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Executive Summary

FDA ACCEPTANCE OF FOREIGN DATA SHOWING "FANTASTIC" PROGRESS, Glaxo Group Research Medical Director Goran Ando, MD, declared at a Sept. 13 symposium sponsored by the American Pharmaceutical Association's Academy of Pharmaceutical Research and Science. The Glaxo director of worldwide clinical development praised the U.S. regulatory agency's ability and willingness to accept foreign data as pivotal for approval filings. Ando noted that the current attitude toward foreign trials at FDA is a switch from a decade ago when foreign data as pivotal submissions were "more or less a no-no." Ando noted that at least three products have been approved by FDA recently based on pivotal work all conducted outside the U.S.: Asta's MESNEX cancer adjuvant for use with ifosfamide; McNeil's Haldol (halperidol decanoate); and Kabi-Vitrum's Cyclokapron. Two of the products with non-U.S. data clearly represented special situations. Mesnex, marketed in the U.S. by Bristol-Myers Squibb, is a key prophylactic for use with Ifex; once the ifosfamide approval decision was made, FDA was virtually obliged to approve Mesnex. The McNeil dosage form was approved in 1985 based on two studies including a French active control study. At the time, FDA indicated that special consideration was given to the fact that McNeil was seeking a new dosage for an existing product. The Glaxo exec noted further that five products have been approved by FDA with one U.S. trial: Buspar (McNeil); Losec (Merck/Astra); Marinol (Roxane); Nimotop (Miles); and Nolvadex (ICI). Several of the products in this group are significant commercial items. Indications of a change in FDA attitude toward foreign trials are important as the major pharmaceutical firms turn more toward international clinical development programs. Glaxo is attempting to cut the size and overlap of worldwide clinical development through standardization of procedures and a project team organization. Ando stressed the importance of standardization. "In order to do a full-scale Phase III program involving a number of countries, you need to standardize," Ando told the APhA seminar. Companies should attempt, Ando suggested, to standardize their protocol, their case record forms and the way their investigators assess patients ("which is the ultimate challenge"). "You also need to start to standardize obviously the way you analyze and report," he added. Glaxo also has turned to more frequent meetings and contact between investigators to maintain uniformity. "A way to success for us," Ando said, "has been for us to have very frequent meetings with investigators and to bring all investigators involved in one protocol together: not once, not twice, not three times; but over and over and over again to get to know each other and to get accultured together and they produce data that at least we think is fairly homogenous." The attempt to homogenize trial procedures is leading Glaxo to look to fewer, but more similar, countries for development. Ando said it may "not be so good" to attempt to have a trial with multiple centers in a wide variety of countries. "Just by limiting the number of countries and bringing countries together that are reasonably homogeneous, you may make life easier for yourself," he said. A second key for international drug development, Ando said, "is [the establishment of] project teams." Ando said that Glaxo is turning to teams with one project leader, drawing from clinical development staff in different operating divisions. "I believe very firmly in a single project team, running a project throughout the world," Ando said. It is necessary, he maintained, "to give that project leader sufficient authority to actually lead the project. It means a lot of travel involved for the team members because they should be drawn from the various parts of the R&D organization. They should meet, not twice a year, but probably monthly. It is the only way not to deviate from the original plans." Glaxo is also setting up a 24-hour audio-visual link between North Carolina and the U.K. research centers to "reduce some of the misunderstandings that you find." From a worldwide development plan, Ando said, a company can "end up with the same database which from a regulatory standpoint is very important. We will file roughly the same data worldwide, which simplifies for us in the pharmaceutical industry the compilation of the data. It simplifies for regulatory authorities the review of the data." Similar databases may also contribute eventually to narrower dosage ranges worldwide. "If we do one set of decent dose-ranging studies, we will have a far better chance of coming up with a dose than if we do two sets or three sets or four sets," Ando said. Ando suggested that improving internal company procedures may cut as much time from regulatory review as improvements within regulatory agencies. "I resent people who blame the regulatory authorities for all their problems because although there are differences [between the regulatory agencies] I think there are differences that can be overcome," Ando said. "In many ways," he declared, "we are our own worst enemies and complicate life for ourselves." The Glaxo exec, who has previously been affiliated with Astra, Bristol-Myers and Pfizer, noted that coordinating trials will reduce the number of trials and could mean that there will be fewer back-up studies in case a pivotal trial runs afoul of administrative problems. Similarly, the fewer trials could cut the chances for pre-approval introduction to the professions. "We will involve fewer local opinion leaders in the various countries, which have some drawbacks when you once want to introduce your new medication," Ando observed.



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