Saint Joseph’s Translational Research Institute (SJTRI) has opened a new 18-bed phase I unit on the campus of Saint Joseph’s Hospital in Atlanta to focus on cardiovascular, gastrointestinal and orthopedic studies.

The idea for the unit was hatched last year when Kristy Nichols, president and CEO of two-year-old Atlanta CRO Peachtree BioResearch Solutions, bumped into SJTRI President and CEO Nicolas Chronos at a Georgia BIO International meeting. “Kristy mentioned looking for a good phase I unit that her CRO could work with,” said Charles Romano, SJTRI’s new director of phase I research. “Dr. Chronos said, ‘Really? I’ve been wanting to start a phase I unit.’ And the rest is history.”

Finding a good phase I unit with which to align in Atlanta is harder than one would think, said Romano.

“There is a lack of hospital-based phase I units that are open to industry work here in Atlanta, or they are very specialized such as they only do psych or behavioral studies,” he said.

SJTRI leased space formerly occupied by an oncology ward within St. Joseph’s Hospital, outfitting it to accommodate phase I research. It opened in early July. Already the new unit has a contract in place for 45 patients in an upcoming women’s health study. Six more contracts are being negotiated.

Romano says SJTRI—an 11-year-old, non-profit preclinical research entity—has a robust database of about 3,500 potential volunteers (1,500 sick; 2,000 healthy) culled from SJTRI’s recruitment booths: one in the lobby of the hospital and the other that it takes to college campuses. This will give the unit a good start on recruiting.

Four people will be on staff in the unit, and nurses will rotate through from the hospital. Being in a hospital gives the unit a safety advantage over stand-alone phase I units, Romano said. “The ER is just two floors down.”

The new unit makes the research offerings of the health system more complete, said Romano, explaining that St. Joseph’s Health System has a three-year-old phase III and IV (and sometimes II) facility called St. Joseph’s Research Institute (SJRI), and it has SJTRI, which had done only preclinical work. Now the missing piece of a phase I offering is no longer missing. “We’ve bridged that gap,” Romano said.

Romano has some big plans. First, he’s looking to establish relationships with the top five CROs to keep volume high in the new unit. Next, he’s considering expanding the concept and opening other phase I units elsewhere—including overseas. Also, Romano said he’s been approaching other local phase I units that are associated with academic medical centers and suggesting they combine their volunteer databases so each can ramp up recruitment and make better use of their space. He said 
he expects to have that in place by the end of the year.

SJTRI, which specializes in cardiovascular indications for devices and drug therapies, is a subsidiary of St. Joseph’s Health System, as is SJRI. All entities are owned by Catholic Health East.

The unit is the second to open recently in Atlanta. Earlier this year, investigator site Clinical Research Atlanta launched a stand-alone 20-bed phase I/IIa unit to focus on pediatrics and ailments common in African-American populations, such as hypertension.

—Suz Redfearn