Clinical trials have gotten lots of attention lately with historically significant vaccine trials launching across the country to combat COVID-19. In Charlotte, NC, local newscasters Kristi O’Connor and Dee Dee Gatton at WBTV 3 showcase a prominent independent medical practice and local investigational site. Selected by Moderna for its pivotal mRNA-1273 vaccine trial targeting the deadly SARS-CoV-2 pathogen, Tryon Medical Partners is the only site in the area of nearly 3 million inhabitants conducting the clinical trial. The medical provider has roots caring for Charlotte patients since the 1930s. Recently, the medical practice with 90 physicians also closed a forward thinking deal bringing the clinical research as a care option to Charlotte via the fast growing startup venture Javara.
Tryon Medical Partners SouthPark clinic will serve as the site to test the effectiveness of the mRNA-1273 vaccine under development to prevent COVID-19. With a goal of preventing the virus for up to two years, Tryon Medical Group seeks to enroll over 350 participants.
Tryon Medical Partners represents the coming together of 90 physicians centered on the importance of the patient-doctor connection. Afterall this is the foundation of better health. That this is an independent group is notable in an age of giant health systems. Hence, Tryon Medical Partners believes it can “remain true to our principles, while delivering better care rooted in stronger relationships.”
The group’s roots go back to one of the region’s great medical pioneers. Dr. James Moses Alexander first opened a medical practice on Tryon Street in Uptown Charlotte, North Carolina back in 1936. Over the decades like-minded doctors teamed up with him. By 1972, they were called Mecklenburg Medical Group. The name may have changed but this provider is notable for both its longevity and reputation.
They maintain clinical practices where embracing innovation is key to ensure patients in Charlotte receive the absolute best care possible. Key therapeutic areas or “specialties” include dermatology, endocrinology, gastroenterology, pulmonary, rheumatology, and sleep medicine. Their provider directory can be found here.
The Principal Investigator on the Vaccine
The study is led there by Dr. Ryan Shelton who met with O’Connor to educate Charlotte region residents as to the attributes of this novel and investigational vaccine. Dr. Shelton highlighted that “Its not a live vaccine. It’s a spike protein.” He continued, “So, it’s a piece of the coronavirus, this novel strain. That is in the vaccine and its just enough to cause our body’s own internal defense mechanism to recognize that this is something foreign and to start mounting the antibodies, which is a protein that can help us fight it off if its encountered again.”
Shelton emphasized the recent positive news from the sponsor Moderna on the strong immune response from ongoing research as well as the take way that the product is generally safe and well-tolerated. Dr. Shelby followed up, “Actually, there were pretty minimal side effects. A local infection where you might get a little redness or soreness. Maybe you feel a little achy or sluggish for a day or so. But this medium-dose that was studied, that’s what’s being used in the Phase 3 trial, this one was the best tolerated and highly effective as well.”
The Phase 3 Study
Targeting a total of 30,000 participants from 87 research sites, Moderna commences the study as soon as July 27. See the link for more details.
The Javara Connection & Clinical Research as Care Option
TrialSite profiled a start up vendor called Javara. The company focuses on turnkey offerings involving clinical research as a care option for community practices. Back in 2019, Javara came together with Tryon Medical Partners to form a collaboration to offer industry-sponsored, outpatient clinical trials to the clinic.
Dr. Dale Owen, CEO of Tryon Medical Partners called the deal a “win-win for both our patients and doctors.” Following, “Our patients will now have an opportunity to directly participate in advanced medical trials at no cost, and our doctors will be able to work closely with Javara’s medical professionals on the development of an array of innovative new drugs and interventions. It is also another significant milestone in Tryon’s rapid growth and development since we opened our first of eight clinics in the Charlotte region last September.”
Perhaps Moderna’s selection of Tryon Medical Partners as the site for Charlotte, NC, evidences the positive influence of the Javara partnership.
Call to Action: Are you from the Charlotte area and want to contribute to the COVID-19 vaccine study? Remember if this one is successful, the U.S. has a vaccine! Contact Tryon Medical Partners for more information. Industry sponsors: the Tryon Medical Partners and Javara combination looks valuable for pharmaceutical sponsors and CROs.