October 1, 2025
Gillette Stadium

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CoP Session: ATMP CoP Introduction

12:00 PM – 12:30 PM | East Red Level, Suite 20

ATMP CoP Introduction

The presentation will open with a brief overview of what are Advanced Therapeutic Medicinal Products (ATMPs) and what are some of the major challenges. ISPE is actively working to share knowledge and develop best practices for these modalities. Several existing resources will be discussed. The ISPE ATMP Community of Practice (CoP) is focused on further developing ISPE resources for the industry on ATMPs and will present some of the on-going CoP activities. Concluding we will mention how to get involved and take any questions or input on what the CoP should address on ATMPs.

Speaker:

Nessiem Samuel, Owner and Partner, GxP Impact Consulting LLC.

Biography:

Owner and Partner of GxP Impact Consulting LLC. Experienced Sr. Director with a demonstrated working history in the biological sciences and pharmaceutical industries. Skilled in Validation and Verification (V&V), GLP, Change Control, and GxP. Expert in validation life cycle approaches, CSV, process, and cleaning validation. Strong business acumen, CQE, SSGB, Bachelor of Science, Industrial Engineering, Master of Science in Manufacturing Processes, and Management both from New Jersey Institute of Technology.