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Report from the NIST Workshop: Launch of the Rapid Microbial Testing Methods Consortium
NIST is establishing a Rapid Microbial Testing Methods (RMTM) Consortium to convene stakeholders in the pre-competitive space and address the need for measurements and standards, including reference materials, for rapid testing of microbial contaminants in regenerative medicine and advanced therapy products. The purpose of this workshop is to launch and inform future directions of the RMTM Consortium. Participants will learn about the state-of-the-art in rapid microbial testing methods, help to identify pressing measurement challenges and standards needs, and provide initial feedback on the proposed directions of the Consortium. This workshop is open to all as an opportunity to provide input and learn about RMTM activities. Future meetings of the Consortium will further refine and implement Consortium plans.
Speakers and Panelists
Printable PDF of Speaker Abstracts and Speaker/Panelist Bios
Speakers
- SHENG LIN-GIBSON, Chief of the Biosystems and Biomaterials Division, NIST
- SPENCER HOOVER, Independent Consultant
- JUDITH ARCIDIACONO, International Regulatory Expert, Standards Liaison, FDA
- DAWN HENKE, Senior Scientific Program Manager, Standards Coordinating Body
- KAI NESEMANN, Product Manager, Microbiology, Sartorius Lab Instruments GmbH & Co. KG
Panelists
- RICHARD HAMMOND, Technology Director, Cambridge Consultants Ltd.
- TOM LEACH, Associate Director, Drug Product Process Engineering and Packaging, AstraZeneca
- 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)
- CLAUDIA ZYLBERBERG, CEO, Akron Biotech
Agenda (Printable PDF)
1:00pm - 5:00pm ET
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