Delivering on the Promise of Cell and Gene Therapy Distributed and Point-of-Care Manufacturing

This series consists of 5 panels, including:

• Regulatory Challenges – Distributed and Point-of-Care Manufacturing Models. “Do we Have a Regulatory Framework?” With Heath Coats, Dark Horse Consulting
• Regulatory Challenges – Product Quality (CMC) Challenges and Opportunities with David Lewandowski, Azenta Life Sciences
• 5 Minutes with Germfree, with Kevin Kyle, Germfree
• Distributed and Point-of-Care Manufacturing – Pharmaceutical QMS Essentials Digital Systems with Lynn Fischer, Title21 Health Solutions and Najib Rehman, ATMPS
• Building Infrastructure and Capacity with Edwin Stone, Cellular Origins and Krisha Patel, Assurea, LLC

Panel 1: Regulatory Challenges – Distributed and Point-of-Care Manufacturing Models. “Do we Have a Regulatory Framework?”

This first panel features insights from Heath Coats, Senior Practice Expert at Dark Horse Consulting.

Panel 2: Regulatory Challenges – Product Quality (CMC) Challenges and Opportunities

This panel features insights from David Lewandowski, Director, Business Development at Azenta Life Sciences.

Panel 3: 5 Minutes with Germfree

This 5 minute interlude features insights from Kevin Kyle Chief Executive Officer at Germfree.

Panel 4: Distributed and Point-of-Care Manufacturing – Pharmaceutical QMS Essentials Digital Systems

This panel features insights from Lynn Fischer, Chief Executive Officer, Title21 Health Solutions and Najib Rehman, Digital Automation Lead at ATMPS.

Panel 5: Building Infrastructure and Capacity

This panel feature insights from Edwin Stone, Chief Executive Officer at Cellular Origins and Krisha Patel, Co-Founder of Assurea, LLC.

These panels were produced in partnership with Germfree.