Houston is poised to become a center for the development of regenerative medicine. With 54 health care institutions at the Texas Medical Center, more than seven million patients are seen each year. Not only is that a huge population from which to gather research, it is also a diverse and unique population.
But the sheer size of the medical infrastructure in Houston is also one of its biggest challenges. How do 54 clinical programs coordinate the data they glean from seven million patients? Two leaders in the Houston regenerative medicine field came together with two experts in entrepreneurship at an Enlightened Speakers’ Series event to discuss that challenge. They were Doris Taylor, Ph.D., the director of regenerative medicine research at the Texas Heart Institute and the Center for Organ and Cell Biotechnology at Texas A&M CVM; Michael Alvarez, the executive director of the M.D. Anderson Center for Professional Development and Entrepreneurship; Atul Varadhachary, M.D., Ph.D., managing partner of Fannin Innovation Studio; and Stephen Navran, Ph.D., the chief scientific officer of Synthecon.
“Aging and chronic disease is a failure of stem cells,” said Doris Taylor. As we age, we lose cells, and the cells we retain decrease in number. If a two-year-old falls and hurts himself, he won’t have a scar, because cells can repair the body. But if a 62-year-old falls, he probably will have a scar, because he no longer has the cells to repair it.
“If we can replenish those cells in number and function, we can reverse aging, and that’s what we’re about,” Taylor said. That will also lead to the development of new diagnostics and therapies, not only for humans, but for veterinary patients as well. For example, she said, if we collected blood samples from everyone, we could measure the stem cells in the blood and tell how old a person is biologically. They will tell if a person looks to be 35 or 55. Storing the cell information in “biobanks” will enable the collection of massive amounts of data, which could make it possible to learn why stem cells fail. Then, said Taylor, we can actually keep people alive longer.
But the challenge facing regenerative medicine researchers in Houston is getting their ideas to market. “If we can’t get it to product commercialization, we might as well stop,” asserted Taylor.
First of all, coordination between all the different entities is vital. “I’ve only been here for two years, but I know what it’s like to get 54 people into a room and talking together, much less collaborating across 7.2 million patient visits,” Taylor said. She lauded the vision of Dr. Bobby Robbins, the CEO of the Texas Medical Center, for his efforts to put together an Institutional Review Board common to all 54 institutions in the TMC and engage the philanthropy in Houston to support the venture. “People don’t think about the Texas Medical Center with its 7.2 million patient population as an entity that can be leveraged, and we’ve got to change that,” she said.
Besides cell therapies, at Texas Heart, Taylor is building a heart in her lab. By using a cadaveric heart, washing out all of its cells, and reloading it with 100 billion human stem cells, they developed a beating heart.
Such new breakthroughs will need a new approach when it comes to regulations and funding, said Michael Alvarez. “These are new and uncharted waters,” he said. “The science is significantly in front of our ability to understand and develop appropriate policies.” The existing model, he said, is calibrated for drugs and devices and we don’t know how to go about dealing with the types of benefits and risks associated with stem cell treatments.
Money is a challenge from both the funders’ side and the payer side, Alvarez said. Historically, research funding comes from
institutions focused on a particular disease, such as cancer or Alzheimer’s. The structure doesn’t support the development of the tools of all of the capacity of regenerative medicine, he said.
On the payer side, Alvarez said health insurance is based on a “pill a day” style of treatment. Stem cell therapy could cost as much as $250,000, but it would be a permanent fix and the patient would incur no more expenses associated with the disease. “It’s a risk that the insurance companies don’t want to take,” he said. “It’s better to pay for a pill the patient will take for the next 20 years.”
Atul Varadhachary posed a basic question: “Has regenerative medicine really come of age?” he asked. Most big pharma research is focused on cell-based therapies, he said. But the market is indicating that gene therapy is attracting a lot of attention, with four companies landing financing that’s approaching triple-digit millions in that area.
What we’re seeing right now, Varadhachary said, is concentration on the “low hanging fruit” of regenerative medicine. Current products on the market are either in dermatology – wound healing – and musculoskeletal – accessible tissue. But we’re moving beyond the low hanging fruit, he added. Over 50 basic clinical trials are currently underway, and over 300 early stage clinical trials. Regenerative medicine companies have raised over $3 billion dollars. “It’s safe to say we’ll see additional products in the market helping patients.” he said.
Now, research is investigating therapies in more difficult areas, such as spinal cord injury and stroke, Varadhachary said. Regenerative medicine is maturing all across the country. “It’s especially encouraging to see the work being done and innovation at our institutions here in Houston,” he said, “and I suspect we in Houston will be among those helping commercialize those projects.”
But commercializing projects is still problematic for Houston companies, said Stephen Navran. “We haven’t done as good a job here as I think is possible compared to the other hotbeds like Boston or San Diego,” he told the audience.
The reason is that, although Houston has great advantages in the areas of basic science and patient populations, as well as a low cost of doing business, it lacks a well developed biotechnology community. “We are growing, but we’re not growing at the rate that we could,” he said.
One problem, he noted, is getting basic scientists to think of developing their work commercially. In Houston, organizations such as BioHouston, the Gulf Coast
Consortia for Quantitative Biomedical Sciences, and the Houston Technology Center are all resources for developing business. For start-up firms, the funding needs might be as low as $30,000, and several government programs are designed to provide that kind of money.
Varadhachary said the challenge is getting life science executives to take technologies and get them in front of venture capitalists to get funded. “The analogy I often use is that we wouldn’t use a medical researcher to drill an oil well, nor should we ask them to start a company,” he said.
Taylor added that basic scientists are not given the opportunity to learn business. “If we can educate scientists about even just the business vocabulary, we could move forward in a tremendous way,” she said.
Navran said the resources are available. “There are numerous companies, including ours, who have been successful who could provide advice to these investigators if they wanted it,” he said. “We have to provide a forum, an umbrella organization, where these people feel they can get this type of advice.”