AveXis to implement data integrity regime in Longmont plant

LONGMONT  — AveXis Inc., the Chicago-area gene therapy company opening a 692,000-square-foot plant in Longmont, is setting up a company-wide data integrity system in its plants after a data manipulation scandal rocked it and its parent company.

In filings released last week by the U.S. Food and Drug Administration, AveXis and its parent company Novartis AG (NYSE: NVS) will implement “compliance action plan” measures at the Longmont plant and its existing Durham, N.C., plant by bringing its quality control plans to those held at Novartis’ corporate-level standards.

The company will also set up stricter data reporting systems in its San Diego research site and create a formal procedure for researchers to voice concerns of fraud or misconduct to upper management.

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A spokeswoman for AveXis said in a statement that the data program will not affect the plant’s opening date, set for before the end of the year.

AveXis became the center of scandal in August after the FDA revealed the company knowingly provided falsified animal testing data for its flagship drug Zolgensma to the agency before it was approved for sale this year. Although the FDA affirmed the drug’s safety and efficiency, it said it may pursue civil or criminal penalties against AveXis.

AveXis fired two of its top researchers in connection with the incident.