NIST-Hosted Workshop on 

Collaborative Efforts to Enable Adoption 

of Rapid Microbial Testing Methods for 

Advanced Therapy Products 

 

 

 

Date: Tuesday 25-April-2023 

Time: 9:00am-5:00pm (ET) 

Location: IBBR (Rockville, MD)/Virtual 

Hosted By: NIST 
2 NIST-HOSTED RMTM WORKSHOP | 2023

NIST

The National Institute of Standards and Technology (NIST) was founded in 1901 

by Congress to improve U.S. industrial competitiveness by advancing its 

measurement infrastructure. Now a part of the U.S Department of Commerce, the 

mission of NIST remains to promote US innovation and industrial competitiveness 

by offering measurement science, standards, and technology to enhance 

economic security and improve the quality of life. With a vision to be the world’s 

leader in creating measurement solutions, NIST bolsters three core 

competencies in measurement science, rigorous traceability, and standards 

development and use.

-Adopted from About | NIST (https://www.nist.gov/about-nist)

 

NIST Rapid Microbial Testing Methods Consortium

Bringing together experts across the regenerative medicine field, including 

stakeholders in industry, academia, and the government, the NIST Rapid 

Microbial Testing Methods (RMTM) Consortium seeks to address the need for 

measurement standards for rapid microbial testing of regenerative medicine and 

advanced therapy products. 
3 NIST-HOSTED RMTM WORKSHOP | 2023

CONTENTS 

Welcome and Overview 

Agenda 

Speaker/Panelist Biographies 

Acknowledgements

Planning Committee 

Additional Information 
4 NIST-HOSTED RMTM WORKSHOP | 2023

WELCOME AND OVERVIEW

With great pleasure, we welcome you to the 2023 NIST Rapid Microbial Testing Methods 

Consortium Workshop. Traditional methods for assessing contamination in pharmaceutical 

products take weeks, but emerging advanced therapy products require more rapid results. Rapid 

microbial testing methods (RMTMs) are available but have not been widely adopted, due in part 

to the need for manufacturers to independently validate rapid microbial methods as well as the 

lack of tools to support this validation. In 2020, NIST established the RMTM Consortium to 

convene stakeholders in the pre-competitive space and develop measurement solutions and 

standards that increase confidence in the use of RMTMs. Outside of NIST, other organizations 

are similarly focusing on tools and solutions to support the use of rapid microbial methods for 

sterility and adventitious agent testing. This workshop will bring together organizations including 

the NIST RMTM Consortium, the Standards Coordinating Body (SCB), the United States 

Pharmacopeia (USP), the National Institute for Innovation in Manufacturing Biopharmaceuticals 

(NIIMBL), and others - to share their current and future activities. Together, we will discuss how 

to support one another, leverage and align activities, and identify opportunities for collaboration 

to accelerate the adoption of RMTMs in the advanced therapy community and beyond. This oneday, hybrid workshop is open to all.

Workshop Goal

Identify opportunities for leveraging and coordinating ongoing and future efforts on rapid 

microbial testing methods (RMTMs) to accelerate the validation and adoption of RMTMs in 

advanced therapy products.

 

Expected Outcomes Include

 

• An established line of communication among professional organizations supporting the use 

of rapid microbial methods

• Identification of common themes, unique roles, areas of overlap, and gaps in activities to 

support RMTM adoption

• Follow-up meetings to discuss potential collaborations and how to leverage activities

• Workshop report
5 NIST-HOSTED RMTM WORKSHOP | 2023

AGENDA

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 
6 NIST-HOSTED RMTM WORKSHOP | 2023

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
7 NIST-HOSTED RMTM WORKSHOP | 2023

SPEAKER/PANELIST BIOGRAPHIES 

KEYNOTE SPEAKER

 

Veera Dheenadhayalan, PhD, Director of Biosafety at AstraZeneca

1994, Graduated in Biology and received PhD in Immunology from India.

Joined Cornell University in 2000 for Post-Doctoral research focusing on DNA vaccines. Later 

joined CBER, FDA as a visiting fellow to continue the post-doc studies on novel PE/PPG gene 

family of M. tuberculosis, candidate vaccine development and also developing a safety 

evaluation model for tuberculosis.

In 2005, joined as a scientist at Aeras (non-profit organization advancing the development of 

tuberculosis vaccines), performing immunogenicity studies, vaccine efficacy assessment and 

clinical end-point assays for various candidate vaccines programs.

In 2015, joined IDT Biologika (CDMO focusing viral vaccines and gene therapeutics) as Director 

Quality Control & Assay Development, supporting various viral vectors, recombinant proteins 

and bacterial vaccine’s specific assay developments, qualifications and lot release activities.

