The Project Managers Role

As mentioned above, an important role for the project manager on the TaxolB PDT was that of arbitrator. As is often the case with a hq$ profile project, stress management becomes a major issue. No time could be wasted by pointing fingers and blaming others. This fact was emphasized as the project progressed in complexity and the target date for the fhg of the NDA came ever closer. On occasion, differences of opinion among team members could not be resolved at the PDT meetings since such problems usually were between just two or three line function representatives. In such cases, with the assistance of the project manager, problems could be resolved via teleconference calls. In other more difficult cases, the project manager would arrange sub-team meetings to discuss the issues in detail. In addition, in the case of TaxolB, face-to-face discussions between the project manager and the various affected team representatives took place. This latter strategy proved to be very effective since PDT members were scattered among various sites within BMS, including research and development sites in New Jersey, New York, and Connecticut. At such face-to-face encounters, the importance of the representative's contributions to the development strategy were reiterated, thus rekindling the "sense of pride" alluded to above. As the time for the NDA submission drew closer, the project manager's interaction with members of the Regulatory Affairs Department became increasingly

frequent. Through this interaction, report submission dates, and so on could be readily monitored, and if major problems were foreseen that could not be resolved at the team level, upper management could be informed without delay, and the solutions could be found at that level. The project manager's roles during the development of TaxolB were those of project monitor, facilitator, communicator, and peacemaker. Given the high priority of the TaxolB project, these roles were supported by management. In essence, the project manager was given the opportunity to do what had to be done to get the project accomplished

REGULATORY AFFAIRS AND THE " FAST-TRACK

A significant t factor in the ability to get a rapid review of the TaxolB dossier by the FDA was the fact that regulatory affairs personnel established a good rapport with agency personne through regular communication throughout the development of TaxolB. This communication not only included BMS personnel, but also those from NCI. As part of the CRADA agreement, a joint NCI-BMS steering committee for Taxol@w as established. This committee met on a regular basis to discuss all aspects of the drug's development. This committee is still functioning at the present time, and there are no plans to disband it. The close collaboration between the NCI and BMS was best revealed when the NDA was reviewed at the FDA; both NCI and BMS personnel participated in the presentations before the reviewing body. Perhaps the best example of the successes of this collaboration and of the close communications with the FDA was that at the NDA review meeting, it was stated that the TaxolB dossier was the best organized application that the reviewing body had seen, and that it could serve as a "model" for other oncologic drug applications. It is also apparent, however, that no matter the degree of FDA-company communication, the application would not have been reviewed with the alacrity that it was if TaxolB were not in such great demand, especially by the thousands of patients suffering from essentially untreatable ovarian cancer. The political pressures existing at the time surely played a major role in the agency's rapid review of the Taxolm NDA. However, the application was one of high quality (see above), so the review was no less complete than would have been the usual case.

List a few characteristics of the described project manager's role which you would consider important.