Willie Vann | Chief, Laboratory Of Bacterial Polysaccharides, Cber
FDA

Willie Vann, Chief, Laboratory Of Bacterial Polysaccharides, Cber, FDA

Dr. Vann joined CBER as a research chemist in 1979, after several years as a von Humboldt Fellow at the Max-Planck Institute in Freiburg, Germany, where he determined the structure of capsular polysaccharides of pathogenic Escherichia coli. Since his appointment at CBER, he has served as the primary expert in polysaccharide chemistry and as such has made major contributions to the development and licensure of polysaccharide based vaccines. He was appointed to the position of Chief of the Laboratory of Bacterial Toxins in 1996, where he was responsible for supervising the research and review responsibilities for products related to diphtheria, tetanus, and botulinum toxins. In 2006 he was appointed as Chief of Laboratory of Bacterial Polysaccharides. As Chief of the Laboratory of Bacterial Polysaccharides, he has supervisory responsibility for the scientific and regulatory work of several principal investigators that is related to encapsulated pathogens. He is also a principal investigator in the Laboratory and manages a research program on the glycobiology of pathogenic bacteria.

Appearances:



April 14 Pre-congress Workshop Day @ 13:30

HALF DAY WORKSHOP H: BIOPROCESSING

Approaches to establishing clinically relevant specifications for vaccine bioprocessing Workshop leaders: Dr Basav Ghosh, Senior Director, Manufacturing Sciences and Technology, Pfizer &Dr Aparna Deora, Senior Director, BioPharmaceutical Sciences, PfizerAn analytical perspective on patient-centric specificationsUnderstand what quality attributes may influence clinical outcomes, both efficacy and safety, and how to established a link between product attributes and clinical data. Considerations for batch selection for clinical trials and their potential impact on clinical experience. Specification setting approaches and their connection to manufacturing experience, process and analytical variability and lot selection. A regulatory/process perspectiveUnderstand regulatory considerations and perspectives on how to approach specification setting and clinical experience. Understand the difference between clinical relevance and clinical experience.Clinical perspective on traditional vaccines (bacterial and viral)Case studies for microbial and viral vaccines. Approaches and considerations for novel technologiesConsiderations for developing novel approaches for new medicines and vaccines for meeting critical unmet medical needs:CRISPR-enhancedbacteriophage cocktails for treatment of infection and microbiome engineering

April 16 Day 2 - 10 Co-conferences @ 10:15

Experts in bacterial vaccines critiquing FireChats

last published: 11/Apr/19 16:05 GMT

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