Virginia Commonwealth University
Greg Miller, PhD, is a Professor in the Department of Pathology at Virginia Commonwealth University Medical Center in Richmond, Virginia, where he directs the Clinical Chemistry Laboratory and the Pathology Information Systems. Before his presidency at CLSI, he served as CLSI 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 the Co-Chairholder of the Chairholders Council, the Chairholder of the Consensus Committee on Clinical Chemistry and Toxicology, and a member of numerous document development committees. He is also the current CLSI Delegate for Virginia Commonwealth University Medical Center.
Outside CLSI, Dr. Miller is a past-president of the American Association for Clinical Chemistry (AACC), Chair of the Laboratory Working Group of the National Kidney Disease Education Program, Chair of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Working Group on Commutability, Chair of the Harmonization Oversight Group of the International Consortium for Harmonization of Clinical Laboratory Results, and a member of the Executive Committee of the US Technical Advisory Group to the International Organization for Standardization (ISO) Technical Committee 212 – Clinical laboratory testing and in vitro diagnostic test systems. Dr. Miller received the AACC Outstanding Lifetime Achievement Award in Clinical Chemistry and Laboratory Medicine in 2007, the CLSI Excellence in Consensus Management Award in 2007, the CLSI Excellence in Global Leadership in Standards Development Award in 2012, and the IFCC Robert Schaffer Award for Outstanding Achievements in the Development of Standards for Use in Laboratory Medicine in 2014. Dr. Miller holds a PhD from the University of Arizona in Tucson, Arizona, and received postdoctoral training in Clinical Chemistry at The Ohio State University in Columbus, Ohio.
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. 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, development applications and clinical evaluations, and standardization and harmonization of clinical diagnostics. Dr. Zakowski has been active in various professional laboratory organizations and has served terms as Secretary and Treasurer on the CLSI Board of Directors. He was also involved with the American Association for Clinical Chemistry (AACC), ISO Technical Committee 212 – Clinical laboratory testing and in vitro diagnostic test systems, the Patient Safety Task Force of the AACC Management Sciences Division, the National Kidney Disease Education Program, and the National Glycohemoglobin Standardization Program, among other organizations.
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. 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 serving as a member of various working groups; Vice Chairholder, and then Chairholder of the Consensus Committee on Quality Systems and Laboratory Practices; Board of Directors member; and Secretary of the Board of Directors. He currently serves as the Treasurer on the Executive Committee of the CLSI Board of Directors. Mr. Mottram is also a member of the Board of Trustees for the National Board for Respiratory Care and 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.
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.
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.
Advanced Medical Technology Association
Khatereh Calleja, JD, is Senior Vice President of Technology and Regulatory Affairs for AdvaMed, the Advanced Medical Technology Association. AdvaMed is the world’s largest association representing manufacturers of medical devices, diagnostic products, and medical information systems. In that role, she works on a variety of device regulatory issues and also leads the Association’s diagnostics technical working groups, including the Diagnostics Task Force, Personalized Medicine and Molecular Diagnostics Working Group, and Diagnostics Standards Subteam.
Ms. Calleja joined AdvaMed’s Technology and Regulatory Affairs Department in December 2007, as the US Food and Drug Administration (FDA) was embarked on implementing the provisions of the Medical Device User Fee and Modernization Act II legislation to support innovation and improve the device regulatory review process. Since that time, she also played an instrumental role in assuring appropriate implementation of key device provisions in the FDA Safety and Innovation Act (the Medical Device User Fee Amendments of 2012).
Ms. Calleja has extensive policy, regulatory, legal, and government affairs background in health, device, and diagnostic issues. She previously served as federal affairs manager and established a Washington office for the American Society of Plastic Surgeons. Before that, Ms. Calleja directed legislative and regulatory affairs outreach activities at the American Academy of Otolaryngology—Head and Neck Surgery, in Alexandria, Virginia. She has also provided strategic consulting for the pharmaceutical industry, health care professional groups, and Fortune 500 companies.
Ms. Calleja is a graduate of Emory University and Villanova University School of Law.
