Robert W. Malone, MD, MS Robert W. Malone, MD, MS Madison, VA 22727 PROFESSIONAL EXPERIENCE The original inventor of mRNA and DNA vaccination technologies (1989); including in-vitro and in-vivo RNA transfection. Dr. Malone is a specialist in clinical research, medical affairs, regulatory affairs, project management, proposal management (large grants and contracts), vaccines and biodefense. This includes writing, developing, reviewing and managing vaccine, bio-threat and biologics clinical trials and clinical development strategies. He has been involved in developing, designing, and providing oversight of approximately forty phase 1 clinical trials and twenty phase 2 clinical trials, as well as five phase 3 clinical trials. He has served as medical director/medical monitor on both phase 1, phase 2 and phase 3 clinical trials, including those run at a well-known vaccine-focused Clinical Contract Research Organizations. He has served as principal investigator on some of these. Examples of his infectious disease pathogen advanced (clinical phase) development oversight experience include HIV, Influenza (seasonal and pandemic), Plague, Anthrax, VEE/EEE/WEE, Tularemia, Tuberculosis, Ebola, Zika, Ricin toxin, Botulinum toxin, and Engineered pathogens. In many cases, this experience has included vaccine product development, manufacturing, regulatory compliance, and testing (manufacturing release and clinical) aspects. In most cases, his oversight responsibilities have included clinical trial design, regulatory and ethical compliance, and laboratory assay strategy, design, testing and performance. 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 vaccine to be developed very rapidly. Currently, Dr. Malone is leading a large team since January 10, 2020, focused on clinical research design, drug development, computer modeling and mechanisms of action of repurposed drugs for COVID-19 treatment. This work has included multiple manuscripts summarizing most recent findings relating to famotidine and overall insights into the mechanism of COVID-19 disease, and others focused on celecoxib and famotidine are being reviewed for publication. He has 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 been involved with is a DTRA/DOMANE-funded development and performance of a virtual outpatient clinical trial designed to test new monitoring and data capture technology while using COVID19 as a live-fire example. He has helped open two IND for famotidine and celecoxib use for treatment and prevention of COVID19 disease including an associated 1 Robert W. Malone, MD, MS drug master file, and has enabled teaming/pharmaceutical supply arrangements with two major pharmaceutical firms. Dr. Malone is an internationally recognized scientist and is 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 DNA and RNA/mRNA vaccines. His expertise includes virology, immunology, molecular biology, pathology and pharmacology. Scientifically trained at UC Davis, UC San Diego, and at the Salk Institute Molecular Biology and Virology laboratories, Dr. Malone received his medical training at Northwester