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| From left to right: Researchers Jerry Thursby, Matthew Higgins and Marie Thursby--Courtesy of the Georgia Institute of Technology |
Drug development bottlenecks are typical--and often inevitable--in clinical trials, but there may be more holdups during the discovery and preclinical phase than previously thought, according to a new study.
An analysis of 835 patented university inventions licensed to biotechnology companies reveals early delays in the development process, indicating that the path to commercialization is not so linear.
Specifically, the study found that when biotech companies give up on a drug candidate and transfer the technology to other biotechs, the recipients of these products tend to repeat, postpone or never perform basic science on these compounds, essentially resetting the development timeline. This happens often when companies transfer or sell a candidate to another company for repurposing in a new disease category.
Of the 835 inventions studied, only 27% appeared in a second license. The average time between invention and first license was 5 and a half years, and the average time between first and second license was three and a half years. Of the first-licensed products that list a stage of development, 92% were either at the discovery or lead molecule stages, while only 6% had entered clinical trials. Among the second-licensed drugs, 22% made it to clinical trials or beyond. The findings were published Aug. 20 in the journal Science Translational Medicine.
"We were surprised primarily at the uncertainty after a license is executed at a university. Even after that, there's an enormous amount of uncertainty," study co-author Jerry Thursby, a professor at the Georgia Institute of Technology, told FierceBiotechResearch.
Thursby's study, which he conducted along with wife Marie Thursby and Matthew Higgins, also professors at Georgia Tech, is part of a series of studies commissioned by the U.S. National Institutes of Health to help measure the productivity of the agency's funding in translating biomedical research into products.
"In terms of scientific discoveries, NIH is very productive," Jerry Thursby said of the findings. "In terms of generative final products, it's very hard to measure."
He said one of the factors impacting these stoppages at the discovery level is that companies rarely share their basic science research, such as in open-access journals, with the rest of the scientific community. The study authors suggest that an open-source translational research database that complements clinicaltrials.gov might be a way to speed up the commercialization process.
- read the full study in Science Translational Medicine
- get the press release
Editor's Corner: Janssen rethinks drug discovery in a changing R&D environment