Dr. Abraham is currently Distinguished Scientist, Global Vaccine Technical Operations at Merck in West Point, Pennsylvania, U.S.A. where he is responsible for technical operations for vaccines.
Over the last twenty years, he has worked in various capacities to support research, process development, commercial manufacturing development and technology transfer of Glyco-Conjugate, Microbial, Recombinant, and Viral Vaccines at Merck. Most recently he led the Product Leadership Group for the late stage development and commercialization of Vaccines, including the approval and launch of GARDASIL9.
Dicky received his Ph.D. in Biochemistry, from Cornell University, New York.
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