IFPAC `07, Day 1

 WBaltimore in the A.M.here IFPAC has been held in a hotel in suburban Virginia for the past few years, this year's conference is going on in Baltimore (click on the photo for more detail), near the Inner Harbor, a nice location offering more opportunities to get out after hours.   (Although temperatures are now hovering in the 20's F) Our senior editor, Bill Swichtenberg, who joined the magazine last October and is attending IFPAC for the first time, filed the following brief recap of Day 1 of the conference. "...Being new to the industry, Im finally beginning to see how these FDA initiatives fit together. Today at the IFPAC show in Baltimore, Mary., both Dr. Janet Woodcock and Dr. Moheb Nasr explained the Critical Path Initiative and Pharmaceutical Qualtiy for the 21st Century, focusing on quality by design. While I'm sure that neither of these talks would have been earth-shattering for PAT veterans, I found the talks interesting.  Worthy soundbites of Dr. Woodcocks speech were: Manufacturers should be trying to satisfy customers, not the FDA. Dr. (Andrew C.) von Eschenbach is committed to move PAT forward. PAT is a move from empirically-devised trial and error methods to a rigorous mechanistically-based and statistically controlled process. Dr. Woodcock emphasized that the FDA needed science to move pharmaceutical manufacturing along because there hasnt been (and wont be?) any additional funding from Congress. In addition, better linkage between clinical performance and quality parameters was needed. Dr. Nasr picked up where Dr. Woodcock left off. He explained that the goal of the FDA was to create an efficient pharmaceutical manufacturing industry that can manufacture safe and reliable products without much oversight. Whether this happens or not is another story. He also stated that  FDA is more interested now (in PAT) than ever before. He also said that FDA is heading toward a regulatory strategy that is specific to the product and/or process. This means manufacturers should stop worrying about directives and focus on ways to improve their products. FDA's CMC pilot project is currently looking at 11 projects with four already approved and another one to be approved shortly. Known for his expressions, another ˜Nasrism seems to be these new initiatives are not about reproducibility but about robustness. With all the talk about Six Sigma and Lean manufacturing, today I also learned about the theory of constraints. Dee Bradbury Jacob of The Avraham Y. Goldratt Institute, New Haven, Conn., explained that this method defined improvement as acknowledging and managing inter-dependencies that exist within an organization through the entire supply chain. The key to improvement in this method is exploiting the systems constraints. You need the right people on the right tasks in order to improve constraints. According to Jacob, if you improve these constraints, real value will ensue. Anyone can swing a hammer, the trick is learning where to hit and how hard. Advocates  hope that PAT projects will make that hammer hit the bell..." Bill Swichtenberg