Some healthcare innovators call it “The Valley of Death.”  It’s the period of time when early government and academic grants begin to run out, but the promising medical research or technology under development is still too unproven to attract traditional venture funding.

Bridging that gap at Stanford is the Wallace H. Coulter Translational Research Grant Program, which supplies the resources needed to accelerate academic innovations into commercially available products.  Stanford is one of ten universities across the country selected as an early partner in the program.

Véronique Peiffer and Justin Huelman received a Coulter grant to develop their prototype solution for palmar hyperhidrosis, or excessively sweaty palms. (Image credit: Stacey Paris McCutcheon)

“The Coulter Translational Grant program looks for practical, applied projects that have high potential to improve patient outcomes or positively affect the delivery of care,” said Gordon Saul, executive director of the Stanford Byers Center for Biodesign, and the Coulter-Stanford program director. “This means that the teams at Stanford and the other university partners must have more than just an interesting idea. They need preliminary proof of concept data, a feasible development path and a plan for how they will use the grant funding to measurably advance the innovation.”

Stanford Biodesign, together with the Department of Bioengineering, administers the Coulter Translational Grant program at Stanford. The grants, which are available to multi-disciplinary research teams led by a bioengineering faculty member and a clinician research collaborator, provide up to $100,000 per project, as well as individualized mentorship and project oversight. Six Stanford teams were selected to receive Coulter Grants in 2018, which will be formally awarded on May 16.

Jennifer Cochran, chair of the Department of Bioengineering said the supported projects cross many different aspects of healthcare, “We see teams working at the intersection of all different engineering disciplines – bioengineering, artificial intelligence, computer science, materials science – as well as all divisions of medicine.”

Sweaty palms

For example, Biodesign Innovation Fellowship alumni Justin Huelman and Véronique Peiffer, together with primary investigators Ross Venook, a lecturer in bioengineering, and dermatologist Marlyanne Pol-Rodriguez, are developing a user-friendly solution for palmar hyperhidrosis, or excessively sweaty palms with a grant they received in 2017. “Roughly six million individuals in the U.S. have palmar hyperhidrosis,” said Peiffer. “Available solutions are largely ineffective, leaving sufferers – especially adolescents and young adults – with a problem that is so awkward and embarrassing that their depression rates are actually tripled.”

The team applied for a translational grant after demonstrating that their approach was effective in a small clinical study, and confirming through a larger market survey that patients were interested in a more effective, wearable treatment. The award funded essential product development and market research. “Our goals were to work with design consultants to transform our glove-style solution from a prototype to a more user-friendly product, and to test the potential for online marketing as a way to reach patients who wouldn’t necessarily see a doctor for their condition,” said Peiffer.

The Coulter Grant program introduced the team to mentor Geoff Gurtner, a plastic and reconstructive surgeon who also runs a medical technology incubator. “Geoff has been invaluable in connecting us to people to assist us in achieving these milestones, as well as in helping us think about the best way to take this forward,” said Peiffer.

Inflammatory bowel disease

Another team is working on a better solution for inflam­­matory bowel disease (IBD) with a grant they received in 2014.

“Currently, the best available treatment for mild-to-moderate IBD is topical therapy, which is most commonly an enema that contains an anti-inflammatory drug,” said team member Ravi Pamnani, also a Biodesign fellowship alum. “However, the treatment protocol is difficult to follow because it requires retaining the liquid for up to eight hours in the rectum. As a result, compliance is low and the disease tends to progress.”

The team also includes primary investigators Sidhartha Sinha, a gastroenterologist; Paul Yock, an interventional cardiologist, professor of bioengineering, and the founder of Stanford Biodesign; and Aida Habtezion, a gastroenterologist.

Working with other Stanford researchers, the team designed a drug delivery formulation that is liquid at room temperature but becomes a viscous gel at body temperature. “The gel is not only easier to retain, but forms a coating on the colon wall, allowing for better drug absorption, and improved efficacy and patient comfort,” said Pamnani. They tested the delivery method in a small group of healthy volunteers before receiving the grant and then used the funding to test the formulation in people with IBD.

Pamnani said that due to the expense of testing in patients, it generally happens later in the innovation cycle. “The Coulter Grant made it possible to take this essential step forward early, which helped build a lot of value as well as confidence that we’re going in the right direction,” he said.  The team also benefited from Coulter mentors and from the professional review and validation of their intellectual property that was part of their grant application.

Direct impact

The Coulter Translational Grant program at Stanford got its start in 2006, under the leadership of Yock, who was the founding co-chair of the Stanford’s Department of Bioengineering. Since then, 79 projects have been funded, leading to the formation of 25 start-ups, of which 11 are in clinical development or commercially available, plus another 5 projects that have been licensed to outside companies.

Reflecting on the success of the Coulter program at Stanford, Cochran calls Yock an “essential contributor.”

“Paul spearheaded the initial Coulter grant and has been instrumental in helping to shape and shepherd it,” she said. “And in doing so, he was an inspiration to me and many others – Coulter essentially taught me how to think like an entrepreneur and elevate our work for translation and impact.”