BioTalk US 2022

1. Open Panel Discussion: Current Advances in Continuous Manufacturing
• Enabling Real-Time Model-Based Advanced Process Control, Optimization and Automation.
• Assessment of Process Manufacturability, Demonstration of ‘Closed System’ Operation and Performing ‘at scale’ Studies to Support
Continuous Manufacturing Process Development
• Overcoming High Capital Costs and Minimal Reduction in Raw Material Requirement
• Analyzing Key Enabling Technologies for Continuous Processing – Acoustic Wave Separation (AWS), Multicolumn chromatography,
virus inactivation and single-pass tangential flow filtration (SPTFF), disposable bioreactor, cell retention technology and
novel counter-current operation
• A Paradigm Shift Towards A More Sustainable Future for Continuous Manufacturing and Process Facility Modelling to Measure
the Performance and Sustainability of Process Intensification

Chairperson:
Henry Lin, Global Head, Cell Culture Process Development, Sanofi
Panel Members:
Michael Coolbaugh, Associate Director, Sanofi
Irina Ramos, Director in Bioprocess Technologies & Engineering group, AstraZeneca
Ben Dionne, Director BioProcess Development, EQRx
Ujjwal Bhaskar, Senior Principal Scientist, Bristol Myers Squibb

2. Open Panel Discussion: Strategic Outsourcing and Effective Tech Transfer in CMC Development
• The benefits and challenges with outsourcing CMC development and manufacturing of biologics
• Deciding when to outsource and when to manufacture in-house
• Best practices for partner selection
• Innovative & Phase Appropriate Process Development and Optimization
• Proactive GAP analysis and Risk Management
• Effective technology & knowledge transfer
Chairperson:
Geoffrey Hodge, CEO, Sotio
Panel Members:
Dan Custar, Director, Drug Substance CMC, Mersana Therapeutics Inc.
Blair McNeill, Senior VP CMC Biologics and Gene Therapy, Sumitovant Biopharma
Vijay Sharma, Head of Process Implementation function in Bio-Process Development, Takeda
J. Ashley Groves, Associate Director Cell Culture Process Development, Technical Transfer, and Production Support, Sanofi

3. Open Panel Discussion: The CMC challenges of innovative and breakthrough biological therapies
• Innovative biological therapies create opportunities & challenges for CMC development and manufacturing from both a technical
and organizational view
• How speed to clinic can be achieved for innovative biologics in the absence of platforms
• CMC process scaling up & technology transfer
• Specifications & regulatory filing with limited time
• New modalities are often coupled with breakthrough products and the future is now
• Integrated approach across divisions, strategies for streamlining CMC packages
• Minimising changes during development, Front-loading versus fast to IND
Chairperson:
Geoffrey Hodge, Chief Executive Officer, SOTIO
Panel Members:
Raghu Shivappa, Vice President-Biologics and Gene Therapy Process Development, Takeda
Shyam Subramanian, Ph.D, Chief Technical officer and Head Technical Development, Manufacturing and Quality, Obsidian Therapeutics
Geoffrey Hodge, Chief Executive Officer, SOTIO Biotech US
Blair McNeill, Sr. VP CMC Biologics and Gene Therapy, Sumitovant Biopharma