By Dan Fost
Some of the best inventions come not from Thomas Edison-like inventors, tinkering in their labs, but from actual workers practicing their crafts and dreaming of a solution that could help solve a problem they're having.
That concept was on full display at UCSF Catalyst Program's most recent report-out in January, where surgeons, radiologists, oncologists and others presented their innovative solutions to problems they've encountered in their practices.
"We want to solve a palpable problem," said Hobart Harris, MD, MPH, chief of the Division of General Surgery, who presented his idea for a silver foam that could be used during the closing of a surgical incision to prevent hernias. "When our product is available, I'll be a user."
Harris referred to people like him as "user-innovators," and said UCSF's support for their efforts continues to grow.
"There's never been a more rich, nurturing environment for bio-entrepreneurship at our institution than at this very moment," Harris said.
Harris's idea, along with other medical devices, diagnostic tools, and digital health innovations were among the Catalyst award finalists seeking further support on their move to the marketplace. The Report Out covered Catalyst's Fall 2017 cycle, in which industry-based advisors worked with UCSF scientists to take projects to the next level. "We're mixing academia with industry know-how and resources," said Cathy Tralau-Stewart, PhD, Catalyst's interim director. "That's the secret sauce. That's how we move projects forward."
Catalyst relies on an impressive rolodex of advisors who can give UCSF's scientists and clinicians valuable tips on how to bring a product to patients—everything from filing intellectual property protections and formulating a business plan to identifying a market and meeting regulatory requirements.
January's event marked a coming out party of sorts for Catalyst's next phase. UCSF established Catalyst in 2010 to help accelerate translational medicine, and the program has in turn inspired UCSF to expand its efforts. In 2017, UCSF hired biotech industry veteran Harold E. "Barry" Selick, PhD, as its first vice chancellor for business development, innovation and partnerships. Selick has established the new UCSF Innovation Ventures group, and brought Catalyst under its umbrella.
The Innovation Ventures group also includes the Office of Technology Management, the Entrepreneurship Center, and Office of Strategic Alliances, among others. "All of those groups in some ways were overlapping, and now they're working together and are more focused," said Tralau-Stewart.
Tralau-Stewart also praised Selick's concept of raising money through philanthropy to act as an in-house venture fund, giving seed money to enable the development of promising innovations. "We would love to have philanthropy directly supporting the work of UCSF scientists in developing patient solutions," Tralau-Stewart said.
"There is just a tremendous amount of innovation, technology and entrepreneurship among the faculty scientists at UCSF, but so little of it makes it out as a commercial product," said Michael Lesh, MD, a consultant to Innovation Ventures, himself a physician, inventor and serial medical technology entrepreneur. "Yet part of the mission of the University of California is to make great science for the benefit of the population. That's what the taxpayers are funding."
"The Catalyst program embodies that role, taking great ideas and technology and moving them through the process so that they can become viable products," Lesh said.
One of those ideas now advancing is Harris's proposal to solve the problem of incisional hernias, which affect thousands of people, causing tremendous distress and requiring a subsequent surgery to repair. Efforts to solve the problem have included special suturing techniques as well as using a preventive mesh. Harris was inspired by old silver wire prosthetics, which had been used for the first half of the 20th century.
"We're trying to use silver microparticles to enhance the wound healing," he said. It would be easy for a surgeon to use, and requiring no change to customary practices, he said.
In a question and answer session that followed Harris's presentation, people said the biggest hurdle would be obtaining the necessary regulatory approval. They also suggested considering alternative formulations. Those sorts of questions are essential elements in what makes Catalyst work: the advice from industry mentors. Lesh, who had served as a Catalyst advisor in the past, said that while most scientists, or principal investigators, "spend their whole life writing grant proposals. Initially, they view Catalyst as one more place to get a grant. But once they see the type of advice they get, that mindshare is far more valuable than the nominal amount of money they get to support their research."
Catalyst recognized some of its most valuable advisors in January, including Linda McAllister, MD, PhD, vice president of scientific affairs for Becton Dickinson; Rick Pesano, MD, PhD, vice president and chief medical officer, global markets and precision medicine at Quest Diagnostics; and Sue Wollowitz, PhD, a pharmaceutical development consultant and educator who was previously vice president chemistry and manufacturing at Medivation.
"Many universities say this is what they want to do, to bring tests (they developed in academic labs) to the diagnostic market, but they don't know how to do it," Pesano said. "The Catalyst program is structured in such a way that it helps move the needle."
Scientists and clinicians may be brilliant, he said, but not know the intricacies of product development—integrating their invention in an existing platform, succeeding in a high-throughput environment, getting the idea past regulators, and studying competitors who have tried similar approaches. "If it's really novel, they may not get reimbursed," Pesano said. "You don't always think about that if you're doing bench research. There are so many pieces to this."
