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Executive Summary

MOLECULAR ENTITY; CURRENT ANTIBIOTIC PROJECT IS REQUIRING 10,000 PATIENTS MOLECULAR ENTITY; CURRENT ANTIBIOTIC PROJECT IS REQUIRING 10,000 PATIENTS "We think that it takes about 3,300 person years of effort in support of the development of an NME," Thompson estimated. "It's very important to recognize," Thompson declared, "that when you try to equate the magnitude of the efforts that goes into a single NME NDA approval, that effort is increasingly exponentially at an astonishing rate." Part of tis expansion can be attributed to the increasing complexity of the biology and chemistry involved in developing new drugs. Thompson observed. "Technology inflation" is also playing a role. Thompson pointed out that the CRAY II supercomputers, used to create three-dimensional molecular models, each cost between $18-20 mil. The largest factor in the rising research costs, Thompson declared, is the increasing amount of information required to support NDAs, and in particular, "the expansion of the magnitude of clinical trials." Thompson illustrated the increase by pointing to the difference in clinical trial requirements for the 1979-approval Ceclor (cefaclor) involved 1,493 patients, Thompson said, "and we're going to be required to study 10,000 patients." That increase adds up to "about a 19% per year growth rate" during those 11 years in the size of clinical trials, according to Thompson. "That means a doubling in size every 3.6 years." Totalling figures from all the Lilly NDAs approved since 1949, Thompson estimated that, overall, the number of patients in clinicals needed to support an NDA for a new molecular entity had doubled every six years throughout the past four decades. Visits to physician investigators by patients doubled every four years during that time. Routine clinical laboratory tests have doubled every two years, and pages of clinical report forms submitted in NDAs doubled every year and a half, reaching 470,000 pages for Lilly's recently developed Pindac (pinacidil), a vasodilator currently pending at FDA. Another graphic example of this information explosion, the Lilly VP said, is the pachyderm-sized NDA for Permax (pergolide mesylate), approved in 1988, which "weighed 4,000 pounds at birth." The nineties may bring an increase in productivity for the U.S. pharamaceutical industry, Thompson told his audience: "Looking at the actual NME NDAs for the 60's, 70's and 80's, and by linear projection into the 90' the major companies that we've tracked, there's predicted a 13% increase in the number of NME NDAs approved." But R&D costs, he maintained, are likely to keep rising as well. "The rate of change in the number of NDAs being actually quite small, compared to the enormous inflation, exponentially, in the magnitude of research, its complexity, the cost of new technology, the number of people involved, and then actually as a minor factor, the deflation of the financial value of the money involved," Thompson said. "There are a lot more people, a lot more buildings, and a lot more pages, and a lot more dollars involved in pharmaceutical research today that even a couple of years ago, and my guess is, that this will not turn off, in terms of this continued spending."

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