Jonathan R. Genzen, MD, PhD, MBA

Arup Laboratories | University of Utah Department of Pathology
Panelist

Dr. Jonathan Genzen is a professor at the University of Utah Department of Pathology and serves as Chief Medical Officer and Senior Director of Government Affairs at ARUP Laboratories, a not-for-profit enterprise of the University of Utah. He previously served as ARUP’s Chief Operations Officer. Dr. Genzen is currently a medical director in ARUP’s chemistry division and is medical director of ARUP’s laboratory automation team. His clinical and research focus is on automated clinical chemistry, quality improvement initiatives, and the impact of laboratory regulatory proposals on patient care.

David Hess, PhD

Nevada State Public Health Laboratory | Santa Clara University
Presenter

Dr. David Hess is currently State Genomic Scientist and Associate Research Professor at the Nevada State Public Health Laboratory, as well as Associate Professor and Chair of Biology at Santa Clara University. He received his Ph.D. in Genetics at Harvard University.

Barb Jones, PhD

Clinical and Laboratory Standards Institute (CLSI)
Presenter & Moderator

Dr. Barb Jones was appointed Chief Executive Officer of CLSI in May 2022. She is the third CEO in CLSI's 59-year history. Dr. Jones’ experience includes operations leadership, laboratory management, pharmaceutical and quality standards development, regulatory policy, and business development at both the national and international levels. Prior to her role as CLSI’s CEO, Dr. Jones was Senior Vice President, Scientific Operations and Regulatory Affairs at Vyant Bio in San Diego, California. 

Kristen J Kanack, PhD

Qiagen
Panelist

Kristen Kanack is Vice President and Head of Global Regulatory Affairs at QIAGEN, where she leads global regulatory strategy and postmarket surveillance across a broad portfolio of molecular diagnostics, companion diagnostics, and life science tools. Previously, Kristen held executive leadership roles at BioFire Diagnostics/bioMérieux, where she directed regulatory and clinical affairs, postmarket surveillance, and strategic initiatives that accelerated the deployment of innovative diagnostics in infectious disease and biothreat detection. She successfully guided multiple landmark submissions, including De Novo authorizations for the first COVID-19, MERS-CoV, and multiplex meningitis/encephalitis panel IVDs, as well as the first CLIA-waived highly multiplexed molecular diagnostic system. Kristen earned her Ph.D. in Molecular Microbiology and Immunology from the University of Maryland, Baltimore. She has served as a principal investigator on NIH and DoD-funded diagnostic development programs, bringing together scientific expertise and regulatory leadership to advance next-generation healthcare solutions.

Tabby Kern, MS, MLS(ASCP)CM

CLSI 
Presenter

Tabby Kern is the Assistant Vice President for Standards Development at CLSI and has been a part of the organization for over seven years. She has her Master’s degree in Medical Laboratory Science and is an ASCP-certified Medical Laboratory Scientist. Prior to CLSI she spent 12 years working in an Immunology and Flow Cytometry medical laboratory. Her previous project focus has been on documents in Method Evaluation area. Ms. Kern has helped with the development and implementation of this novel product.

Anthony A. Killeen, MD, MSc, PhD

Dept. of Laboratory Medicine & Pathology
University of Minnesota
Moderator

Dr. Killeen is Director of Clinical Laboratories at the University of Minnesota Medical Center, Fairview, Vice Chair for Clinical Affairs in the Department of Laboratory Medicine and Pathology, and a member of the Division of Molecular Pathology and Genomics. He also chairs the College of American Pathologists' Committee on Laboratory Accuracy Surveys and the Instrumentation Resource Committee. The committee monitors the quality of laboratory assays across the country through the distribution, collection and analysis of proficiency testing specimens and brings problems it identifies to the attention of the clinical pathology community.  Dr. Killeen conducts his clinical research through ARDL, a central laboratory for large-scale clinical trials and is the Principal Investigator for the central laboratory activities of the Systolic Blood Pressure Intervention Trial (SPRINT), an NIH-funded multi-center, randomized clinical trial designed to test whether a treatment program aimed at reducing systolic blood pressure will reduce cardiovascular disease risk.

Paula Ladwig, MS, MLS(ASCP)

Mayo Clinic
Presenter 

Paula Ladwig, MS, MLS(ASCP) is currently a Principal Developer at Mayo Clinic, where she has contributed to public health for over 25 years. She has been actively involved with CLSI for over a decade and received the Excellence in Standards Development Award in 2022. In her many roles, Paula has been incredibly effective in working with the evaluation protocols volunteers and has instilled the concepts of consensus into a challenging technical area.

