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.
Mr. Mottram is the Technical Director of the Mayo Clinic Pulmonary Function Laboratories and Pulmonary Rehabilitation Program and holds the academic rank of Associate Professor of Medicine in the Mayo Clinic College of Medicine. 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; Secretary and then Treasurer of the Board of Directors, and is now President-Elect. Mr. Mottram also serves on the National Board for Respiratory Care (NBRC) where he serves in several capacities including the Vice Chair of the Pulmonary Function Examination committee. Mr. Mottram is a consultant to the Diagnostic Accreditation Program (DAP), the organization responsible for accrediting laboratories in British Columbia Canada.
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.
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.
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.
Immediate Past President, CLSI
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.
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).
Centers for Disease Control and Prevention
Nancy Anderson, MMSc, MT(ASCP), is Chief of the Laboratory Standards Practice Branch, Division of Laboratory Systems at the Centers for Disease Control and Prevention (CDC). She has been in this role since 2008, managing a number of CDC’s responsibilities under the Clinical Laboratory Improvement Amendments (CLIA) program that oversees medical laboratory testing in the United States, in collaboration with the Centers for Medicare & Medicaid Services and the US Food and Drug Administration. Before this position, she served in the Branch for 15 years and has contributed to developing quality standards for approximately 10 CLIA regulations and several guidelines promoting good laboratory practices. Ms. Anderson’s clinical laboratory experience includes her work in hospital laboratories in New York, Florida, and Georgia, and in the CDC Special Bacteriology Reference Laboratory, and serving as the Coordinator for Emory University’s Master of Medical Science (MMSc) degree programs in the clinical laboratory sciences.
Ms. Anderson holds an MMSc degree in Clinical Microbiology from Emory University and is certified as a Medical Technologist by the American Society for Clinical Pathology. She is active in CLSI, where she chaired the subcommittee that developed M50, and was a member of the document development committee for M52. She was a member of the Consensus Committee on Microbiology (2009–2013) and is currently an advisor to that committee. Her other professional affiliations include serving as the CDC liaison to The Joint Commission Professional Technical Advisory Committee and the Association of Public Health Laboratories’ Laboratory Science and Standards Committee, and she is a member of the American Society for Microbiology.
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.
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.
Patrick Collyer is the Director, IT Solutions and Digital Strategy, at Instrumentation Laboratory in Bedford, Massachusetts. Mr. Collyer has more than 10 years’ experience in clinical information systems with an emphasis on laboratory information systems and laboratory middleware, as well as point-of-care information management and connectivity, having worked on projects across multiple international territories. He has participated in the IVD Industry Connectivity Consortium to improve interoperability between in vitro diagnostic devices and health care informatics, and participates as a contributor in the CLSI document development process. Mr. Collyer received an MBA from ESADE Business School in Barcelona and a BA in Foreign Languages & Literatures from Washington State University.
Massachusetts General Hospital
Mary Jane Ferraro, PhD, MPH is a Professor of Pathology and Professor of Medicine at Harvard Medical School and Co-Director of the Clinical Microbiology Laboratory at Massachusetts General Hospital in Boston. In her current position, Dr. Ferraro serves as Co-Director of the largest and most comprehensive clinical microbiology laboratory among the Harvard Medical School teaching hospitals. Dr. Ferraro received her PhD from Boston University School of Medicine (Medical Sciences), and her MPH from the Harvard School of Public Health, where she was the recipient of a US Public Health Service grant designed to train directors of large infectious disease laboratories. She has been a member of the Clinical and Laboratory Standards Institute (CLSI) Subcommittee on Antimicrobial Susceptibility Testing since 1990, and she served as the Chairholder of that Subcommittee from 1997 until 2002. From 2003 to 2009 she was Chairholder of the CLSI Area Committee on Microbiology, and was named Vice-Chairholder of the Expert Panel for Microbiology in 2016. Dr. Ferraro is a Fellow of both the American Academy of Microbiology and the Infectious Diseases Society of America and has served as National Councilor and Program Chair for Division C of the American Society for Microbiology (ASM). Her clinical and laboratory research includes studies on the development and validation of new approaches to antimicrobial susceptibility testing; methods for early, direct detection of microorganisms in clinical specimens; and appropriate use and cost-effectiveness of diagnostic tests in microbiology. She is the author of over 150 publications in scientific journals, as well as numerous textbook chapters and review articles. She has been a member of the Editorial Board of the Journal of Clinical Microbiology, and served as Co-Editor of the Clinical Microbiology Newsletter and Section Editor for the ASM Manual of Clinical Microbiology.
