The industry is using old tools to develop new drugs," former FDA officer Carl Peck told the audience of industry leaders at the Best Practices Awards ceremony. Peck, founding director of the Center for Drug Development Science at Georgetown University, and a former director of the FDA's Center for Drug Evaluation and Research, entreated his listeners to review and participate in the FDA's new Critical Path Initiative, designed to offer solutions to "the pipeline problem." 
"EDC has been possible for decades, but few companies have exploited it."
Sylva Collins, Novartis |
"As everyone here knows," Peck said, "many drugs are being discovered, few are being evaluated, and even fewer are being approved each year." The problem, he said, is that product-development science — those activities that go beyond translational science and into product testing and commercialization — has stagnated. "Despite the industry's huge R&D budgets," Peck said, "the FDA is receiving fewer new drug applications than it did in the mid-'90s. Moreover, the rate of drug failure in late-stage testing is increasing. Almost 50 percent of applications fail in Phase III trials. Some niches, such as cancer therapies, have failure rates of two-thirds of all drugs tested in Phase III."
That's the most expensive way to fail, he noted. "A successful drug sponsor is one who learns how to fail early, and therefore much more cheaply. But you can only do this with better predictive tools."
"A successful drug sponsor is one who learns how to fail early."
Carl Peck, Georgetown University |
The Critical Path Initiative, according to Peck, "has identified several low-lying-fruit-type opportunities for improvement." In discovery, for instance, companies could make better use of computer models to screen drug candidates, with only those molecules likely to be safe and effective finally being tested on people. "The industry could use a new 'omics' not only to identify drug targets, but also to identify biomarkers — particularly disease remission and screening tools — that help us recognize patterns and therefore predict toxicity and efficacy," Peck said. On the safety side, he added, "the concept of model-based drug development, in which pharmaco-statistical models of drug efficacy and safety are developed from preclinical and clinical data, offers a way to improve drug-development knowledge management and decision making."
'The Hard Part'
While Peck encouraged the audience with his vision of "a new day" in drug development, the next speaker didn't hesitate to chide them. "Today we find the drug industry facing relentless pressure to become faster and more efficient," said Sylva Collins, global head of advanced clinical systems at Novartis. (See our interview with Collins on page 26.) "Yet many of its product-
development processes are no more modern than they were 30 years ago."
Collins used electronic data capture (EDC) for clinical trials to illustrate her point. "EDC has been possible for decades," she contended, "but few companies have exploited it. Some have even regressed."
She told the story of how, 25 years ago, a large pharma pioneered an EDC system using floppy disks to capture clinical data. The disks were sent back and forth from clinical sites to the data processing center via U.S. mail. "I'm sure all of us here would sneer at this effort as laughably primitive if it were proposed today," Collins said. "Nonetheless, many companies represented here tonight aren't even as advanced as that pharmaceutical firm was in 1979."
The pioneering company Collins referred to, Merck, eventually abandoned its EDC efforts and returned to using paper.
She contrasted this scenario with her own company's more recent experience, whereby Novartis has purportedly saved more than a quarter-billion dollars in less than three years from implementing EDC. The company has also "shaved at least three months from its drug-development cycle," Collins said. "Nonetheless, few others have emulated Novartis' practice."
"You here this evening have accomplished an important task," she said. "You've embraced a critical new technology that may transform part of your organization — or even our industry. To be truly successful, however, you will have to transform your organization to exploit that new technology. This is the hard part."