Cell Therapy Insight Series

This bi-annual event will focus on Preparing for your IND/CTA, providing practical guidance for cell therapy projects.

Why attend?

• Learn actionable strategies from eight international experts on regulatory pathways and clinical development
• Gain insights directly applicable to early-stage biotech programs
• Network with peers and global stakeholders in cell therapy
• Participate in person or online, wherever you are

Speakers & Topics:

• Ana Hidalgo, Head of Advanced Therapies at EMA European Medicines Agency
  Topic: Regulatory and Access Strategy
• Richard Dennett, Senior CMC Regulatory Strategy Director at Thermo Fisher Scientific
  Topic: IND versus CTA: differences to be aware of and common pitfalls
• Richard McFarland, Chief Regulatory Officer at Advanced Regenerative Manufacturing Institute (ARMI USA)
  Topic: Safety & Risk Assessment: Practical Regulatory Insights for IND Preparation
• Renee Hart, President and Chief Business Officer at LymaCyte
  Topic: Precision Analytics for Regulatory Success: Bridging Cellular Insight and Manufacturing Confidence
• Uma Lakshmipathy, Site Head of Patheon Cell & Gene Translation Services and Senior Director of R&D at Thermo Fisher Scientific
  Topic: Future-Proofing Cell Therapy Manufacturing: Process, Product, and Patients
• Vincenzo di Cerbo, Program Head of Digital Innovation at Catapult
  Topic: Accelerating Patient Access: How Can Digital Innovation Unlock the Full Potential of Cell & Gene Therapy?
• Chris Demers, Head of Digital & Data at Skellig Automation
  Topic: Data First: The key to cell therapy success
• Elizabeth Woo, Vice President/ General Manager, Cell and Gene Therapy at Thermo Fisher Scientific
  Topic: No One Succeeds Alone: Collaborative Pathways to Impact