Sessions
Moving the Industry Towards Automated Systems for Scale-up Success
Workforce of the Future: Talent, Change Management and Enabling Future Development
Delivering Projects and Managing Timelines in the Variable, Continuously Changing Environment Of Cell and Gene Therapy
How to Market my Biotech to Investors: Lessons Learned from Successful Investment and Funding Rounds
Patient and Payer Challenges: Enabling Access to Patients through Market Access, Pricing and Patient-Led Discussion
Tech Review: New Platforms and Closed-Systems to Enable Commercial Success
Working With a CDMO is not Just an Outsourcing Contract but a Partnership: Learnings from Successful Biotech/CDMO Partnerships

Overcoming Challenges and Setting Up for Success on the Path to Commercialisation
Moving the Industry Towards Automated Systems for Scale-up Success
15:30 Chairperson’s Opening
J Kelly Ganjei, President & Chief Executive Officer, AmplifyBio
15:35 The Value of Automated, Closed-Systems in CGT Manufacturing
- In this presentation, Kim Raineri will explore the value of automated, closed manufacturing systems
- Advantages of automation for consistency, transfer and scalability
- Advantages of closed systems for safety and efficiency
- Impact of automation and closed systems on cost of goods
- Case study of AVROBIO’s approach to automated, closed-system manufacturing
Kim Raineri, Chief Manufacturing and Technology Officer, AVROBIO
15:55 Process Analytical Technologies (PAT) and Automation in Bioprocessing
- PAT and technology benefits within bioprocessing
- MVDA (multivariate data analytics) and modeling utilization for real-time monitoring and feedback control
- PAT orchestration including automation framework
Edita Botonjic-Sehic, Director of Analytics, Pall Corporation
16:15 Lessons Learned From Developing Automated Systems for Industrialised Processing of Autologous Cell Therapies
Dan Strange, Head of Cell Therapy Technology, TTP plc
16:35 Speaker Q&A and Panel Discussion, joined by:
Richard McFarland, Chief Regulatory Officer, ARMI/BioFabUSA