Post by partimefriend on Mar 6, 2020 14:32:15 GMT -5
rnaibased-therapeutics.com/
July 21-23, 2020
Boston, MA
12:00 pm Risk Assessment of Quality Attributes of Synthetic Oligonucleotides Targeted at Silencing Gene Expression
Sharmistha Ghosh
Associate Director of CMC Analytical Development, Arrowhead Pharmaceuticals
Synopsis
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
Also 30 min before Sharmistha Ghosh
11:30 am Transforming Traditional SM ADME Assays to Support the Translation of siRNA Pharmacology from the Benchtop to the Clinic
Brooke Rock
Principal Scientist, Amgen
Synopsis
The physicochemical properties of siRNA push this new modality outside of the small molecule classification
Applying learnings from small molecules to underwrite the PK-PD relationships, inform structural integrity, and understand biodistribution
Sharing the strategy to effectively characterize siRNA from early discovery into the clinical setting