{"317581":{"#nid":"317581","#data":{"type":"news","title":"Early Bottlenecks in Developing Biopharmaceutical Products Delay Commercialization","body":[{"value":"\u003Cp\u003EAn analysis of patented university inventions licensed to biotechnology firms has revealed early bottlenecks on the path to commercialization. To open these roadblocks, the researchers suggest that better communication of basic research results during the discovery stage could lead to faster commercialization down the road.\u003C\/p\u003E\u003Cp\u003EBiopharmaceutical drugs are frequently derived from discoveries made in university laboratories and licensed to biotechnology firms. Bottlenecks are well known during clinical trials, which have a high failure rate. But a new study pinpoints how much time is lost earlier in the pathway, when biotech companies give up on an invention and transfer the technology to other biotech firms for repurposing in a new disease category. Companies rarely share their basic research on an invention, which highlights what the researchers consider to be an underappreciated cost of commercialization as basic science research is then repeated, postponed, or never performed.\u003C\/p\u003E\u003Cp\u003E\u201cThe timeline for commercialization is much longer than most people think. There is so much turmoil and churn within the process,\u201d said co-author Jerry Thursby, a professor and the Ernest Scheller, Jr. Chair in Innovation, Entrepreneurship, and Commercialization at the Scheller College of Business at the Georgia Institute of Technology.\u003C\/p\u003E\u003Cp\u003EThe study was sponsored by the National Institutes of Health (NIH) and was published August 20 in the journal \u003Cem\u003EScience Translational Medicine\u003C\/em\u003E.\u003C\/p\u003E\u003Cp\u003EThe standard path to the marketplace for biotechnology is for universities to do most of the basic research and then license a discovery to a small biotechnology firm that advances the research. The small biotech firm will then sublicense the discovery to a large biotechnology firm that can afford to run clinical trials. The study found that basic research rarely proceeds in this straightforward path to commercialization, often zigzagging across biotech firms and research areas before a drug is finally developed.\u003C\/p\u003E\u003Cp\u003E\u201cWhat these data reveal is that there\u2019s a lot of bench to bench translational research. It\u2019s not linear,\u201d said Marie Thursby, a study co-author and the Hal and John Smith Chair in Entrepreneurship at the Scheller College of Business. Matthew Higgins, an associate professor of strategic management, was also a co-author of the study.\u003C\/p\u003E\u003Cp\u003EFor the study, the researchers built a database of 835 patents in 342 university licenses with biotech firms. The researchers then traced the path of patents to document whether they were subsequently sublicensed to another firm for testing in a new disease category or whether the sublicense was to a large firm for clinical trials or marketing. Sublicensing often resets the development timeline in what the authors refer to as bench-to-bench translational research.\u003C\/p\u003E\u003Cp\u003E\u201cA very large fraction of the time, an invention pops out as something else and the timeline for the discovery stage starts all over again,\u201d said Jerry Thursby.\u003C\/p\u003E\u003Cp\u003EOf the 835 inventions studied, 27 percent appeared in a second license. The average time between invention and first license was five and a half years, and the average time between first- and second-license was three and a half years.\u003C\/p\u003E\u003Cp\u003EThis time span for the upstream phase of the translation process is substantial, the study says, given that the average time from discovery to approval of new drugs (including biologics) by the U.S. Food and Drug Administration (FDA) is 13 years.\u003C\/p\u003E\u003Cp\u003EOf the first-licenses that list a stage of development, 92 percent were either at the discovery or lead molecule stages (the earliest two stages, respectively), with only 6 percent listed in clinical trials. Among the second-licenses, only 22 percent were in clinical trials or beyond.\u003C\/p\u003E\u003Cp\u003E\u201cNobody knew the magnitude of how much licensing changes and the stages at which they change,\u201d said Marie Thursby. \u201cThe biotechnology industry is quite fragmented, and there are all sorts of informational problems.