Beyond the Science:
The CMC Decisions That Shape Cell Therapy Success

LIVE WEBINAR
Thursday, September 10 | 11am ET

Duration: 1 hour
Can't make the live date? Register and we'll send you a link to the recording. ​

Cell therapy has entered a new era. As autologous therapies continue to demonstrate durable outcomes and emerging modalities, including allogeneic, iPSC and in vivo approaches, expand into new therapeutic areas, sponsors face increasingly complex manufacturing decisions. A robust Chemistry, Manufacturing and Controls (CMC) strategy has become a critical driver of commercial success, influencing scalability, cost, product quality and long-term program viability.

Join Catalent and BioPharma Dive for a discussion exploring how CMC strategies are evolving across cell therapy modalities and what sponsors can do today to prepare for tomorrow's commercial landscape. Industry experts will examine manufacturing trade-offs, regulatory considerations, commercialization challenges and the strategic decisions that can help organizations build competitive, future-ready cell therapy programs. You'll learn how to:

  • Evaluate CMC strategies across different cell therapy modalities 
  • Balance manufacturing costs, scalability and commercial viability
  • Understand evolving FDA guidance and its impact on development strategies
  • Navigate centralized versus decentralized manufacturing approaches
 

SPEAKERS

John Tomtishen
John Tomtishen
Global Head Cell Therapy, Field Application Scientists & Strategic Alliances, Catalent


Bruno Marques
Bruno Marques
SVP Technical Operations, Morphocell Technologies


Karen Walker
Karen Walker
Former CTO, Kyverna Therapeutics


Martin A. Giedlin, Ph.D.
Martin A. Giedlin, Ph.D.
CTO, RegCell

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