As a young trainee at a hospital in India, Suhrud Rajguru, Ph.D., was captivated by the biomedical technologies that physicians were using to care for patients: dialysis devices, heart-lung machines and imaging equipment, to name a few.
“I was introduced to the emerging field of biomedical engineering at a young age, and I was fascinated by the idea of merging biology, medicine and engineering to develop tools to improve human health,” said Rajguru.
Inspired by the possibilities, Rajguru pursued an undergraduate degree in biomedical engineering at the University of Mumbai in India and a doctoral degree in bioengineering at the University of Utah, where he began studying balance disorders afflicting the inner ear. In his subsequent postdoctoral work at Northwestern University, he researched technology to improve cochlear implants, which are electronic devices surgically implanted in the inner ear to replace lost function.
In 2011, Rajguru accepted a position as an assistant professor in the University of Miami Departments of Biomedical Engineering and Otolaryngology and continued his work on cochlear implants. Efforts in his laboratory involved addressing a problem with current cochlear implant surgeries: Inserting the device can damage inner ear cells and impair patients’ residual hearing. Preserving residual hearing is critical, as it enables patients to benefit from supplemental hearing aids and other therapies. Rajguru knew that exposing nerve cells to low temperatures — termed “mild therapeutic hypothermia” — after trauma and injury could protect them from damage. Initial studies in his laboratory suggested that using this approach with inner ear cells during cochlear implant surgery might have a similar effect, possibly preventing residual hearing loss. Through a collaboration with Lucent Medical Systems in Seattle, Washington, and researchers at the University of Miami, Rajguru developed a device to deliver hypothermia during surgery. However, he needed additional funding to continue testing this innovative technology.
While attending a research “boot camp” offered through the University of Miami’s Clinical and Translational Science Institute (CTSI), funded through NCATS’ Clinical and Translational Science Awards (CTSA) Program, Rajguru learned about the range of CTSI research resources available to scientists. NCATS’ CTSA Program supports a national network of medical research institutions — called hubs ― through which researchers work together to improve the translational research process to get more treatments to more patients more quickly.
Through its CTSI pilot research awards program, the University of Miami provides funds for new investigators with promising translational research projects to generate preliminary data for further research. Rajguru successfully applied for the CTSI pilot funding and used it to further refine and test his hypothermia device in a rat model of cochlear implantation. Rajguru and his team found that rats receiving therapeutic hypothermia with the device had less implantation-related inner ear damage and significantly better-preserved residual hearing compared to those not given the treatment. While the device showed promise in rats, the path to treating human patients was less clear.
“While developing the technology, I realized how little I knew about the therapeutic development process and the commercial considerations involved in translating science into the clinic,” said Rajguru.
Rajguru soon had an opportunity to learn more. In February 2015, he presented this work at the University of Miami’s CaneSearch Research Symposium, a CTSA Program-supported translational research poster competition. Rajguru’s poster was among the winners, and, as part of his award, he participated in the Translational Medicine Certificate Program at the Eureka Institute for Translational Medicine in Siracusa, Italy. The course is designed to help scientists move research innovations into commercial space.
“It was my first introduction to the facets of translational medicine beyond the pre-clinical stage, such as starting clinical trials, navigating regulatory issues and considering the business aspects of moving innovations into the commercial space,” Rajguru said.
Upon his return to Miami, Rajguru worked to disseminate his knowledge gained at Eureka to other translational scientists. He and his CTSI colleagues successfully applied for a supplemental award from NCATS’ “train-the-trainer” program to develop Innovation Corps (I-Corps) at the university.
The NIH I-Corps program is a collaborative effort with the National Science Foundation, which established I-Corps team training to help accelerate the commercialization of early-stage biomedical technologies. The “train-the-trainer” program’s aim is to foster I-Corps leaders who, in turn, provide entrepreneurship training for other translational scientists. These individuals also will help disseminate the best evidence-based practices in a systematic way to benefit a broad range of researchers and others. As project director of the program, at the time this article was written, Rajguru was attending a spring 2016 training and planned to develop an I-Corps short course program at the university.
In the interim, Rajguru is continuing his work to advance his hypothermia approach to the clinic. He has developed two successful NIH grant proposals for awards from the National Institute on Deafness and Other Communication Disorders (NIDCD). The NIDCD funds are supporting work to develop a hypothermia device for humans and to determine the mechanisms by which hypothermia therapy protects inner ear cells. Rajguru credits senior mentors leading the CTSI’s grant writing workshop and biostatistics core for this success.
“Dr. Rajguru’s work embodies an important goal of the CTSA Program: to equip the next generation of researchers with the skills needed in translational science,” said Petra Kaufmann, M.D., M.Sc., director of the Office of Rare Diseases Research and Division of Clinical Innovation at NCATS. “By developing innovative scientific approaches, demonstrating their utility and disseminating their results and knowledge to the scientific community, he sets a prime example of how our CTSA Program is making a crucial difference.”
Rajguru and his colleagues also have engaged with a potential industry partner to bring the hypothermia device to practice and plan clinical trials. Experts from the CTSI’s Novel Clinical and Translational Methods, Technologies and Resources program helped Rajguru with disclosures, patent filings and contract negotiations with the industry partners.
“The support NCATS provided through the CTSA Program has played a tremendous role in helping advance my research from the laboratory to the clinic, where I hope it can improve cochlear implant surgery and lead to better outcomes and quality of life for patients,” said Rajguru.
Posted April 2016