FDA and the California-based IT company, Conformia, have been at work for the past few years on a cooperative research and development agreement (CRADA) designed to analyze knowledge management within the drug industry and FDA, to pinpoint what is making drug development so costly. Initial findings from the first phase of the CRADA, a blinded research study called "Challenges and Opportunities in Pharmaceutical Development," will be released this Summer. Anjali Kataria, principal investigator on the CRADA and chief marketing officer for Conformia recently discussed some of the obstacles preventing industry and FDA from improving the overall drug development and approval process.
The fundamental problem is one of data transfer and knowledge management. Today, the most senior scientists at some pharma companies spend 30-40% of their time on mundane administrative tasks, and simply looking for data that already exist. The same holds for FDA; at both organizations, a great deal of important information is still kept on paper, in scattered databases and in the heads of key staffers. Information management must be improved, the research suggests. But so must organizational thinking. In order for the industry to move to a true "Quality by Design" drug development model, FDA must improve the connection between review and inspector teams for small molecule drugs, while senior managers within the industry must get directly involved in promoting the crossfunctional culture that QbD demands. Both CRADA partners welcome and encourage more industry participation in this important research. Pharma companies can take part in joint FDA/Industry workshops on QbD. So far, three of these workshops have been held in Washington, involving over 200 participants in pharma biotech, and generics manufacturing, some of whom had not been exposed to QbD concepts and had never applied them to FDA submissions or their internal processes. These workshops, Ms. Katari says, allow top managers from very different companies to discuss crossfunctional implementation, and specific ways to apply ICH Q8 and 9; they also offer a neutral, open venue in which FDA and the industry can communicate issues and problems in the spirit of "continuous improvement." Companies can also participate in case histories. Currently, biopharma unit operation case histories are being developed, but the CRADA will establish a chemistry manufacturing and control information management (CMC -IM )working group to analyze real life mock submissions and apply quality systems management principles and knowledge management strategies. Originally, nine pharma, biopharma and generics companies took part in this research, but Ms. Kataria expects the number to increase to 25 by this summer. We will be covering this research in much greater depth in our magazine and web site, with a regular update, but for more information on the CRADA and how to participate in the conferences and case studies, visit [email protected], or contact Conformia at 408-625-3881. -AMS
