Makda Fisseha

Managed projects that involved preparing, regulatory affairs, clinical trials, and scientific documents. Coordinated projects with close communication with scientists and project leaders. Responded to questions from regulators/reviewers, and ensured that all requirements and deadlines are met. Prepared documents including Clinical Summaries and Overviews using Common Technical Documents format, clinical trials protocols and study reports, and briefing books all according to ICH guidelines. Prepared respo

Designed and constructed recombinant lactic acid bacteria for the delivery of molecules with health benefits. Characterized a novel Bifidobacterium longum protein with possible role in host interaction. Assessed, for business department, bacterial properties with impact on the marketing of products. Evaluated, for different groups within Nestlé (Allergy and Gut Health), the feasibility of expressing various eukaryotic molecules of interest in lactic acid bacteria. Supervised technician.

Organized and managed the activities of external experts of the Initiative for Vaccine Research steering committee on new vaccine delivery systems. This involved mobilizing twelve experts and developing strategies for supporting vaccine research. Implemented plans for identifying and funding research on vaccine technologies. Surveyed and summarized technical information on mucosal and transcutaneous vaccine delivery, vaccine stability, and vaccine delivery devices for the advisory committee members. Monit

Responsible for projects involving the construction and characterization of Neisseria meningitidis vaccine strains. Involved in product development and pre-clinical testing and analysis of vaccines. Developed detoxified vaccine strains by genetically modifying lipopolysaccharide biosynthesis genes. Designed and performed pre-clinical tests including toxicity assays (LAL, cytokine release) and analyzed pre-clinical vaccine preparations. Developed standardized protocols for genetically modifying and charact