BY MICHELE MILLER
What’s What New Port Richey
You might have passed by the sign and not taken notice while taking the short trek down Gulf Drive. Its location, nestled in the downtown outskirts among medical facilities and other businesses, begs forgiveness for those casually passing who might not have a clue about what goes on within the walls of the Suncoast Clinical Research building.
For over 25 years Suncoast Clinical Research has been making a big impact in the local community and beyond while managing clinical trials for pharmaceuticals and medical devices needing approval from the Food and Drug Administration.
Remember the early days of COVID testing when you had to line up in your car for a rather uncomfortable nose swab and then wait days to find out if you had tested positive or not? Well, Suncoast Clinical Research was at the forefront of managing a trial for the Covid Rapid test.
Suffice it to say, it’s cutting edge. And that’s just the tip of the iceberg.
Alzheimer’s Disease, Diabetes, Endometriosis, Hypothyroidism, Pediatric Migraines, weight loss, and Psoriatic Arthritis are just some of the many trial studies that have been or are being conducted at the dedicated research clinic in New Port Richey as well as a second location in Palm Harbor. (See the complete list of trials here.)
And that Covid Test trial – because of study rules, trial subjects could not be told whether they tested positive or negative, so the owners of Suncoast Clinical Research opted to pay for a second swab so their patients would have the results.
Suncoast Clinical Research is one of several exceptional area businesses that tend to fall under the radar, said Lauren Miceli, Director of Marketing and Communications for the Pasco EDC.
In fact, the independent research clinic was recently named a finalist for the Economic Development Award in the Pasco Economic Development Council’s 35th Annual Awards event held in September that honored twenty local businesses for their achievements in Pasco County.
According to the Pasco EDC, the Economic Excellence Award “recognizes a business that has made a commitment to improving the overall economic health and quality of life in Pasco County, creating a diverse workforce, and providing exceptional value to customers, all while demonstrating ingenuity, integrity, and leadership.”
It’s an honor won twice before, back in the days when co-workers and friends, Bobbi Tafara and Barbara Manning ran the business. It was an opportunity the two friends embarked on together after parlaying their mutual experience working in clinical trials with Manning’s time working in hospital administration and Tafara’s experience running large medical practices.
Now their adult children, Jennifer Selk and Greg Manning are at the helm. Both joined the company in 2008, with Selk purchasing her mother’s share in 2011 and Manning buying his share in January of 2023.
The business boasts several long-time employees, including a Medical Director, several Certified Research Coordinators and Professionals, senior management and support staff.
“We really have the best employees. We’ve been like family for years,” Selk said.
“It all started off in my mom’s house,” she said, recalling one of the first big heartburn studies that had patients downing chili and orange juice followed by medication or a placebo in a rented space at the New Port Richey Rec Center.
Selk served as a table monitor, making sure nobody ducked outside to take an antacid or have a smoke – actions that could skew the study.
Today Suncoast Clinical Research is counted as one of the top enrollees in the country for various clinical trials.
They are known in local circles including the many public and private organizations that provide elder care and are part of the Pasco Aging Network coalition and the Pasco Economic Development Council. Some altruistic connections include The ROPE Center, Lighthouse for the Blind, CARES, Rotary, and The Good Samaritan Clinic.
PHOTO | MICHELE MILLER
Referrals come from national ad campaigns, area organizations, and local physicians seeking options for their patients.
“We are working with several pharmaceutical companies, seeking to get Alzheimer’s drugs approved, including Lilly and Cassava,” Selk said, adding, “We were also just awarded an Alzheimer’s trial with Bristol Myers Squibb.”
None of those studies would be possible without volunteers who qualify for a stipend/payment for their part in being a “Medical Hero,” said Recruitment Manager, Marina McLoone. “For some, it helps to supplement their income. Some are seeking an alternative to their current treatment. Some people just want to make a difference in the world.”
McLoone, who serves as secretary for the Pasco Aging Network and as membership chair for the Community Service Council of West Pasco said she applied for the recruitment position at the suggestion of a friend who thought it might be right up her alley.
“I was looking for something new and this is a company that truly supported my ambitions in supporting the community,” she said, noting that her tagline at community events is, “You know who we are, now let us tell you what we do.”
“The trials often appeal to the uninsured or underinsured. That’s where a lot of doctor referrals come from,” she said. “And there’s word-of-mouth. I like that. If you’re happy with what we do you’re going to tell your friend.”
A stringent screening process means that while many apply, many are excluded if they do not fit the criteria.
“We might have just four randomized patients that move to the clinical phase after interviewing hundreds,” McLoone said. “We start by getting a full medical history to see what studies people might qualify for and what their interests are. They sign a consent form, outlining all of the details of the trial.”
Volunteers can withdraw from the study at any time if they don’t feel like it’s working for them, McLoone said. “We encourage them to stick with it because it’s the only way we can help the company move forward with FDA approval or to show that it’s not working and shouldn’t move forward and that information is just as helpful.”
“We’re not for everyone and we don’t have a study for everyone. But if we don’t have a study for you that doesn’t mean there isn’t help for that condition. In that case, we try to refer (applicants) to a health care provider in the area,” she said. “We are family here and with that, there’s a lot of listening, understanding, processing, and compassion in what we do.”
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PHOTO | MICHELE MILLER
Suncoast Clinical Research is located at 5604 Gulf Drive in New Port Richey and 3890 Tampa Road, Suite 301 in Palm Harbor. For information the website at www.suncoastclinicalresearch.com or call (727) 849-4131 (New Port Richey) or (727) 781-3655.
