Friday, November 17, 2017
Business

Clinical trials conducted in Hernando play vital role in research, approval of new drugs

RECOMMENDED READING


BROOKSVILLE — An opportunity to play a role in advancing medical knowledge, usually available only in university neighborhoods or bioscience parks, is firmly established right here in Hernando County.

Meridien Research, founded in 2000 and now with five Central Florida sites, draws on community volunteers — hundreds yearly from Hernando — to take part in clinical trials of medications that nationwide pharmaceutical and biotechnology firms are testing for eventual submission to the federal Food and Drug Administration's approval board.

Current trials at the site west of Brooksville are for pharmaceuticals to treat diseases of high concern nationally: Alzheimer's, arthritis, diabetes, cardiovascular risk and nine others.

Meridien CEO Tony Busa Jr., 64, explained: "For the most part, we're looking at a new drug or a comparative drug to demonstrate better efficacy versus what's on the market. It's the job of research to determine the value of a drug and its safety."

The drugs being tested already have passed Phase 1 animal testing. Phase 2 study, which Meridien performs, seeks mainly to determine safety parameters and how well the drug performs its intended function.

Meridien's clinical trials — more than 1,200, in which more than 50,000 volunteer patients have taken part — are conducted via contracts with research organizations and pharmaceutical companies, including such well-known names as Bayer, Merck, Pfizer and AstraZeneca.

The contractors pay Meridien, so study subjects receive free medications as well as free physician oversight and consultation between Meridien and the volunteer's primary care physician.

Volunteers, who might receive compensation for time and travel, ordinarily receive oral or injected medications — the real thing or a placebo — and might be required to keep a home journal of their diet, exercise, other activities, symptoms and their relief.

Trials have ranged from one day to six years, with each clinic visit an hour or two, said Brooksville facility manager Katie Leonard, a registered nurse.

Most studies require blood samples on scheduled visits. If tests such as an MRI, colonoscopy or optometry are needed, service providers in the local community are called upon, also paid by the contractor. Thus, Busa said, Meridien plays a role in the area economy beyond its own staffing.

A full-time medical doctor heads the 10-person Brooksville staff, which includes several part-time physicians plus nurses, lab technicians and medically trained study coordinators.

"Brooksville is generally receptive to requests for volunteers," Leonard said. "We get a lot of calls for our memory trials … diabetes and migraines."

"Most (volunteers) are trying to help find new treatments for their diseases," marketing director Stephanie Jones explained. "Many … have personally experienced (Alzheimer's and dementia) and what this means for themselves and their family members and are willing to do whatever it takes to prevent their children from having to experience the same thing.

"Pain disorders are also very difficult to cope with, and many come to us looking for new solutions or hoping to advance these treatments for others."

Volunteer intake begins with a phone call to Meridien and answering a few questions to see if the person qualifies for a particular trial. Among the factors determining qualification are age, gender, general health and the specific affliction.

The clinical research conducted at Meridien "plays a very important role in approval of new drugs," Busa said. "Drug discovery can't happen without volunteers."

With the country's gentrification and many diseases common in an older population, Meridien chose its Central Florida location because of its higher average age populace. "Various populations" are important to other particular trials, Busa added.

Other Meridien sites are in Tampa, St. Petersburg, Lakeland and Bradenton. Brooksville's highway access contributed to its selection as a site in 2005. The Brooksville clinic attracts volunteers, Jones said, from Citrus County, the Villages, Florida's Panhandle and as far away as Georgia.

Contact Beth Gray at [email protected]

Comments
Tesla’s latest creation: An electric big rig that can travel 500 miles on a single charge

Tesla’s latest creation: An electric big rig that can travel 500 miles on a single charge

The main course was expected: a pair of sleek silver Tesla semi-trucks that get 500 miles per charge, go from zero to 60 mph in five seconds and — if the hype is to be believed — promise to single-handedly transform the commercial trucking industry.B...
Updated: 13 minutes ago
Florida jobs recover from Irma, unemployment rate drops

Florida jobs recover from Irma, unemployment rate drops

The tough hit that Florida jobs took from Hurricane Irma was not long lived, as predicted by economists. The state added 125,300 jobs in October, almost breaking even from the 127,400 jobs it lost in September. According to state figures released Fri...
Updated: 1 hour ago
Trigaux: State of Tampa Bay startups? Disconnected we falter but there’s a plan to fix that

Trigaux: State of Tampa Bay startups? Disconnected we falter but there’s a plan to fix that

How are we doing?That was the Big Question posed more than once this past week in Tampa Bay. First, the Tampa Bay Partnership and USF debuted in-depth and new ways to measure Tampa Bay across a wide range of indicators to gauge whether we are gaining...
Updated: 3 hours ago
We ask Tampa Bay startup leaders how best to advance entrepreneurial ecosystem

We ask Tampa Bay startup leaders how best to advance entrepreneurial ecosystem

What one thing could be added to the Tampa Bay startup community to help it grow and prosper?The Tampa Bay Times reached out to these leading area entrepreneurs and startup experts for answers.RELATED COVERAGE: Trigaux: State of Tampa Bay startups? D...
Updated: 3 hours ago
Before you hit the mall: here are some key holiday shopping hours

Before you hit the mall: here are some key holiday shopping hours

Plotting a shopping strategy for the holiday weekend? Here’s a look at holiday store opening hours for some major retailers:Thanksgiving8 a.m.: Kmart1 p.m.: JCPenney4 p.m.: GameStop5 p.m.: Best Buy, Macy’s, Toys "R" Us, Kohl’s6 p.m.: Old Navy, Target...
Updated: 5 hours ago
Electric, autonomous vehicles featured at Tampa auto show

Electric, autonomous vehicles featured at Tampa auto show

TAMPA — The two biggest trends in the automotive space are ones you’ve likely heard of: electric vehicles and autonomous cars. Both will feature prominently at the Tampa Bay International Auto Show today through Sunday. The event at the ...
Published: 11/17/17
Developer changes approach as downtown Largo project lags in financing

Developer changes approach as downtown Largo project lags in financing

LARGO — Driving down West Bay Drive, you may notice some changes to downtown Largo.A new 29-unit apartment complex on Ridge Road stands finished and ready for residents. South of the complex, land that was formerly home to a community of rundown cott...
Published: 11/17/17
New vegan prepares for Thanksgiving with meat loving family

New vegan prepares for Thanksgiving with meat loving family

This will be my first Thanksgiving as a vegan. And, I’m nervous.It’s also first time back in my hometown of Milwaukee in five years. In a three-day span, I will visit at least 15 different relatives’ houses. All of whom welcome you in with a smile, a...
Updated: 27 minutes ago
In Tampa Bay and elsewhere, early numbers show record sign-ups for Obamacare

In Tampa Bay and elsewhere, early numbers show record sign-ups for Obamacare

Despite the budget cuts, the attempts to repeal and replace, and reports of sharp rises in premiums, Floridians and other Americans are signing up for health insurance under the Affordable Care Act at record rates this year.Enrollment has surged 47 p...
Updated: 4 hours ago
A Santa flight academy? Malls pull out stops to counter online shopping

A Santa flight academy? Malls pull out stops to counter online shopping

TAMPA — One of Santa’s helpers warns the grown ups to stand back. Sawyer Baker is about to be fitted for his virtual flight academy suit.The four-year-old from Safety Harbor holds his arms straight out, just like he’s told, and sees a moving, mirror ...
Updated: 4 hours ago