NEW YORK, Nov. 14—Hurry up and wait: the biotech revolution, touted as the transformation that would speed sluggish drug development times and boost efficiency in the pharmaceutical industry, seems so far to have slowed the process down. The finding comes from a new study released Tuesday by the Tufts Center for the Study of Drug Development.
The report tracks the clinical drug development process during the last two decades, and finds that the time spent on clinical trials has surged upward by nearly 80 percent since the mid-1980s, from an average of 33 months to an average of 68 months.
But it’s not the fault of regulators and bureaucrats: the study also reports that the average time for regulatory approval by the US Food and Drug Administration has shortened by about 40 percent, from 24 to 15 months.
What happened? Biotechnology, said study author Janice Reichert, a senior research fellow at the Tufts center. “Maybe in the future development times will come down as a consequence of the use of these techniques,” she said. “At the moment, I think they’ve contributed to lengthening the times.”
Reichert points to a cluster of causes, including the focus on more complicated diseases that have previously defied drug treatment, the demand for safer and more efficient drugs, and the scientific exploration of new drug mechanisms.
Quirks of the industry are also partly to blame. Some biotech drugs may bounce from company to company as they track through clinical trials, lengthening the overall development time. In other cases, a small company might quickly put a drug through phase I clinical trials as proof of concept, but spend years rounding up the cash to get the drug into expensive phase III trials.
At first, genomics may slow the process down even more, Reichert said—simply because the barrage of new techniques and new targets may take a while to weed through. “Right now, people are in the learning phase,” she said. “People are trying to figure out what things mean—what does it mean if you have five mutations in one gene? Is that reasonable and sufficient to design a diagnostic?”
So much information is now flooding into the discovery stage, said Reichert, that genomics may actually push development times up for a while. Then, as these technologies become more robust and deliver their promise—more intelligently designed diagnostics and the identification of better drug targets—the process will speed up again, she predicts. With current drug development times ranging around five years, though, that acceleration may not kick in for another eight to ten years.
Plus, genomics won’t have a major impact on the most time-consuming part of the process: grinding through clinical trials. “The genome is not going to revolutionize the process,” she said. “It may revolutionize the information going into it, but not the process. It still takes the same amount of time to get through a phase I study. If you have to do a six-month study with a one-year follow up, it still takes six months and one year to do it.”