Robert W. Malone MD, MS is a US-based physician-scientist who operates a consultant practice specializing in advanced development of medical countermeasures for infectious diseases (vaccines and drugs). He has served as an Assistant and Associate Professor of Pathology and Surgery at UC Davis, University of Maryland, and the Armed Forces University of the Health Sciences. Core competencies include clinical development, regulatory affairs, project management, and contract development. His medical degree is from the Northwestern Feinberg School of Medicine. He completed the Harvard Medical School fellowship as a Global Clinical Research Scholar in 2016, and was scientifically trained at UC Davis, UC San Diego, and at the Salk Institute Molecular Biology and Virology laboratories. Dr. Malone is an internationally recognized scientist (virology, immunology, molecular biology) and the original inventor of mRNA Vaccination, DNA Vaccination, and multiple non-viral DNA and RNA/mRNA delivery technologies. Dr. Malone holds numerous fundamental domestic and foreign patents in the fields of gene delivery, delivery formulations, and vaccines: including for fundamental DNA and RNA/mRNA vaccine technologies. He has approximately 100 peer-reviewed publications and published abstracts and about 12,000 citations of his peer reviewed publications (per Google Scholar with an “outstanding” impact factor rating). He has been an invited speaker at over 50 conferences, has chaired numerous conferences and he has sat on or served as chairperson on numerous NIAID and DoD study sections.
Dr. Malone has a history of assembling and managing expert teams that focus on solving complicated biodefense challenges to meet US Government requirements. He was instrumental in enabling the PHAC/rVSV ZEBOV (“Merck Ebola”) vaccine to move forward quickly towards BLA and (now recently granted) licensure. Dr. Malone got the project on track in support of DoD/DTRA and NewLink Genetics, recruited organizations to team with USAMRIID/WRAIR to develop the immunoassays, put WHO and Norwegian government philanthropic leadership in touch with Pentagon leadership to expedite the initial WRAIR clinical and ring vaccination trials, recruited a management team, recruited Merck vaccines to purchase the product candidate from NewLink, helped write and edit the clinical trials developed by the World Health Organization and lead the development of the BARDA and DTRA contracts – yielding over 200M$ in resources. Dr. Malone’s early involvement in this project allowed for the Merck Ebola vaccine to be developed very rapidly.
Currently, Dr. Malone has been leading a large team since January 10, 2020 focused on clinical research design, drug development, computational discovery and mechanisms of action for COVID-19 repurposed drug treatments. This work has included multiple manuscripts summarizing team findings relating to famotidine, mast cells, and the mechanism of COVID-19 disease. Manuscripts in review focus on clinical effects of celecoxib, famotidine, and dexamethasone in COVID-19. He developed and wrote the initial clinical trial design: A Single Center, Randomized, Double Blinded Controlled Crossover Observational Outpatient Trial of the Safety and Efficacy of Oral Famotidine for the Treatment of COVID-19 in Non-Hospitalized Symptomatic Adults. Another project he has supporting is development and performance of a virtual COVID-19 outpatient clinical trial employing novel on-line patient centered outcomes research capabilities. He has participated on the NIH/FNIH ACTIV review panel for the last year and has also helped open an IND for famotidine use for treatment and prevention of COVID19 disease, an IND and protocols for clinical testing of famotidine + celecoxib for treatment of COVID-19 and has enabled teaming/pharmaceutical supply arrangements with two major pharmaceutical firms. His contract development and management efforts have resulted in over 130M$ US in federal research contract funding during the last year to support this work.