NIST-Hosted Workshop on Collaborative Efforts to Enable Adoption of Rapid Microbial 

Testing Methods for Advanced Therapy Products

Tuesday, April 25, 2023, 9:00 AM – 5:00 PM (all times are EDT)

AGENDA

(updated 4/24/2023)

OPENING

9:00 AM – 9:25 AM Welcome and Opening Remarks

Scott Jackson, PhD, Leader, Complex Microbial Systems Group, Biosystems and 

Biomaterials Division (BBD), Material Measurement Laboratory (MML) at the 

National Institute of Standards and Technology (NIST) 

Stephanie Hooker, PhD, Acting Director, MML at NIST

9:25 AM – 10:00 AM KEYNOTE PRESENTATION

A Pathway for Implementing Rapid Microbial Test Method

Veera Dheenadhayalan, PhD, Director of Biosafety at AstraZeneca 

SESSION 1: Efforts that Support Rapid Microbial Testing Methods for Advanced Therapies

Moderator: Kirsten Parratt, BBD, MML, NIST

10:00 AM – 10:15 AM USP Evolving Position on Use of Rapid Microbial Methods 

Huiping Tu, PhD, Senior Principal Scientist at USP

10:15 AM – 10:30 AM PDA Activities Related to Rapid Microbial Methods 

Fred Ayers, Advisor – Global Quality Systems at Eli Lilly and Company

10:30 AM – 10:45 AM Accelerating Adoption of Rapid Microbial Detection Technologies

Jennifer Mantle, PhD, Regulatory Committee Coordinator/Technical Project 

Manager at the National Institute for Innovation in Manufacturing 

Biopharmaceuticals (NIIMBL) 

10:45 AM – 11:00 AM BREAK 

11:00 AM – 11:15 AM Advanced Virus Detection Technologies Interest Group (AVDTIG) - Advancing the 

Adoption of NGS for Adventitious Agent Detection 

Siemon Ng, PhD, Senior Director of Analytical Development and Quality at Notch 

Therapeutics

11:15 AM – 11:30 AM An Overview of the Modern Microbial Methods Collaboration

Allison Scott, PhD, Principal Scientist at MicronView LLC

11:30 AM – 11:45 AM NIST Rapid Microbial Testing Methods (RMTM) Consortium: Activities and Directions

Nancy Lin, PhD, Leader, Biomaterials Group, BBD, MML at NIST

11:45 AM – 12:00 PM Current State of Standards for RMTMs in Advanced Therapies

Dawn Henke, PhD, Senior Technical Program Manager, Standards Coordinating 

Body for Regenerative Medicine (SCB)

LUNCH (on your own)

12:00 PM – 1:30 PM

SESSION 2: Feedback and Discussion on Rapid Microbial Testing Methods

Moderator: Nadratun Chowdhury, BBD, MML, NIST

1:30 PM – 1:45 PM Introduction to Breakout Sessions

Nadratun Chowdhury, PhD, National Research Council Postdoctoral Fellow, BBD, 

MML at NIST

1:45 PM – 2:55 PM Breakout Sessions 

2:55 PM – 3:25 PM Breakout Session Report-out and Discussion
Breakout Session Moderators, NIST

3:25 PM – 3:45 PM BREAK

3:45 PM – 4:45 PM Panel Discussion

Moderator: Scott Jackson, NIST

Panelists: 

• Guo-Chiuan Hung, PhD, Chemistry, Manufacturing, and Control (CMC) Reviewer 

at FDA/CBER/Office of Advanced Therapies (OTAT)/Division of Cellular and 

Gene Therapies (DCGT)/Gene Therapy Branch

• Michael Miller, PhD, President at Microbiology Consultants, LLC

• Jennifer Robbins, Senior Principal Scientist in Cell Therapy Development at 

Bristol Myers Squibb 

• Tricia Vail, Regional Segment Marketing Manager – Applied Research Markets 

at Sartorius Corporation

CLOSING

4:45 PM – 5:00 PM Concluding Remarks

Scott Jackson, NIST

SLIDES ONLY (No presentation)

Activities of the MIT Center for Biomedical Innovation Related to Rapid Microbial Methods

Stacy Springs, PhD, Executive Director, MIT Center for Biomedical Innovation