New Master's Translates More than Medicine
Master's student Ramya Chitters learned about all steps necessary to bring a device for heart patients from concept to commercial product.
Cardiovascular disease affected 65 million people in the U.S. in 2010. Annually more than 33 percent of American deaths are attributed to it, 17 percent of which are caused by acute myocardial infarction (AMI or heart attack). Ramya Chitters' grandfather was one of them. She was in high school, and the experience left her wishing she could have done something to help. Now, through the Master's in Translational Medicine program, she is.
The Master's is a one-year joint graduate program between the UCSF Department of Bioengineering and Therapeutic Sciences and the UC Berkeley Department of Bioengineering. While the program currently grants a Master's of Science in Bioengineering with a focus on translational medicine, plans are underway to transform the degree into a Master's of Translational Medicine within the next two years.
As part of the program, Chitters and her partner Derek Dashti, with the guidance of their faculty mentors Kevin Healy, PhD, at UC Berkeley and Yerem Yeghiazarians, MD, at UCSF created a hypothetical company called StemVasc. It is geared toward developing a biotherapeutic synthetic device for heart attack patients.
They are targeting high-risk patients whose hearts' left ventricles are severely damaged from the AMI. During the infarction, many cells in the left ventricle die, so the heart no longer pumps blood as efficiently. Current therapeutic options for these patients include a left ventricular assist device, which is only able to sustain them while they wait for heart transplants. However, with only 1,800 heart transplants performed per year, the remaining option is a stem cell transplant. Currently in clinical trials, stem cells are just 10 percent effective in attaching to the left ventricle.
StemVasc also takes a stem cell approach, but promises to attach these cells more effectively. The company aims to use a breakthrough technology to extract cardiac stem cells from a patient's left ventricle, isolate the cardiac progenitor cells, integrate them with a synthetic matrix – which helps the cells properly attach when re-inserted – and inject the complex back into the infracted heart tissue. The complex thereby repairs the left ventricle's damaged cells and restores its blood pumping efficiency.
Despite what it may seem, the new Master's is "not a program to create start-up companies," explains Tejal Desai, PhD, UCSF director of the program. For Chitters and Dashti, and for their 14 fellow students, their scientific solutions are the axles around which they became masters of the translational medicine wheel. The spokes are the classes students take in bioengineering, clinical research and development – including cost effectiveness and regulatory aspects – and business and entrepreneurship, all of which are necessary in bringing a drug or device from concept to commercial product.
The Master's program was conceived by Andy Grove, PhD, co-founder and former CEO of Intel. An expert in the business of information technology and suited to the jack-rabbit rate at which those companies iterate and respond to the market, Grove was frustrated that drug development moves at a snail's pace in comparison. That's according to his good friend Marc Shuman, MD, UCSF professor and program advisor.
As a result, Grove donated $1.5 million to UCSF and UC Berkeley to launch the Master's program, one of the first of its kind in the nation.
"It wasn't just Andy," says Desai. "It's a feeling that's present at UCSF and other campuses doing medical research. There's this gap between hypothesis driven basic science and the real clinical problems that need to be solved. They're not always compatible."
And it's not just a feeling at universities; the National Institutes of Health (NIH) and the U.S. Congress have noticed, too, according to Shuman. Despite the nearly $30 billion annual investment in federal research funding, there has been increasing concern that those investments have not resulted in the expected cures for life-threatening diseases. While inflation-adjusted spending doubled from 1995 to 2005, new drug approvals were flat, according to S. Claiborne "Clay" Johnston, MD, PhD, associate vice chancellor of research at UCSF and the director of the UCSF Clinical and Translational Science Institute, which helped launch the Master's program and assists in its oversight.
"What we have learned from decades of rapid development of information technology is that the key is relentless focus on ‘better, faster, cheaper' – in everything," Grove said in 2009. That was the year he laid out his vision for the Master's program at a conference on technology's role in lowering the cost of health care. He continued, "The best results are achieved through the cooperative efforts of different disciplines, all aimed at the same objective."
The new joint Master's program is designed to help physicians gain the skills to be entrepreneurs, teach engineers to understand clinical problems, and business majors to consider the scientific method. "The place they work together best is industry, not academia," says Shuman. "This concept is new to academia. The program is not designed to make students a scientist or doctor or MBA; it's to train them to understand the importance of all those components and how to integrate them."
"We want our students to really understand all the different hurdles one might expect as they move technologies forward," concurs Desai.
In Chitters, at least, they succeeded. As the first class graduates and the second class begins, Chitters says, "The program really puts every-thing into perspective. We've been trained to think about business, about the regulatory process, about all of the different aspects we need to go through. But really, we're helping get these new innovations to patients, to make a difference in their lives."
Published for UCSF Insider, April 2012