the re-engineering push at the FDA. Among some of the other tools that SAS is working on includes: PROC CDISC, CDISC Viewer, XML Engine, XML Map Extension, new SAS formats, CDISC SDTM metadata templates for ETL studio and SAS Drug development. SAS Drug development forms a frame work to provide a solution for a compliant environment.
Most of the problems which the FDA has identified can not be solved by technology alone. There has to be corporation between vendors and FDA. Other solutions involve further development and evolution of technology.
Nancy and Susan concluded the opening session by pointing out some themes for this year’s conference. Validation is a definite theme. Other themes include CDISC, standards and electronic submissions. It was a great opening session with lots of interesting information. It is getting late so I will sign off and will report more tomorrow… actually it is already Monday morning… later today.
# posted by Sy Truong @ 12:07 AM 
