NYMC Collaborates with Regeneron for COVID-19 Clinical Drug Trials
Drug trial at Westchester Medical Center puts NYMC among top researchers in the nation racing to find an effective treatment to fight COVID-19
When COVID-19 first hit our shores in early March with no vaccine nor proven drug treatment in sight, new innovative collaborations sprouted up across the nation, as leading research institutions, pharmaceutical companies and hospitals joined forces to find a solution fast. Among them—a collaborative clinical drug trial by New York Medical College (NYMC) and Regeneron launched at Westchester Medical Center (WMC) within the first few weeks. Seeking a partner with whom to establish a clinical drug trial that could be used to treat critically ill patients with COVID-19, Regeneron Pharmaceuticals proposed the collaboration—not only for NYMC’s state-of-the-art virology labs and internationally regarded experts—but because of the College’s decades-long involvement in the annual development of the influenza vaccine.
“As a result of COVID-19, people from across all sectors are coming together to help drive efforts to find a treatment and stop the virus.” says Salomon Amar, D.D.S., Ph.D., vice president for research at NYMC and provost for biomedical research at Touro College and University System. “In any situation, wherever there is darkness—any negative impact—there is always some light. For the COVID-19 crisis, this new collaborative spirit represents that light.”
What’s more, in order to approve and launch NYMC’s drug trial in a timely manner—as required by the current global health crisis—the U.S. Food and Drug Administration worked beside leaders in higher-education, medical, pharmaceuticals, finance and data collection in order to expedite the IRB approval process, which normally takes anywhere from six to nine months.
Leading the charge for NYMC in conjunction with WMC—Lawrence DeLorenzo, M.D., professor of clinical medicine, joint chief, Division of Pulmonary, Critical Care and Sleep Medicine, director of the Medical ICU and medical director of the Respiratory Therapy Department at NYMC/WMC, Donald Chen, M.D., assistant professor of medicine and hospital epidemiologist for the Infection Prevention Department at WMC, and Alison Lennox, M.D., clinical assistant professor of medicine—have been tasked with working on the clinical trial to test the efficacy of a drug to treat COVID-19. Specifically, they are testing the drug Sarilumab, (trademarked as Kevzara by Regeneron and the Paris-based pharmaceutical company Sanofi), which is known to inhibit inflammation.
As the principal local Investigator for NYMC and WMC on the randomized clinical trial of Sarilumab, Dr. Chen explains, “With COVID, drug companies, hospitals and medical schools have partnered to quickly and collaboratively launch studies. This could be a model for future studies where time is of essence.” Yet in spite of the current and unique need for urgency, Dr. Chen is quick to point out that the study’s systematic approach remains status quo—executed in a methodical and precise manner. “It is important that potential therapies for COVID be studied in a systematic manner as a part of clinical trials, in order to ascertain which therapies actually provide benefit,” he says. Dr. Amar adds, “While we can’t have definitive results from the drug trial until the test is complete, that may be as soon as the middle of this summer.”
Speaking to what the future may bring for NYMC in the context of COVID-19, Dr. Amar says, “Will there be a lasting impact from COVID-19? Will this event change the way we collaborate with other hospitals and the way we work with all of our potential partners? The answer is of course.” Dr. Amar continues, “NYMC has an opportunity to create bonds with the pharma industry, to establish the fact that we are an appropriate partner in this process. Word of mouth is very important in the pharma industry and that's the reason I wanted the clinical trials to be associated with the College. Because once the word is out that NYMC is a mover and shaker in a very prominent high profile clinical trial, other companies may be tempted to come back to us for other things. Not just in the context of COVID-19 trails, but in other trials down the road.”