NIST Rapid Microbial Testing 

Methods Workshop “Addressing the Needs for Measurements and Standards for Rapid Testing of 

Microbial Contaminants in Regenerative Medicine”

 

 

Date: Tuesday 19-April-2022 

Time: 11:00am-3:30pm (ET) 

Location: Cisco WebEx Virtual Meeting 

Hosted By: NIST 
2 NIST RMTM WORKSHOP | 2022

2022 NIST RMTM Workshop

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 RMTM WORKSHOP | 2022

CONTENTS 

Welcome 

Agenda 

Speakers and Panelists 

Speaker Biographies 

Planning Committee & 

Acknowledgements 

Additional Information & Resources 

How to Get Involved 
4 NIST RMTM WORKSHOP | 2022

WELCOME 

With great pleasure, we welcome you to the 2022 NIST Rapid Microbial Testing Methods 

Consortium Workshop. Rapid microbial testing methods (RMTMs) have the potential to 

detect microbial contaminants more quickly in advanced therapy products, as compared 

to compendial methods that can take weeks. However, RMTMs are not widely adopted 

in the industry. NIST is hosting this workshop to discuss challenges and standards-based 

solutions that will help facilitate the use of RMTMs for advanced therapy products and 

support the activities of the NIST RMTM Consortium.

Workshop Goals Include 

§ Learning about the state of the field for RMTMs in the advanced therapy sector

and prioritizing measurement challenges and standards needs

§ Discussing hurdles in the adoption of RMTMs for advanced therapies

§ Sharing and obtaining feedback on current activities and future directions of the 

RMTM Consortium 

Expected Outcomes Include 

 

● Shared knowledge of challenges and recent advances in RMTMs

● Increased awareness of the NIST RMTM Consortium and its activities

● Stakeholder feedback to help inform the Consortium Work Plan 

Consortium activities to be discussed are the development of methods to quantify 

microbial cell properties, including total cell count and total genome copy number; 

application of those methods to microbial whole-cell reference materials; and

interlaboratory studies to assess fitness for purpose of the reference materials.

It is an opportune time for all of us as we gather to expand our work's impact and help 

address the needs of the regenerative medicine community. Thank you all once again for 

joining us as we work together to inform better practices and advance the implementation 

of RMTMs for advanced therapy products.

-NIST RMTM Consortium Leadership Team
5 NIST RMTM WORKSHOP | 2022

AGENDA

Tuesday April 19, 2022, 11:00am-3:30pm ET

WELCOME 

11:00 AM-11:15 AM Opening Remarks and Brief Overview of NIST RMTM Consortium

Nancy Lin (NIST) and Sheng Lin-Gibson (NIST)

Session 1: Barriers and Potential Solutions to Adoption of RMTMs

Moderator: Nancy Lin

11:15 AM-11:30 AM Topic: Regulatory Landscape

Speaker: Margaret Riley, JD, Professor of Law, University of Virginia 

Talk Title: The Regulatory Context for Sterility Standards in Cell-Based 

Therapies

11:30 AM-11:50 AM Topic: End User Case Study on Implementation of RMTMs

Speaker: Anna Lau, Ph.D., Chief Sterility Testing Services, NIH Clinical 

Center

Talk Title: Creating GMP in an Academic Research Setting and Clinical 

Hospital Environment – Challenges and Lessons Learned at the NIH

11:50 AM-12:10 PM Topic: Barriers to Adoption of RMTMs

Speaker: Michael Miller, Ph.D., President, Microbiology Consultants LLC

Talk Title: Rapid Microbiological Methods: A Roadmap for Implementation

12:10 PM-1:05 PM Panel 1: Barriers and Potential Solutions to Adoption of RMTMs

Moderator: Nancy Lin

Panelists: Margaret Riley, Anna Lau, Michael Miller, Sheng Lin-Gibson, and 

Judith Arcidiacono (FDA)

BREAK

1:05 PM-1:15 PM

Session 2: Technologies and Tools for Rapid Microbial Detection

Moderator: Jason Kralj (NIST)