Michael J. Loeffelholz, Ph.D., D(ABMM)

Cepheid
Panelist

Dr. Michael J. Loeffelholz is Vice President, Scientific Affairs at Cepheid. After completing a post-doctoral fellowship in medical and public health microbiology at the University of Rochester in 1990, he was a Senior Scientist at Roche Molecular Systems from 1990-1995. From 1995-2008 Dr. Loeffelholz held leadership positions in public health laboratories and private reference laboratories. From 2008-2018 he held the rank of Associate Professor, then Full Professor, with tenure, in the Department of Pathology at University of Texas Medical Branch, and Medical Director of the Clinical Microbiology Laboratory. Dr. Loeffelholz joined Cepheid has served as a member of the Board of Scientific Counselors to the US Centers for Disease Control and Prevention (CDC) and as associate editor of the Journal of Clinical Microbiology. He is currently a member of the Board of Directors of the Clinical and Laboratory Standards Institute (CLSI) and advisor to the CLSI Expert Panel on Point-of-Care Testing. He has authored over 100 research and review papers and book chapters.

Vishakha Sharma, PhD

Roche Diagnostics
Panelist

Vishakha Sharma is a Development Lead, Senior Principal Imaging Scientist in Roche Diagnostics Solutions. In this role, she leads machine learning (ML) initiatives in digital pathology to generate key insights that advance the navify® product portfolio, ultimately enabling more efficient and improved patient care. Vishakha has authored 55+ peer-reviewed publications and proceedings and has delivered more than 25 invited talks. She serves on several international scientific and technical program committees, and as a panelist at AI/ML/NLP conferences (including NeurIPS, ICLR, AMIA, HIMSS). Prior to joining Roche, her research work was funded by the NIH Big Data to Knowledge (BD2K) initiative and focused on developing NLP precision medicine software. Vishakha is a senior member of the Association for Computing Machinery (ACM) and the Institute of Electrical and Electronics Engineers (IEEE), and a fellow of the American Medical Informatics Association (AMIA). She holds a PhD and MS in Computer Science, and a BE in Computer Engineering.

Kayla Van Benten, BS, M(ASCP)

BD
Presenter

Kayla Van Benten is Senior Manager of Medical Affairs for BD Diagnostic Solutions and certified as a Medical Technologist. She brings more than a decade of experience in clinical microbiology, including six years in laboratory leadership and management roles. At BD, Kayla leads the global post market evidence generation strategy for the microbiology portfolio and oversees the worldwide Medical Science Liaison team. Her professional interests include ID/AST, antimicrobial resistance, and antimicrobial stewardship, with a particular focus on connecting scientific evidence with strategic decision making to support improved patient care.

Wendy Winckler, PhD

Droplet Biosciences
Panelist

Dr. Wendy Winckler is Chief Scientific Officer at Droplet Biosciences, where she oversees assay development, informatics, and the CLIA laboratory. She brings over 20 years of experience across academia, pharma, and biotech startups, with deep expertise in genomics, oncology, and diagnostictest development. Previously, she held senior leadership roles at the Broad Institute, Novartis Institutes for Biomedical Research, and Glympse Bio. Across these roles, she has launched multiple laboratory-developed tests and commercial diagnostics and overseen molecular testing and data analysis for hundreds of thousands of patient samples. Dr. Winckler holds a PhD in Genetics from Harvard University and a BS in Microbiology and Molecular Genetics from UCLA.

Rena Xian, MD

Johns Hopkins School of Medicine
Presenter

Dr. Xian is Associate Professor of Pathology and Oncology at Johns Hopkins University, School of Medicine, where she serves as Director of the Division of Molecular Pathology and Medical Director of the Molecular Diagnostics Lab. Dr. Xian received her medical degree from Northwestern University, and completed residency in AP/CP, followed by fellowships in Hematopathology and Molecular Genetic Pathology. In addition to an active clinical service focused on morphologic diagnosis of lymphoma and molecular characterization of various tumors, Dr. Xian leads a translational research program focused on cancer genomics and liquid biopsy approaches to diagnose and monitor aggressive B cell lymphomas. Dr. Xian is an expert in the molecular evaluation of B cell lymphoma to identify markers that can subclassify diseases and guide personalized treatments. Dr. Xian is also a leader in national pathology societies, and is involved in developing clinical guidelines for liquid biopsies and molecular testing for hematologic malignancies.