In 2020, joined AstraZeneca as Director, Biosafety and bioassay development. In the current 

role, providing scientific and strategic leadership for the biosafety testing of biologics including 

viral vaccines, monoclonal antibodies and cell therapy products. Also, working on introducing 

nucleic acid technologies for biosafety testing for sterility, mycoplasma and adventitious agent 

testing for biologics.

INVITED SPEAKERS

 

Stephanie Hooker, PhD, Acting Director, Material Measurement Laboratory at NIST

Dr. Stephanie A. Hooker is the Acting Director of the Material Measurement Laboratory (MML) 

at the National Institute of Standards and Technology (NIST). She holds a Ph.D. in Ceramic 

Engineering from Clemson University, with a minor in Analytical Chemistry. She began her 

career at NASA developing detector technology for atmospheric sensing, leading the 

development of a spaceflight experiment that demonstrated first-of-its-kind superconducting 

electronics and cryocooler technology in space. From 1998-2002, she served as Business 

Development Manager for Nanomaterials Research, LLC, a startup company developing both 

nanoparticle technology and nanostructured devices. During that time, she secured venture 

capital investments, large partnerships with Fortune 500 companies, and exclusive licensing to 

spin out two new businesses in the nanotech space. Since joining NIST in 2002, she has 

served as Group Leader, Division Chief, Program Director, Associate Director (MML), Acting 

Deputy Director (MML), and, most recently Acting Director (MML). She has led programs in 

nanotechnology, impact-resistant materials for head health, and plastics recycling, as well as 

being a founding member of NIST’s diversity and inclusivity strategy development.
8 NIST-HOSTED RMTM WORKSHOP | 2023

Huiping Tu, PhD, Senior Principal Scientist at USP

Dr. Tu has been working with USP for over 10 years. Currently she is the senior Principal 

Scientist to manage the Microbiology Expert Committee and leads the effort to develop the 

microbiology related USP general chapters. Her previous role in USP was the Director of the 

Biologics Laboratory, and she managed the bioanalytical, bioassay and microbiology teams. 

She oversaw daily operation of the laboratory and interactions with other USP departments, the 

global biological units and stakeholders to promote good quality of biotherapeutic products 

globally.

Prior to joining USP in 2012, she worked most recently at Merck, where she was a Senior 

Research Scientist at Cardiovascular Diseases Franchise to work in early drug discovery 

process ranging from target identification/validation, lead compound identification /optimization 

and safety assessment.

Dr. Huiping Tu received her M.S. in Organic Chemistry and Ph. D. in Physiology. Dr. Tu has a 

broad scientific background in the fields of cardiovascular and neurological diseases with deep 

and broad expertise in microbiology, molecular/cell biology, biochemistry, and analytical 

chemistry. She has more than 20 years’ experience in pharmaceutical industry, academia, and 

regulatory science with in-depth knowledge of USP-NF and the development of reference 

standards relevant to pharmaceutical products. Dr. Tu is the leading author or co-author of 

many prestigious peer-reviewed publications including Cell; J. Clinical Investigation and Neuron 

and holds several patents.

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

Jennifer Mantle, PhD, Regulatory Committee Coordinator/Technical Project Manager at 

the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL)

Jennifer Mantle received her BS in Chemical Engineering from Villanova University and her PhD 

in Chemical and Biomolecular Engineering from the University of Delaware. She has been 

working for the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) 

since 2017. In her tenure at NIIMBL, she has managed the Regulatory Considerations 

Committee, served as a project manager for over 20 multi-organization technical and workforce 

development projects, and is currently the lead scientist for the NIIMBL Next Generation 

Sequencing Test Bed, which is being built to support the community around adventitious agent 

testing and product characterization for new modalities.

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

Therapeutics

Dr. Siemon Ng is the Senior Director, Analytical Development and Quality at Notch 

Therapeutics and is responsible for developing and implementing the analytical strategy for 

Notch’s iPSC-derived immunotherapies. Dr. Ng has extensive experience with analytical 

development including next generation sequencing and NGS data analysis, digital PCR, qPCR, 

and other molecular and immunological techniques. Dr. Ng is an active member of the PDA 

Advanced Virus Detection Technologies Interest Group and has participated in multiple 

collaborative studies involving the use of NGS. Prior to joining Notch Therapeutics in 2022, Dr. 

Ng was the Head of the Molecular Biology Centre at Sanofi Pasteur, Analytical Sciences for 

vaccine development. Dr. Ng completed his PhD at Simon Fraser University studying the 

Atlantic salmon genome. Subsequently, he worked on mouse genomics at The Jackson 
9 NIST-HOSTED RMTM WORKSHOP | 2023

Laboratory. In 2008, Dr. Ng moved to Toronto to study the genomic landscape of stem cells at 

the Ontario Institute for Cancer Research.