1:15 PM-1:25 PM Topic: ATP-Based Technologies

Speaker: Jonathan Kallay, Senior Technology and Marketing Manager, 

Charles River Laboratory 

Talk Title: Celsis ATP Bioluminescence: From Cell Culture to Sterility

1:25 PM-1:35 PM Topic: CO2-Based Technologies

Speaker: Felix Montero, Scientific Director-Health and Personal Care 

Business, bioMérieux

Talk Title: TBD

1:35 PM-1:45 PM Topic: Solid Phase Cytometry-Based Technologies

Speaker: Felix Montero, Scientific Director-Health and Personal Care 

Business, bioMérieux

Talk Title: Application of Solid Phase Cytometry for rapid microbial testing for 

advanced therapy products

1:45 PM-1:55 PM Topic: PCR-Based Technologies

Speaker: Alexandra Muller-Scholz, Manager PCR & Microbiology, Sartorius 

Talk Title: Rapid sterility of ATMPs prior treatment - Validation of a qPCRbased test

1:55 PM-2:05 PM Topic: Raman-Based Technologies

Speaker: Oliver Valet, Founder and Managing Director, mibic GmbH & Co. 

KG

Talk Title: TBD

BREAK

2:05 PM-2:15 PM
6 NIST RMTM WORKSHOP | 2022

2:15 PM-2:35 PM Topic: Consortium Directions

Speaker: Scott Jackson, NIST

Talk Title: Current Progress and Activities of the NIST RMTM Consortium

2:35 PM-3:25 PM Panel 2: Technologies and Tools for Rapid Microbial Detection

Moderator: Scott Jackson

Panelists: Jonathan Kallay, Alexandra Muller-Scholz, Felix Montero, Oliver 

Valet, Kevin Wheeler (AlloSource)

CLOSING

3:25 PM-3:30 PM Closing Remarks

Scott Jackson and Nancy Lin
7 NIST RMTM WORKSHOP | 2022

SPEAKERS

Judith (Judy) Arcidiacono M.S.

U.S. Food and Drug Administration

International Regulatory Expert and Leads for Standards for Regenerative Medicine 

Therapies 

Immediate Office of the Director (IOD)

Office of Tissues and Advanced Therapies (OTAT)

Scott A. Jackson

Leader, Complex Microbial Systems Group

NIST 

Jonathan Kallay

Senior Technology and Market Development Manager

Microbial Solutions | Charles River

Anna F. Lau, Ph.D., D(ABMM)

Chief, Sterility Testing Service

Department of Laboratory Medicine

Clinical Center, National Institutes of Health

Sheng Lin-Gibson, Ph.D.

Chief, Biosystems and Biomaterials Group

Material Measurement Laboratory

NIST
8 NIST RMTM WORKSHOP | 2022

Michael J. Miller, Ph.D.

President

Microbiology Consultants, LLC

Felix Montero

Scientific Director of the Healthcare Business

bioMérieux

Alexandra Müller-Scholz, Ph.D.

Manager PCR & Microbiology Applications

Lab Essentials Applications Development

Sartorius

Margaret Riley, JD

Professor of Law

University of Virginia

Oliver Valet

Founder and Managing Director

mibic GmbH & Co. KG
9 NIST RMTM WORKSHOP | 2022

Kevin Wheeler

Microbiology Scientist

AlloSource
10 NIST RMTM WORKSHOP | 2022

BIOGRAPHIES 

Judy Arcidiacono

Judy is the Lead for the Standards Development Program for Regenerative Medicine 

Therapies (RMT). She leads FDA’s participation in ISO TC 276 and serves as a liaison 

to ASTM F04 Committee on Tissue Engineered Medical Products (TEMPs). She works 

closely with the National Institute for Standards and Technology (NIST) and the 

Standards Coordinating Body (SCB) to foster the development of standards that support 

innovation and product development in the RMT field. 

In her position as an International Regulatory Expert, Judy is responsible for representing 

FDA/CBER/OTAT points of view in developing international regulatory policies and the 

development standards for regenerative medicine therapies. She serves as the 

secretariat for the International Pharmaceutical Regulators Forum (IPRP) Cell Therapy 

Working Group and Gene Therapy Working Group. She is also the co-chair of the Centers 

for Regulatory Excellence for Advanced Therapies at the APEC Regulatory 

Harmonization Center Steering Committee. 

Judy has been at FDA for almost 32 years. For the first 18 years, she worked in the 

Division of Cell and Gene Therapy as a research/reviewer. In this role, she researched

the human immunological response to xenotransplantation products and reviewed clinical 

trial applications for NK cell and T cell therapies and xenotransplantation products.

