BioCore Diagnostics, LLC.
Mary Lou Gantzer, PhD, FACB, is the CEO of BioCore Diagnostics, LLC. In addition to her Board membership, Dr. Gantzer is a past Chairholder of both the Quality and Education Committee and Financial Audit Committee, and serves as a CLSI Delegate. Dr. Gantzer is also Past President, American Association for Clinical Chemistry (AACC).
Virginia Commonwealth University
Greg Miller, PhD, is a Professor in the Department of Pathology at Virginia Commonwealth University, where he directs the Clinical Chemistry Laboratory and the Pathology Information Systems. He was recently elected as President-Elect of CLSI and formerly served as Treasurer and Chair of the Finance Committee. In addition to his governance duties, Dr. Miller has been a long-time active participant in the CLSI consensus process, including serving as Co-Chairholder of the Chairholders Council and Chairholder of the Consensus Committee on Clinical Chemistry and Toxicology, as well as being a member of numerous document development committees for standards and guidelines. Currently, in addition to his membership on several document development committees, he is the CLSI Delegate for Virginia Commonwealth University. Outside CLSI, Dr. Miller serves as the immediate past-president of the American Association for Clinical Chemistry and Chair of the Laboratory Working Group of the National Kidney Disease Education Program, and is active in International Federation of Clinical Chemistry and Laboratory Medicine and International Organization for Standardization activities. Dr. Miller holds a PhD from the University of Arizona and received postdoctoral training in Clinical Chemistry at The Ohio State University.
Immediate Past President, CLSI
Centers for Disease Control and Prevention
Janet K. A. Nicholson, PhD, is the Senior Advisor for Laboratory Science, Office of Infectious Diseases at the Centers for Disease Control and Prevention. Dr. Nicholson is Immediate Past President of CLSI. Previous work with CLSI includes serving on the first Subcommittee for Clinical Applications of Flow Cytometry: Quality Assurance and Immunophenotyping of Peripheral Blood Lymphocytes and participating in development of Fluorescence Calibration and Quantitative Measurement of Fluorescence Intensity. She holds a PhD from Emory University.
Beckman Coulter, Inc.
Jack Zakowski, PhD, FACB, is the Director of Scientific Affairs and Professional Relations for the Diagnostics Division of Beckman Coulter, Inc. in Brea, California, USA. His career in the clinical diagnostics industry has been spent mostly in research and development and product development areas working on the development of chemistry reagents and analyzer systems. He has also worked in technical marketing and support, in development applications and clinical evaluations, and in standardization and harmonization of clinical diagnostics. Dr. Zakowski has been active in various laboratory professional organizations and has completed a term as Secretary on the Board of Directors of CLSI. He has also served with the American Association for Clinical Chemistry (AACC), the International Organization for Standardization Technical Committee 212 on In Vitro Diagnostic Products, the Patient Safety Task Force of the AACC Management Sciences Division, the National Kidney Disease Education Program, the National Glycohemoglobin Standardization Program, and several others.
Carl D. Mottram, RRT, RPFT, FAARC, is the Director of the Mayo Clinic Pulmonary Function Laboratories and Pulmonary Rehabilitation Program and holds the academic rank of Associate Professor of Medicine at the Mayo Clinic College of Medicine in Rochester, Minnesota, USA. He is a graduate of the Mayo Clinic’s Respiratory Therapist program and currently serves as adjunct professor for the Mayo Clinic/University of Minnesota program. He is also the former Chairholder of the American Association for Respiratory Care’s Clinical Practice Guideline Committee. Mr. Mottram has served in numerous roles with CLSI, including a member of various working groups, Vice-Chairholder of the Area Committee for Health Care Services, and currently serves as the Chairholder of the Consensus Committee for Quality Systems and Laboratory Practices. He is a member of the Board of Trustees for the National Board for Respiratory Care. He also serves as a consultant to the Diagnostic Accreditation Program of British Columbia. Mr. Mottram is a recognized expert in the field of pulmonary diagnostics and is the author and editor of the definitive textbook in the field. He has published numerous abstracts, articles, and book chapters, and has given hundreds of lectures at national and international meetings.
Chief Executive Officer, CLSI
Glen Fine, MS, MBA, CAE, has been the Chief Executive Officer of CLSI since November 2004. Mr. Fine has the overall responsibility for the strategic, programmatic, administrative, marketing, and financial management operations of the organization; and for providing leadership to the Board of Directors and staff in formulating policy, developing and implementing strategy, and implementing programs. Mr. Fine holds a bachelor’s degree and a master’s degree in Clinical Laboratory Sciences from Temple University as well as an MBA from St. Joseph’s University, both located in Philadelphia, Pennsylvania, USA. He is also a Certified Association Executive (CAE) from the American Society of Association Executives (ASAE).
