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 New study: How stable is the West Antarctic Ice Sheet?
09.02.2016 | Alfred-Wegener-Institut, Helmholtz-Zentrum für Polar- und Meeresforschung

nachricht Online shopping might not be as green as we thought
08.02.2016 | University of Delaware

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: Production of an AIDS vaccine in algae

Today, plants and microorganisms are heavily used for the production of medicinal products. The production of biopharmaceuticals in plants, also referred to as “Molecular Pharming”, represents a continuously growing field of plant biotechnology. Preferred host organisms include yeast and crop plants, such as maize and potato – plants with high demands. With the help of a special algal strain, the research team of Prof. Ralph Bock at the Max Planck Institute of Molecular Plant Physiology in Potsdam strives to develop a more efficient and resource-saving system for the production of medicines and vaccines. They tested its practicality by synthesizing a component of a potential AIDS vaccine.

The use of plants and microorganisms to produce pharmaceuticals is nothing new. In 1982, bacteria were genetically modified to produce human insulin, a drug...

Im Focus: The most accurate optical single-ion clock worldwide

Atomic clock experts from the Physikalisch-Technische Bundesanstalt (PTB) are the first research group in the world to have built an optical single-ion clock which attains an accuracy which had only been predicted theoretically so far. Their optical ytterbium clock achieved a relative systematic measurement uncertainty of 3 E-18. The results have been published in the current issue of the scientific journal "Physical Review Letters".

Atomic clock experts from the Physikalisch-Technische Bundesanstalt (PTB) are the first research group in the world to have built an optical single-ion clock...

Im Focus: Goodbye ground control: autonomous nanosatellites

The University of Würzburg has two new space projects in the pipeline which are concerned with the observation of planets and autonomous fault correction aboard satellites. The German Federal Ministry of Economic Affairs and Energy funds the projects with around 1.6 million euros.

Detecting tornadoes that sweep across Mars. Discovering meteors that fall to Earth. Investigating strange lightning that flashes from Earth's atmosphere into...

Im Focus: Flow phenomena on solid surfaces: Physicists highlight key role played by boundary layer velocity

Physicists from Saarland University and the ESPCI in Paris have shown how liquids on solid surfaces can be made to slide over the surface a bit like a bobsleigh on ice. The key is to apply a coating at the boundary between the liquid and the surface that induces the liquid to slip. This results in an increase in the average flow velocity of the liquid and its throughput. This was demonstrated by studying the behaviour of droplets on surfaces with different coatings as they evolved into the equilibrium state. The results could prove useful in optimizing industrial processes, such as the extrusion of plastics.

The study has been published in the respected academic journal PNAS (Proceedings of the National Academy of Sciences of the United States of America).

Im Focus: New study: How stable is the West Antarctic Ice Sheet?

Exceeding critical temperature limits in the Southern Ocean may cause the collapse of ice sheets and a sharp rise in sea levels

A future warming of the Southern Ocean caused by rising greenhouse gas concentrations in the atmosphere may severely disrupt the stability of the West...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

Symposium on Climate Change Adaptation in Africa 2016

12.02.2016 | Event News

Travel grants available: Meet the world’s most proficient mathematicians and computer scientists

09.02.2016 | Event News

AKL’16: Experience Laser Technology Live in Europe´s Largest Laser Application Center!

02.02.2016 | Event News

 
Latest News

LIGO confirms RIT's breakthrough prediction of gravitational waves

12.02.2016 | Physics and Astronomy

Gene switch may repair DNA and prevent cancer

12.02.2016 | Life Sciences

Using 'Pacemakers' in spinal cord injuries

12.02.2016 | Medical Engineering

VideoLinks
B2B-VideoLinks
More VideoLinks >>>