10:30am Chair Introduction

Chairperson: Frank Thielmann, Head Lean, Global Operational Excellence, Takeda

10:35am Presentation: FiCAT (Find-cut-and-transfer) Innovative Gene Writing Platform for Advanced Therapies.

• Gene-writing platform and technology development overview at Integra Therapeutics.
• Gene Therapy program for viral-free systemic deployment
• Cell engineering using advance gene writing technology

Avencia Sanchez-Mejias, Co-Founder & Chief Executive Officer, Integra Therapeutics

10:50am Presentation: How Technologies Successfully Move Advanced Therapies Around the World  

• Smart, innovative shippers for effective transportation while fulfilling regulatory requirements 
• Integration in orchestration systems assures full traceability while driving patient safety 
• Cryostorage technology protects therapies and enables market access 

Paula Pulsoni, Vice President, Sales and Services, WorldCourier

11:05am Presentation: Creating Foundations For “Simple” and Scalable Processing Platforms Virtually: The Alder Story

• Tech operational challenges of a virtual start-up
• Risks and mitigation strategies to support process and analytical development for the manufacture of allogeneic therapies from pluripotent stem cells

Ricardo P. Baptista, Chief Technology Officer, Alder Therapeutics AB

11:20am Presentation: Gorilla Adenoviral Vector, GRAd: an Innovative, Versatile Technology for Advanced Therapies and Genetic Vaccines 

• Technology validation for GRAd vector technology 
• Manufacturing based on the intensified production process 
• The versatility of technology for advanced therapies and genetic vaccines 

Angelo Raggioli, Head of Technology Development, ReiThera

11:35pm Closing Panel with Q&A

With all session participants