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Wednesday, June 19 • 4:30pm - 5:30pm
#376: Challenges in Quality Control for Cell and Gene Therapy Development: Regulatory Perspectives and Best Practices

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-675-L04-P; CME 1.00; RN 1.00

This session will describe key challenges in quality assessment for cell and gene therapies, focusing on challenges related to raw materials; discuss regulatory perspectives; and present best practices to control and evaluate raw materials.

Learning Objectives

Identify the key current challenges in quality control for cell and gene therapy development; Explain global regulators’ perspectives on quality control, including raw material selection, control, and qualification; Discuss best practices, including standards and reference materials, to support the development and manufacture of cell and gene therapies.

Chair

Fouad Atouf, PhD

Speaker

Qualification and Selection of Raw Materials During Early Stage of Development
Mo Heidaran, PhD

Perspective on the Selection of Raw Materials for Cell Therapy Manufacturing
Haritha Vallabhaneni, PhD

Cell and Gene Therapy Products: Global Regulatory Perspective
Michael Day, PhD


Speakers
avatar for Fouad Atouf

Fouad Atouf

Senior Vice President, Global Biologics, United States Pharmacopeia (USP), United States
Dr. Atouf has over 20 years’ experience in research, product development, characterization and quality assessment of biologics including cell and gene therapies (CGT). At USP, he heads the Biologics program and oversees standards development, stakeholder engagement and external... Read More →
MD

Michael Day

Senior Director, Regulatory Science, Voisin Consulting Life Sciences (VCLS), United States
avatar for Mo Heidaran

Mo Heidaran

Chief Regulatory Scientist, Cellx Inc., Consulting, United States
Dr. Mo Heidaran is currently Chief Regulatory Scientist at Cellx Inc. He previously worked as Head of Translational and Regulatory Strategy at GCTx (GC Therapeutics). He is a recognized expert in the development of cell and gene therapies with more than 9 years of experience at the... Read More →
avatar for Haritha Vallabhaneni

Haritha Vallabhaneni

Biological Reviewer, Office of Cellular Therapy and Human Tissue CMC, CBER, FDA, United States
Dr. Vallabhaneni is a CMC Reviewer in the Division of Cell Therapy 1, CBER, FDA. She is involved in CMC review of regulatory applications involving cellular therapy products. She has extensive research experience in stem cells previously working on multiple research projects investigating... Read More →

Wednesday June 19, 2024 4:30pm - 5:30pm PDT
Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Session |   06: TranslationalDelivery Tech-PrecMedicine, Session |   10: RegCMC-Product Quality, Session