Big Pharma companies often take an initial hands-off approach when they acquire a biotech to avoid stifling the innovation for which they have sometimes spent billions of dollars. But that approach led to a serious credibility issue for Novartis as a data manipulation scandal has unfolded at gene therapy biotech AveXis. Going forward, Novartis says, it will be hands-off no longer.
The Swiss drugmaker says not only will AveXis’ quality team be folded into its organization, it will happen as quickly as possible. The pledge came this week in Novartis’ response to the FDA about the unreported data manipulation that took place at AveXis ahead of the agency’s approval of Zolgensma, its super expensive gene treatment.
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And while the blame for the data manipulation has been laid at the feet of two former top execs at the AveXis—who were, in fact, turned in by an AveXis subordinate—Novartis says it intends to retrain the biotech’s employees to “instill a culture of quality in AveXis’s operations.”
Novartis has already taken steps to meld the quality approach of the two organizations by putting Novartis veteran Page Bouchard into the role of senior vice president of research and chief scientific officer at AveXis. He took on the responsibilities of AveXis’ former chief scientific officer and company founder Brian Kaspar and his brother Allan Kaspar, previously AveXis’ senior vice president of R&D. The two were fired for allegedly ordering and then covering up the data manipulation. Brian Kasper has denied the allegations through an attorney.
Additionally, Novartis will have the AveXis head of quality assurance (QA) compliance sit on an extended Novartis QA Compliance extended leadership team. The drugmaker says it also has created a “Speak Up” whistleblower-type program to encourage employees to bring issues like this forward.
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All of this and more are detailed in AveXis’ 59-page Form 483 response, which lays out a timeline explaining why it took AveXis and Novartis three months to notify the FDA about the issues at hand. The FDA wasn’t informed until a month after it had approved the gene treatment for spinal muscular atrophy, a genetic disorder that can be fatal to infants. It was primarily to get ownership of that treatment that Novartis last year laid out $8.7 billion for AveXis.
The response goes to great lengths to point out the the data manipulation involved a test no longer used in the manufacturing process of Zolgensma and that even the FDA agrees the treatment is safe and effective. It says there is no evidence the event had any “impact on patient safety, product efficacy or quality.”
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While the top execs were the ones the company says are responsible for the ethics breach, Novartis said its investigation found there was a “lack of a cultural emphasis on data integrity" at the San Diego site where the troubles went down. It says it is convinced that the steps it is taking to integrate AveXis into its own culture will remedy that.
Just to be sure, it also has hired an outside manufacturing consultant to review the plans and processes at the company. It is tightening up its operating procedures and its electronic data keeping and also hiring extra employees where needed.
“Until recently, Novartis’s alignment with AveXis focused primarily on establishing and defining the lines of communication between the AveXis and Novartis quality organizations from a functional perspective,” Novartis says in the document.
But in light of the data integrity issues, “Novartis senior leadership has made the decision to completely integrate AveXis into Novartis’s global quality network and will accelerate several key integration actions to ensure that this integration occurs quickly and effectively.”