Next Generation Biobanking: Operational and Regulatory Requirements for Reporting Results Clinically
Biobanking for Precision Medicine Series
Presented by the NCI Biorepositories and Biospecimen Research Branch
Date: Wednesday, February 16, 2022, 1:00 – 2:30 p.m.Location: VirtualWebEx RegistrationOpen to the public. Registration using the WebEx link prior to the meeting is required to join this event.
The seminar series is brought to you by NCI’s Biorepositories and Biospecimens Research Branch (BBRB) and addresses current topics in biobanking science, policy and operations. In the era of precision medicine, high quality biospecimens are central to understanding complex diseases, biomarker discovery and unraveling the mechanisms of resistance to therapies. This seminar series is planned to be forward-looking with a focus on improving awareness of best practices for collection of biospecimens and associated data as well as expanding research participation through biobanking.Our focus for spring 2022 is on “Creating biobanking infrastructures that enable return of results.” The seminar by Dr. McCall is the first of a two-part mini-series on this topic.
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Shannon J. McCall, M.D.Associate Professor & Vice-chair for Translational Research, Department of PathologyDirector, BioRepository & Precision Pathology CenterCo-Leader, Precision Cancer Medicine & Innovative Therapeutics ProgramDuke Cancer Institute & Duke University School of Medicine |
AbstractDuring this talk, Dr. McCall will briefly review the creation and goals of the Clinical Laboratory Improvement Amendments of 1988 as well as the relevant definitions pertaining to reporting laboratory testing results clinically. She will discuss the pathways for obtaining a CLIA certificate and the spectrum of translational and clinical research activities in this context with an emphasis on tissue-based laboratory testing. The talk will conclude with operational and regulatory requirements invoked by specific activities and project goals concerning research.About the SpeakerDr. McCall obtained undergraduate degrees in Chemical Engineering and Biochemistry from North Carolina State University and then went on to obtain her M.D. from Duke University. She remained at Duke University for Anatomic and Clinical Pathology Residency, where she served as Chief Resident. She then took on a fellowship in GI and Liver Pathology before joining the Duke faculty as a gastrointestinal surgical pathologist. After performing and supporting translational research for several years, she turned her attention to human biospecimen procurement, analysis and banking in 2010, co-founding and then directing the BioRepository & Precision Pathology Center (BRPC) shared resource at Duke University. She has become a national leader in biobanking. She has served on the College of American Pathologists’ Biorepository Accreditation Program Committee since 2014 and is currently serving as the Chair of this committee. She also serves as a member of the Standards Com mittee of the International Society of Biological & Environmental Repositories (ISBER). Dr. McCall obtained her board certification in Clinical Informatics in 2017 and has co-developed software to manage clinical next generation sequencing data in a form that can be used to annotate biospecimens. This work contributed to the success of the Duke BRPC in being named the new Southern Division of the NCI’s Cooperative Human Tissue Network in 2019. Dr. McCall’s ongoing work in precision cancer medicine supports both translational and clinical research and she now co-leads the Precision Cancer Medicine & Investigational Therapeutics Program of the Duke Cancer Institute. She has authored or contributed to 114 peer-reviewed publications. She was promoted to Associate Professor with Tenure and named Vice-chair for Translational Research in the Department of Pathology at Duke University in 2020.Please note that, with our speakers’ authorization, NCI records presentations for the NIH and the general public.Event contact information: Veena Gopalakrishnan
If you are an individual with a disability who needs reasonable accommodations to participate in this event, please contact Veena Gopalakrishnan, 240-276-5123 at least three business days before the event, so that we can discuss your accommodation request.