Operation Warp Speed (OWS)
Therapeutics Development
Woodcock, who recused herself from FDA’s approval decision, is leading OWS’s effort on therapeutics development. Woodcock said, “Even with success, some people will not respond to vaccines, and some people will not get vaccinated. So, therapeutics will always be needed.” There is hope convalescent plasma could lessen the severity of a COVID-19 infection, but it is still unclear if the therapy works. She noted the limited window to retrieve plasma from recovered COVID-19 patients.
Antibody Development Programs + Protocols
Around 50 monoclonal antibody development programs are currently active. The Biomedical Advanced Research and Development Authority sponsored an antibody treatment developed by Regeneron, which is now in Phase II trials. An Eli Lilly antibody treatment is in a Phase I trial. Officials hope uniform clinical trial designs or “master protocols” will make expectations of drug manufacturers clear, make it easier to compare the safety and efficacy of different treatments and speed the development process.
OWS and the National Institutes of Health developed two master protocols for COVID-19 monoclonal antibody clinical trials. One will test the use of monoclonal antibodies in the outpatient setting, and another is for inpatient use. They are scheduled to start testing this month.
Stay tuned for additional details, and in the meantime …
Tracy Everhart
Tracy Everhart is the Editor for Drug Law Journal. A highly-trained and certified medical professional, Tracy is also an accomplished medical writer. After spending years on the front lines of the medical profession, Tracy now devotes her expertise and skills to researching and reporting on new drugs and devices that enter the market, as well as their side-effects and the real-life stories involved. Prior to joining Drug Law Journal, Tracy wrote for benchmark online healthcare resources focused on families and, in particular, women’s health issues. Tracy holds post-graduate degrees from both the American College of Healthcare Sciences and the Yale School of Nursing. She is also a graduate of both Hampshire College, where she studied microbiology and the University of South Carolina school of nursing.