By Paul Thomas, Managing EditorJanet Woodcock, M.D., FDAs deputy commissioner for operations, detailed the status of the Agencys Critical Path initiative at the recent ISPE Annual Meeting in Phoenix. Since it was introduced early in 2004, the Critical Path has brought a renewed emphasis upon scientific practices and investments beyond the R&D arena, something that been lacking within the industry.Weve always put a huge amount of money and brainpower into R&D, Woodcock notes, but we havent put the same emphasis on the process of bringing medications to the public. This has hampered the industrys progress and FDAs efforts to develop enabling standards. Our standards are only as good as the science that they are derived from, she stresses.Adding to the industrys woes has been the fact that academic research in pharmaceutical science has not been well-funded, and that the industry has kept the technical aspects underlying its products and processes under a proprietary lock and key.What FDA has learned since embarking upon the Critical Path initiative, Woodcock says, is that:
- There has not been an adequate funding source for much-needed research in pharmaceutical development and manufacturing.
- The industry still has serious concerns about intellectual property;
- There are no good business models available for optimizing the Critical Path;
- There are insufficient academic rewards for pursuing cutting-edge research;
- There is a lack of trained, interdisciplinary personnel within the industry.