Streamline Supply Chain Communications to Optimize Phase Appropriate QC Testing, Comparability & GMP Manufacturing of Raw Materials & Achieve Regulatory Compliance of Scalable Cell & Gene Therapies
Unlock the future of cell and gene therapy manufacturing at the 2nd Raw Materials for Cell & Gene Therapy Summit. This is your exclusive opportunity to hear directly from regulatory and standards leaders from the FDA, USP, and more as they share the latest thinking on BLA review expectations, raw material characterization, and the evolving global standards landscape.
With the cell and gene therapy industry facing increasing complexity and supply chain uncertainty, top innovators from Vertex, Genentech, and Bristol Myers Squibb will reveal how they're reengineering supplier strategies, through dual sourcing, co-development, and rigorous vendor qualification.
Explore real-world solutions to qualification challenges and variability risks with insights from Ultragenyx, Abeona Therapeutics, and Metagenomi. Through hands-on workshops, strategic roundtables, and high-impact networking, you’ll walk away with the connections and frameworks needed to strengthen your quality programs and stay ahead of regulatory expectations. The time to align, adapt, and advance is now.
Stay Ahead of the Evolving Regulatory Landscape
Tackle the Regulatory Minefield Slowing Cell & Gene Therapy Progress:
Regulatory uncertainty around raw materials is one of the biggest obstacles facing cell and gene therapy developers today, causing costly delays, failed batches, and GMP compliance nightmares. Our must-attend regulatory sessions bring together USP, FDA, SCB, ISO, IPEC, and EXCiPACT leaders to provide the clarity and actionable guidance you need. Hear directly from Lili Belcastro (USP), Andrey Sarafanov (FDA), Dawn Henke (SCB), Charlotte McIlvaine (EXCiPACT/IPEC), and Kok-Seong Lim (ISO) to:
- Decode the most challenging raw material standards and compliance expectations
- Reduce regulatory risk that can jeopardize your clinical or commercial programs
- Build a robust strategy to align with global standards and future-proof your supply chain
World-Class Speaker Faculty Includes:
Bring Your Team!
Equip your entire team with the cross-functional strategies, regulatory insights, and supplier partnerships needed to streamline raw material sourcing, enhance quality control, and accelerate the safe, compliant delivery of cell & gene therapies.
Discover below how our meeting applies to each area of work:
Technical Operations
Supply Chain
Quality Control
Quality Analyst
CMC
MSAT
Case studies on scaling processes, managing material transitions, and aligning supplier capabilities with commercial manufacturing needs
Proven frameworks to strengthen supplier resilience, reduce lot-to-lot variability, and secure GMP-ready materials in a volatile global market
Discover advanced testing and risk-tiered qualification strategies to ensure the consistency, safety, and compliance of raw materials
Learn how industry leaders integrate risk assessments, CQAs, and CMAs to build robust quality frameworks for CGT manufacturing
Align with FDA, USP, and ISO standards to streamline raw material qualification and regulatory compliance from clinical development to commercialization
Learn directly from MSAT leaders how to transition RUO materials to GMP grade while ensuring operational readiness and supplier alignment
Sneak Peek at Who's Already Confirmed:
Hear it from Your Peers:
Rocket Pharma
"This summit presented challenges and experiences shared by all industry leaders.”
- Previous Attendee, Raw Materials for Cell & Gene Therapy Summit
Stemcell Technologies
“This event is truly the first of its kind, bringing together therapeutic developers and raw material suppliers to harmonize about what the field needs to ensure safe, effective, and streamlined development of CGT products.”
- Previous Attendee, Raw Materials for Cell & Gene Therapy Summit
Abeona Therapeutics
“The meeting was very informative about where raw materials programs stand now and the expectation for the future.”
- Previous Speaker, Raw Materials for Cell & Gene Therapy Summit
Our Partners:
