azventurecapital.com

Kate Nolan
The Arizona Republic

SCOTTSDALE - Since the federal government started designating cancer centers in the Nixon era, the number of new cancer drugs has soared.

But a challenge persists: How to get the new drugs to more patients faster?

For the past 15 years, the solution increasingly has been for community oncologists, or cancer specialists, to be involved in research and later-stage drug trials.

Two Scottsdale physicians have tweaked that idea. Some say Premiere Oncology, the medical practice they started a year ago, could become a national model for delivering the latest cancer drugs.

Doctors Michael Gordon and David Mendelson specialize in running early phase Food and Drug Administration research trials, testing new cancer drugs by major pharmaceutical companies. Eighty to 90 percent of their patients are on trial drugs.

Premiere Oncology’s dominant activity is early phase research, which usually is done at larger institutions.

Phase 1 and 2 studies tend to be small, short-term and are used to establish safety and dosages. Phases 3 and 4 are conducted later with a broader population to measure effectiveness and side effects. Trial drugs are given only after standard treatments haven’t been effective.
Practice centers
Merging Gordon’s extensive background as an academic researcher with Mendelson’s quarter century as a community oncologist, Premiere gets patients through referrals from community doctors. It runs 30 to 35 studies at any given time, and the doctors see from 8 to 12 patients a year per study, focusing primarily on melanoma and kidney cancer.

“We are experts in both, and there are many unmet needs in those areas,” said Gordon, 45. “We’re also running ovarian cancer drug trials that we hope will extend the lives of women who have relapses where the therapy hasn’t been curative.”

They’ve already run a Phase 1 trial for Genentech Inc., establishing safety for an ovarian cancer treatment. It’s now in Phase 2, where dosages are being fine-tuned before it moves on to larger population studies.

Once a physical therapy office, the 20,000-square-foot north Scottsdale office features an open bay with a cozy arc of recliners where patients receive experimental drugs intravenously.

One recent morning, lab coat-attired Mendelson, 58, saw patients while his partner spoke about the practice.

Gordon’s office is heavy on files and family photos, a much used workspace overseen by twin portraits of Superman and Speed Racer, fitting mascots, although the real mascot of the place is a fist-size painted turtle named Twigs.

Premiere is more harelike.

Gordon says its advantage over institutional researchers is speed.

University researchers can wait months for their Institutional Review Boards to evaluate and approve proposed studies. Institutional reviews are required under National Cancer Institute guidelines, but Premiere uses a commercial IRB whose full-time evaluators respond quickly. Debates over ownership of intellectual property or budget are also reduced in the private sector, Gordon said.

Not long ago, Gordon and Mendelson were deeply ensconced in an institutional setting themselves.

Starting in 2001, they ran the Arizona Cancer Center’s New Therapeutics program at Scottsdale Healthcare.

But last year Scottsdale Healthcare started a new research center, the Scottsdale Clinical Research Institute, and their program was set adrift.

Gordon and Mendelson were offered but declined positions at the new institute. Instead they decided to follow the model of a Los Angeles friend, Dr. Lee Rosen, a physician researcher who had left a research program at UCLA to start Premiere Oncology in Santa Monica, Calif.

The Arizona office is a separate entity but shares some organizational expenses and research projects with Rosen’s.

Gordon and Mendelson remain staff physicians at Scottsdale Healthcare, and Gordon is associate director of clinical research at the Arizona Cancer Center.

Their former boss, Dr. David Alberts, director of the Tucson-based cancer center, said the split turned out well.

“The way it’s set up, Arizona Cancer Center will collaborate on research projects with Premiere Oncology and the Scottsdale Clinical Research Institute,” Alberts said. “It’s a two-way street, and we talk all the time.”
Growing trend
For each patient, Premiere Oncology receives from $12,000 to $25,000 in support from a sponsor, usually a drug company.

The eventual goal is to expand the Arizona office to five physicians, with $25 million in gross annual revenues, said Chris Beardmore, chief of operations for both the Scottsdale and Santa Monica practices. The unit is scheduled to expand into a larger Scottsdale space within six months, Beardmore said.

Still, Gordon and Mendelson, as private doctors conducting early phase research trials, remain a distinct minority.

Dr. Marvin Chassin of Desert Oncology in Mesa agreed they are rare examples.

“Usually what we’re doing in the community is Phase 3, but we don’t put a lot of people on trials,” he said.

Typical among community doctors, Chassin has become involved in research through a National Cancer Institute program that links community physicians with studies.

There’s reason enough to try. Most new Phase 3 therapies, according to Alberts, outperform the standard treatments. But early phase trials don’t always move to the next level, and it can be difficult enrolling patients in them.

Jon McGarrity, chairman of the Arizona Bioindustry Association, said physician/researchers are not new. He points to the long established Pivotal Research Centers in Peoria, run by Dr. Louis Kirby, who specializes in neurological and behavioral research at four sites.

But Premiere’s niche is rare in cancer research, according to Dr. Robin Zon, an Indiana oncologist and research specialist at the American Society of Clinical Oncology.

Zon said more than 50 percent of patients in cancer drug studies come from community settings, but the intensity of early phase cancer research discourages most community practices from getting involved in them. The turnover is quick, with a small number of patients only briefly in the study. Zon said the early trials could use more community involvement.

“It would make sense for Gordon and Mendelson to do this. We can learn from their model how to do Phase 1 trials in the community setting,” she said. Zon expressed confidence that Gordon, known for his work at Indiana University and Sloan-Kettering Institute on tumor-fighting drugs, will be able to protect patient safety and produce credible data. Educator Linda Mottle also sees the new practice positively.

Amid a national shortage of research coordinators, Mottle created a degree program to train them at GateWay Community College.

“We train people how to run those human subject research trials,” Mottle said. Now there are more research projects in Arizona than people to manage them.

“It’s a growing trend that doctors are starting their own research sites. They do it to advance the science within their specialty. Most aren’t making big money doing it,” she said. “We encourage it.”

Members of the Valley’s burgeoning cancer research community agree that advances in genomics and computer technology have accelerated the speed of discovery, and created a need for more research facilities, private or institutional.

Even Gordon’s and Mendelson’s ex, Scottsdale Healthcare, views Premiere Oncology as an asset to the regional oncology arsenal.

“Unfortunately, there’s more than enough cancer to go around. No matter how many people we have, we can’t possibly bring the new drugs to patients fast enough,” said Susan Brown, director of oncology services for Scottsdale Healthcare.

Bookmark to digg, technorati, Google, Del.icio.us, et. al.: