RNAi-

[partimefriend]

July 21-23, 2020
Boston, MA

rnaibased-therapeutics.com/speaker/sharmistha-ghosh/

Risk Assessment of Quality Attributes of Synthetic Oligonucleotides Targeted at Silencing Gene Expression
Time: 12:00 pm
Day: Day One
Details:

Assessment of quality attributes of drug substance and drug product for their criticality that are impacted by process and/or its molecular properties that may affect their stability and potency
Defining the degradation pathways and thereby monitoring the propensity of formation of different degradants through accelerated stress, short-term and long-term stability studies
Develop phase-appropriate stability indicating methods for characterizing the degradants and having process control parameters thereby gaining better understanding of the drug as it progresses to the later phases. Present case studies to explain the process of evaluation of the quality attributes of synthetic oligoribonucleotides




Sharmistha Ghosh
Sharmistha Ghosh
Company: Arrowhead Pharmaceuticals

Job title: Associate Director of CMC Analytical Development

Bio:

I completed my PhD from Louisiana State University A& M College in Biochemistry & Molecular Biology working on unique DNA binding properties of a histone-like protein from a highly radioresistant, dessication resistant organism, Deinococcus radiodurans. During my postdoctoral fellowship in Harvard Medical School, I worked on Bacteriophage T7 DNA replication understanding complex interactions of the DNA polymerase with the replication machinery during the different modes of replication; electrostatic mode and the polymerizing mode.
During my time at Pfizer Vaccines, I was involved in analytical characterization of different antigens, alone or in combination both in bacterial and viral vaccines that were in different phases of the development.
At Bristol Myers Squibb, I was mostly involved in development of late phase immuno-oncology projects, where we developed a phase-appropriate assessment of the quality attributes of drug substance and drug product. Thereafter, at Amicus Therapeutics, I led the Analytical team in biologics and gene therapy, developing unique assays for characterization and understanding the complexities of the drug development in my interaction with CMOs.
Currently at Arrowhead Pharmaceuticals, my team is involved in developing phase-appropriate analytical assays, HPLC, LC-MS and others, for the different synthetic oligonucleotides that knockdown the expression of target genes.

Seminars:
Risk Assessment of Quality Attributes of Synthetic Oligonucleotides Targeted at Silencing Gene Expression 12:00 pm
Assessment of quality attributes of drug substance and drug product for their criticality that are impacted by process and/or its molecular properties that may affect their stability and potency Defining the degradation pathways and thereby monitoring the propensity of formation of different degradants through accelerated stress, short-term and long-term stability studies Develop phase-appropriate stability indicating…Read more

Day: Day One