Asmaa Ahmed Abdelghaffar, is a pharmacist with a PhD in microbiology and immunology from Cairo University and currently serving as the head of the biotech lab at the Central Administration of Biological and Innovative Products and Clinical Trials, Egyptian Drug Authority (EDA).

With 15 years of experience in the field of biological products, she leads a team of specialists to perform the lab different activities including evaluation of the CTD quality module for various biological products, such as viral vaccines, recombinant products, and ATMPs (cell and gene therapy), during stages of clinical trials, registration and post-authorization approvals in Egypt. In addition to performing different lab techniques including ELISA, cell culture, gel diffusion, SDS-PAGE, Western blot and in-vivo techniques on mice, rats, and guinea pigs. She is also actively involved in conducting GMP inspections on both local and international recombinant and biosimilar production facilities.

In addition to her role as a researcher and lab manager, she is involved in different international collaborations, serving as a topic leader in the ICH cell and gene therapy discussion group (ICH CGTDG), a member in IPRP biosimilar working group (BWG) and she has been selected for USP’s Scientific Exchange Program as a visiting scientist to conduct research on Global Standards and Regulatory Expectations for Gene-Modified Cell Therapy Raw and Starting Materials. In addition, she has contributed to the issuing and reviewing of important Egyptian guidelines, including those related to reliance practices during the registration of biological products, the Egyptian biosimilar guideline, and the Egyptian pharmacopeia.

She has also participated as a speaker and a panelist at different workshops focusing on the regulatory aspects of biological products. Including the training held in Egypt with EAC Regional Centre of Excellence for Vaccines, Immunization and Health Supply Chain Management (RCE-VIHSCM) and a workshop on “Advancing access to monoclonal antibodies in Africa” organized by the Africa CDC in Lusaka, Zambia.