Loyola University Medical Center
David W. Hecht, MD, MS, MBA, is the John W Clarke Professor and Chairman of the Department of Medicine, Co-Director of the Division of Infectious Disease and Immunology Institute, and Chair of the Clinical Leadership Council at Loyola University Chicago and Loyola University Health System. Dr. Hecht’s research focuses on Bacteroides antibiotic resistance, for which he is recognized nationally and internationally, and is past president of the Anaerobe Society of the Americas. Dr. Hecht has served as the Chair of the Anaerobe Working Group and voting member of the Antimicrobial Subcommittee for CLSI since 1997. Dr. Hecht received his MS in Medical Microbiology from the University of Missouri, his MD from Stritch School of Medicine, a residency in Internal Medicine at the University of Minnesota, and fellowship in Geographic Medicine at New England Medical Center and Microbiology and Molecular at Tufts University in Boston.
Centers for Disease Control & Prevention
Devery Howerton, PhD, is Director of the Division of Laboratory Science and Standards in the Laboratory Science, Policy and Practice Program Office at the Centers for Disease Control and Prevention in Atlanta, Georgia, USA. She serves as Vice-Chairholder of the CLSI Consensus Committee on Quality Systems and Laboratory Practices and has been active in the field of laboratory quality in both the public and private sectors for the past 20 years. She received a BS in medical technology from the Medical University of South Carolina, and an MS in microbiology/immunology as well as a PhD in pathology/laboratory medicine from Emory University.
Philip Lively has been Vice President, Information Technology Application and Development of ASTM International since June 1999. He is the senior executive responsible for all aspects of ASTM’s information technology (IT) and systems, both internal and Web related. Lively has an MBA in Finance and serves on ASTM’s Investment Committee. He brings several years of marketing experience, including research, promotion, and product development, to his IT responsibilities.
University of Utah Health Sciences Center
Chris Lehman, MD is a Professor in the Division of Clinical Pathology, Department of Pathology at the University of Utah, and serves as Director of Hospital Laboratories. He is certified in Clinical Pathology and Blood Banking/Transfusion Medicine by the American Board of Pathology. He is a past member, and past Vice-Chairholder of the Consensus Committee on Clinical Chemistry and Toxicology and currently serves as an advisor to the committee. He chaired the C54-A subcommittee and served on the H11-A4 and C56-A subcommittees.
Stewart Marsden began his career in the UK National Health Pathology Service obtaining a Fellowship in Clinical Biochemistry from the UK Institute of Biomedical Scientists. Prior to joining BD, he was a Chief Biomedical Scientist and has extensive experience in laboratory automation systems. After joining BD in 1988, he has held various positions in Europe, Asia, and the United States, specifically in sales, marketing, and general management, and is currently Director Corporate Business Development. He was a working member of the original CLSI Specimen and Specimen Carrier team. He has submitted a number of patent applications for which he has received patents.
Fairview Health Services
Rick Panning, MBA, MLS(ASCP)CM, has been in laboratory leadership positions for over 30 years, including most recently as VP of Business Development and Strategy at Fairview Health Services. Previously, he served as the Vice President for Laboratory Services at Allina Hospitals and Clinics, an integrated health system with 10 hospitals and 70 clinic laboratories in Minnesota. For 12 years, he was President of laboratories for Fairview Health Services (Minneapolis) and also served as CEO of the American Red Cross blood services in the North Central region. Rick has been very active in the laboratory profession, especially within the American Society for Clinical Laboratory Science (ASCLS), where he has served as a state president, regional director, and president of the national society. Currently, Rick is the chair of the ASCLS government affairs committee and is the chair of the Coordinating Council for the Clinical Laboratory Workforce (CCCLW). Rick received his BS in clinical laboratory science from Mankato State University and his MBA from the University of St. Thomas, and he is currently pursuing his doctorate in business administration from Metropolitan State University.
New York State Department of Health
Robert Rej, PhD, is Director of Clinical Chemistry and Acting Directory of Hematology at the Wadsworth Center for Laboratories and Research of the New York State Department of Health and Associate Professor of Biomedical Sciences at the State University of New York at Albany, School of Public Health. His interests include best practices for medical laboratories, external quality assurance, and standardization of clinical diagnostics. His laboratory is one of three Centers for Disease Control and Prevention–certified lipid reference laboratories in the United States. He has served on the editorial boards of several laboratory medicine journals and has authored more than 100 papers and book chapters. He has served as member and chair of numerous committees and subcommittees for CLSI, the American Association for Clinical Chemistry (AACC), the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), and the Association of Public Health Laboratories (APHL), and is a member of the International Organization for Standardization (ISO) Technical Committee 212 on Medical Laboratory Testing and In Vitro Diagnostic Test Systems. Dr. Rej has testified before the US Congress on laboratory issues and was a member of the Clinical Chemistry and Toxicology Devices Advisory Panel to the US Food and Drug Administration. Dr. Rej holds a PhD from Albany Medical College of Union University.
