Bao Cai

Company: Sarepta Therapeutics

Job title: Executive Director of Process Development

Seminars:

Ensuring Critical Quality Attributes (CQA) Consistency in Oligo Drug Development: Managing Analytical Considerations Through Drug Comparability 3:30 pm

• Regulatory agencies expectations for comparability assessments to manage changes  in the manufacturing process and ensuring CQAs are maintained through the product  development process • Analytical comparability of drug substances, methods that not only compare CQAs in  the release specifications but also conduct additional in-depth characterization and  impurity profiling • The importance of comparability assessments…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

Panel Discussion: Exploring Novel Oligonucleotide Drug Development: Unlocking New Opportunities, Overcoming Market Challenges & Advancing Innovative Oligos Through Pipelines 8:30 am

• Validating strengths and new opportunities that have emerged in the space • Analyzing weaknesses and threats that oppose commercial market access  • Overview of different oligo modalities and their positioning in clinical development Read more

day: Day One AM