" class="no-js "lang="en-US"> Coave Therapeutics Strengthens Leadership Team with the Appointments of Catherine Mathis as Vice President Regulatory Affairs and Julien Berger as Head of Legal Affairs - Medtech Alert
Wednesday, June 19, 2024

Coave Therapeutics Strengthens Leadership Team with the Appointments of Catherine Mathis as Vice President Regulatory Affairs and Julien Berger as Head of Legal Affairs

Coave Therapeutics (‘Coave’), a clinical-stage biotechnology company focused on developing life-changing gene therapies for CNS (Central Nervous System) and eye diseases, today announced the appointments of Catherine Mathis, PharmD, as Vice President Regulatory Affairs and Julien Berger, as Head of Legal Affairs.

Ms. Mathis will define and oversee the regulatory strategy and operations supporting the advancement of Coave’s programs. Mr. Berger will lead the Company’s legal activities and act as Corporate Secretary.

We are delighted to welcome Catherine and Julien to the team at Coave. The newly created regulatory and legal positions demonstrate the growth of the company and the rapid advances we are making with our pipeline of novel coAAV gene therapies focused on CNS and eye diseases. Catherine brings a depth of experience in regulatory affairs for gene therapy based programs that will be invaluable as we plan and implement our regulatory strategy for our three CNS programs targeting protein degradation. Julien has extensive experience representing and advising companies in various legal activities at all stages of the pharma and biotech life cycle, supporting the implementation of operations while ensuring the protection of the companies’ rights and interests. Catherine and Julien are key and timely additions to our leadership team and we look forward to working with them as we strive to transform the treatment of CNS diseases with our first-in class gene therapy products,” said Rodolphe Clerval, CEO of Coave Therapeutics.

Catherine Mathis, PharmD
Catherine has over 30 years’ experience in clinical research and regulatory affairs in the pharmaceutical and biotech industries and has developed robust expertise for gene therapy development from Phase 1 to Phase 3 under US and EU regulations. She conducted many regulatory filings, IND and Scientific Advice meetings with the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and other European national competent authorities.

Catherine spent 20 years at Transgene as Senior Director, Head of Regulatory Affairs setting up and leading the regulatory affairs department and supervising global regulatory activities for the development of Transgene’s gene therapy products. Since Transgene, she has held senior leadership and regulatory roles at Voisin Consulting Life Sciences, TxCell (a subsidiary of Sangamo Therapeutics), Elsalys Biotech and most recently Enterome.

Catherine holds a PharmD and a Master’s degree in applied and basic toxicology from Paris University. She began her career in clinical research roles at Ipsen and Sanofi Pasteur.

Julien Berger
Julien brings to Coave almost 20 years of global, regional and local healthcare legal affairs experience among corporate, commercial, medical, R&D, clinical operations and M&A activities. He joins Coave from Galapagos where he served as Senior Legal Counsel Director providing legal support and advice to its global teams.

Prior to Galapagos, Julien spent over 15 years in the legal team at Genzyme, most recently as Legal Director at Sanofi Genzyme following its acquisition. Julien developed and led the legal department for Genzyme’s French entity, supporting the growing business in five therapeutic areas, managing the launch of products in addition to supporting Genzyme’s acquisition by Sanofi.

Julien is a Business Law graduate from the universities of Lyon and Strasbourg.

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