George Bou-Assaf
Company: Biogen
Job title: Associate Director Analytical & CMC Development
Seminars:
Methods for Establishment of Stereochemical Comparability in Phosphorothioated Oligos: Analytical Approaches & Development Strategies 9:00 am
• Designing ASO sequences with different stereochemical content • Evaluation of three analytical methods CD, NMR, and NP1/LCMS for assessing stereochemistry • Developing a robust comparability criteria and strategy based on analytical outputs to assess and control stereochemistry across batchesRead more
day: Day Two AM
Panel Discussion: Lowering the Barrier to Entry for Oligonucleotide Drug Development 1:30 pm
• How can companies in the oligo space collaborate to ease entry for small biotechs • Exploring attempts to lower costs of analytical development and manufacturing and their subsequent impacts • Balancing innovation of analytical methods and technology versus cost- saving practises Read more
day: Day Two PM
Panel Discussion: Producing a Comprehensive Drug Comparability Framework 4:00 pm
• Creating a consistent impurity profile across manufacturing and vendors through a robust comparability assessment • Taking a proactive approach to comparability submission packages- thinking beyond just your manufacturing steps • Developing strategies for effectively managing and documenting any changes in compliance with agency guidelines, while proactively engaging with regulatory bodies to ensure the drug’s…Read more
day: Day Two PM
Chair’s Opening Remarks 8:55 am
day: Day Two AM
Chair’s Closing Remarks & End of Conference 4:30 pm
day: Day Two PM