Introductory Remarks
|
1:00 PM – 1:10 PM
|
Welcome and Overview RMTM Consortium and Workshop Goals
NANCY LIN, Leader of the Biomaterials Group, Biosystems and Biomaterials Division (BBD), Material Measurement Laboratory (MML), NIST
|
1:10 PM – 1:20 PM
|
Overview of NIST Advanced Therapy Program
Sheng Lin-Gibson, Chief of the BBD, MML, NIST
|
1:20 PM – 1:30 PM
|
Overview of NIST Microbial Metrology Program
SCOTT JACKSON, Leader of the Complex Microbial Systems Group, BBD, MML, NIST
|
|
Session 1: Challenges in Selecting and Applying a Rapid Microbial Test
Moderator: Jason Kralj, NIST
|
1:30 PM – 2:00 PM
|
Key Characteristics of Rapid Microbial Test Methods for Cell and Gene Therapies
Spencer Hoover, Independent Consultant
|
2:00 PM – 2:20 PM
|
FDA Requirements and Recommendations for Sterility Testing of Regenerative Medicine Therapies
JUDITH ARCIDIACONO, International Regulatory Expert, Standards Liaison, FDA
|
2:20 PM – 3:05 PM
|
Panel Discussion: Measurement Challenges and Needs
Moderator: Scott Jackson, NIST
|
|
- Spencer Hoover, Independent Consultant
|
|
- Tom Leach, Associate Director, Drug Product Process Engineering and Packaging, AstraZeneca
|
|
- CLAUDIA ZYLBERBERG, CEO, Akron Biotech
|
|
3:05 PM – 3:15 PM
|
BREAK
|
Session 2: Ongoing and New Efforts to Address Challenges
Moderator: Sandra Da Silva, NIST
|
3:15 PM – 3:20 PM
|
Introduction to Session 2
NANCY LIN, NIST
|
3:20 PM – 3:35 PM
|
Progress Toward Documentary Standards to Support Rapid Microbial Testing
Dawn Henke, Senior Scientific Program Manager, Standards Coordinating Body
|
3:35 PM – 3:55 PM
|
Rapid Detection of Bacteria and Fungi in ATMPs Prior Treatment – Validation of a Real-time PCR-based Test
Kai Nesemann, Product Manager, Microbiology, Sartorius Lab Instruments GmbH & Co. KG
|
3:55 PM – 4:45 PM
|
PANEL DISCUSSION: Potential Solutions and Paths for the Consortium
Moderator: Nancy Lin, NIST
|
|
- JUDITH ARCIDIACONO, International Regulatory Expert, Standards Liaison, FDA
|
|
- RICHARD HAMMOND, Technology Director, Cambridge Consultants LTD
|
|
- Richard McFarland, Chief Regulatory Officer, ARMI|BioFabUSA
|
|
- STACY SPRINGS, Senior Director of Programs; Executive Director Biomanufacturing Initiatives, Massachusetts Institute of Technology’s Center for Biomedical Innovation
|
|
- RADHAKRISHNA TIRUMALAI, Principal Scientific Liaison, US Pharmacopeial Convention (USP)
|
|
|
Concluding Remarks
|
4:45 PM – 5:00 PM
|
Summary and Next Steps
NANCY LIN and SCOTT JACKSON, NIST
|
|