Currently, Judy is the lead for policy development for xenotransplantation products. 

Scott Jackson

Dr. Scott Jackson joined The National Institute of Standards and Technology (NIST) in 

May of 2014. At NIST, Dr. Jackson is currently the leader of the Complex Microbial 

Systems Group in the Biosystems and Biomaterials Division. In this current role, Dr. 

Jackson is leading international efforts to improve microbiome and metagenomic 

measurements by organizing inter-lab studies, developing reference materials and 

reference methods.

Prior to joining NIST in 2014, Dr. Jackson spent 11 years as a principal investigator at 

FDA where he developed advanced genomic tools for characterizing the global genomic 

diversity of enteric pathogens, with applications in food safety, bioforensics and public 

health.

Dr. Jackson completed his PhD research in biochemistry and biophysics at The University 

of Maryland and Johns Hopkins University where he focused on the evolution of mobile 

genetic elements. Dr. Jackson performed his undergraduate studies in Chemistry and 

Geology at the University of South Carolina.
11 NIST RMTM WORKSHOP | 2022

Jonathan Kallay 

Jonathan (Jon) Kallay is a Senior Technical & Market Development Manager working 

remotely for the Microbial Solutions product lines. He is a subject matter expert on 

microbiological investigations for manufacturing facilities that make regulated products.

Jon provides practical laboratory experience to help clients identify the optimal path 

forward for their labs. Jon received his Bachelor’s degree in biochemistry from Denison 

University before earning a post-graduate diploma in pharmaceutical microbiology from 

the University of Manchester.

Anna Lau

Dr. Lau earned her PhD from the University of Sydney, Australia, where her research 

focused on the development of novel diagnostic platforms for invasive fungal diseases.

In 2011, she joined the NIH to complete a fellowship in Clinical Microbiology in the 

Department of Laboratory Medicine. Following her fellowship, she joined the Clinical 

Microbiology Service as a Staff Scientist where she co-directed the Bacteriology, 

Specimen Processing, Parasitology, and Molecular Epidemiology sections. In 2018, Dr. 

Lau was promoted to Chief of the newly created Sterility Testing Service to support the 

NIH-wide cGMP aseptic processing and manufacturing of cellular therapy and drug 

pharmaceuticals for NIH clinical protocols. 

Dr. Lau's translational research has focused on the development of rapid diagnostic 

platforms using molecular-based techniques and mass spectrometry. Her current 

research involves advancing testing platforms used in the biopharmaceutical setting 

whilst also meeting the Food and Drug Administration requirements for quality and patient 

safety. Her work is reflected in nearly 50 publications and book chapters, and she has 

been recognized with numerous awards to include eight NIH Clinical Center CEO and 

Director’s awards, and the Forbes 30 Under 30 Award for Healthcare Science. 

Dr. Lau serves on the Editorial board for the Journal of Clinical Microbiology; is a member 

of the American Society for Microbiology, the Parenteral Drug Association and the United 

States Pharmacopeia; and she chairs the NIH Environmental Monitoring Advisory 

Committee for cGMP. Dr. Lau is board certified through the American Board of Medical 

Microbiology. 

Sheng Lin-Gibson 

Dr. Sheng Lin-Gibson is the Chief of the NIST Biosystems and Biomaterials Division. She 

oversees a multidisciplinary research portfolio that includes regenerative medicine and 

advanced therapies, precision medicine, synthetic biology, and complex microbial 

systems. She leads and coordinates the development of global standards for emerging 

biotechnology, many of which support regenerative medicine and advanced therapy. She 

has coauthored over 80 peer-reviewed publications, serves on many Interagency 
12 NIST RMTM WORKSHOP | 2022

Working Groups as well as numerous expert review panels and advisory boards. She has 

received two Department of Commerce Gold Medals. 

Michael Miller 

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 non-sterile 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.

