Aparna Deora is a Senior Director in Pfizer’s Biotherapeutics PharmSci Analytical Research & Development (ARD) organization and leads the Quality Control, Stability and Microbiology (QCSM) line with labs located in Chesterfield, MO, Andover, MA, and Chapel Hill, NC. Aparna has been with Pfizer since 2002. She began her industrial career developing bioassays, and has worked in developing products across numerous biotherapeutic modalities including mAbs, ADCs, vaccines, cell therapies and gene therapy.
Aparna received her B.S. from the University of Michigan with a double major in Chemistry and Cellular & Molecular Biology. She received her Ph.D. at Washington University in Molecular Genetics
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
last published: 11/Apr/19 16:05 GMT