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February 16, 2022 ENCORE NewsUncategorized

Jacksonville Center for Clinical Research is Participating in ORCA-3, a Phase 3 Clinical Research Study Evaluating an Investigational Smoking Cessation Therapy

Jacksonville Center for Clinical Research is enrolling eligible volunteers into ORCA-3, a U.S. Phase 3 clinical research study evaluating the safety and efficacy of cytisinicline, an investigational therapy for smoking cessation in adults who smoke ten or more cigarettes per day, intend to quit smoking and have failed at least one previous attempt to stop smoking with or without therapeutic support.

A recent report showed, in 2020, for the first time in twenty years, there was an increase in cigarette purchases[1]. Despite the clearly defined health risks associated with cigarette smoking, it is estimated that there are 34 million adults who are current cigarette smokers.[2] Prescription medication and counseling have been shown to improve quit rates yet are used by a minority of those trying to quit. Among the 68% of smokers who want to quit, less than 7% reported using counseling and only 29% reported using pharmacotherapy, and less than 5% used both.[3]

Cytisinicline is a plant-based, naturally-occurring investigational compound that is structurally similar to nicotine and is believed to aid in smoking cessation by binding more specifically to a certain nicotinic receptor in the brain. This binding partially stimulates dopamine release, which reduces nicotine cravings and the severity of nicotine withdrawal symptoms. It also directly inhibits nicotine binding, reducing the satisfaction typically associated with smoking.

The FDA-approved non-nicotinic smoking cessation therapies, varenicline and bupropion, can improve rates of smoking cessation, but they are associated with troublesome side effects. Additional treatment options are needed if we are to help more people successfully quit smoking and reduce their smoking-related health risks. While the benefits of quitting cigarette smoking are well understood in both the medical and consumer communities, it is encouraged that cigarette smokers make quitting a resolution for 2022 and to speak with their health care providers about options that can help them succeed, including potential clinical trial participation when appropriate.

ORCA-3 is being conducted to learn more about the effectiveness and safety of 3.0 mg cytisinicline for 6 and 12 week study treatment periods in combination with behavioral support in people trying to quit cigarette smoking. The research will also assess the safety and tolerability of the study drug.

Jacksonville Center for Clinical Research is a clinical site participating in ORCA-3. The study is open to adults at least 18 years of age who currently smoke ten or more cigarettes per day, intend to quit smoking, and have failed at least one previous attempt to stop smoking with or without therapeutic support. Participants must be willing to set a quit date within 5-7 days of starting treatment and be willing to actively participate in the study’s smoking cessation behavioral support provided throughout the study.

If you or someone you know is interested in joining the study, please call 904-730-0166


[1] Cigarette Report for 2020 – (n.d.). Retrieved November 9, 2021, from

[2] Centers for Disease Control and Prevention. Current Cigarette Smoking Among Adults in the United States. Available at: Updated November 18, 2019.

[3] Adams AJ and Hudmon KS. Pharmacist prescriptive authority for smoking cessation medications in the United States. J Am Pharm Assoc. 2018;58(3):253-257. doi: 10.1016/j.japh.2017.12.015


January 17, 2022 ENCORE News

Jacksonville Cardiologist and JCCR Founder, Dr. Michael Koren M.D., published as first author an article in the prestigious journal Nature Medicine about a new, first-in-class Lp(a) lowering therapy called Olpasiran.  Lp(a) is the lipoprotein that includes an LDL particle and the apolipoprotein a (protein portion that surrounds the LDL molecule) called LPA.  Olpasiran prevents the LPA gene from forming apolipoprotein a; therefore, Lp(a) is not made.

Lipoprotein a, Lp(a), is an independent risk for cardiovascular disease.  It is associated with a higher risk of heart attack or stroke and is pro-inflammatory. There are currently no pharmacotherapies directly targeting Lp(a) available for clinical use.

Still confused? Go to for more details on this exciting breakthrough.

(Images from FH Foundation)



December 1, 2021 ENCORE News

First FDA Approved Therapy for Presbyopia (Age-Related Blurry Near Vision)

Vuity is the first FDA-approved therapy for presbyopia, and ENCORE Research Group helped make it a success.

