SAN DIEGO--(BUSINESS WIRE)--Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a leading clinical-stage messenger RNA medicines company focused on the development of infectious disease vaccines and significant opportunities within liver and respiratory rare diseases, announced the appointments of Dr. Nirdosh Jagota as the Chief Regulatory Officer and Dr. Dushyant B. Varshney as the Chief Technology Officer.
“We are very pleased to have Dr. Jagota and Dr. Varshney join our management team at Arcturus. Both bring extensive experience in prominent biopharma positions, and have played key leadership roles in the approvals of numerous significant vaccines and therapeutics. As leaders in their respective fields, Nirdosh and Dushyant add invaluable expertise and depth to our leadership team as we expand manufacturing platforms for our pipeline assets and engage with regulatory agencies across the world,” said Joseph Payne, President & CEO of Arcturus.
Dr. Jagota is responsible for regulatory affairs at Arcturus and joins the company with more than 30 years of experience in leading roles in drug development, quality, and regulatory sciences for vaccines, biologics and small molecules. Most recently, he was the Senior Vice President in Global Regulatory Affairs and Clinical Safety at Merck & Co., where he oversaw engagement and strategy with regulatory agencies across the world, including those in the United States, Europe, Latin America, Canada, Japan, and China. Previously, Dr. Jagota held the position of Vice President of Global Regulatory Affairs at Genentech and Pfizer.
“I am tremendously thrilled about my opportunity with Arcturus Therapeutics and am looking forward to helping strategically guide and advance our portfolio to ensure global access for our vaccines and medicines,” said Nirdosh Jagota Ph.D. Chief Regulatory Officer of Arcturus.
Dr. Jagota holds a Ph.D. in clinical pharmacokinetics and pharmaceutical sciences from University of Georgia, MS in biotechnology from University of Toledo, Ohio, and a BS/MS in pharmacy from Indian Institute of Technology (IIT) Varanasi. Dr. Jagota has served on several committees of the Pharmaceutical Research and Manufacturers of America (PhRMA) including the Regulatory Sciences steering committee. He is also the past chair of Regulatory Science section of the American Association of Pharmaceutical Scientists (AAPS), the Drug Information Association (DIA), and International Society for Pharmaceutical Engineering (ISPE). He currently serves on the “One-Voice-of-Quality” committee for the Parenteral Drug Association (PDA). Dr. Jagota is also member of the Advisory committee for College of Pharmacy Graduate program at University of Georgia. Dr. Jagota is an active sponsor of Sharing Science Solutions (CASSS) and a founding member of the CASSS Japan and China forum, which is a leading organization for converging Quality requirements in Japan and China with the International Council for Harmonization (ICH) for Biologics and Vaccines Development.
In his career, Dr. Jagota has led and contributed to development, approval, and expansion of more than 30 vaccines and therapeutics including Gardasil®9, Kadcyla®, Erivedge®, Zelboraf®, and Keytruda®.
Dr. Varshney is responsible for Global CMC, Technical Operations & Quality at Arcturus. An accomplished biotech executive with over 25 years of experience in leading entire product lifecycles of diverse modalities including mRNA, gene & cell-based therapeutics, biologics, vaccines and sterile injectables, Dr. Varshney has contributed to licensure and commercialization of more than 30 products and ensured supply of more than 7B+ doses, driving over $20B in revenues. Before joining Arcturus, Dr. Varshney was the Global Head of Manufacturing, Science & Technology at Kite Pharma (a Gilead company) where he led rapid commercialization strategy for successful technology transfers, launch & patient access of Yescarta®, Tecartus®, viral vectors and clinical products. Prior to Kite, he served as the Vice President, Global Head of Technical Services, Operations & Supply at Jubilant, and as the Head of Manufacturing, Science & Technology at Pfizer. Before that, he worked on commercial technology transfer and manufacturing of Flucelvax® and pre-pandemic vaccine stockpiles at Novartis.
“I am greatly excited about my journey at Arcturus and I look forward to advancing the innovative platform technologies and pipeline to the clinic and toward commercialization,” said Dr. Varshney, Chief Technology Officer of Arcturus. “It is an honor to work with the team to build out our global manufacturing footprint and integrated supply chain network for the next-generation of vaccines and new medicines.”
Dr. Varshney received his Ph.D. in chemistry from University of Iowa, M. Pharm from Institute of Chemical Technology, Mumbai, and B. Pharm from University of Pune in India. He has served on multiple academic and professional boards, and has made over a hundred conference presentations and publications.
About Arcturus Therapeutics
Founded in 2013 and based in San Diego, California, Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a clinical-stage mRNA medicines and vaccines company with enabling technologies: (i) LUNAR® lipid-mediated delivery, (ii) STARR™ mRNA Technology and (iii) mRNA drug substance along with drug product manufacturing expertise. Arcturus’ diverse pipeline of RNA therapeutic and vaccine candidates includes mRNA vaccine programs for SARS-CoV-2 (COVID-19) and influenza, and other programs to potentially treat ornithine transcarbamylase (OTC) deficiency, and cystic fibrosis along with partnered programs including glycogen storage disease type III, hepatitis B virus, and non-alcoholic steatohepatitis (NASH). Arcturus’ versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA, replicon RNA, antisense RNA, microRNA, DNA, and gene editing therapeutics. Arcturus’ technologies are covered by its extensive patent portfolio (patents and patent applications issued and filed in the U.S., Europe, Japan, China and other countries). Arcturus’ commitment to the development of novel RNA therapeutics has led to collaborations with Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, Ultragenyx Pharmaceutical, Inc., Takeda Pharmaceutical Company Limited, CureVac AG, Synthetic Genomics Inc., Duke-NUS Medical School, and the Cystic Fibrosis Foundation. For more information visit www.ArcturusRx.com. In addition, please connect with us on Twitter and LinkedIn.
Forward Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact included in this press release, are forward-looking statements, including those regarding strategy, future operations, collaborations, the likelihood of success (including safety and efficacy) of the Company’s pipeline, the likelihood or timing of any regulatory approval, the likelihood that a patent will issue from any patent application, its current cash position and expected cash burn and the impact of general business and economic conditions. Actual results and performance could differ materially from those projected in any forward-looking statements as a result of many factors. Arcturus may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in any forward-looking statements such as the foregoing and you should not place undue reliance on such forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties, including those discussed under the heading "Risk Factors" in Arcturus’ Annual Report on Form 10-K for the fiscal year ended December 31, 2020, and in subsequent filings with, or submissions to, the SEC. Except as otherwise required by law, Arcturus disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.
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