Lucia Septién-Velez has stepped down (PDF) as chief medical officer of DBV Technologies. The departure of Septién-Velez is part of a wider reshuffle that gives DBV’s management a new look as it seeks to get its BLA back on track.

DBV appointed Septién-Velez in July 2016. By then, enrollment in the PEPITES phase 3 trial that is key to DBV’s pitch for approval of its peanut allergy treatment was completed. But DBV nonetheless saw the appointment of Septién-Velez as a key piece of its attempt to guide Viaskin Peanut through phase 3 and regulatory submissions.

The advance of Viaskin Peanut has subsequently hit several big bumps in the road. In October, DBV revealed PEPITES had missed its primary endpoint. DBV went ahead and filed for approval anyway, only for deficiencies in its manufacturing and quality control sections to force it to pull the BLA.

In the wake of the withdrawal of the BLA, DBV has made several changes to its leadership team. Septién-Velez has left the company "to pursue other opportunities," leaving Chief Scientific Officer Hugh Sampson to fill in as CMO on an interim basis. Sampson will lead both the scientific and medical teams and report directly to CEO Daniel Tassé. 

DBV is recruiting a full-time CMO in the U.S., but Sampson will hold the role during a key period in which he will need to work with the company’s regulatory team on submissions for Viaskin Peanut. 

The other changes relate directly to the deficiencies in the Viaskin Peanut filing identified by the FDA. DBV has tapped Julie O’Neill to direct "all product development, manufacturing, supply chain, quality assurance and end-to-end process optimization" at the company. O’Neill served as executive vice president of global operations at Alexion Pharmaceuticals until June. 

In addition, DBV has given its head of global regulatory affairs, Alan Kerr, a direct line of reporting to CEO Tassé. 

Shares in DBV rose 17% in trading in Paris following the release of news of the reshuffle. Even after the gains, DBV’s stock is still well down on the price it traded for prior to the withdrawal of the BLA. 

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