12/1/21- Jacksonville, FL- Nature Coast Clinical Research Crystal River (NCCR-CR), a part of ENCORE Research Group, hosted clinical trials that led to the FDA approval of VUITY™. VUITY is the first FDA-approved therapy to treat presbyopia. 

“The FDA approval of VUITY™ is so important because it treats a very common condition for anyone who is reaching 40,” Nina Smith, site manager at NCCR-CR. “We are happy to be a part of such a successful trial!”

Many adults find themselves using reading glasses, holding text further away, and increasing the font size and brightness on screens due to presbyopia. Presbyopia shows its signs nearing the age of 40 and affects over 128 million adults in the United States. 

VUITY is a once-daily eye drop prescription that works as early as 15 minutes and lasts up to 6 hours. Clinical trials have shown that it improves near-sighted vision without impacting distance vision. VUITY’s success rate prompted other clinical trials as well to treat presbyopia. ENCORE Research Group is enrolling in new VUITY studies to test the product further. See the details below for more information on participation. 

ENCORE Research Group is a premier clinical research organization with multiple research offices in Florida; three are located in Jacksonville. ENCORE Research Group sites have conducted more than 2,500 clinical trials over 24 years and have worldwide recognition for providing patients access to cutting-edge medical research. 


People interested in participating in a clinical research trial can visit or call our headquarters office at (904) 730-0166


Contact: Sharon Smith

Phone: 904-730-1066



November 18, 2021 ENCORE News

First Messenger RNA, RSV Vaccine Patient Dosed in Jacksonville, Florida

The first patient in a phase 2 study in the United States received a new, investigational Respiratory Syncytial Virus (RSV) vaccine in Jacksonville Center for Clinical Research.

11/17/2021- Jacksonville, Fl – Jacksonville Center for Clinical Research, a member of ENCORE Research Group, became the first in the United States to dose a new, investigational, Messenger RNA (mRNA), RSV vaccine to a patient in a phase 2 trial sponsored by Moderna, Inc. This helps the U.S.  become closer to finding a preventative vaccine for RSV. RSV commonly has symptoms similar to influenza, COVID, and other highly pathogenic viruses.

“It is exciting to be a part of history,” Amber DeVries, study coordinator for the trial, says. “More than anything, though, it is an important step toward finding a vaccine for a virus that can be deadly.”

RSV infection rate has been on the rise, with cases skyrocketing in the summer of 2021. The cases were increasing so rapidly that the CDC issued a Health Alert on June 10, 2021. RSV is a virus that mainly affects children and adults over 65. RSV may cause severe complications to immunocompromised people.

“We should talk about and protect ourselves from the dangers of RSV,” Dr. Michael Koren, CEO of ENCORE Research Group, says. “COVID has captured our focus and rightfully so, but RSV cases have risen and continue to increase. Teamwork from the ENCORE Research Group, Moderna, and the clinical trial participants, has brought us one step closer to eradicating this virus.”

The RSV vaccine uses the same mRNA technology as the breakthrough COVID vaccines. The mRNA technology provides real-time instructions to make the proteins necessary to help our immune system fight off RSV. Many physicians and scientists believe mRNA has significant potential to improve patients’ lives.

ENCORE Research Group is a premier clinical research organization with multiple research offices in Florida; three are located in Jacksonville. ENCORE Research Group sites have conducted more than 2,500 clinical trials over 24 years and have worldwide recognition for providing patients access to cutting-edge medical research.


People interested in participating in a clinical research trial can visit or call our headquarters office at (904) 730-0166


Contact: Sharon Smith

Phone: 904-730-1066



December 8, 2020 ENCORE News

We are proud to announce that the US Food and Drug Administration (FDA) has approved lumasiran (now called OXLUMO™) for the treatment of primary hyperoxaluria type 1 (PH1). PH1 is a rare disorder that affects the kidneys causing severe pain in both children and adults.

