Ciby Abraham

Company: AstraZeneca

Job title: Senior Director & Group Manager - Project, Product Leadership Chemistry, Manufacturing & Controls Regulatory Affairs

Seminars:

Panel Discussion: Recognizing Emerging Modalities for Continuous Manufacturing Applications to Advance Your Pipeline & Meet Demands 10:30 am

How are emerging modalities adapting to continuous manufacturing? How must continuous manufacturing evolve as a standardized method for cell and gene therapy production? Where are the gaps in transitioning from small to commercial scale for continuous manufacturing of biologics and novel modalities?Read more

day: Conference Day Two

Case-Study: Bridging Clinical Phase I to III Studies for Small Molecule Development to Demonstrate Quality Consistency & Safety 9:00 am

Understanding how to use a bridging study to communicate process similarity to health authorities and regulators for streamlined approval Outlining the use of modelling to aid bridging studies for similarity demonstrations for maximal efficiency Pinpointing data and cost limitations for large biologics and using this as a decisionmaking tool to explain when is best to…Read more

day: Conference Day Two