Agenda - Tuesday 16th September, 2025 - Workshop & Keynotes

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Keynote Plenary

2:00pm - 2:05pm

Welcome to Cell and Gene Therapy International and Chairperson’s Opening Remarks

2:05pm - 2:50pm

Keynote Panel Discussion: Big Pharma’s CGT Playbook - Top Investment Priorities and Emerging Opportunities

Wolfram Carius - EVP Pharmaceuticals, Bayer
Erin Kimbrel - President & Head, Astellas Institute for Regenerative Medicine
Stephen Kennedy - Head of Technical Operations, CRISPR Therapeutics

2:50pm - 3:30pm

Investor Panel Discussion: Investments in Cell and Gene Therapies and Enabling Technologies

Bryan Poltilove - Strategic Advisor and Independent Board Director, Independent
Daniel Friedman - Principal, BroadOak Capital
Aaron Fisher - Director, Life Sciences Investments, ARCHIMED

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Keynote Plenary

4:30pm - 5:10pm

Keynote Presentation and Fire Side Chat: Lessons Learnt of the Path to Commercialization

Case Studies: Success stories of regulatory approvals and commercialization
Overcoming Hurdles: Key challenges from R&D to approval—and how to tackle them
Scaling Up: Strategies for manufacturing, validation, and CMC data packages
Regulatory Insights: Feedback from authorities on characterization, specifications, and approval pathways
Post-Approval Management: Long-term data tracking, durability studies, and lifecycle strategies
End-to-End Logistics: Mastering supply chain and global distribution
Pathways to approval –Case study on the journey from discovery to commercial development and beyond

5:10pm - 5:30pm

Commercialization of Cell and Gene Therapies: A Representative from FUJIFILM DioSynth Biotechnologies

Tuesday 16th September, 2025 - Workshop & KeynotesTuesday, 16 September 2025 - ET (Eastern Time, GMT-05:00)