ENCORE Research Group played a significant role in the clinical development of OXLUMO™ and we could not be prouder of all of our staff. However, none of this would be possible without the commitment and heroism of our patients who dedicated their time to improve medicine.


We asked, “What motivates you to participate in clinical trials?” With over 160 responses, the answer is clear. People who participate in clinical trials are dedicated to helping others by improving medicine for future generations.

We also found that very few were participating in order to receive the stipend for time and travel. This says a lot about the type of people who are willing to participate in clinical trials. They are in it for the cutting edge treatment, and the need to help others.

There is truly only one way to improve healthcare, and that is to participate in clinical trials. Thank you to everyone who responded to our survey, and everyone who participates in these trials.


We are excited to announce another FDA approved drug that was tested at ENCORE Research Group’s Nature Coast Clinical Research office In Crystal River Florida. Upneeq™, is a drug to help adults with blepharoptosis, or ptosis, which is a condition where there is an abnormal drooping of the upper eyelid causing a loss in vision. Upneeq™ is currently the only FDA approved medical treatment for drooping eyelids (ptosis).


For more information about this, view the full press release here:



March 19, 2020 ENCORE News

To our ENCORE Community and Industry Partners,

ENCORE is taking the COVID-19 crisis seriously, in part by understanding that clinical trials will provide the only durable solution to this crisis and other afflictions facing our community and country.

All of our ENCORE sites are open for business for both patient and industry visits. We have added precautions to minimize the risk of virus transmission to patients and employees and to ensure that ongoing clinical trials are completed.

We have instituted more frequent and aggressive cleaning and infection control procedures. We also ask anyone with acute influenza-like symptoms or those who have been in close contact with individuals that have tested positive for COVID-19 to reschedule after following the federal guidelines for 14-day self-isolation. In taking sensible precautions, we hope our patients and industry partners will feel comfortable that our ongoing operations don’t put our community at risk…only benefit it.

We do understand some of our industry partners have implemented additional requirements for their staff and we are prepared to accommodate them remotely or virtually in order to keep projects moving forward.

Analysis of shows there are nearly 80 clinical trials worldwide for investigational new treatments and vaccines in development. About 15 of those have been expanded to take place in the United States, of which, we aim to take part.


Michael Koren, MD, FACC, FAPCR, CPI Medical Director and Chief Executive Officer


February 8, 2019 ENCORE News

JACKSONVILLE, FL – ENCORE Research Group (ERG) and Borland Groover Clinic (BGC) announced today a clinical research joint venture. Effective March 1, 2019, Borland Groover Division of Research and Jacksonville Center for Clinical Research join forces under the newly organized entity, ENCORE Borland Groover Clinical Research (EBGCR). EBGCR will participate with seven other sites in Florida under the ENCORE umbrella. The partnership will bring the best of gastroenterology care and clinical research together with the goal of maximizing clinical trial opportunities for community patients and sponsors.

“EBGCR represents a terrific opportunity for physicians within and across specialties to cooperate on world class clinical research. We believe that the new joint venture will facilitate access to trials for appropriate patients and qualified physicians” according to Dr. Michael Koren, CEO of ENCORE Research Group.

Dr. Kyle Etzkorn, CEO of BGC said, “Borland Groover Clinic provides state of the art GI care. Our research joint venture with ENCORE enables us to more broadly apply our knowledge and technology to clinical research development programs”.

The clinical research industry has become more challenging in recent years for a variety of reasons including greater regulatory scrutiny, increasing complexity of trials and the unpredictability
of the duration and success of individual projects. As Florida’s leading health providers, BGC and ERG strive to deliver easy access to the high potential, advanced, and innovative treatments offered in clinical trials.

For more information contact Cynthia Buda, RN, CCRC, EBGCR Lead at


ENCORE Research Group currently conducts research at seven locations in the State of Florida. Sites include Fleming Island Center for Clinical Research, Jacksonville Center for Clinical Research, Nature Coast Clinical Research – Crystal River, Nature Coast Clinical Research – Inverness, River City Clinical Research, St. Johns Center for Clinical Research and Westside Center for Clinical Research.  In addition, ERG has established an information technology division that conducts research training, develops software products for clinical trialists and serves as an incubator for web-based IT products that link physicians and their patients.

