15:30 – CHAIR INTRODUCTION

Chair: Stuart Curbishley, Head of Business and Project Development – Advanced Therapies, University of Birmingham

15:35 – PRESENTATION: How Can Digitalisation Enable A Large-Scale Application of CAR-T Cell Therapies? 

• Introduction into digitalisation and Industry 4.0 concepts and their potential for advanced therapies
• Presentation of an use case for digitalised CAR-T cell manufacturing
• Vision on an interconnected, AI-driven manufacturing network in Europe

Speaker: Simon Hort, Group Manager, Adaptive Production Control, Fraunhofer IPT

15:50 – PRESENTATION: AN ITERATIVE APPROACH TO PROCESS VERIFICATION – HOW ELECTRONIC BATCH RECORDING FACILITATES C&GT MANUFACTURING OVER PRODUCT LIFECYCLE 

• The specific challenges in digitizing a CGT process and how to address them
• Presentation of a best practice approach to digital data management

Speaker: Judith Koliwer, Principal Consultant Cell and Gene Therapy, Körber Pharma Software

16:05 – Unlocking Scalability with Digitisation- Real-World Implementation at the University of Birmingham’s Advanced Therapies Facility

• Where are the current bottlenecks between the Clinic and Manufacturing
• How seamless digitalisation can increase scale and compliance while reducing risk
• Digital tour of the clinical workflow and manufacturing touchpoints

Speaker: Kwok Pang, Chief Operating Officer, Autolomous

16:20 – Digitalization: From R&D to GMP manufacturing

• Current possibilities and limitations
• Look outside the manufacturing box
• How digitalization can reduce COGS, development timelines and therapy access while improving quality and compliance

Speaker: Friedemann Übele, Head of Process Science, Tigen

16:35 – SPEAKER Q&A

Joined by: 

Judith Koliwer, Principal Consultant Cell and Gene Therapy, Körber Pharma Software

Kwok Pang, Chief Operating Officer, Autolomous

Simon Hort, Group Manager, Adaptive Production Control, Fraunhofer IPT

Friedemann Übele, Head of Process Science, Tigen