Novartis fired top two R&D scientists in-charge of Avexis unit before FDA manipulation data scandal revealed


In early May this year, AveXis’s two top scientists were fired, at around the time that Novartis confirmed internally that the Zolgensama approval application contained data manipulation but, important to note, before it notified the FDA.

These two scientists were former Chief Scientific Officer, Brian Kaspar and his brother Allen Kaspar. They no longer work at Avexis and Novartis has been quick in replacing their roles to a combined position, to be taken over by Page Bouchard, the most recent head of preclinical safety for Novartis institutes for BioMedical Research.

Novartis CEO, Vas Narasimhan, has stated that the company is in the process of eliminating ‘a small number of AveXis scientists.’ According to reports from call data from Novartis, executives were first notified of the data manipulation in mid-March. Then conducted an internal probe in Mid-May before waiting to announce to regulators on the 28th June, a full month after Zolgensama was approved by the FDA.

The CEO went on to say: ‘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.’

Luckily for Novartis, the FDA have deemed Zolgensama safe and fit for use as manipulation was only implemented towards the animal assay data. Data that was not used in the manufacturing of the commercial product. However, where the issue arises is the process that happened after the data manipulation was revealed internally. With the delay in the notification to the FDA creating questions surrounding Novartis’s conduct and integrity.

Senate Finance Committee Chair Chuck Grassley has started an investigation into the timeline of events that occurred. With Grassley requiring information on who was/will be fired as well as what Novartis will do to stop something like this from happening again.

No comments:

Post a Comment

Coranavirus and its relationship with IP exclusivity

With the global shutdown that has occurred due to COVID-19, its presence has caused long-lasting effects in all aspects of our lives and t...