Basav Ghosh | Senior Director
Pfizer

Basav Ghosh, Senior Director, Pfizer

Basav Ghosh is currently Sr Director/Team lead of Manufacturing Sciences and Technology (MSAT) in Global Technology Services at Sanford. Basav is responsible for process development support of clinical and commerical manufacturing of vaccines, oncology and immunotherapeutic products at multiple PGS sites. Prior to her current role Basav was Senior Director/ Team Lead of Vaccine R&D (Wyeth) at Sanford. Basav is a member of the Global Bio Manufacturing Sciences and Technology Group which plays a key role in Pfizer Global Supply.
Basav has over 15 years of experience in Large Molecule Biotechnology. She has been with Pfizer for 5 years, and was previously employed by Biogen and Covance-Diosynth. Her roles have extended across several functions including technical leadership roles in proteins, vaccines, small molecules, ADCs and MAb process development. Throughout her career she has contributed in the areas of Research and Development, Manufacturing, Manufacturing Sciences, OE/Innovation, QbD/control strategy, new technologies and analytical sciences.
Basav holds a BS/MS in Biochemistry/Cell Biology and a PhD in Biochemistry and Biotechnology from IIT, India. She also completed her post-doctoral studies with the Dept.of Biochemistry at the North Carolina State University (NCSU) and worked as a staff toxicologist in the EPA, RTP, NC, before joining the biotech industry. 
Basav likes to spend her personal time with her family. Basav is committed to the enhancing STEM in NC middle/high school. She is a member of several STEM clubs and an active coach for North Carolina Science Olympiad. In her free time she enjoys reading and listening to world music.

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

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