fiercepharmaSeptember 07, 2018
Tag: Moderna Therapeutics , Merck & Co. , U.S. FDA
Moderna Therapeutics, carrying a valuation in the billions of dollars and testing several mRNA vaccine programs in early stages, has a new leader in vaccines. The company lured FDA official Wellington Sun, M.D., to help discover new candidates and advance existing programs.
Sun will take the position of head of vaccine strategy and regulatory affairs later this month, according to Moderna. The appointment comes several months after former Moderna vaccines head Giuseppe Ciaramella, Ph.D., stepped down to pursue a startup biotech opportunity. Now, Ciaramella is chief scientific officer at Beam Therapeutics.
Sun brings a decade of FDA experience to his role at Moderna. At the agency, he oversaw approvals for 28 new vaccine applications in infectious diseases, plus more than 100 applications for new indications. He also worked with other federal agencies on infectious disease policy, as well as with the World Health Organization and other agencies to address the H1N1 pandemic, plus the Ebola and Zika epidemics.
Before serving at the FDA, Sun worked at the CDC leading research against dengue and West Nile virus. And prior to the CDC, he was a clinician and a vaccine researcher for 27 years at the U.S. Army Medical Corps.
Moderna Chief Medical Officer Tal Zaks, M.D., said in a statement that Sun's experience makes him "uniquely qualified to shape our development strategy" as the company advances its portfolio.
Moderna’s mRNA vaccine pipeline includes candidates against cancer, influenza, Zika, Chikungunya and more. The company advanced a range of programs into human testing in 2016 and 2017, and has partnerships with Merck, AstraZeneca and Vertex. The company has seven infectious disease vaccines in phase 1 testing. Instead of small molecules or biologics, Moderna’s mRNA drugs are "sets of instructions" that direct the body to fight or prevent disease, according to the company. The biotech is testing its platform in a broad range of diseases, and the technology’s promise has catapulted the company to a $7 billion valuation.
Moderna raised $500 million in a series G round in February, pushing its fundraising to date past $1.4 billion. The company followed that up with an expanded Merck collaboration in May worth $125 million. And this summer, it opened a $110 manufacturing plant in Norwood, Massachusetts, to support its mRNA programs.
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