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Avoiding the ‘Valley of Death’

Dr. Suhrud Rajguru helps faculty entrepreneurs avoid missteps as they bring ideas to commercial life.
Suhrud Rajguru, Ph.D.

Suhrud Rajguru, Ph.D.


o the layman, the term “valley of death” sounds pretty ominous, like someplace Indiana Jones has to daringly escape. But to scientists, researchers, physicians, engineers and other practitioners who delve into the biomedical realm, those words have real-world meaning — and implications. “The valley of death is the obstacles and challenges that everyone interested in developing their biomedical research into new medical diagnostics, therapies and devices will face,” said Suhrud Rajguru, Ph.D., a professor of otolaryngology and biomedical engineering at the University of Miami.

Dr. Rajguru addressed the subject head-on during a discussion in November for the university’s Clinical and Translational Science Institute, where he is co-director of the Workforce Development program. He recently recalled the gist of his discussion: “How do we take something from basic biomedical research and translate it into clinical practice or the commercial market to benefit people and improve human health?” All too often, he said, that opportunity is lost — in the valley of death.

Dr. Rajguru cited statistics estimating that, on average, it costs $2.5 billion and takes 15 to 18 years to bring a new drug to market. For medical devices, the cost can reach hundreds of millions of dollars and take many years. The arduous pathway from concept to approval by the Food and Drug Administration is fraught with challenges regarding funding, research reproducibility, transdisciplinary expertise, clinical trials, regulatory and administrative processes, and business development. “Scientists often don’t understand what they need to do, nor are we taught during our training what the obstacles will be and how to overcome those,” he said.

To help, the university, including the Miller School, has launched a number of initiatives in which Dr. Rajguru is involved. For example, through CTSI, he spearheads a five-week entrepreneurial training course based on the National Science Foundation’s Innovation Corps (I-Corps) program. To tailor it for life sciences, he worked with colleagues at institutions funded by the National Institutes of Health Clinical and Translational Science Awards (NCATS) and helped develop I-Corps@NCATS. With this program, “we’ve already trained 72 teams in Florida and 300-plus across the United States, and a number of them have gone on to create grant-funded startup companies,” he said.

In October, the University Student Accelerator program, known as USTAAR, was inaugurated, bringing together multidisciplinary teams of students and trainees from the Miller School, the College of Engineering, the Miami Herbert Business School, the School of Law and other areas across the university to nurture ideas from inception to implementation. “USTAAR is providing fundamental training, mentorship and financial support for idea development and commercialization,” said Dr. Rajguru, who serves as the program’s director.

Besides his varied academic roles, Dr. Rajguru represents a case study in translational research. Beginning in 2011, when he joined the U, the NeuroTherapeutics Group has studied how different injuries to the inner ear might lead to hearing loss and balance dysfunction. “Collaborating with Dr. Hillary Snapp, chief of the Division of Audiology, we focused on firefighters in South Florida to understand how the hazardous and loud noises in their environment, such as alarms, firetruck engines and sirens, negatively impact their hearing and balance health long term,” he explained.

The team has developed a novel therapeutic approach to benefit not only firefighters and military and first responders, but also construction workers, musicians and others at risk of noise-induced hearing loss. “One of the first things we do after an injury is use ice or cooling to reduce related inflammation,” he said. Based on his findings and those accumulated from the literature, they have tested and designed a cold-therapy device, resembling an audio headset, that is currently FDA-registered as a Class 1 medical device and scheduled for clinical trials this year.

In partnership with Curtis King, an experienced developer of medical devices, “I have created a startup company called RestorEar Devices LLC, funded by the National Institutes of Health small business grants, and designed a line of products,” Dr. Rajguru said. He recalled having to learn how to generate intellectual property and patents, navigate FDA regulations, develop business plans, and understand consumer marketing and other aspects of bringing a product to market. “As a researcher, I had never been trained in any of this,” he said.

Backed by assistance from CTSI, the Office of the Vice Provost for Research and Scholarship, where he is an assistant vice provost, and the university, Dr. Rajguru is now passing along the knowledge gained through his own experience. “Our goal is to increase the probability of success so that we have more improvements in human health,” he said. And, along the way, avoid the valley of death.