About Borland Groover Clinic

Over the past 70 years, Borland Groover has grown into one of Florida’s largest gastroenterology practices with more specialists, more locations and more hospital partnerships to deliver the most advanced treatments and the best possible patient care. BGC physicians provide care for more than 100,000 patients each year with digestive disorders and conditions that include inflammatory bowel disease, liver disease including hepatitis, irritable bowel syndrome, acid reflux disease, esophageal disorders and more. BGC physicians perform more than 50,000 colonoscopies a year, the only procedure used effectively for colon cancer prevention, and for diagnosing colonic disease.

Name of Press Contact: Cynthia Buda
Date: 08 Feb 2019
Phone: 904-621-0390


August 2, 2018 ENCORE News

Register to attend our 17th annual Clinical Research Training for Physicians! This TransCelerate GCP approved course will earn you CME credits while exploring the ethical, legal, and medical nuances of being an investigator in clinical trials. The course takes place November 2nd and 3rd 2018 at the University of North Florida in Jacksonville, Florida. Visit for details on speakers, agenda, and registration.


September 17, 2017 ENCORE News

ENCORE, now a nationally recognized research group, proudly announces the launching of the ENCORE Lipid Center of Excellence.  ENCORE stands for ENcouraging COmmunity Research and Education.  Our new Lipid Center extends our previous successes in this important area of public health.  Lipid problems account for a huge number of heart attacks, strokes and other vascular disease problems each year.

ENCORE CEO and Founder, Dr. Michael Koren, a cardiologist and renown researcher in the area of lipids, has had a long standing interest the treatment of challenging lipid disorders.  He will be leading the Center along with Lori Alexander, a Clinical Lipid Specialist and researcher who is very active with the National Lipid Association.  They both have been a part of ENCORE Research since its formation, and will be putting together resources to bring new lipid treatment studies to the Center.  Previous successes have involved major contributions in widely prescribed cholesterol drugs such as Lipitor and Crestor.

There are many exciting new medications currently being developed to treat conditions such as elevated lipoprotein (a), an important risk factor for heart disease, which will be conducted at the Lipid Center of Excellence.  These studies can offer an opportunity for the community to access cutting-edge treatments.  Join your fellow community members who have already derived educational and health awareness benefits from their participation in research studies.  Donna Toy, a wonderful, longstanding patient who has suffered many family losses from severe cholesterol problems may have said it best: “I have such peace of mind knowing that we can be helped in controlling our heart disease and learn more about our conditions with hands-on help.”

Patients can contact Sharon Smith at 904-730-0166 or Lori Alexander, Director at 904-730-0101 for more information on the Lipid Center of Excellence. Sponsors can contact Jolenne Wolfer 904-732-6683


June 22, 2016 ENCORE News

Jacksonville Center for Clinical Research (JCCR) University site has conducted over 1,000 clinical trials since 1997. Our four acre campus also houses the corporate offices for centralized site services for Encore Research Group (Our network of sites in the state of Florida). The impressive investigator panel includes more than 50 physicians conducting trials in 25 therapeutic areas. JCCR is well equipped to perform Phase 1 through Phase 4 studies, including first-in-human PK and PD protocols. Enhanced capabilities of our site include long-term stay facilities, and treadmill equipment, and an active inpatient trial team.


  • Michael J. Koren, MD, FACC, CPI – Chief Executive Officer
  • Richard Smith, RN – Lead Coordinator

Facility Description

  • Multiple Bedrooms
  • Treadmill & Cardiorespiratory diagnostic capabilities room
  • Private bath with shower
  • 1 mile to emergency room
  • Full kitchen

Encore logo

As a proven clinical research organization, we take every precaution to assure the safety of and maximize the value for our research volunteers. Qualified doctors, nurses and study coordinators on staff provide support and care throughout the research trial. Participation is always voluntary. We appreciate the time and effort that research volunteers bring to this important process.

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