The long road to the market
The path from a biotechnological discovery to a treatment method can be shortened
Researchers from the Georgia Institute of Technology (Georgia Institute of Technology), USA, examined in detail the path of a patent for a biotechnological invention from a laboratory to clinical trials. It turned out that due to the existing practice of patent development by a single biotech company in one therapeutic area, the period from discovery to treatment method is significantly extended.
It is well known that a huge number of new drugs do not enter the market based on the results of clinical trials. It is these studies that make up the longest and most expensive part of drug development. In the work of Higgins et al. Bench-to-Bench Bottlenecks in Translation, published in the journal Science Translational Medicine, shows that even at the preclinical stage, a significant loss of time and money is possible.
Translation, transfer, of a biotechnological discovery (an intracellular molecular target or a new mechanism of action of an enzyme) into practice consists of several stages. In the USA, innovative inventions applicable in the field of biopharmaceuticals are usually made in university laboratories. A government agency sells a license for the practical application of the discovery to a small biotech firm. Further, a number of preclinical studies are carried out, usually aimed at applying the invention in a specific therapeutic area. In case of failure, the patent is often resold to another company for development according to new indications. Large companies with the resources to conduct expensive clinical trials often acquire technology that has already proven its prospects.
The authors of the study tracked the fate of 835 patents from 342 universities transferred to biotech firms. It was assessed whether the development license was resold to another company for study with new indications, or whether it was immediately transferred to a large firm capable of conducting large-scale research in humans. Twenty-seven percent of all patents were resold at the preclinical stage of development.
On average, it took five and a half years from the invention to the first license, and three and a half years between the first and second license. Of the first licenses for 92% of discoveries, development was stopped at the stage of selecting promising molecules or earlier, and only 6% came to the stage of clinical trials. Of the second licenses, new medicines created on the basis of inventions were considered in human studies in 22% of cases. Thus, the preclinical stage of development can be shortened by several years if a new discovery is evaluated for several indications and the number of duplicate studies at the early stages of the search for new treatments is reduced.
The authors call for greater accessibility of preclinical results and suggest creating an open resource that would combine information about patents and licenses for fundamental biological discoveries that are promising for the creation of new drugs.
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