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Report Evaluates Industry-Academic Biotech Partner Roles

Genetic testing illustration

(National Institute of General Medical Sciences, NIH)

16 June 2015. A report released today by Biotechnology Industry Organization, or Bio, indicates academic research labs are playing an increasingly key role in research and development of new therapies, but it also highlights areas where partnerships between academia and industry are still evolving. Bio released the report, Advancing Translational Research for Biomedical Innovation: Measuring Industry-University Connections, conducted by the Battelle research institute, at Bio’s annual meeting in Philadelphia.

The Battelle study is an attempt to identify and measure contributions of academic labs working with biotechnology enterprises, about a decade after Food and Drug Administration and National Institutes of Health began initiatives underscoring the challenges of translating academic research into practical medical advances. The findings were presented as part of a forum exploring ways to overcome stagnating government support for basic biomedical research and financing for early-stage enterprises.

The report identifies four stages in the development of new biotech therapies where academic researchers are making an impact:

– Basic and applied research, where scientific questions are answered, but outcomes are often uncertain

– Technology development, in which biotech proof-of-concept questions are resolved and intellectual property takes shape

– Clinical trials that test safety and efficacy of new therapies

– New product launch, where regulatory approvals are secured

The findings show more biotech and drug companies are engaging academic labs, particularly in the early basic and applied research stage. In 2013, says the report, biomedical research accounted for $1.73 billion or nearly half (49%) of all industry-support research on university campuses. In addition, over the past 10 years, the number of biomedical journal publications with both industry and academic (including hospital and research institute) authors rose by 23 percent.

In the technology development stage, says the report, academic labs are also making more of a contribution today than earlier. In the 5-year period of 2010 to 2014, some 50,000 industry patents cited academic research articles, an 81 percent jump over the 2000 to 2004 period, when about 27,500 industry patents cited academic research. By comparison, biomedical industry patents overall rose 60 percent during this period.

Biotech and drug companies often use academic medical centers as sites for clinical trials, but the report indicates academic partnerships are beginning to go beyond hosting and recruitment. The study’s findings show about 1 in 8 clinical trials (12%) include academic institutions as co-sponsors or collaborators, particularly for drug interventions. Companies engage academic labs in clinical trials generally in early-stage or post-marketing studies — such as for identifying adverse effects — but not in critical late-stage trials testing drugs in large samples against a placebo or alternative treatment.

In the product launch phase, Battelle finds more academic participation in industry patents citing academic research, but this time focusing on novel chemical entity drugs and biologics associated with intellectual property. In the 5-year period of 2010 to 2014, more than 9 in 10 of those industry patents (93%) cited academic research, compared to 64 percent of new drug or biologic patents in the 2000 to 2004 period a decade earlier.

The report lists areas where partnerships between academic labs and industry are likely to evolve, with the findings organized in the same four stages of biotech research and development:

– Companies and academic labs can expect to see more use of open innovation models, such as challenges, in basic and applied research as well as multi-institutional and multi-company collaborations.

– In the technology development stage, academic and industry collaborators can expect to use more systematic and replicable models for engagement, capturing scientific and business expertise for later applications, rather than one-off projects.

– In complex and expensive clinical trials, says the report, expect to see more use of regional clinical trial organizations, contract research companies, and centralized patient registries.

– Under product launches, academic and industry collaborators can expect to engage in new types applied research partnerships, including experimental therapy centers and advanced biomanufacturing facilities.

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