Novartis has said it shuffled staff at its under-the-gun gene therapy unit AveXis. Now we know who and when, at least when it comes to the top scientific leaders in that business.
AveXis' two top scientists were shunted aside in early May, right around the time Novartis confirmed internally that its gene therapy Zolgensma's approval application contained manipulated data—but before it notified the FDA.
AveXis’ former chief scientific officer, Brian Kaspar, and his brother Allan Kaspar, previously AveXis’ senior vice president of R&D, are no longer with the company, AveXis said Wednesday. In fact, they “have not been involved in any operations at AveXis since early May 2019.”
And by the time the FDA was ready to go public with the data manipulation scandal, AveXis had a new scientific chief. The Kaspar brothers' jobs, rolled into one, went to Page Bouchard, most recently global head of preclinical safety for Novartis Institutes for BioMedical Research (NIBR).
Bouchard stepped into the job Aug. 5, AveXis said, the day before the agency announced it was considering criminal and civil penalties for the faulty submission.
Novartis CEO Vas Narasimhan has said the company was in the process of terminating “a small number of AveXis scientists” involved in Zolgensma data falsification. And the Kaspar brothers look to be among them.
According to Narasimhan on a recent call with analysts, Novartis first received allegations of the manipulated data mid-March. Then an internal probe confirmed the allegation early May, though it didn’t inform the FDA until June 28, over a month after Zolgensma was approved by the FDA.
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When asked about changes Novartis would make to its oversight, Narasimhan said it had appointed new leaders in the AveXis science areas.
“We need scientists, of course, who follow rigorous procedures and we need leaders who then ensure that there is a strong culture of data integrity and data quality,” the CEO said on the call.
Brian Kaspar had been a board member at AveXis since October 2013 and took on the CSO title in June 2015. Allan Kaspar was first employed by AveXis’ former wholly-owned subsidiary Sixeva before moving to AveXis in January 2014, the company’s 2017 annual securities filing shows.
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Novartis has said the suspect data are limited to an animal assay that’s not used in manufacturing the commercial product. The human trial data used in its drug application package weren't tampered with. Both the FDA and the company say the drug is safe and effective and should remain on the market.
But the very fact that manipulated data was submitted and the delay in notifying the FDA have drawn fire, putting Novartis’ conduct into question.
Senate Finance Committee Chair Chuck Grassley started investigating the detailed timeline of events. The influential Republican also wants to know who has been or will be fired, as well as Novartis’ plan for preventing similar problems in the future. Now at least part of that request has been answered with the Kaspars’ departure.