\u201d\u003C\/p\u003E\u003Cp\u003EThis analysis of early-stage biomedical translation suggests that stakeholders need to design policies and initiatives that enhance early translation by more efficiently driving more inventions into multiple disease pipelines.\u003C\/p\u003E\u003Cp\u003EOne option might be the formation of an open-source translational research database that complements clinicaltrials.gov, where patents and licenses for fundamental biomedical research believed to be destined for eventual therapeutic use initially would be logged and shared.\u003C\/p\u003E\u003Cp\u003E\u201cWhat might be a failure to a biotech firm could be a success to society as a whole,\u201d Jerry Thursby said.\u003C\/p\u003E\u003Cp\u003E\u003Cem\u003EThis research is supported and based on three separate subcontracts with the Office of Science Policy Analysis, Office of the Director, National Institutes of Health, under award number HHSN26320100002IC. Any conclusions or opinions are those of the authors and do not necessarily represent the official views of the sponsoring agency.\u003C\/em\u003E\u003C\/p\u003E\u003Cp\u003E\u003Cstrong\u003ECITATION\u003C\/strong\u003E: Marie Thursby, et al., \u201cBench-to-Bench Bottlenecks in Translation.\u201d (Science Translational Medicine, August 2014).\u003C\/p\u003E\u003Cp\u003E\u003Cstrong\u003EResearch News\u003Cbr \/\u003E Georgia Institute of Technology\u003Cbr \/\u003E 177 North Avenue\u003Cbr \/\u003E Atlanta, Georgia\u0026nbsp; 30332-0181\u0026nbsp; USA\u003Cbr \/\u003E \u003C\/strong\u003E\u003Ca href=\u0022https:\/\/twitter.com\/GTResearchNews\u0022\u003E\u003Cstrong\u003E@GTResearchNews\u003C\/strong\u003E\u003C\/a\u003E\u003C\/p\u003E\u003Cp\u003E\u003Cstrong\u003EMedia Relations Contacts\u003C\/strong\u003E: Brett Israel (\u003Ca href=\u0022https:\/\/twitter.com\/btiatl\u0022\u003E@btiatl\u003C\/a\u003E) (404-385-1933) (\u003Ca href=\u0022mailto:brett.israel@comm.gatech.edu\u0022\u003Ebrett.israel@comm.gatech.edu\u003C\/a\u003E) or John Toon (404-894-6986) (\u003Ca href=\u0022mailto:jtoon@gatech.edu\u0022\u003Ejtoon@gatech.edu\u003C\/a\u003E)\u003C\/p\u003E\u003Cp\u003E\u003Cstrong\u003EWriter\u003C\/strong\u003E: Brett Israel\u0026nbsp;\u003C\/p\u003E","summary":null,"format":"limited_html"}],"field_subtitle":"","field_summary":"","field_summary_sentence":[{"value":"An analysis of patented university inventions licensed to biotechnology firms has revealed early bottlenecks on the path to commercialization."}],"uid":"27902","created_gmt":"2014-08-20 14:23:31","changed_gmt":"2016-10-08 03:16:56","author":"Brett Israel","boilerplate_text":"","field_publication":"","field_article_url":"","dateline":{"date":"2014-08-20T00:00:00-04:00","iso_date":"2014-08-20T00:00:00-04:00","tz":"America\/New_York"},"extras":[],"hg_media":{"317571":{"id":"317571","type":"image","title":"Early Bottlenecks in Developing Biopharmaceutical Products Delay Commercialization","body":null,"created":"1449244974","gmt_created":"2015-12-04 16:02:54","changed":"1475895027","gmt_changed":"2016-10-08 02:50:27","alt":"Early Bottlenecks in Developing Biopharmaceutical Products Delay Commercialization","file":{"fid":"199977","name":"15c10200-p1-001.jpg","image_path":"\/sites\/default\/files\/images\/15c10200-p1-001_0.jpg","image_full_path":"http:\/\/www.tlwarc.hg.gatech.edu\/\/sites\/default\/files\/images\/15c10200-p1-001_0.jpg","mime":"image\/jpeg","size":2235472,"path_740":"http:\/\/www.tlwarc.hg.gatech.edu\/sites\/default\/files\/styles\/740xx_scale\/public\/images\/15c10200-p1-001_0.jpg?itok=n0Gqk4R9"}}},"media_ids":["317571"],"groups":[{"id":"1188","name":"Research Horizons"}],"categories":[],"keywords":[{"id":"100561","name":"biopharmaceuticals"},{"id":"100571","name":"jerry thursby"},{"id":"13925","name":"Marie Thursby"},{"id":"100581","name":"matthew higgins"},{"id":"2269","name":"translational research"}],"core_research_areas":[{"id":"39441","name":"Bioengineering and Bioscience"}],"news_room_topics":[{"id":"71891","name":"Health and Medicine"}],"event_categories":[],"invited_audience":[],"affiliations":[],"classification":[],"areas_of_expertise":[],"news_and_recent_appearances":[],"phone":[],"contact":[{"value":"\u003Cp\u003EBrett Israel\u003C\/p\u003E\u003Cp\u003E404-385-1933\u003C\/p\u003E\u003Cp\u003E\u003Ca href=\u0022http:\/\/www.twitter.com\/btiatl\u0022\u003E@btiatl\u003C\/a\u003E\u003C\/p\u003E","format":"limited_html"}],"email":["brett.israel@comm.gatech.edu"],"slides":[],"orientation":[],"userdata":""}}}