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

Dr. Stacy Springs is the Executive Director at the MIT Center for Biomedical Innovation (CBI). 

The Center integrates the Institute’s technical, scientific, and management expertise to solve 

complex biopharmaceutical challenges. CBI leads multi-stakeholder, multidisciplinary research 

and educational initiatives with real world impact, including MIT's Biomanufacturing Consortium, 

(BioMAN), and its Consortium on Adventitious Agent Contamination in Biomanufacturing, 

(CAACB). Dr. Springs is a principal investigator on several research programs in biologics 

manufacturing, from application of data analytics and PAT in the continuous production of 

monoclonal antibodies, viral vectors and vaccines; to development of innovative rapid sterility 

tests and new approaches to adventitious agent contamination through long read sequencing. 

Dr. Springs is part of SMART CAMP, where she is focused on and serves as the Chair of 

Landmark Bio’s Science and Technology Committee. Dr. Springs’ research interests include 

biopharmaceutical development and manufacturing, risk management, regulatory and 

translational science and food safety and food supply chains. She holds a PhD in Chemistry 

from the University of Texas at Austin and gained postdoctoral training in protein and 

biophysical chemistry at Princeton University.

Allison Scott, PhD, Principal Scientist at MicronView LLC

Allison Scott is a member of the Modern Microbial Methods Collaboration Steering Committee 

and a facilitator for one of its three sub-teams. She has worked on evaluating modern methods, 

their diverse applications in air and water monitoring, and in supporting their implementation in 

the pharmaceutical and related industries for over thirteen years. Allison is also a principal 

scientist at MicronView LLC where she specializes in particle and microbial monitoring 

solutions. She holds a joint Doctorate Degree in Materials Science and Engineering from the 

University of Arizona and in Materials Chemistry from the University of Rennes.

Nancy Lin, PhD, Leader, Biomaterials Group, Biosystems and Biomaterials Division at 

NIST

Dr. Nancy Lin is the Leader of the Biomaterials Group in the Biosystems and Biomaterials 

Division, Material Measurement Laboratory at the National Institute of Standards and 

Technology. Her research focuses on developing measurements and standards to enable 

detection, characterization, and quantification of microbes and microbial communities, with an 

emphasis on microbial cell reference materials, biofilm-material interactions, antimicrobial 

efficacy, microbiome, and biosurveillance. Nancy holds a BS in Mechanical Engineering from 

Valparaiso University and a PhD in Biomedical Engineering from Case Western Reserve 

University.

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

Regenerative Medicine (SCB)

Currently Dawn works to oversee all of the Standards coordinating body’s technical effort in 

standards develop and education for advanced therapies. Dawn holds a PhD in Genetics and 

Genomic Sciences from University of Alabama at Birmingham. 
10 NIST-HOSTED RMTM WORKSHOP | 2023

Prior to joining SCB, she worked as a post-doctoral fellow at the National Institutes of Health in 

the National Eye Institute performing stem cell research developing retinal organoids for testing 

and therapeutic purposes from stem cells.

INVITED 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

Dr. Hung earned his PhD from the University of Melbourne, Australia, where his research 

focused on developing diagnostic molecular assays for equine parasitic infections. In 2009, he 

joined CBER, FDA as a Staff Fellow in the laboratory of human tissue microbiology where his 

responsibilities were to establish the basic capability of clinical microbiology culture systems for 

the detection and characterization of microbes with safety concerns in human tissue grafts and 

to develop rapid detection molecular technology for pathogens of main safety concerns in 

tissues intended for transplantation. Additionally, Dr. Hung played a key lead role in the 

development of high-throughput next generation sequencing (NGS) capabilities and

bioinformatic pipelines for the detection and characterization of previously unknown 

microorganisms. He received CBER Honor awarded in 2011 and FDA Honor Award in 2020 for 

his outstanding scientific achievements. In 2021, Dr. Hung joined the Gene Therapy Branch in 

the Division of Cellular and Gene Therapies (DCGT), Office of Advanced Therapies (OTAT), 

CBER as a full-time chemistry, manufacturing and control (CMC) reviewer.

Michael Miller, PhD, President at Microbiology Consultants, LLC 

Dr. Michael J. Miller is an internationally recognized microbiologist and subject matter expert in 

pharmaceutical microbiology, contamination control and the validation and implementation of 

rapid microbiological methods (RMM). He is currently the President of Microbiology Consultants, 

LLC (http://microbiologyconsultants.com), and owner of http://rapidmicromethods.com, an 

educational website dedicated to the advancement of rapid microbiological methods within a 

variety of healthcare, pharmaceutical, consumer and related industry sectors.

