Women celebrate 20 years of life-saving clinical research
Warwick-based and women-owned Omega Medical Research is celebrating 20 years as one of the nation’s top clinical research centers in the country, having conducted more than 450 pharmaceutical, medical device and biotechnology clinical trials over the past two decades.
Cranston residents and native Rhode Islanders, Omega Medical president and CEO Johnna Pezzullo, BSN, RN, and vice president Lynne Haughey, MSN, FNP, had a vision to bring the field of clinical trials into the community to help those suffering from a variety of medical conditions gain access to the latest medicines, devices and therapy available. Conducting their work out of the Warwick Medical Building for many years (they started in a different building in Warwick), they have been able to support the advancement of medical treatment in the areas of internal medicine, gastroenterology, pediatrics, women’s health, men’s health, urology, dermatology and vaccines.
“We’re proud of that. We want to have the reputation of having spectacular data for our clients,” explained Pezzullo.
Pezzullo began her career as a registered nurse in an area hospital.
“I got into the field of research there,” explained Pezzullo.
But then she had an idea to bring prescription drug research out of the hospital setting and into the community.
In October 1994, the Independent Research Nurses was born.
“We were going to have contracts with physicians and hire out nurses to conduct the surveys,” explained Pezzullo.
Haughey joined the team right at the start. She was working as a nurse practitioner on trials for HIV treatments, the first clinical trial for Independent Research Nurses.
“We kind of grew around that,” explained Haughey.
But that doesn’t mean that the two women did not face their share of struggles, one of which was the fact that they were women.
“In this field, it is predominately a physician-owned company. The medical field is predominately men,” said Pezzullo when explaining how she and Haughey had to break a stereotype with their female, nurse-owned company. “The name was something holding us back; they didn’t want to give us the work because we were research nurses.”
So the name was eventually changed to Omega Medical Research, although they are incorporated as Independent Research Nurses.
Haughey recalled the challenges they faced just being women business owners, nevertheless in the medical field. She recalled walking into banks to set up business accounts and getting laughed out of the room.
Fast forward to 2014 and Omega Medical Research is one of the country’s leading clinical research centers, having conducted 450 trials over the past 20 years with no less than 10 going on at any given time.
Today, the banks are fighting for their business.
“It makes us laugh now,” said Haughey. “Once you’re established, you get the respect.”
While it might have been tough at first to be recognized in the clinical trial field, the two are happy to say they have seen things changing for women in both their field and others. While they could not say for sure if they are the only women-owned clinical research company in the state or the country, they believe they are one of the largest and longest running.
“I think there are only a handful,” explained Haughey.
Haughey believes that it can be difficult to run a successful clinical trial research company outside of a hospital because one needs to dedicate 100 percent of their time.
“It’s so highly regulated. It takes a full-time workload. We couldn’t research and practice at the same time,” explained Haughey.
In fact, even Pezzullo has left the research behind to focus on running the business. Haughey still works on the trials.
For their clinical trials, a physician oversees all trials with support from registered nurses and nurse practitioners hired by Omega Medical to ensure the safety and care of volunteers in the trial.
“We want to be able to provide them [volunteers] with high quality care,” explained Pezzullo. “[Trial administrators] are not going to be interested in this field without a medical background.”
Every prescription drug available on the market has to undergo multiple clinical trials to ensure it is safe; Omega Medical most often conducts trials at a later stage in the process (Phases 2, 3, or 4), although they have also worked on Phase 1 trials. Pezzullo explained their trial is often the last one before the drug gets to market.
Omega Medical Research has built up a patient database of about 19,000 volunteers in their 20-year history, many found through a network of physicians who work with and support the center. While they do not keep a record of where volunteers come from, Haughey noticed a large number from Kent County while going over patient information.
Pezzullo and Haughey admit some volunteers are nervous to be “guinea pigs” for medications, but the care and monitoring provided to volunteers is a priority for Omega Medical and there is a tremendous amount of safety built into all trials.
“It provides them medical care they can’t otherwise afford,” added Haughey, pointing out that the volunteers also receive regular care for their condition and stipends for their time. “Overall, it’s a win-win for everyone.”
The pharmaceutical company provides the budget for Omega’s studies, and no insurance company or patient is ever charged.
Haughey explained that while they do a vast array of trials, vaccine trials are one of their most common, having conducted 55 of them.
“That is a special interest of ours,” she said, explaining that they are currently working on a trial for a Meningitis B vaccine.
“The B-strain is the one from the recent college outbreaks that happened.”
The vaccine had to be flown in from England to treat the outbreak; Haughey explained the vaccine may already be approved there.
Another vaccine Omega Medical was part of testing was the H1N1 flu vaccine.
“We were the only one in the area that was testing that vaccine that you take now,” explained Haughey.
They have also been part of testing a vaccine for small pox in the event of a bioterrorism attack.
While Pezzullo and Haughey feel a sense of importance in all of the trials completed by their business, conducting clinical trials on treatments for HIV in the early ’90s sticks out in their minds.
“It was pretty new,” said Pezzullo. “We were involved in a lot of the early trials for the treatments for HIV that are available today.”
Haughey called those trials “rewarding work” that was very important to them.
“Many didn’t do well, but some did,” recalled Haughey about the trials.
Currently the two said their research on new treatments for celiac disease is very exciting because they will hopefully be able to help those suffering from a gluten allergy.
In addition to vaccines and medication, Omega Medical has also conducted trials involving medical devices such as at-home ultra sound therapy and treating stroke patients with the Wii video game system.
Looking to the future, Pezzullo and Haughey would not only like to expand into other therapeutic areas for trials (their newest field of testing is urology), but they would also like to form better partnerships with Rhode Island hospitals interested in doing clinical trials. Pezzullo explained that many pharmaceutical companies don’t want to go through the review process to conduct a trial through the hospital because there are a number of layers to go through.
“It’s time-consuming. Omega can get started quicker,” said Pezzullo, explaining they only have one review board to go through before gaining approval for a trial.