Biotech: Scientist Works
On Synthetic Body Parts
Gail Naughton, who admitts she is consumed by “cells on a scaffold,” was named “Inventor of the Year 2000” last week.
The president and COO of Advanced Tissue Sciences (ATS) in La Jolla said she’s especially thrilled to receive the honor at the onset of the new millennium.
“Over the next few years, we are going to see vast new innovations that are going to change how medicine is done,” Naughton said.
Naughton received the honor from the Intellectual Property Owners Association (IPOA) on June 28 in Washington, D.C.
IPOA, a trade group that honors recent American inventors, selected Naughton, 44, for her contributions in the field of bioengineering.
Naughton pioneered the nascent field of tissue engineering whereby scientists grow entire body parts from skin to cartilage for transplantation.
At ATS, researchers have been combining living cells, organic chemicals and various synthetic materials to grow artificial skin, heart blood vessels, collagen, cartilage and other human tissue since 1987.
The technology evolves from one single seed cell from neonatal foreskin. Such cells are grown on a three-dimensional mesh called a “scaffold.”
It’s really a trick whereby the cells are made to “think” they are growing inside the body, she said.
Tricking Cell Growth
So far, ATS has tricked cells to grow into skin, cartilage, collagen, blood vessels, and other tissue.
But the technology has yet to make a breakthrough.
In October 1997, ATS received government approval for its first and only product, TransCyte, a treatment for second- and third-degree burns.
The firm has suffered setbacks with the Food and Drug Administration in getting approval for a second product, a skin replacement for diabetic foot ulcers called Dermagraft.
In 1998, the agency asked ATS to initiate another late-stage study with Dermagraft.
The study is nearly completed and ATS is planning to file for pre-market approval this summer, Naughton said.
She hopes to launch Dermagraft with its British-based research and marketing partner, Smith & Nephew, in early 2001.
Bud Leedom, editor of the San Diego Stock Report, projects cautious optimism.
“It looks good, but I would have said that the last two times too,” Leedom said, referring to the repeated setbacks.
While he applauded Naughton for receiving the award, Leedom added it won’t have much pull on Wall Street.
He insisted ATS’s fiscal well-being depends on Dermagraft’s approval.
Validation Of The Technology
“This product is what it’s all about,” he said. Investors will have a hard time sinking their teeth into that if they (ATS) aren’t successful.”
Still for Naughton, the honor represents a validation of the firm’s technology.
The product pipeline is churning, she added.
ATS developed a collagen treatment to smooth out wrinkles and treat urinary incontinence, she said.
Naughton said its Santa Barbara-based marketing partner, Inamed, a maker and marketer of facial and breast implants among other products for cosmetic surgery, will provide the collagen syringes to plastic surgeons, outpatient surgery centers, and hospitals next summer if the FDA grants approval.
Naughton also hopes to move multiple products into the clinic next year.
If all goes as planned, both the cartilage product and experimental “patches” that stimulate growth of blood vessels in damaged heart muscles will be tested for safety soon, she said.
ATS and Smith & Nephew also plan to test the same cell line used for diabetic foot ulcers for other applications.
Leedom, however, points to the many years it will take to move products through clinical trials.
Approval Critical
To put it bluntly: “The rest is pie in the sky if Dermagraft doesn’t get approved,” he said.
Leedom is not alone.
Critics have long been skeptical of bioengeneering, which has yet to make a breakthrough. Enthusiasts like Naughton say it’s only a matter of time before the technology will prove itself.
“It’s (her award) important for the company, because it validates our core patent,” Naughton said.
Somehow, the award also confirms the notion of the “superwoman” being able to manage it all: Motherhood, business, science and continued education.
“Just being a mother of more than one child, you learn to juggle,” said Naughton, who is the mother of two teen-age girls and a 10-year-old boy.
Still, the drive to do more never failed her.
These days, Naughton spends every other Friday and Saturday in a classroom at UCLA where she learns “new ways of doing business.”
The executive MBA degree she hopes to earn will go nicely with her other achievements. She already holds a master’s of science degree and a Ph.D. in science from New York University.
Naughton said she counts on her children to put things in perspective.
“My children keep me balanced and make me laugh and realize there are other things beside cells on a scaffold,” she said.
