With its COVID-19 vaccine hopeful cycling through clinical trials, shot maker Novavax is working to flesh out its executive team to help lead the company to the commercial stage. But you can't get regulatory approval without a sturdy manufacturing operation—and now Novavax has hired an exec to get that operation in order.
Novavax tapped Ben Machielse as its executive vice president of chemistry, manufacturing and controls (CMC) as the vaccine maker works to take its COVID-19 and four-strain flu hopefuls across the finish line, the company said Monday.
Machielse, a veteran of rare disease company Vtesse and MedImmune, will bring his more than 25 years of pharmaceutical experience to help Novavax take the leap from the clinical to commercial stage, CEO Stanley Erck said in a release.
Machielse's appointment comes just weeks after Novavax appointed AstraZeneca veteran Filip Dubovsky as its chief medical officer, signaling the company's push for its first FDA approval and amid a fundraising spree that's yielded more than $500 million for its vaccine development.
Dubovsky and Machielse will serve in complementary roles as Novavax angles for approvals, with the former tasked with overseeing development of the company's COVID-19 candidate and the latter putting the manufacturing apparatus in place to pass regulatory muster and successfully scale production.
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For his part, Machielse touted Novavax's recent "rapid and precise" manufacturing moves as a major attraction of his newest role.
“The rapid and precise steps Novavax is taking to increase manufacturing capacity for NVX-CoV2373 demonstrate both the validity and the viability of our program as a significant part of the world’s COVID-19 vaccine solution,” Machielse said in a release. “I am excited to work with the team as we rapidly advance development activities and manufacturing capabilities and ensure we deliver safe, innovative vaccines to prevent a broad range of infectious diseases worldwide.”
Novavax is also working to bring its flu vaccine hopeful NanoFlu to an approval. The four-strain flu candidate notched positive phase 2 data in January 2019 showing trial participants on Novavax's shot had better antibody responses against several H3N2 flu viruses, including drifted strains, than Sanofi’s Fluzone HD. It also beat another flu shot in the same trial.
The latest C-suite addition at Novavax comes as other horses in the COVID-19 vaccine race make similar moves to flesh out their leadership teams.
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Earlier this month, Moderna added former Amgen exec David Meline as its chief financial officer in anticipation of a commercial launch for its COVID-19 shot. The company has since recruited another Amgen vet, Ray Jordan, to serve as chief corporate affairs officer.
In the meantime, Novavax has also worked to built out the rest of its own senior management team. Monday, the company said it had hired John Trizzino as its chief business officer and chief financial officer, John Herrmann III as chief legal officer and Jill Hoyt as chief human resources officer.
Earlier this month, Novavax added Silvia Taylor—who previously served at Autolus, Sucampo, AstraZeneca and Pfizer—as SVP of investor relations and corporate affairs. Days before, the company named David Mott, a biotech veteran who led MedImmune for years before its 2007 sale to AstraZeneca, as an independent director. Prior to February, Mott was global head of healthcare investing at New Enterprise Associates.
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All of those appointments come on the heels of Novavax securing a run of financing from the U.S. government and international health organizations.
In May, the company scored a deal worth up to $384 million with the Coalition for Epidemic Preparedness Innovations. Then, the Department of Defense (DOD) inked a $60 million contract with the biotech. Under that deal, Novavax will deliver 10 million doses of the vaccine to the DOD this year.
Earlier this month, Novavax unveiled a $200 million private placement with life sciences investment firm RA Capital.