Crossject expands board and hires ex-FDA lead ahead of ZEPIZURE launch
Crossject has expanded its Executive Board from two to five members and hired a former US Food and Drug Administration official to head regulatory affairs in the United States, as the Dijon-based company shifts from development into industrialisation and commercial launch of its ZENEO needle-free auto-injector platform.
The Supervisory Board unanimously approved the appointments of Olivier Lacombe, Didier Morin and Lionel Seltz on 24 September 2026, with immediate effect and terms running to February 2029. They join existing board members Patrick Alexandre, who chairs the Executive Board, and Isabelle Liebschutz, Quality and Regulatory Director and Qualified Person.
A leadership structure built for execution
The restructuring reverses a deliberate contraction made in February 2025, when the Supervisory Board reduced the Executive Board to two members to concentrate decision-making on ZEPIZURE's FDA registration. With that process now advancing, Crossject says the priority has shifted to manufacturing scale-up, initial deliveries and building a commercial footprint in the United States.
Lacombe brings 21 years of pharmaceutical development experience from stints at Laboratoires Fournier, Abbott, Solvay and Inventiva, and has led pharmaceutical development of the ZENEO platform since joining the company in 2021. Morin, who joined in 2023, contributes 30 years of industrial and supply-chain experience, including roles at IDS and Axess Vision. Seltz joined in January 2026 and brings 25 years of life sciences finance experience, including CFO positions at three listed medtech and biotech companies, as well as international roles at Cegedim and IQVIA/IMS Health in Asia-Pacific. His remit extends beyond finance to cover legal, intellectual property, US government contracts, human resources and information systems.
Chairman Philippe Monnot described the trio as "immediately operational," noting they continue to hold their existing functional responsibilities alongside their board seats. The combined Executive Board now carries 140 years of experience across pharmaceuticals, medical devices and industrial operations, the company said.
US regulatory hire targets FDA and BARDA engagement
On the US side, Crossject has appointed David Pudwill as Vice President, Regulatory and Scientific Affairs at Crossject US, reporting to Chief Operating Officer Tony Tipton. Pudwill spent nine years at the FDA, where he served as a lead medical device reviewer and branch chief, before building a further decade of experience across regulatory affairs, product development, quality and clinical strategy. His background spans medical devices, pharmaceuticals, biologics and drug-device combination products, a profile the company says maps directly onto the hybrid nature of the ZENEO platform, which combines a drug substance with a delivery device.
Pudwill's remit includes US regulatory, clinical and scientific strategy for ZEPIZURE and future ZENEO-based products, as well as maintaining relationships with the Biomedical Advanced Research and Development Authority (BARDA) and other US government partners. BARDA's involvement is commercially significant: ZEPIZURE is intended for the US Strategic National Stockpile, meaning government procurement contracts, rather than retail pharmacy, represent the primary near-term revenue pathway.
The broader market context is worth noting. Needle-free and auto-injector platforms for emergency indications attract interest from both defence procurement bodies and hospital systems, and Crossject competes in a segment that includes established auto-injector suppliers with significant manufacturing capacity. Successfully scaling production and securing FDA authorisation will be the decisive tests of whether the expanded leadership team can convert a decade of platform development into a viable commercial business. Investors on Euronext Growth will be watching for an FDA decision timeline and BARDA contract milestones as the next material catalysts.