NIST-Hosted Workshop on Collaborative Efforts to Enable Adoption of Rapid Microbial Testing Methods for Advanced Therapy Products

KEYNOTE SPEAKER

Veera Dheenadhayalan, PhD, Director of Biosafety at AstraZeneca

INVITED SPEAKERS

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)

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 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

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 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.

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

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

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.