- Novartis has replaced both the chief scientist and R&D head of AveXis, announcing Wednesday the appointment of a veteran Novartis executive to both roles at the biotech developer of the gene therapy Zolgensma.
- Neither Brian Kaspar nor his brother Allan Kaspar have been involved in operations at Avexis since early May, when Novartis confirmed internally the manipulation of preclinical data used to support the approval of Zolgensma. Both were placed on administrative leave and are now no longer with the company.
- In their place, Page Bouchard, most recently head of preclinical safety at Novartis' research institute, assumed on Aug. 5 the positions of senior vice president of research and chief scientific officer at AveXis.
The executive shake-up is the first public change Novartis has made in response to a data scandal that enveloped the company and its CEO Vas Narasimhan.
Following the Food and Drug Administration's revelation that Novartis' application for Zolgensma (onasemnogene abeparvovec) contained manipulated data, Narasimhan confirmed the Swiss pharma was in the process of "exiting" a few AveXis employees involved in the data inaccuracies.
The departure of Brian and Allan Kaspar is notable, as both played significant roles at AveXis, which Novartis bought last year for $8.7 billion.
Brian Kaspar, formerly a clinical trial investigator at Nationwide Children's Hospital, was a scientific co-founder of AveXis and served as its chief scientific officer since June 2015. He at one point owned the largest stake in the biotech held by an individual, at 6.7%. According to an April regulatory filing, Kaspar stood to receive more than $380 million related to the Novartis acquisition.
AveXis directly employed Allan Kaspar as vice president of research and development since early 2014.
Both were placed on administrative leave in May, when Novartis was in the process of investigating internal allegations that testing data comparing two versions of Zolgensma in mice had been manipulated. The company concluded technical reviews in late June, when it informed the FDA of the discrepancies it had found.
That acknowledgement to regulators, however, came roughly a month after the approval of Zolgensma, a fact that spurred the FDA to issue an unusual warning of potential civil or criminal penalties for AveXis and, by extension, Novartis.
Wilson Bryan, head of the FDA's Office of Tissues and Advanced Therapies, indicated in an agency memo that had the FDA known of the data issues, it wouldn't have approved Zolgensma when it did.
The agency is confident in Zolgensma remaining on the market, and the manipulation appears contained to preclinical testing. Still, the incident has marred what was a landmark approval for Novartis and the gene therapy field.
Zolgensma is only the second gene therapy for an inherited disease to be cleared for use in the U.S., and testing in humans showed it to be a potential cure for infants born with a deadly neurodegenerative condition called spinal muscular atrophy.
Novartis continues to investigate the data manipulation, but claims the issues are limited to the actions of a handful of employees. What role Brian and Allan Kaspar played is unclear.
"We do believe this was an issue that was historic in nature and relegated to a few individuals within the company," said Dave Lennon, who was appointed president of AveXis in June 2018, on a recent conference call.