Loyola University Medical Center
David W. Hecht, MD, MS, MBA, is a Professor of Medicine and Infectious Diseases, and former Chair of the Department of Medicine Loyola University Chicago. He is currently the Senior Vice President of Clinical Affairs at Loyola University Health System in Maywood, Illinois. Dr. Hecht’s research focuses on Bacteroides antibiotic resistance, for which he is recognized nationally and internationally, and he is the past-president of the Anaerobe Society of the Americas. Dr. Hecht previously served as the Chairholder of the Anaerobe Working Group and a voting member of the CLSI Subcommittee on Antimicrobial Susceptibility Testing from 1997–2012. Dr. Hecht received his MS in Medical Microbiology from the University of Missouri in Columbia, Missouri; his MD from Stritch School of Medicine in Maywood, Illinois; a residency in Internal Medicine at the University of Minnesota in Minneapolis, Minnesota; a fellowship in Geographic Medicine and Infectious Disease at New England Medical Center in Boston, Massachusetts; and a fellowship in Microbiology and Molecular at Tufts University in Boston, Massachusetts.
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.
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.
James H. Nichols, PhD, DABCC, FACB, is a Professor of Pathology, Microbiology, and Immunology; Medical Director of Clinical Chemistry; and Associate Medical Director for Clinical Operations at Vanderbilt University School of Medicine in Nashville, Tennessee. 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. 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, 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.
Dr. Nichols has been involved with CLSI in a number of roles. He was a member of the Subcommittee on Point-of-Care Testing, as well as Vice-Chairholder and Chairholder of the Consensus Committee on Point-of-Care Testing. Dr. Nichols served on the Chairholders Council; participated as a member of the Consensus Committee on Evaluation Protocols; and was an advisor, member, Chairholder, and Co-Chairholder of several document development committees.
HealthPartners and Park Nicollet Hospital
Rick Panning, MBA, MLS(ASCP)CM, has been in laboratory leadership positions for over 30 years, including most recently as Senior Administrative Director of Laboratory Services for HealthPartners and Park Nicollet in Minneapolis-St. Paul, Minnesota (leadership for 6 hospital laboratories, clinic laboratories for two large medical groups, and a central laboratory). Previously, he served as Vice President of Business Development at Fairview Health Services (supporting Laboratory, Imaging, Pharmacy, and Rehab Services) and 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 in Minneapolis and also served as Chief Executive Officer 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 Past 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, is the Deputy Director in the Division of Microbiology Devices in the Office of In Vitro Diagnostics and Radiological Health (OIR) at the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH). Dr. Scherf has extensive regulatory experience and has been involved in standards development since 2004. He approves/clears premarket applications (PMAs) and notifications (510ks) by determining the safety and effectiveness of these devices for marketing in the United States. Before joining the FDA, Dr. Scherf was Senior Director for Genomics Research & Development at a genomic gene expression profiling company. Before his career in industry, Dr. Scherf performed cancer research at the National Cancer Institute (NCI)/National Institutes of Health. There, in collaboration with Dr. John Weinstein, he developed a gene expression database for the molecular pharmacology of cancer on the NCI 60 human cancer cell lines. During his time 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 Area Committee on Molecular Methods from 2004–2010 and a member of the Advisory Board of the School of Computational Sciences at 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.
Maxfield Williams is the Director of Global Marketing at Bio-Rad Laboratories, Quality Systems Division, in Irvine, California. Mr. Williams has more than 19 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; member of the Leadership Conference Steering/Planning Committee; member of the US Technical Advisory Group to International Organization for Standardization Technical Committee (ISO/TC) 212 Working Group 1; contributor to numerous documents (including GP27); and observer on several CLSI Consensus Committees, including Evaluation Protocols, General Laboratory, and Quality Systems and Laboratory Practices. Mr. Williams received an MPA in Health Care Policy and Economics from the University of Washington’s Daniel J. Evans School of Public Affairs, and a BA in International Studies from the University of Washington’s Henry M. Jackson School of International Studies in Seattle.