For more than 30 years, he has held numerous R&D, manufacturing, quality, business 

development and executive leadership roles at Johnson & Johnson, Eli Lilly and Company and 

Bausch & Lomb. In his current role, Dr. Miller consults with multinational companies in providing 

technical, quality, regulatory and training solutions in support of rapid methods, sterile and nonsterile pharmaceutical manufacturing, contamination control and remediation, environmental 

monitoring, sterilization and laboratory operations.

Dr. Miller has authored more than 100 technical publications and presentations and is the editor 

of PDA's Encyclopedia of Rapid Microbiological Methods. He currently serves on the editorial 

and scientific review boards for American Pharmaceutical Review, European Pharmaceutical 

Review and the PDA Journal of Science and Technology. Dr, Miller serves as the chairperson 

for the revision.
11 NIST-HOSTED RMTM WORKSHOP | 2023

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

Myers Squibb 

Jennifer Robbins leads the Molecular Analytics team in Cell Therapy Development at Bristol 

Myers Squibb. The team is primarily responsible for development and GMP validation of novel 

qPCR and ddPCR methods for characterization and release of CAR T cell therapy products. 

The team has a focus on safety methods and supports both clinical and commercial programs. 

Prior to joining BMS, Jennifer most recently worked at Novartis on development and validation 

of molecular release assays for Kymriah, the first commercially approved CAR T cell therapy. 

Jennifer holds a BS in Microbiology from Michigan State University. 

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

Sartorius Corporation

With over 20 years’ experience with microbiology and filtration, Tricia Vail has extensive 

experience in multiple markets including foods & beverages, water, air, cannabis, cosmetics, 

and pharmaceuticals. She is an active member of ASTM, ANSI, AOAC & ISO and represent 

the United States on a multitude of regulatory committees focusing on test methods for 

microbiology. She is also a member of the American Society of Brewing Chemists (ASBC) and 

the Brewers Association (BA). She has a passion for microbiology and is dedicated to helping 

the any industry achieve their quality needs.

ACKNOWLEDGEMENTS

We would like to express our gratitude to all speakers and panelists for their contributions 

to this event. We also thank the Nicole Tenly and the team at the Institute for Bioscience 

and Biotechnology Research (IBBR) for technical support and the NIST microbial team 

for note-taking and breakout session support.
12 NIST-HOSTED RMTM WORKSHOP | 2023

PLANNING COMMITTEE

NIST

Nadratun Chowdhury, Ph.D.

Complex Microbial Systems Group

Tara Eskandari, M.S., B.S.

Biosystems and Biomaterials Division-HQ

Scott Jackson, PhD

Complex Microbial Systems Group

Shaswat Koirala, M.S., B.S.

Biosystems and Biomaterials Division-HQ

Jason Kralj, PhD

Complex Microbial Systems 

Nancy Lin, PhD

Group Leader, Biomaterials Group 

Stephanie Servetas, PhD

Complex Microbial Systems Group 

Standards Coordinating Body for Regenerative Medicine 

(SCB)

Dawn Henke, PhD

Senior Technical Program Manager

Melody Sanders, PhD

Scientific Program Manager 
13 NIST-HOSTED RMTM WORKSHOP | 2023

ADDITIONAL INFORMATION 

Overview of the NIST-Led RMTM Consortium

The NIST Rapid Microbial Testing Methods (RMTM) Consortium addresses the need for 

measurements and standards, including reference materials, to increase confidence in 

the use of rapid testing for microbial contaminants in regenerative medicine and advanced 

therapy products. The Consortium is organized into three working groups (WGs).

WG01 MISSION: The Reference Material Working Group (WG01) aims to identify and 

facilitate the development, characterization, and qualification of reference materials 

(RMs) to support the broad adoption of new and existing Rapid Microbiology Test 

Methods (RMTMs) within the Advanced Therapy Industry.

WG02 MISSION: The Methods and Validation Schemes Working Group (WG02) aims to 

develop a framework for validating methods to support the broad adoption of new and 

existing Rapid Microbiology Test Methods (RMTMs) by the Advanced Therapy Industry.

WG03 MISSION: The Interlaboratory Study Design and Implementation Working Group 

(WG03) aims to design and implement interlaboratory studies to assess the analytical 

performance of various RMTMs while also evaluating the performance and fitness of 

candidate reference materials.

HOW TO GET INVOLVED

Become A Member

• Complete the Letter of Interest Form

• Participants will sign a Cooperative Research and Development Agreement 

(CRADA); Federal Agencies may join under a Letter of Agreement

• No cost to join the Consortium 

Member Benefits 

• Access to a neutral forum to address pre-competitive needs

• Participation in the development of reference materials, methods, and protocols, 

and interlaboratory studies

• Access to tools developed by the Consortium ahead of public release 

• Institutional representation in Consortium directions

For more information, please contact Nancy Lin (nancy.lin@nist.gov) and Scott Jackson

(scott.jackson@nist.gov)