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; 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.
US Food and Drug Administration
Kelly S. Oliner, PhD is the Deputy Director, Division of Immunology and Hematology Devices in FDA’s Office of In Vitro Diagnostic Devices and Radiological Safety. She earned her PhD in Molecular Genetics from the Johns Hopkins University School of Medicine and subsequently held two post-doctoral fellowships at Somatix Gene Therapy Corporation and Chiron Corporation. Following these fellowships, she was a research scientist at Chiron Corporation, Protein Pathways, and Amgen. While at Amgen (2003-2015), Dr. Oliner held successive positions from Staff Scientist to Scientific Director. Initially, she managed a laboratory group that developed and validated therapeutic drug potency assays in a GLP testing environment. In 2006, Dr. Oliner transferred to the clinical biomarker group where she was responsible for leading biomarker development efforts for clinical programs from early preclinical stage to marketed products. In this position, she had a small laboratory group that developed and validated biomarker assays (ELISA, RT-PCR, NGS) for use in Amgen clinical trials. Dr. Oliner also lead extensive outsourcing efforts (ELISA, IHC, FISH, PCR, and NGS) to small and large clinical testing laboratories in the US, Europe, and China to support global clinical trials. Several clinical biomarker efforts were successful. In 2012, Amgen formed a small, specialized in vitro diagnostic group to specifically support companion diagnostic programs at Amgen. Through collaborative partnerships with diagnostic companies, clinically validated biomarker assays were developed. Dr. Oliner led long-term efforts to develop, validate, and obtain global regulatory approval for KRAS and RAS biomarkers for the use of panitumumab, and EGFR antibody for colorectal carcinoma.
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.
Siemens Medical Solutions USA, Inc.
James F. Pierson-Perry is a Principal Key Expert in the Assay Development group of Siemens Healthcare Diagnostics. He has worked in research and development of in vitro diagnostics products for 38 years, developing and leading local and multinational teams that have commercialized more than 70 assays and instrument systems for global markets. His interests include assessing new clinical markers and technologies, optimization and data analysis techniques, process and design validation, and improving the product development process. Mr. Pierson-Perry has been active in CLSI for many years. He served as Chairholder for development of CLSI documents EP25 and EP17, as a member of the document development committees for EP05 and EP21, and as Vice-Chairholder and Chairholder of the Evaluation Protocols Consensus Committee. He received the 2013 CLSI award for Excellence in Consensus Management. Mr. Pierson-Perry is currently a member of the Consensus Council and Chairholder of the new EP25 document development committee. He also has given webinars on new CLSI EP documents and served on the StatisPro Expert Panel. Outside of CLSI, Mr. Pierson-Perry is the Corporate Representative on the IFCC Scientific Division Executive Committee, representing the voice of all corporate members. He is a member of ISO TC 212 Working Group 3 and contributed to the development of ISO 23640 on IVD reagent stability. Mr. Pierson-Perry is a member of the AACC Industry Division, and received the Louis J. Dunka, Jr. memorial service award in 2011.
Nebraska Department of Health and Human Services
Thomas L. Williams, MD, FACB, FASCP, FCAP recently retired after 22 years as Laboratory Medical Director of Methodist Hospital, Omaha, Nebraska. He subsequently held the position of Chief Medical Officer and Director, Division of Public Health, Nebraska Department of Health and Human Services. He is an anatomic and clinical pathologist and is board-certified in Chemical Pathology (ABP). He has served as a member or chair of a number of CAP working committees in chemistry, proficiency testing quality control, publications, and education. He is a past member of CLIAC of CDC working groups promoting good practices for waived and genetic testing. He has lectured nationally on laboratory emergency preparedness, served as Co-Chair of the committee which developed emergency communications for health care for metropolitan Omaha and neighboring counties, and served as Chairholder of CLSI document GP36, Planning for Laboratory Operations During a Disaster. He is a past member and Vice-Chairholder of the CLSI Consensus Committee on Chemistry and Toxicology and past Advisor to the Consensus Committee on Quality Systems and Laboratory Practices.