January 7, 2019

Hartford HealthCare bringing early stage clinical trials to region

Photo | Contributed
Photo | Contributed
Dr. Omar Eton gives Hartford HealthCare staff a tour of a recently completed phase 1 clinical trial unit for cancer research.
HBJ Photo | Matt Pilon
Dr. Peter Yu (right), physician-in-chief of HHCs Cancer Institute, about a year ago recruited Dr. Omar Eaton, who was an early phase clinical trial specialist in Boston.
Photo | Contributed
One of four infusion rooms at HHCs new clinical-trials unit.
Dr. Patricia LoRusso, Director of Innovative Medicine, Yale Cancer Center

Aiming to boost both its research reputation and the hopes of cancer patients who visit its doctors 50,000 times a year, Hartford HealthCare is stepping into the specialized and competitive world of early phase oncology drug trials.

As part of the effort, the state's second-largest hospital system recently completed build out at its flagship Hartford Hospital campus of a $1.3 million, four-bed facility for phase 1 cancer drug research.

The facility, staffed by a team of more than a dozen doctors, nurses, technicians and others, can accommodate 200 patients annually, and is expected to land its first phase 1 clinical trial by spring. It builds on a research partnership Hartford HealthCare (HHC) forged with New York City-based Memorial Sloan Kettering in 2014, which has brought more phase 2 and 3 clinical trials to Hartford. HHC is also hoping to expand its relationships with pharmaceutical companies.

While later-phase trials include more patients and occur closer to when new cancer drugs actually make it to market, phase 1 trials often represent the first time new drugs are used in humans, which requires more patient oversight as researchers work to gauge safety, side effects and proper dosages.

"These are more complex studies," said Dr. Peter Yu, physician-in-chief of the Hartford HealthCare Cancer Institute. "They involve a lot more nursing time, a lot more time with the research coordinators; our laboratory has to collect specimens and prepare them, and it's really a totally separate workflow and separate personnel."

It's an ambitious move for Hartford HealthCare to step into the phase 1 clinical trials arena, which has long been the domain of major academic and research hospitals.

Becoming a "development house" for cancer drugs could give Hartford HealthCare more visibility among drugmakers — including the big cluster not far away in Cambridge, Mass. — that often bring their trials to major cancer centers like Memorial Sloan Kettering, Texas's MD Anderson, Minnesota's Mayo Clinic, and Boston's Massachusetts General.

There are other potential benefits. It could help Hartford HealthCare keep more patients within its six-hospital system, while giving cancer patients access to new experimental drugs closer to home. It should also help with doctor and researcher recruitment.

Meantime, Hartford HealthCare's largest in-state competitor — Yale New Haven Health (YNNH) — has also taken steps to bolster its own phase 1 cancer trials program. It now counts 50 active phase 1 oncology trials, up from just a handful in 2013.

Pharma demand

Aside from its existing relationship with Memorial Sloan Kettering, which Yu says has more than 200 ongoing phase 1 cancer trials, HHC is betting that pharmaceutical companies are looking for reliable drug trial partners.

Dr. Omar Eton, medical director of the HHC Cancer Institute's melanoma and skin cancer center, who Yu recruited to Hartford last year because of his three-decade experience with phase 1 cancer trials, said developing a reputation with industry will be crucial.

"The demand is way beyond the supply, currently," Eton said. "Once we hook up with a [drug] company, the odds are it's going to continue for life, because those hookups are hard to set up, and once they are set up, they just continue."

There are more early phase drug trials available to hospitals, as scientists use genetics to gain better understanding of how to target specific biological pathways or cancer mechanisms, according to Dr. Patricia LoRusso, director of innovative medicine at the Yale Cancer Center.

And while clinical trials used to be viewed as a last-ditch option for a cancer patient, that is slowly changing.

"Now the trend is that doctors might not wait until all treatment options fail before putting a patient on a trial, particularly those patients with certain genetic or other biologic markers that point to specific treatment options," LoRusso said.

Having a dedicated unit where patients can be comfortable as they spend hours getting blood draws, electrocardiograms and other tests as experimental drugs are administered, provides a leg up, Eton said.

"You have to have something like this or else the drug companies will snore through your presentation," Eton said of Hartford HealthCare's newly built facility, which features modern medical equipment and TV monitors that can link doctors and patients to specialists at Memorial Sloan Kettering in New York.

Yale, Connecticut's largest health system by patient revenue, built an 11-bed phase 1 oncology unit in 2016. HHC's new 1,700-square-foot facility means there are now two such units in Connecticut, though at least one other system, UConn Health, is also involved with phase 1 trials.

There may be a competitive angle at play as more hospitals pursue early stage research.

"They are looking for the right site," LoRusso said of drug developers.

LoRusso said Yale's phase 1 unit is near capacity. Future expansions are being discussed, including establishing a phase 1 site at its Smilow Cancer Hospital location at St. Francis Hospital and Medical Center in Hartford.

While Hartford HealthCare has a modest-sized phase 1 unit now, it's just one piece of a larger picture.

"Our longer-term strategic plan is to build a new Hartford HealthCare Cancer Institute here at the Hartford campus," Yu said. "As physician-in-chief, I'm thinking 'well, what am I going to put in that building?' "

If things go as planned, part of the answer could be a much larger phase 1 cancer drug trials unit.

"Our vision is not small, we're going big here," he said.

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