DCVMN WHO PQ Workshop

Dr. Malika Al Mansouri is a regulatory affairs expert with over 20 years of experience in the pharmaceutical sector, including more than 15 years in the vaccine industry. She has extensive expertise in global vaccine regulatory strategy, CMC and clinical submissions, and regulatory systems strengthening.

At Coalition for Epidemic Preparedness Innovations (CEPI), she contributed to regulatory strategy for vaccine development programs, including Middle East Respiratory Syndrome (MERS) vaccines, and led regulatory strengthening initiatives across Africa and the Middle East. She currently works as an independent consultant supporting organizations such as Developing Countries Vaccine Manufacturers Network (DCVMN) and PATH to advance regulatory strategies and strengthen vaccine manufacturing capacity in developing countries.

Catherine Hoath is CEPI's Global Regulatory Affairs Strategy Lead based in Washington, DC, with a focus on developing and executing innovative global regulatory strategies in highly complex environments. Her work centers on bringing senior leaders and cross-functional teams from leading vaccine research, development and manufacturing organizations together with representatives from National Regulatory Authorities to navigate regulatory challenges, anticipate policy developments, and support long-term public health objectives geared toward equitable access.

Dr. Etna is a Resident Researcher in the Department of Infectious Diseases at the Istituto Superiore di Sanità (Rome-Italy). She holds her Ph.D. in Medical Microbiology and Immunology in 2014 from University of Rome “Tor Vergata” working on the evasion mechanism exploited by Mycobacterium tuberculosis in subversion of host immune response and in particular, on the autophagy process in human primary cells. From 2013 to 2017, she obtained a fellow at Istituto Superiore di Sanità (Rome-Italy) for the identification of novel autophagy-regulated host targets to improve BCG vaccine immunogenicity. During this period, she also carried out a research training in the Unit of Cytokine Signaling at Pasteur Institute (Paris-France) for the characterization of the translatome of human dendritic cells infected with Mycobacterium tuberculosis. From 2017 she obtained a research contract at Istituto Superiore di Sanità (Rome-Italy) to optimize the Monocyte Activation Test (MAT) within the IMI2 VAC2VAC – Vaccine lot to vaccine lot comparison by consistency testing – project. She is currently the expert of MAT assay at Istituto Superiore di Sanità (Rome – Italy) for the batch release of vaccines for human use and in particular for the anti-meningococcal B vaccine. She has been actively involved in training activities on MAT for the Developing Country Manufacturers Network (DCVMN). She has been a member of the NC3Rs pyrogenicity testing focus group. In addition, her research activity focus on Immune-pathogenic mechanisms of infectious diseases and escaping strategies evolved by pathogens; transcriptional profiling of responses to infectious agents; immunotherapy of infectious diseases; development of alternative in vitro human cell-based methods to test vaccine potency and efficacy for the replacement of animal models; implementation of MAT to determine the pyrogenicity of vaccines. She is author of several scientific papers in international scientific journals and conference proceedings.

Matthias Angelmaier is the Global Product Manger Isolator Technology at Syntegon. He has a bachelor’s degree in industrial and mechanical engineering as well as a master’s degree in business development. He joined Syntegon Technology GmbH in 2009. For 3 years, he was a project manager for handling complex customer projects. Since 2012, he has been the globally responsible product manager for barrier systems, isolator and process technology. His expertise includes process engineering, sterilization, bio-decontamination, aseptic and high-potent Isolator applications, glove testing systems as well as topics related to advanced aseptic processing. He is a frequent speaker on international symposia and conferences including organizations like ISPE and PDA.