Tech Transfer eNews Blog

Life sciences IP suffers from pinball effect in licensing as new indications emerge

By David Schwartz
Published: November 19th, 2014

In a perfect world of life sciences licensing TTOs may dream of, a discovery made at a university is patented and licensed to a biotech company, which continues developing it until it has established proof-of-concept in humans.Then a larger firm with the capabilities to conduct expensive late-stage clinical trials swoops in and carries the molecule the rest of the way to FDA approval and market launch. Unfortunately this linear model, though ideal, rarely plays out in the development of new drugs. Instead, the path to market is bumpy and laden with inefficiencies – from funding gaps to lag time as license agreements are sought and made between universities and companies.

A trio of business professors from Georgia Institute of Technology recently documented what they say are significant inefficiencies in the drug commercialization process and have offered their prescription for reducing the time and cost required for a new drug to reach FDA approval – which they calculate to be 13 years on average with a price of several billion dollars.

What’s needed, they say, are more initiatives that encourage the sharing of basic research during the earliest stages of development. Matthew Higgins, Jerry Thursby and Marie Thursby in Georgia Tech’s Scheller College of Business authored the paper “Bench-to-Bench Bottlenecks in Translation,” recently published in Science Translational Medicine. Their analysis looks specifically at one challenge that appears to be one of the biggest areas of disconnect in life sciences commercialization: Inefficiences that occur as inventions are passed from university to company to company for development in indications beyond those in the original patent or license.

They examined the twisting commercialization paths of some 835 patents involved in 342 license deals among universities and biotech firms to see how many compounds were eventually sublicensed to a second firm for development in a new disease category. Because companies rarely share their research, a sublicense essentially resets the development timeline – a process the authors refer to as bench-to-bench translational research.

They found that 27% of the inventions appeared in a second license agreement after an initial deal between a university and a biotech firm. This could indicate that a molecule progressed in development beyond a firm’s capabilities, or was found to have potential in an area beyond the interests of the initial licensor.

But most telling of the bottlenecks in early-stage development is their finding that, of the 92% of molecules that were at the discovery/lead molecule stage when they were first licensed, 70% of those eventually sublicensed were still in the discovery stage at the time of second licensing. And the average time between first and second licensing was 3.5 years — nearly a quarter of the  average time it takes a drug to go from discovery to approval.

Four in five molecules involved in a second license saw some change in disease indication with the second license. This mean that new uses for drug candidates are often discovered during the mid-stages of development. “During the earliest stages of study and experimentation, it’s highly unlikely that an academic lab can identify all relevant disease categories an invention may serve,” the authors write. And, because institutions typically guard specific information about their early-stage programs carefully, it typically takes years for a second licensee to emerge. A detailed article on the study’s findings and recommendations appears in the October issue of Technology Transfer Tactics. To subscribe and access the full article, as well as the publication’s rich eight-year archive of proven success strategies and best practices for TTOs, CLICK HERE.

Posted under: Tech Transfer e-News

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