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2016 Board of Directors Nominee Profiles

James H. Nichols

James H. Nichols, PhD, DABCC, FACB

Nominated for Director, Professions Constituency Position
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 in Rochester, Minnesota. He is board certified by the American Board of Clinical Chemistry in both Clinical Chemistry and Toxicological 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. His 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.

James F. Pierson-Perry

Nominated for Director, Industry Constituency Position
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.

Deridre Astin

Deirdre Astin, MS, MT(ASCP)

Nominated for Director, Government Constituency Position
New York State Department of Health

Deirdre Astin, MS, MT(ASCP) is the Deputy Director of the New York State Department of Health Division of Hospitals and Diagnostic and Treatment Centers, which supports the state’s licensing, surveillance, regulatory and policy development activities as they relate to hospitals, clinics, and ancillary health care facilities. Ms. Astin worked for the Department’s Wadsworth Center from 1994-2011, serving first as Deputy Director, then Director, of the Clinical Laboratory Evaluation Program. She went on to serve as the Director of Regulatory Affairs. From 2011-2015, Ms. Astin worked with the Department’s Division of Financial Policy and Planning on projects related to the statewide implementation of health care reform. Ms. Astin 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. Ms. Astin serves on the CLSI Board of Directors and the Finance Committee. Her interests include quality management systems, global health, and laboratory performance improvement. She actively participates in CLSI document development projects and in 2009 she spent three months as a CLSI laboratory mentor in Tanzania.

Kelly S. Oliner, PhD

Nominated for Director, Government Constituency Position
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.

Thomas L. Williams, MD, FACB, FASCP, FCAP

Nominated for Director, Government Constituency Position
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.

 

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