US biotech Tessera Therapeutics, which is backed by Flagship Pioneering, has appointed Anne-Virginie “AV” Eggimann as chief regulatory officer responsible for leading US and global regulatory science and program and portfolio management for the company’s GENE WRITING development programs.
Ms Eggimann joins Tessera from bluebird bio, where she spent nearly eleven years guiding regulatory strategy for the company’s gene therapy portfolio, culminating in her role as chief regulatory officer.
During her tenure, Ms Eggimann oversaw cross-disciplinary teams responsible for identifying efficient development pathways leading to several US and European approvals for three novel gene therapy products in severe genetic diseases and oncology, including most recently the approval of Zynteglo, the first lentiviral vector gene therapy in the USA for the treatment of beta-thalassemia.
In parallel, she has also contributed to shaping US regulatory policy for advanced therapies as chair of the Regulatory Committee of the Alliance for Regenerative Medicine (ARM) and currently as the co-chair of the Biotechnology Innovation Organization (BIO) Regenerative Medicine Committee where she recently participated in the PDUFA VII negotiations with industry trade associations BIO and PhRMA and the Food and Drug Administration.
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