Francisco Leyva, a 2007 toxicology Ph.D. graduate of the University of Montana, is on the forefront of researching possible therapeutics for the novel coronavirus. As the medical officer for the National Institute of Allergy and Infectious Diseases, he oversees clinical trials of the Division of Microbiology and Infectious Diseases with the National Institutes of Health.
Leyva, who is a native of Peru, shared how his work contributes to coronavirus research.
What does your role as a medical officer within the National Institute of Allergy and Infectious Diseases entail?
I am part of the team that manages clinical trials funded by the National Institute of Allergy and Infectious Diseases. My responsibility as physician-scientist in the Respiratory Diseases Branch is to ensure individual safety and compliance according to our Code of Federal Regulations for human protection. Some of these projects could be Phase 1 or Phase 2 clinical trials testing products in the pipeline for future FDA approval.
The first step in vaccine development is safety. Once its safe use is known and described, dose optimization and time intervals for administration aimed to efficacy can be determined.
How has your research involved coronavirus?
As a medical officer, I work for NIAID’s Division of Microbiology and Infectious Diseases, which does not have a laboratory or clinic. However, we are continuously working collaboratively with various other government agencies (FDA, CDC, BARDA, etc.) in helping facilitate the development of new resources such as diagnostic tools, vaccines for prevention or treatment, and the development of antivirals for emerging pathogens, including the current SARS-CoV-2 public health emergency.
How is your work challenged by coronavirus?
As a scientist, I know it is difficult to predict the future, moreover in the global context. In the U.S., we are working diligently to facilitate the development of vaccines and antivirals to prevent COVID-19 disease and stop its transmission.
This is a new disease and, as part of the international scientific community, we are learning more about the virus and the disease (COVID-19) each day, which is helping us develop strategies to combat the outbreak and treat the disease.
Three months ago, my expertise in coronavirus was very limited. However, as a medical officer of the Respiratory Diseases Branch, I have been part of a multidisciplinary team evaluating novel flu vaccines and antibiotics to treat drug-resistant tuberculosis.
This expertise, together with my previous experience working with cell cultures and different disease models at UM’s Center for Environmental Health Sciences, have been very helpful when planning the development of new clinical trials to assess novel and safe therapeutics for any infectious disease, including coronavirus.
While at UM, I became an expert at using molecular techniques aimed to make cells express foreign proteins and to detect those induced cellular responses. All this knowledge had been very useful to understand the design and action of the 2019-nCoV Vaccine currently in Phase 1 of clinical development and already announced by our director, Dr. Anthony Fauci.
How did you fall into your current line of research?
I don’t remember when in my life I decided to become a physician. By the time I was in elementary school, I already knew that I wanted to go to medical school. My father also was a physician, and I loved visiting his workplace (the hospital) and his former medical school just across the street from the hospital. I consider myself extremely curious and a problem-solver, so being a physician-scientist is the perfect combination to explore humanity’s oldest challenge – disease – and to find a solution through research and drug development.
My passion for the respiratory system began while I was at medical school in Lima, Peru, so I have followed this path for my entire career. I did research in mechanical ventilation, acute respiratory distress syndrome (ARDS), asthma, pneumoconiosis (due to dust inhalation), and other infections (bacterial, viral and mycobacteria). In 2009, while at Johns Hopkins, I was assigned a first-in-human clinical trial, and soon after that I decided I wanted to continue working in the drug development pipeline to bring to the public innovative products aimed to cure or reduce illness and improve quality of life.
Contact: Francisco J. Leyva, Respiratory Diseases Branch medical officer, National Institute of Allergy and Infectious Diseases, email@example.com.