Complementary strengths fuel research duo’s success

PIECING IT TOGETHER: Omega Medical Research Vice President Lynne Haughey, left, and President and CEO Johnna A. Pezzullo met in 1987 as nurses at Roger Williams Medical Center, forming their company six years later. / PBN PHOTO/TRACY JENKINS
PIECING IT TOGETHER: Omega Medical Research Vice President Lynne Haughey, left, and President and CEO Johnna A. Pezzullo met in 1987 as nurses at Roger Williams Medical Center, forming their company six years later. / PBN PHOTO/TRACY JENKINS

When Johnna A. Pezzullo and Lynne A. Haughey met in 1987, they were both nurses at the Roger Williams Medical Center in Providence.
As the two became friends and colleagues, Pezzullo left her hospital job in intensive care to conduct dermatology research, but discovered through the pharmaceutical industry that she could be doing the research on her own. Combining Pezzullo’s business acumen and drive with Haughey’s expertise in hands-on clinical care, the two started Omega Medical Research.
That was on Oct. 19, 1993. Now in its 21st year, the company is the largest of its type in the state, working with such pharmaceutical giants as Pfizer, GlaxoSmithKline and Merck, and international companies.
Omega conducts all stages of clinical trials for pharmaceutical, medical-device and biotechnology therapies in an outpatient setting. More than 400 research studies to date provide companies with clean, quality data and optimal recruitment and retention of testing subjects – those people with medical conditions participating in the testing, the partners said.
Pezzullo, 47, of Cranston, the president and CEO, is “the voice” of the company – and that endorsement comes from her partner, Haughey, 52, also of Cranston, who is executive vice president and chief operating officer.
Pezzullo “makes them want to work with us,” Haughey said, referring to the major pharmaceutical corporations that Pezzullo is constantly bidding to work for. “She tells a story well.”
As Pezzullo explains, the pharmaceutical companies she was working with indicated that the hospitals’ Institutional Review Boards – or oversight panels – typically take months to authorize clinical trials – that is, the testing of drugs or medical devices in humans before the product gets approval from federal agencies like the Food and Drug Administration. Pezzullo learned that an independent site like Omega, however, with its own procedures for finding voluntary test subjects and handling blood testing through its own lab, can take weeks instead of months to do the same work.
“I saw the need to bring things from the hospital into the community, so it was the need and the opportunity [that led to starting the business],” she said. “I was fearless when it came to taking a chance. I knew I had my nursing degree to fall back on if I failed.”
Far from failing, Pezzullo and Haughey figured out early that conducting clinical trials through physicians’ offices was not as effective as having their own offices and labs. In 2000, they moved from the Calart Towers on Reservoir Avenue on the Providence/Cranston line to the Warwick Medical Building at 400 Bald Hill Road near the Warwick Mall, where they are today.
As a team, Pezzullo and Haughey are articulate, enthusiastic about their work and so in sync that they frequently finish each other’s sentences.
“Running a business comes naturally to me and clinically taking care of subjects comes naturally to Lynne,” Pezzullo said.
“We don’t have egos,” added Haughey. “It’s just a nice synergy.”
Omega abides by the oversight of the independent, commercial Institutional Review Boards, which safeguard subjects so that they aren’t unduly influenced, and ensure the firm is using ethical, sound practices.
“That’s the most important thing – that the [subjects] are cared for and safe,” Haughey said.
When the duo started their research clinic, Pezzullo was conducting HIV trials while still working at night as a nurse, and Haughey was working at an HIV center and training to become a nurse practitioner.
A pivotal point in their careers came with a clinical trial in 1996 for a preventative Lyme disease vaccine called LYMErix that, though approved, was ultimately discontinued because of long-term side effects involving arthritis. “It pushed us to the next level,” said Pezzullo. “It was a large trial with 350 subjects enrolled. It gave us the experience to do vaccine trials. We’ve now conducted 55 vaccine trials to date. It showed the pharmaceutical companies that we can handle large trials and give them the quality data, and it put us out there in the community.”
Of those 55 vaccine trials conducted, it is not known how many actually led to regulatory approvals for drugs that are still on the market, said Pezzullo, but “we’ve definitely seen some of our work come to the market.”
If a trial doesn’t go well, “there’s still a lot of learning that comes from it,” Haughey said.
Together, Pezzullo and Haughey lead a staff of 10 that includes five RNs, a phlebotomist, regulatory worker, receptionist, research assistant and data-entry assistant.
Over the past 20 years, they have made contact with more than 19,000 possible subjects, not all of whom actually enroll in clinical trials, mostly from Rhode Island and southeastern Massachusetts. Subjects, who often have no insurance, get treatment of their conditions for free and are paid small stipends of $50 to $75 a visit for their participation, the women said.
Omega takes no insurance, they added.
Both women say that caring for people is their primary concern. The industry’s regulatory hurdles have only become more of a challenge over time, Pezzullo said.
“Finding the right subject for the study is much more difficult today,” she added by way of example, because of the sheer amount of criteria that must be met.
The successes make the challenges worthwhile, Pezzullo said.
“When we see a new drug approved by the FDA that we were a part of, that makes us feel good – to know we [helped] bring it to the general public,” she said. •

No posts to display