Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Early Bottlenecks in Developing Biopharmaceutical Products Delay Commercialization

22.08.2014

An 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.

Biopharmaceutical 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.


Georgia Institute of Technology

From left to right, Jerry Thursby, Matthew Higgins and Marie Thursby. The research team identified bottlenecks in the development of biopharmaceutical products and proposes a way to avoid the setbacks.

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.

“The timeline for commercialization is much longer than most people think. There is so much turmoil and churn within the process,” 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.

The study was sponsored by the National Institutes of Health (NIH) and was published August 20 in the journal Science Translational Medicine.

The 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.

“What these data reveal is that there’s a lot of bench to bench translational research. It’s not linear,” 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.

For 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.

“A very large fraction of the time, an invention pops out as something else and the timeline for the discovery stage starts all over again,” said Jerry Thursby.
Of 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.

This 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.

Of 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.

“Nobody knew the magnitude of how much licensing changes and the stages at which they change,” said Marie Thursby. “The biotechnology industry is quite fragmented, and there are all sorts of informational problems.”

This 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.

One 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.

“What might be a failure to a biotech firm could be a success to society as a whole,” Jerry Thursby said.

This 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.

CITATION: Marie Thursby, et al., “Bench-to-Bench Bottlenecks in Translation.” (Science Translational Medicine, August 2014).

Research News
Georgia Institute of Technology
177 North Avenue
Atlanta, Georgia 30332-0181 USA
@GTResearchNews

Contact Information

Brett Israel
Communications Officer II
brett.israel@comm.gatech.edu
Phone: 404-385-1933

Brett Israel | newswise

More articles from Studies and Analyses:

nachricht R&D - Fit for future
28.04.2015 | Fraunhofer-Institut für Arbeitswirtschaft und Organisation IAO

nachricht Emotion recognition ability pays off
27.04.2015 | WHU - Otto Beisheim School of Management

All articles from Studies and Analyses >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: The random raman laser: A new light source for the microcosmos

Texas A&M University researchers demonstrate how a narrow-band strobe light source for speckle-free imaging has the potential to reveal microscopic forms of life

In modern microscope imaging techniques, lasers are used as light sources because they can deliver fast pulsed and extremely high-intensity radiation to a...

Im Focus: Pulsar with widest orbit ever detected

Discovered by high school research team

A team of highly determined high school students discovered a never-before-seen pulsar by painstakingly analyzing data from the National Science Foundation's...

Im Focus: Erosion, landslides and monsoon across the Himalaya

Scientists from Nepal, Switzerland and Germany was now able to show how erosion processes caused by the monsoon are mirrored in the sediment load of a river crossing the Himalaya.

In these days, it was again tragically demonstrated that the Himalayas are one of the most active geodynamic regions of the world. Landslides belong to the...

Im Focus: Through the galaxy by taxi - The Dream Chaser Space Utility Vehicle

A world-class prime systems integrator and electronic systems provider known for its rapid, innovative, and agile technology solutions, Sierra Nevada Corporation (SNC) is currently developing a new space transportation system called the Dream Chaser.

The ultimate aim is to construct a multi-mission-capable space utility vehicle, while accelerating the overall development process for this critical capability...

Im Focus: High-tech textiles – more than just clothes

Today, textiles are used for more than just clothes or bags – they are high tech materials for high-tech applications. High-tech textiles must fulfill a number of functions and meet many requirements. That is why the Fraunhofer Institute for Silicate Research ISC dedicated some major developing work to this most intriguing research area. The result can now be seen at Techtextil trade show in Frankfurt from 4 to 7 May. On display will be novel textile-integrated sensors, a unique multifunctional coating system for textiles and fibers, and textile processing of glass, carbon, and ceramics fibers to fiber preforms.

Thin materials and new kinds of sensors now make it possible to integrate silicone elastomer sensors in textiles. They are suitable for applications in medical...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

Green Summit 2015: the summit of the essential

05.05.2015 | Event News

HHL Energy Conference on May 11/12, 2015: Students Discuss about Decentralized Energy

23.04.2015 | Event News

“Developing our cities, preserving our planet”: Nobel Laureates gather for the first time in Asia

23.04.2015 | Event News

 
Latest News

From brittle to plastic in 1 breath

05.05.2015 | Materials Sciences

Ocean currents disturb methane-eating bacteria

05.05.2015 | Earth Sciences

Slowdown after Ice Age sounds a warning for Great Barrier Reef's future

05.05.2015 | Earth Sciences

VideoLinks
B2B-VideoLinks
More VideoLinks >>>