Sponsors who buy an unsuccessful product from another company to repurpose it for a different disease often lose time repeating basic research. Universities, drug firms and CROs (clinical research organisations) can speed up development and save money by sharing their original research to prevent it being repeated or lost forever, according to a study funded by National Institutes of Health.
"The timeline for commercialization is much longer than most people think. There is so much turmoil and churn within the process," said Jerry Thursby, one of the paper’s authors.
Findings are lost when small firms sublicense their inventions to larger companies that can afford to run clinical trials. Similar “information asymmetries” happen when early work is transferred to CROs, co-author Matthew Higgins told us:
“In most cases CROs are contracted for clearly defined tasks versus exploratory development. If a CRO is focused on task X they may very well ignore ancillary discoveries that are outside of the parameters of their contract.”
Fines for refusal
The scientists suggest patents and inventions destined for eventual therapeutic use be entered in “an open-source translational research database that complements clinicaltrials.gov. […] Reporting into the database could be required by journals and for any research that receives federal funding.” If the US Food and Drug Administration (FDA) makes reporting a requirement for any molecule that a firm intends to take into clinical trials, this would encourage companies to register their findings early.
When Outsourcing-Pharma.com asked if companies will be reluctant to share information they consider commercially confidential, the authors told us they recommend civil fines for non-compliance, as in the case of trial reporting.
“Let’s not forget, this is an industry that benefits from significant societal resources committed to basic science and early-stage research in addition to monopoly protection for approved products,” said Higgins. “Pulling back the curtains a bit may prevent duplicate or triplicate spending in areas of research that have failed.
“It may also allow firms to modify their approach, which may improve chances for ultimate success. Such a reporting system may also be beneficial to a firm because if they discover a molecule may be applicable in another area, it gives them a mechanism to identify potential license partners. Likewise, it may also allow potential license partners to find them.”
Source: Science Translational Medicine
Vol. 6, Issue 250, p. 250fs32, 20 August 2014. DOI: 10.1126/scitranslmed.3009000