On Tech Ethics with CITI Program
On Tech Ethics with CITI Program
CITI Program
Understanding the Regulation of Cell Therapy Products - On Tech Ethics
32 minutes Posted Apr 7, 2026 at 4:00 pm.
Podcast Introduction and Episode Overview
Guest Backgrounds and NMDP’s Role
What Cell Therapy Products Are and How They’re Used
Emerging Cell Therapy Modalities
Investigational vs. Approved Therapies
Overview of U.S. Cell Therapy Regulation
Understanding 351 vs. 361 Products
Why Cell Therapies Are Uniquely Regulated
Consequences of Misclassifying Products
Minimal Manipulation and Homologous Use Explained
Business and Compliance Risks of Getting It Wrong
Why Training in Cell Therapy Regulation Matters
Developing the Cell Therapy Regulation Course
Who the Course Is For
Operational Benefits of Shared Regulatory Understanding
Reducing Risk and Improving Outcomes Through Education
Final Reflections on Regulation and Training
Closing Remarks and Resources
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Show notes
Discusses the regulation of cell therapy products and the importance of training on this topic. Our guests today are Kathy Loper and Jared Schuster. Kathy serves as the Director of Regulatory Affairs for NMDP, a nonprofit providing life-saving cellular therapies to patients. Kathy has extensive experience in biological product manufacturing and works closely with regulatory agencies, professionals, and other organizations to move the industry forward. Jared also has ...