More than a decade ago, the NIH Roadmap and the FDA Critical Path Report brought significant public attention and new programmatic efforts to advance sponsored and translational research. These programs act as bridges between the promise of bioscience discoveries and the advancement of new biomedical innovations to improve the lives of patients.
Of particular importance for accelerating translational research and overcoming the challenging environment for bioscience innovation is advancing collaborations between industry and academia, as a means to both improving R&D productivity and reducing the costs of translating discoveries into new medical products.
That call for greater industry-academia partnerships reflects the unique nature of bioscience innovation when compared to other industrial sectors. For instance, not only is there a greater commitment by the bioscience industry to conduct internal R&D, there is also existing close ties between industry, clinical care, and academic communities due to the necessary interface of “bench and bedside” required for biomedical innovation to move forward.
Two recent BIO reports affirms the stakeholder dynamics including a review of the economic impact of licensing of academic research to industry and a report on ways in the states that the biotech industry and academic research communities are crossing new frontiers of innovation.
A study released in June 2017 by BIO provided data on the importance of university/industry research and development partnerships to the U.S. economy. The study of university technology licensing from 1996 to 2007 shows a $187 billion dollar positive impact on the U.S. Gross National Product (GNP) and a $457 billion addition to gross industrial output, using very conservative models.
Before the passage of the Bayh-Dole Act in1980, inventions arising from the billions of taxpayer dollars invested annually in university research remained largely on laboratory shelves and were rarely commercialized because of restrictive patenting and licensing practices. This situation changed with passage of the Bayh-Dole Act, which allows university inventors to patent their discoveries and license them to commercial partners with maximum flexibility and limited federal bureaucracy. As a result, the biotech revolution was born, turning inventions into products that are improving public health, cleaning our environment, and feeding the world.
Other key findings of the study include:
- University-licensed products commercialized by industry created at least 279,000 new jobs across the U.S. during the 12-year period;
- The annual change in U.S. GDP due to university-licensed products grew each year, illustrating that the impact of university patent licensing grows even more important each year.
- The study was funded by BIO and the Association of University Technology Managers (AUTM) and headed by Dr. David Roessner, Professor of Public Policy Emeritus at the Georgia Institute of Technology.
Sponsored Research Engagement: Academic and Industry Principles
A second BIO national report entitled Biotechnology-Research Engagement Opportunities: Eight Guiding Principles affirms that when biotechnology companies and universities work in tandem to push the frontiers of biotechnology based knowledge, they become a powerful engine for innovation and economic growth.
According to authors Peter M. Pellerito and Austin M. Donohue, academic and industry partnerships that work well have created strategic view of the value of R&D and commercialization merge the discovery-driven culture of the university with the innovation-driven environment of the biotechnology company.
But to make the chemistry work, each side must overcome the cultural and communication divide that can impair biotech industry-university partnerships and undercut their potential.
Guiding Principle # 1: Successful university-industry collaborations reflect an understanding of the mission and culture of each partner:
Successful sponsored research transactions require all parties – industry and academia – to identify the core mission of their organizations early in the process and defining the scope and focus of the proposed alliance.
Guiding Principle #2: Alliance management resources are essential:
Industry and university participants engaging in strong alliance management strategies devote resources, energy and attention to maintaining relationships and working together in an ongoing effort to facilitate productive, transparent outcomes to ensure sponsored research success.
Guiding Principle #3: Universities and industry participants should understand the objectives and benefits to each party that will result from collaborations:
Goals, objectives, and timelines for completion are essential for productive end results in partnerships; each party must understand and support the objectives and proposed research benefits of the other party.
Guiding Principle #4: Commitments in sponsored research agreements should ensure legal integrity and consistency:
Commitments contained in sponsored research agreements concerning future research results shall be consistent with all applicable laws and regulations and with any contractual obligations the University or biotechnology company may owe to others.
Guiding Principle #5: Parties should have a clear focus on each other’s licensing strategies:
Both industry and academia must commit to engaging in open and honest discussions to develop creative and effective licensing strategies that promote global access to innovation. The mutual goal should be an authentic partnership where each party understands the collaboration goals and objective of the other party and is committed to each party achieving success.
Guiding Principle #6: Parties should focus on streamlining negotiation protocols:
Universities and biotechnology industry should focus on the benefits to each party that will result from collaborations by streamlining negotiations to ensure timely conduct of the research and the development of the research findings.
Guiding Principle #7: Negotiator training is essential:
In order to effectively navigate towards an overall success rate for the institution, all sponsored research officers, contract negotiators and licensing officers, and especially those early in their careers, must understand how each research collaboration with which they are engaged reflects forces in the larger world of biotechnology development.
Guiding Principle #8: Partnerships should work to lower the cost of transactional efforts:
Systematically reducing transactional costs should be a major combined effort of both the university and biotechnology industry sector. This includes broader efforts to engage interpersonally through these partnerships in order to lower communication barriers among participants.
From these two reports it is clear that as academic research institutions move in new and innovative multi-partner efforts, there is a new energy and focus in working to bring novel research into the public space and utilize the biotechnology industry continues to be a growing partner.