NIST Workshop: Launch of the Rapid Microbial Testing Methods Consortium

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