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Monday, June 26 • 4:15pm - 5:15pm
Challenges in Analytical Development of Cell and Gene Therapy Products, Regulatory Perspectives, and Convergence

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Component Type: Session
Level: Advanced

This session will describe challenges and opportunities in analytical development of cell and gene therapies, as well as US regulatory updates and the importance of international convergence in the development of cell and gene therapy products.

Learning Objectives

Discuss challenges in analytical development and testing for cell and gene therapies (CGT) (e.g. comparability, potency, impurities); Explain FDA’s benefit-risk assessments, expedited development pathways, and PDUFA VII for CGT products; Describe international convergence initiatives: PIC/s Annex 2A or WHO Consideration on regulatory convergence.

Chair

Maria Amaya, PhD, MS

Speakers
avatar for Maria Amaya

Maria Amaya

Lead External Advocacy, North America, Genentech, A Member of the Roche Group, United States
Maria Amaya is the Lead External Advocacy, North America in Quality Policy & Advocacy at Roche. In this position, Maria works within Roche/Genentech Global External Advocacy community to develop and deliver innovative quality and CGMP regulatory pathways, and collaborate with internal... Read More →

Monday June 26, 2023 4:15pm - 5:15pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  10: RegCMC-Product Quality, Session