Pre-Congress Workshops

 

HALF DAY WORKSHOP H: BIOPROCESSING

 

Panel discussion
April 14, 1:30 - 5:30

 

Approaches to establishing clinically relevant specifications for vaccine bioprocessing Workshop leaders: Dr Basav Ghosh, Senior Director, Manufacturing Sciences and Technology, Pfizer &Dr Bo Arve, Executive 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
 
 
 
 
Scott Woollens Scott Woollens, AVP, Regulatory Affairs-Vaccines CMC, Merck
 
 
 
Anuja Rastogi Anuja Rastogi, Clinical Associate, Food And Drug Administration
 
 
 

 

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