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Dr. Annegret Vaggelas

Senior Consultant

Dr. Annegret Vaggelas is a highly skilled regulatory affairs professional with broad experience in the development and approval of biopharmaceuticals.

Annegret has led multiple ERA (environmental risk assessment) and GMO (genetically modified organism)- related submissions for a broad range of gene therapy products incl. AAV based products in different countries in the EU, the US and Japan. Furthermore, she was responsible for the submission of new substance notifications (NSNs) in Canada, which are required before a new substance can be imported for the first time.

She has also contributed to successful MAAs and NDAs by preparing different CTD documents such as the QOS, 3.2.R biosimilarity assessment report and whitepapers.

Annegret received her degree in veterinary medicine from the Ludwig-Maximilians-University and completed her PhD at the Max-von-Pettenkofer Institute for Hygiene and Clinical Microbiology, both in Munich. During her PhD she gained broad experiences in the development of diagnostic assays and filed a patent for a method for the diagnosis of infectious diseases together with her supervisor. Annegret gained training in regulatory affairs for biopharmaceuticals at the European Centre for Regulatory Affairs (EUCRAF). She is an experienced medical writer, who successfully completed the European Medical Writers Association (EMWA) Professional Development Programme (EPDP), which provides a high-quality training for medical writers. Moreover, Annegret has published articles and prepared posters on aspects of development and regulatory affairs of ATMPs.

Annegret provides scientific as well as regulatory and strategic support based on her knowledge of the regulatory legal requirements applicable to biopharmaceuticals as well as small molecules and the global administrative processes required by agencies such as EMA and FDA. She has been involved in projects covering a wide range of indications and product classes such as gene and cell therapies, tissue-engineered products, oncolytic viruses, monoclonal antibodies, biosimilars, vaccines and first-in class small molecules.

She has managed multiple regulatory interactions in EU and US related to cell, gene and tissue engineered products, oncolytic viruses and biosimilars. She supported scientific advice procedures at the national level as well as at EMA and FDA and helped identifying the key questions to be asked. She acted as the regulatory project manager and contact point for the agency, compiled the briefing documentation and slides for the meetings, participated in the meeting and prepared the minutes. She is experienced in justifying gaps in the program or deviations from regulatory guidelines and can help interpreting the agency feedback after the meeting.
Annegret has also been involved in multiple submissions for clinical trials in both EU and US. She prepared IMPDs, INDs and IBs and supported the development of risk mitigation strategies as well as the dosing rationales for various ATMPs in first in human clinical trials. Furthermore, she is experienced in responding to content queries from the agencies and managing IMPD and IND amendments during the clinical trial life cycle.