McAllister said she loves working with the "incredible talent" at UCSF.
"Early on in my clinical training, I realized we know a lot about science and physiology, but in medicine, we don't get to use it all," she said. "I decided to focus my career on that translation. We could do a lot better."
"This program is a direct vehicle for doing that," she added. "Catalyst is truly bringing new knowledge to bear on health care for the residents of this state and for all patients."
The advisors get something out of their efforts as well. "I like to see these new projects and new ideas," Wollowitz said. "Physicians see issues from the ground up that entrepreneurs may not see. Physicians see needs and look for practical solutions."
The advisors' contributions don't go unnoticed. "It's great to have advisors who give their time to help us think through these issues that can prevent our ideas from becoming real products," said Shuvo Roy, PhD, a professor of bioengineering, among whose many hats includes faculty director of the Master in Translational Medicine program. "The advisors challenge us to think outside the box and get our ideas to patients."
Roy and Harini Sarathy, MD, presented their proposal aimed at the cumbersome, expensive process of dialysis for patients with end stage renal disease (ESRD). They proposed a single implanted device that could deliver continuous therapy, sparing patients long, uncomfortable and risky trips to the dialysis clinic—or long waits for kidney transplants.
Their bio-artificial kidney would "combine the best of technology with the best of cell therapy," Roy said, using a silicon substrate for a membrane that could help remove toxins from the bloodstream, just as the kidneys do in a healthy person. The device would allow for more mobility and better outcomes, without the risks of immunosuppression that come with a transplant.
The big question, Sarathy said, was whether it's safe when the silicon membrane comes in contact with the patient's blood. Indications are that it is, and they are seeking to run a clinical trial to confirm this.
Other projects took similarly bold and innovative approaches to health issues. Stefan Habelitz, PhD, said that root canals removing too much tissue when trying to treat dental caries, and artificial restorations fail over time. A postdoc in Habelitz's lab stumbled upon a lucky find by creating a mixture using a commercially available product to create a cement that protects the tooth and restores its calcium and phosphate.
Otolaryngologist David Conrad, MD, and Romain Roux, MS, were concerned with long-term tracheostomies, which can dislodge or become clogged, threatening patients' lives. They developed a sensor device that plugs into the tracheostomy tube and serves as an alarm and monitoring system. The device can be connected to a smartphone so family members can get alerts. The device results in a faster detection of the problem, allowing a quicker response to correct it.
Aside from the surgeons who stole the show with their devices, two other doctors presented proposals. Elliot Stieglitz, MD, described the development of an epigenetics-based diagnostic tool to help predict the outcome in juvenile myelomonocytic leukemia, or JMML, a rare disease. JMML, like some other cancers, will occasionally spontaneously resolve without treatment, but doctors have a hard time knowing which patients would have that happy outcome, so they typically treat, with risky and expensive stem cell transplants.
If they could use Stieglitz's prediction tool, patients could forgo the transplants and instead see if the problem resolves itself. If it works, doctors might potentially use similar strategies in treating other cancers where epigenetic biomarkers could predicttreatment outcomes.
Jesse Courtier, MD, a pediatric radiologist, and Lan Vu, MD, a pediatric surgeon, closed the day with the most visually entertaining proposal—using augmented reality to give a surgeon a life-sized, three-dimensional view of what's going on in a patient's body before cutting that patient open. Instead of a two-dimensional picture, the new technology creates a three-dimensional hologram that could be manipulated on a screen to see all sides.
"Ultimately what we want to do is get this in the hands of end users," Courtier said. That was music to everyone's ears; they all have the same goal.
In addition to helping UCSF's faculty, Catalyst also helps teach the next generation of scientists and physicians the importance of thinking translationally, through its internship program. The interns work with advisors and PIs to help analyze aspects of a proposal, including prototypes, competitors and market size.
Kuan-Lin Chen, MD is studying in the Master in Translational Medicine program, a joint effort between UCSF and UC Berkeley. "I feel this is the perfect opportunity to be exposed to the actual development of something from a lab to commercialization," he said.
"A good doctor can save one patient at a time," Chen said. "A good product can save millions. I have believed in that for a long time."
Jimmy Ly, PhD, has already worked at a biotech startup and now is a postdoc in Shuvo Roy's lab. He's diving into questions of "what drives the market, what gets funded, what's successful, what's not successful. There are a lot of good ideas out there but they don't all get funding. You need to convince people."
Tsai-Chu Yeh, MD, is also in the MTM program. After working in the clinic, she has enjoyed learning the advisors' perspective "so that we can help the doctors and the PIs make their dream a reality."