The Journey From Discovery to Commercialization
A majority of biomedical discoveries fail to materialize into products and tools that can benefit the society. Lack of development resources and lack of familiarity with the process of product development and commercialization mean that many such discoveries languish. However, a number of academic medical centers and institutions, working closely with the National Institutes of Health and National Science Foundation, are seeking to overcome these obstacles by developing new resources for the systematic review, prioritization and development of projects with commercial potential, as well as educational tools for researchers, students and staff .
Suhrud M. Rajguru, an associate professor in the University of Miami College of Engineering’s Department of Biomedical Engineering and Miller School of Medicine’s Department of Otolaryngology, is collaborating with National Center for Advancing Translational Sciences (NCATS) and eight other institutions in spearheading such an effort. Through a $350,000 grant from NCATS, he is leading development of a training program – tailored specifically to biomedical scientists in academic medical centers – to identify new innovations and to accelerate translation into commercial products. The program is based on the idea that, “to ensure that discoveries translate to real health benefits, scientists need a better way to understand the needs of the people – the expected beneficiaries of our research and delivering this value,” Rajguru explains.
Nurturing Translational Medicine
This area of work is known as translational medicine, part of a multidisciplinary and evolving field. It is seen as central to the goal of converting basic science discoveries to diagnostic and therapeutic tools that can be harnessed to treat disease and improve human health. It encompasses all aspects of medical research, intellectual property, financing, regulation, preclinical and clinical trial studies, and commercialization among other disciplines.
In an effort to help create and spread a national network that can inspire and sustain translational medicine, Rajguru is working with Norma Kenyon, the University’s vice provost for innovation and the Miller School’s chief innovation officer, and Alessia Fornoni, director of the Miller School’s Peggy and Harold Katz Family Drug Discovery Center. They are collaborating closely with the University’s Clinical and Translational Science Institute, as well with Molly Wasko, professor and associate dean for research, innovation and faculty success at the University of Alabama at Birmingham Collat School of Business, NCATS and 7 other medical centers and institutions around the country.
Together, they are developing a Clinical and Translational Science Awards Program (CTSA) Innovation Corps (I-CorpsTM) program specifically for life sciences. I-Corps, founded by the National Science Foundation (NSF), offers a series of programs that prepare scientists and engineers to extend their focus beyond the university laboratory. Its programs develop and nurture a national “innovation ecosystem” that builds on research to develop technologies, products and services that benefit society. I-Corps Sites support local innovation by nurturing and supporting multiple local teams as they transition their research into the marketplace.
The I-Corps@NCATS program that Rajguru and his colleagues are developing will provide research infrastructure, informatics, advice, resources, networking opportunities, entrepreneurship training and modest pilot funding for biomedical research that can be commercialized. The ultimate goal: to speed the translation of research discoveries into improved patient care.
As a researcher engaged in commercialization of several discoveries, Rajguru understands the importance of developing new biomedical- and life sciences-focused I-Corps program. They will develop a standardized, streamlined, short course for instructors and researchers as part of this effort termed I-Corps@NCATS. The curriculum will include providing scientists and medical researchers with real-world, hands-on entrepreneurship training to help overcome key obstacles along the path of innovation and commercialization. It will enable teams to systematically identify and address knowledge gaps in order to understand the most appropriate path forward for commercializing their discoveries.
The team will also recruit and train instructors for this new course, working with multiple CTSA sites, U Innovation and I-Corps’ existing national teaching team. They will host a regional instructor-training program at Miami, and will engage entrepreneurs and advisors in the program.
Finally, the team will collaborate in the development of common metrics to evaluate the effectiveness and impact of the CTSA I-Corps Program across the country. They will share the curriculum, evaluation metrics and other expertise with all of the CTSA institutions in the U.S.
Rajguru has completed was supported by the CTSI and NCATS to be one the I-Corps@NCATS Train-the-Trainer course, completed the Eureka Translational Medicine Certificate Program and successfully led nine University of Miami teams through a regional I-Corps Short Course in May-June 2017. He will serve as the instructor and program director for this new I-Corps@NCATS life sciences program, and will help review and select projects and lead the instructional process.
“We believe that the CTSA program should include in its portfolio of activities, hands-on entrepreneurship training to help scientists overcome key obstacles along the path of innovation and commercialization,” Rajguru says. “It is equally important to make investments to ensure that we are doing the right science. Are our investigators tackling research problems that our stakeholders, patients and communities want and need?”
Ultimately, Rajguru and his team aim to expedite the impact of biomedical discovery on human health and health care delivery.