GAITHERSBURG, Md., Oct. 4, 2021 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced the appointment of Denny Kim, M.D., MPH to the newly created role of Senior Vice President, Chief Safety Officer and Head of Global Vaccine Safety. Dr. Kim will report to Filip Dubovsky, M.D., MPH, FAAP, Executive Vice President and Chief Medical Officer. Novavax also announced the promotions of Raburn Mallory, M.D. to Senior Vice President, Head of Clinical Development, and Marco Cacciuttolo, Ph.D. to Senior Vice President, Process and Analytical Development.
Dr. Kim brings nearly two decades of infectious disease, clinical trial and safety experience to Novavax. He joins the company from Johnson & Johnson (J&J), where he was part of the Office of the Chief Medical Officer with oversight for safety strategies and activities across all therapeutic areas, including direct management responsibilities for the safety of the J&J/Janssen COVID-19 vaccine. Previously, he built and led the global Patient Safety and Pharmacovigilance function at Horizon Pharma, developed a new safety function within Takeda's Vaccine Business Unit, and served as Therapeutic Area Safety Head at both Takeda and Astellas. He holds a Doctor of Medicine from University of Chicago Pritzker School of Medicine, a Master of Public Health from Johns Hopkins University Bloomberg School of Public Health and a Bachelor of Arts from Yale University.
"We welcome Denny at an exciting time for Novavax as we finalize our regulatory filings and transition into a commercial-stage organization," said Dr. Dubovsky. "His leadership and COVID-19 vaccine experience uniquely equip him to lead a best-in-class safety and pharmacovigilance function at Novavax."
Dr. Raburn Mallory has been promoted to Senior Vice President and Head of Clinical Development. In his new role, Dr. Mallory will lead the clinical development organization, provide strategic direction for the life-cycle management of Novavax' vaccines and play a key role in regulatory filings. Prior to joining Novavax, Dr. Mallory was Vice President of Clinical Development and the Global Clinical Lead for the COVID-19 and influenza vaccines at AstraZeneca. Prior to that, he was Medical Director for DynPort Vaccine Company. Earlier in his career, Dr. Mallory was a Robert Wood Johnson Clinical Scholar at Johns Hopkins University and an Academic Hospitalist at Yale-New Haven Hospital, where he completed residency training. He holds a Doctor of Medicine from Yale University School Medicine and a Bachelor of Arts from Brown University.
Dr. Marco Cacciuttolo has been promoted to Senior Vice President of Process and Analytical Development. In his new role, he will continue to ensure the technical quality and safety of Novavax' vaccine candidates. Dr. Cacciuttolo has more than three decades of biochemical engineering experience and has successfully developed commercial processes for many products. Prior to joining Novavax in July 2020, he served as head of manufacturing at Nosocomial Vaccine Corporation, as chief operating officer at PathoVax LLC and as managing director of Batavia Biosciences. He holds a doctorate in Biochemical Engineering from the University of Maryland, Baltimore and a Bachelor of Science from Pontifical Catholic University of Valparaíso.
"We also congratulate Raburn and Marco on their promotions, which reflect their meaningful contributions to advancing NVX-CoV2373, our recombinant nanoparticle protein-based COVID-19 vaccine candidate," continued Dr. Dubovsky. "We look forward to their collective contributions as we move toward commercialization."
Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.
Statements herein relating to the future of Novavax, its operating plans and prospects, the ongoing development of NVX-CoV2373 and other Novavax vaccine product candidates, future regulatory submissions, the anticipated role and responsibilities of certain employees, and the role that Novavax and its employees may play in the fight against COVID-19 are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; and those other risk factors identified in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Novavax' Annual Report on Form 10-K for the year ended December 31, 2020 and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov and www.novavax.com, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.
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SOURCE Novavax, Inc.