Felix Montero

Felix is a Scientific Director of the Healthcare Business of bioMérieux. Felix has over 25 

years of experience in industrial and clinical diagnostics and previously served as the 

Chemunex R&D Director in bioMérieux. Félix graduated from the Autonomous 

Metropolitan University in Mexico as Industrial Biochemistry Engineer and obtained a PhD 

in Immunology from the Aix Marseille II University in France. Felix is a member of different 

scientific organizations (PDA, ISAC) and served as an expert in a panel for the 

Development of Compendial Rapid Sterility Tests for the USP. Félix has been and 

continues to be extensively involved in the implementation and acceptance of rapid and 

alternative microbiological methods. He has authored more than 40 scientific publications 

in basic and applied immunology/microbiology and is an inventor on more than 6 patents 

on immune therapeutic approaches. He is a prominent speaker at congresses and 

conferences and a regular contributor to bioMérieux scientific whitepapers. Félix have 

extensive technical experience includes development of in vitro diagnostic and research 

use reagents and applications, cell and tissue culture systems, microbiology, alternative 

and rapid microbiological methods, sterility testing, mycoplasma detection, compendia 

methods, methods for blood bank testing, cell and gene therapy process.
13 NIST RMTM WORKSHOP | 2022

Alexander Muller Scholz

Alexandra holds a Masters degree in Biotechnology from the Technical University of 

Braunschweig (Germany, 2010) and a PhD in Live Science from the University of 

Hannover (Germany, 2014). Before her start in the current role as Manager PCR & 

Microbiology Applications, she began her career at Sartorius as PhD Student and later 

as scientist in the Microbiology Product Development Department within LPS being 

responsible for PCR related projects.

Margaret Riley

Margaret Foster Riley, Dorothy Danforth Compton Professor at the Miller Center, is 

professor of law at UVA Law School, professor of public health sciences at the UVA 

School of Medicine, and professor of public policy at the University’s Frank Batten School

of Leadership and Public Policy. A scholar working in the intersection of law, regulation, 

policy, and ethics in the Life Sciences, Riley has written and presented extensively about 

health care law, biomedical research, genetics, food and drug regulation, reproductive 

technologies, human and animal biotechnology, and public health. She is currently a 

member of the NIH NExTRAC, a FACA committee that advises the NIH Director on issues 

concerning emerging biotechnologies. Riley has advised numerous state and federal 

agencies, including the Food and Drug Administration; the Environment Protection 

Agency; the Department of Defense; committees of the National Institutes of Health, the 

National Science Foundation, and the National Academies of Science, Engineering and 

Medicine; the Virginia Department of Health; and the Virginia Bar.

Oliver Valet [Placeholder]

Kevin Wheeler

Kevin currently is a Scientist in Quality and Research Microbiology at AlloSource. Kevin 

holds a Master of Science in Biology with special emphasis on microbial ecology and a 

Bachelor of Arts in Biology. He also is a National Registry Certified Microbiologist and 

Certified tissue bank specialist.
14 NIST RMTM WORKSHOP | 2022

PLANNING COMMITTEE

NIST

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 

Acknowledgements

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

contributions to this event.
15 NIST RMTM WORKSHOP | 2022

ADDITIONAL INFORMATION & 

RESOURCES

Consortium Ongoing Efforts and Future Directions

• Identify and/or design fit for purpose microbial cell reference materials 

and develop methods to characterize cell properties beyond colony 

forming units.

• Develop guidance on the use of reference materials in the qualification 

and/or validation of rapid microbial testing methods for advanced therapy 

products.

• Design interlaboratory studies based on candidate reference materials to 

evaluate materials and support the development of best practices and 

standard methods.

Overview of Consortium Organization

The RMTM Consortium Consists of Three Working Groups
16 NIST RMTM WORKSHOP | 2022

WG01 MISSION: The mission of the Reference Material Working Group 

(WG01) is to identify and facilitate the development, characterization, and 

qualification of reference materials (RMs) to support the wide adoption of 

new and existing Rapid Microbiology Test Methods (RMTMs) within the 

Advanced Therapy Industry.

WG02 MISSION: The mission of the Methods and Validation Schemes 

Working Group (WG02) is to develop a framework for the validation of 

methods to support the wide 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) mission is to design and implement interlaboratory 

studies to assess the analytical performance of various RMTMs while also 

evaluating the performance and fitness for purpose of candidate reference 

materials.
17 NIST RMTM WORKSHOP | 2022

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 Letter 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 on Consortium steering 

committee
18 NIST RMTM WORKSHOP | 2022

For More Information

CONTACT

Nancy Lin 

Email: nancy.lin@nist.gov 

Scott Jackson

Email: scott.jackson@nist.gov