BIOPROCESSING STRATEGIES FOR OPERATIONAL EFFICIENCY
Bioprocessing Strategies for Operational Efficiency Opening Remarks
Navigating and Making Better Technology Decisions
Avril Vermunt (senior director, head of manufacturing sciences & technology, Adverum Biotechnologies) and moderator Ben Locwin (executive, Black Diamond Networks) discuss how all biopharma companies must evaluate and strike the right balance between the ROI of implementing new technologies vs. the impact on the P&L. These three mini-case study’s highlight techniques and procedures your company can follow to make better technology decisions.
Getting to 'Yes': How Major Changes at Phase 3 Can Make An Unapprovable Product Approvable
Parrish Galliher (independent bioprocess consultant) and moderator Ben Locwin (executive, Black Diamond Networks) discuss how a biopharmaceutical company realized their Phase 3 clinical trial process was inefficient and not scalable. In partnership with FDA, the company’s CMC group completely overhauled the process resulting in a successfully commercially licensed by the FDA and EMA.
Lower Operational Costs by Reducing GMP Sampling
Josefine Persson (associate director, Genentech/Roche) and Ben Locwin (executive, Black Diamond Networks) discuss how the cost of over-sampling from clinical GMP runs vs. development sources add up very quickly in terms of actual expense and lost opportunity to move a new project into GMP manufacturing. Genentech was able to reduce product sampling volumes by 50+%reducing direct and indirect costs, improving COGS, reducing environmental factors.