FDA’s Center for Devices and Radiological Health (CDRH)
Uwe Scherf, MSc, PhD, has been the Associate Director for Virology in the Division of Microbiology Devices in the Office of In Vitro Diagnostic Device Evaluation and Safety in the US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) since August 2005. Before joining the FDA, Dr. Scherf was Senior Director for Genomics Research & Development at Gene Logic Inc., a genomic gene expression profiling company from 1999 to 2004. Before his work in industry, he worked for several years at the National Cancer Institute (NCI)/National Institutes of Health and developed with Dr. John Weinstein and a collaborator a gene expression database for the molecular pharmacology of cancer on the NCI 60 human cancer cell lines. During his stay at NCI, he also worked on targeting cancer therapy with recombinant fusion proteins.
Dr. Scherf received his PhD in Microbiology from the University of Marburg in Germany. He was a voting member of the CLSI Consensus Committee on Molecular Methods from 2004 to 2010, and a member of the Advisory Board of the School of Computational Sciences at the George Mason University in Virginia.
Centers for Medicare & Medicaid Services
Harriet R. Walsh, MA, BSMT (ASCP), has more than 30 years of clinical, management, quality assurance/risk, administrative, and educational experience in a variety of laboratory and health care settings. She has worked in laboratory positions in Maryland, Wyoming, and Nebraska, as well as England and Belgium. Ms. Walsh was employed by the Centers for Medicare & Medicaid Services (CMS) where she held the position of Deputy Director for the Division of Laboratory Services (DLS) in the Survey and Certification Group of the Center for Medicaid and State Operations from June 2005 to January 2013. DLS is responsible for administering the Clinical Laboratory Improvement Amendments (CLIA) program, which oversees all laboratory testing (except research) performed on humans in the United States. In January 2013, she accepted a new position with the CMS Innovation’s Learning and Diffusion Group. In her new role, she is serving as a technical authority and advisor in the development of approaches and strategic planning for process improvement, performance measurement, and project monitoring, as well as the development of learning programs and large-scale initiatives related to projects that aim to achieve better care for patients, better health for our communities, and lower costs through improvements in our health care system.
The Medicines Company
Matthew A. Wikler, MD, MBA, FIDSA, is the Vice President of New Business Ventures for The Medicines Company, a global pharmaceutical company. Previously, he served as Chief Development Officer of Rib-X Pharmaceuticals, a biopharmaceutical company that develops new antimicrobial therapies. Dr. Wikler has devoted the past 30 years to developing drugs and vaccines for the treatment and prevention of infectious diseases in both the developed and developing world. He has served in senior management positions at both large and small pharmaceutical companies and at a non-profit, including IASO Pharma, the Institute for One World Health, Smith Kline, Burroughs Wellcome, Johnson and Johnson, Bristol Myers Squibb, ViroPharma, Peninsula Pharmaceuticals, and MPEX Pharmaceuticals. From 1994 to 1995, Dr. Wikler worked at the US Food and Drug Administration, and for part of that time served as the Deputy Director of the Division of Anti-infective Drug Products. Dr. Wikler received his BA in Chemistry from Franklin and Marshall College, received his MD from Temple University, completed an Infectious Diseases fellowship at the Hospital of the University of Pennsylvania, and received his MBA from the Wharton School of Business.
Dr. Wikler served on the Antimicrobial Susceptibility Testing (AST) Subcommittee as the Chairholder (2003–2008), the Vice-Chairholder (2009–2011), a Member (1994–2002), and an Advisor (1991–1994). He has served on numerous Working Groups of the AST Subcommittee, and was Chairholder of the M23 Working Group from 1996 to 2001.
Bio-Rad Laboratories, Inc.
Max Williams is the Division Marketing Manager at Bio-Rad Laboratories, Quality Systems Division in Irvine, California, USA. Mr. Williams has more than 16 years of global experience in clinical laboratory advocacy, accreditation, standards development, education, and quality improvement. Previous work with CLSI includes serving as a Member of the Global Advisory/Global Programs Committee, Leadership Conference Steering/Planning Committee, US Technical Advisory Group to International Organization for Standardization Technical Committee (ISO/TC) 212, ISO/TC 212 Working Group 1, contributor to numerous documents including GP27, and observer to several consensus committees including Evaluation Protocols, General Laboratory, and Quality Systems and Laboratory Practices. Mr. Williams received an MPA (Health Care Policy and Economics) from the University of Washington’s Daniel J. Evans School of Public Affairs, and BA (International Studies) from the University of Washington’s Henry M. Jackson School of International Studies.