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. Prior to assuming the presidency, he formerly served CLSI as President-Elect, 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 is a past-president of the American Association for Clinical Chemistry, Chair of the Laboratory Working Group of the National Kidney Disease Education Program, Chair of the Harmonization Oversight Group of the International Consortium for Harmonization of Clinical Laboratory Results, 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.
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 and as Treasurer 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.
Immediate Past President, CLSI
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).
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.
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.
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).
New York State Department of Health
Deirdre Astin, MS, MT (ASCP) is a Health Program Administrator with the New York State Department of Health. She joined the Department in 1994, serving first as Deputy Director, then Director, of the Clinical Laboratory Evaluation Program and as Director of Regulatory Affairs for the State’s laboratory oversight programs. In 2011 Deirdre accepted a position with the New York State Department of Health Division of Financial Policy and Planning where she currently works on projects related to the implementation of health care reform. Deirdre obtained a BS in Medical Technology from Stony Brook University and a Masters in Human Resources from the New School. She spent 20 years practicing as a generalist technologist, hematology/blood bank supervisor, and laboratory manager. Deirdre serves as a member of the CLSI Consensus Committee on Quality Systems and Laboratory Practices and is a member of the CLSI Finance Committee. Deirdre’s interests include quality management systems, global health, and laboratory performance improvement. She actively participates in document development projects for CLSI and in 2009 she spent three months as a CLSI laboratory mentor in Tanzania.
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.
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.
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.
Vanderbilt University School of Medicine
James H. Nichols, PhD, DABCC, FACB, is a Professor of Pathology, Microbiology, and Immunology and the Medical Director of Clinical Chemistry at Vanderbilt University School of Medicine in Nashville, Tennessee, USA. Dr. Nichols received his BA in General Biology/Premedicine from Revelle College, University of California at San Diego. He went on to complete an MS and a PhD in Biochemistry from the University of Illinois, Urbana-Champaign. Dr. Nichols was a fellow in the Postdoctoral Training Program in Clinical Chemistry at the Mayo Clinic, Rochester, Minnesota, USA. He is board certified in both Clinical Chemistry and Toxicological Chemistry by the American Board of Clinical Chemistry. Dr. Nichols spent several years as Associate Director of Clinical Chemistry, Director of Point-of-Care Testing, and an Associate Professor of Pathology at Johns Hopkins Medical Institutions. He later served as Medical Director of Clinical Chemistry for Baystate Health in Springfield, Massachusetts, USA, and was a Professor of Pathology at Tufts University School of Medicine. Dr. Nichols’ research interests span evidence-based medicine, information management, laboratory automation, point-of-care testing, and toxicology.
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.
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.
Arizona State Public Health Laboratory
Victor Waddell, PhD, is currently the Laboratory Director of the Arizona State Public Health Laboratory in Phoenix, Arizona, USA. He earned his PhD in Molecular Biology and Genetics at Queen’s University Belfast, Northern Ireland. Dr. Waddell’s other degrees include an MS in Environmental Sciences and a BS in Biological Sciences, also from Queen’s University Belfast. Dr. Waddell has published many journal articles and co-authored book chapters relating to both public health and molecular biology.
Dr. Waddell has worked for the Arizona State Public Health Laboratory since 2001 and was appointed as Laboratory Director in May 2004. As Laboratory Director, he is responsible for overseeing the entire laboratory, including the Analytical Chemistry, Microbiology, Newborn Screening, BioEmergency Response, and Chemical Emergency Response Sections at the state laboratory. Dr. Waddell was part of the design build team that led the development and planning of the new Arizona State Public Health Laboratory. Dr. Waddell served a three-year term as a Member-at-Large on the Association of Public Health Laboratories (APHL) Board of Directors from 200 6–2009 and served as APHL President from 2011–2012. Dr. Waddell currently serves on several APHL committees and is the Co-Chair for the Joint Leadership Committee of the Laboratory Response Network formed by the Centers for Disease Control and Prevention, APHL, and the Federal Bureau of Investigation in 1999.
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.