Dr. Pedro Huertas, a physician-turned biotechnology manager, is at the forefront of one of the most talked-about and controversial frontiers of medicine.
Earlier this year, he was appointed chief development officer for Alameda, California-based Advanced Cell Technology (ACT), a leader in the field of embryonic stem cell therapy.
Embryonic stem cell technology holds the promise of helping millions of people suffering from debilitating conditions such as Alzheimer's, Parkinson's, and heart disease. And Dr. Huertas, a 52-year-old Chilean native, will oversee ACT's research and the process of moving the technology from the laboratory bench, and its studies on chimeric mice, to the bedside.
"Our intent is to develop therapies and cures for some of the worst diseases that affect humans," he says.
Although federal restrictions have limited funding for research in the field, biotechnology companies, backed by private money and in California, state funds are racing to move the technology from laboratories into clinics.
ACT focuses on finding ways to use embryonic stem cells to help people affected by the eye disease macular degeneration, and to heal burns and other injuries.
ACT is recognized for having one of he best pedigrees in what is admittedly a new field.
"Advanced Cell Technology is a pioneer and continues to push the frontiers of cellular therapy both in terms of embryonic stem cell development and basic science, as well as looking into different clinical applications," says Dr. Garrett Vygantas, a senior associate with the Venture Group at San Francisco's Burrill & Company.
While his company has no investment relationship with ACT, it has advised the firm and ACT officials spoke at Burrill's premiere conference on the subject, The Stem Cell Meeting, in March.
"They're well known enough that they're not going to go away anytime soon," he says of the company, which trades over the counter as ACTC. "The question is, will they have sufficient capital to break even, or to ramp up once they do."
RIGHT PERSON, RIGHT TIME
ACT had been searching for the right person for the position of chief development officer for the best part of a year, says William M. Caldwell, IV, the company's chairman and CEO.
"It was a very rigorous profile we were looking for."
The company needed a scientist who was well versed in the clinical trial process and the many regulatory steps required to have a therapy approved by the federal Food and Drug Administration.
"We needed somebody who could spearhead that," Mr. Caldwell recalls.
Dr. Huertas, he adds, "is one of those unique individuals that is clearly qualified to run a clinical trial. He has extensive experience interacting with the FDA.
"We are looking to Dr. Huertas to take this company to a new level."
He adds that what won ACT executives over was, in part, Dr. Huertas's enthusiasm for embryonic stem cell technology, which he is "absolutely" convinced will translate into therapies or even cures for an array of diseases affecting millions of people.
Embryonic stem cells hold the potential of providing replacement parts for cells ravaged by disease or injury because they can be coaxed to develop into any kind of tissue found in the human body from liver cells to brain cells to skin.
While the promise of embryonic stem cells has caused considerable controversy and been "hyped to a great extent," Dr. Huertas says he believes there's good reason to think it could help a great many people.
"The science has been moving along quite steadily.
"It always puzzled me," he adds, "why it takes so long from a discovery in the lab to something you can give to a patient at the bedside."
BEFORE BIOTECH WAS COOL
Dr. Huertas grew up in the coastal city of Viña del Mar, about 70 miles north of Santiago a place named for the vineyards that were established there in colonial times.
He studied medicine at the University of Chile, but in 1978 at the age 22 he came to the United States to escape the turmoil and brutality of the Pinochet regime.
"Medicine had always been a dream," he says, but once started he had to defer his goals for a while.
While he arrived with nothing and left behind his family, in the United States, Dr. Huertas says, "the opportunities available to somebody in my situation were just immense."
At first, to make a living, he worked in San Francisco for some biotechnology companies before biotechnology was even a common term.
Seven years later he took up medicine again, and received his medical degree from Harvard Medical School/Massachusetts Institute of Technology in 1993, and then a doctorate in cell and developmental biology from Harvard University. He later earned an MBA from the Massachusetts Institute of Technology's Sloan School of Management [where he's currently on the board of the Biomedical Entrepreneurship Program].
Dr. Huertas has practiced medicine at McLean Hospital, Massachusetts General Hospital and Harvard University Health services.
In 1998 he joined Genzyme Corporation as director of strategic development. There he helped develop a treatment for Fabry disease, a malady in which faulty enzymes interfere with metabolism.
Before joining ACT, he served as chief strategy and development officer at Amicus Therapeutics Inc., overseeing research and development and the development of clinical treatments. He also established and managed a network of academic, industrial and governmental thought leaders for Amicus.
As a Hispanic, Dr. Huertas is a rarity in the burgeoning field. According to studies by the National Science Foundation, in 2005 only 227 Hispanics, whether U.S. citizens or permanent residents, earned Ph.Ds in the biological sciences, out of 4,396 awarded in the United States 5 percent of the total, but still a substantial jump from the 3 percent of a decade earlier. Also in 2005, the Bureau of Labor Statistics found that Hispanics account for 4.2 percent of biological scientists working in the United States.
But as an immigrant, he's less unusual. The journal Nature reported in 2004 that 34 percent of all working Ph.Ds and 36 percent in the life sciences are foreign born.
At ACT, Dr. Huertas joins a workforce of several dozen people at a company with a market capitalization that hovers around $30 million, small by most standards but not unusual in the high-risk, high-reward world of biotechnology.
Unlike many of its biotech peers, the company is pursuing a variety of applications for its technologies, knowing that some will hit, some will miss, and some will be sidelined by medical, regulatory, or ethical obstacles even before having a chance to compete in the marketplace.
"I think Advanced Cell Technology's approach, their broad spectrum view of how to align their technology, allows them multiple shots on goal," says Burrill & Company's Dr. Vygantas.
CALIFORNIA THE GOLDEN STATE
ACT holds or has applied for more than 300 patents and Mr. Caldwell says the company expects to begin clinical trials in the next year.
The company's scientists were the first to clone a human embryo prompting vigorous debate on the technology and ACT announced last year that it has developed a method of creating stem cell lines from human embryos without destroying the embryo. This was something they had initially demonstrated in chimeric mice.
Company representatives say they hope this technique might circumvent some of the ethical concerns that prompted the federal restrictions on stem cell research.
It moved its headquarters from Worchester, Massachusetts, where its laboratory facilities are still housed, to Alameda early last year. [Dr. Huertas continues to live in Massachusetts, but travels regularly to ACT's California headquarters.]
The move was made to take advantage of an initiative passed by California voters in 2004, which allocated $3 billion to establish the California Institute for Regenerative Medicine, which spokesman Dale Carlson says will soon be the single largest funder of stem cell research in the world.
California's pioneering initiative was a response to restrictions on federal funding for embryonic stem cell research imposed in 2001.
Since federal money is so important to so much scientific and medical research, the restrictions made embryonic stem cell research "a shoestring-type industry" in the last few years, Mr. Caldwell says.
While Dr. Huertas prefers not to get involved in the controversy over the ethics of the technology, he says, "There is no doubt whatsoever that the political debate has handicapped the capability of the U.S. both at the basic and the applied level."
If those federal restrictions aren't relaxed or lifted, he adds, "We will fall behind."
ACT has an ethics advisory board consisting of seven bioethicists and cell scientists, and Dr. Huertas says the company approaches its work "with responsibility and integrity."
"There is a disconnect between what is the science and what is the public perception of the technology," he says. "It's part of our job to really educate the public at large."
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