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  • Faculty (Biobanking)

     

    Marianna Bledsoe

    Marianna J. Bledsoe, MA, is an independent research professional who teaches, writes, and consults on biomedical research policy matters including the ethical, legal, and social issues related to tissue banking and the use of human specimens in research. She is an adjunct assistant professor in the departments of pathology and clinical laboratory medicine at the George Washington University and associate editor for the journal Biopreservation and Biobanking. Ms. Bledsoe was involved in tissue banking activities for nearly 20 years at the National Institutes of Health (NIH) and the Department of Veterans Affairs (VA). As deputy associate director of the clinical research policy analysis and coordination program in the office of science policy within the office of the director of NIH, she led an interagency effort to streamline and harmonize federal policies related to human specimen research. She participated in the development of federal policies and educational documents related to biobanking, genomic data sharing, privacy and confidentiality, and health information technology. At the NIH and at the VA, she provided scientific oversight and direction for a number of different tissue banks. Ms. Bledsoe has made numerous invited presentations, nationally and internationally, on biobanking issues. She participated in policy development efforts with the US Department of Health and Human Services’ Secretary’s Advisory Committee on Human Research Protections; the Council of Europe working group on human biological materials; and the Organization for Economic Cooperation and Development working group on human biobanks and genetic research databases. She was president of the International Society for Biological and Environmental Repositories (ISBER) from 2007 to 2008, and is a current member of the ISBER board of directors, ISBER Science Policy Committee, and ISBER Publication Committee. She received the 2012 ISBER Distinguished Leadership and Service Award, and a 2013 ISBER Special Act or Service Award.

    Mine CicekMine S. Çiçek, PhD, received her PhD in Genetics from Virginia Tech, Blacksburg, VA in 2001.  Following a Postdoctoral Research Fellowship at the Cleveland Clinic, Lerner Research Institute, she came to Mayo Clinic, Rochester, Minnesota in 2005 as a R25 Cancer Genetic Molecular Epidemiology Fellow. After completion of her training, she then worked in the capacity as a research associate in the Division of Experimental Pathology and Laboratory Medicine from 2006-2010, then the Division of Epidemiology, Department of Health Sciences Research from 2010-2013.  She is trained as a lab-based researcher in the cancer genetic epidemiology field and has worked on multiple tumor types. She has led and published multiple studies with similar research goals on prostate, colon and ovarian cancer genetics.  In 2013, she accepted the position as the laboratory director of the Biospecimens Accessioning and Processing (BAP) core laboratory, Biorepository Program, and Center for Individualized Medicine at Mayo Clinic in Rochester, Minnesota.  Dr. Çiçek presently is an assistant professor of laboratory medicine and pathology in the Mayo Clinic College of Medicine and is a senior associate consultant at the Mayo Clinic, Rochester, Minnesota. Her main focus is to contribute her expertise in research studies and clinical trials overseeing biospecimen collections, processing, and storage.  Dr. Çiçek continuously tries to bring new knowledge and technology to her lab to improve on quality and best practices for biospecimens usage.

     William GrizzleWilliam E. Grizzle, MD, PhD, is a professor of pathology at the University of Alabama at Birmingham (UAB). Dr. Grizzle has an undergraduate degree in chemistry and physics from Harvard University, a PhD in biophysics and MD both from Johns Hopkins University, and has his board certification in anatomic and clinical pathology. Dr. Grizzle has an active ongoing extramural research program (NIH and DOD funded) in basic and translational research that focuses on racial disparities in cancer research and biorepository operations and science, as well as pancreas, breast, and prostate cancers. He has published approximately 500 peer-reviewed manuscripts and book chapters. He is a trustee of the Biological Stain Commission, of which he is past president (2000-2004). Dr. Grizzle has been the director of the Tissue Collection and Banking Facility at UAB since 1983. His interests in this area include ethical and regulatory issues affecting biorepositories. He has presented and participated at several PRIM&R meetings. He is a member of the Bioethics Core of the U54 Grant, Morehouse School of Medicine-Tuskegee University-UAB Cancer Center Partnership. He is past president of the International Society of Biological and Environmental Repositories (ISBER) and, in 2015, received the ISBER Award, Outstanding Achievement in Biobanking.

    Michele Russell-EinhornMichele Russell-Einhorn, JD, is the vice president for Oncology Services, Central Oncology Review Division of Schulman IRB. She oversees the specialized oncology IRB and attendant customized service for cancer centers and others conducting cancer research.  Her expertise is in the areas of protection of human subjects in research, scientific review of cancer research and research administration. She served for 11 years as the senior director, Office for Human Research Studies, Dana-Farber Cancer Institute where she was responsible scientific review, institutional review board review, and other regulatory matters, involving all cancer relevant research involving human subjects conducted at the five Harvard clinical institutions under the umbrella of the Dana-Farber/Harvard Cancer Center. She has over 30 years of professional experience as director of regulatory affairs for the Office for Protection from Research Risks (OPRR), the Office for Human Research Protections (OHRP), and associate general counsel for the J. Craig Venter Institute. She is a co-chair of the Secretary’s Advisory Committee on Human Research Protections, Subpart A Subcommittee; a founder of the IRB Directors Group of the National Comprehensive Cancer Center; former PRIM&R Co-Chair, current core planning committee member, and faculty in the Northeastern University Masters of Regulatory Affairs Program.

    Susan StaynSusan Stayn,JD, is senior university counsel at Stanford University, where she advises the university, the Stanford Hospital and Clinics, and the Lucile Packard Children’s Hospital on legal and regulatory compliance issues in health care and biomedical research. Before joining Stanford, Susan worked in the Office of the General Counsel of Partners HealthCare System, Inc., a leading nonprofit integrated delivery system founded by Massachusetts General Hospital and Brigham and Women’s Hospital, which also includes community and specialty hospitals, a large physician network, and a joint venture with Dana Farber Cancer Institute. She previously worked in the private and public interest sectors. Susan’s professional expertise includes privacy, informed consent, human subjects research, stem cell research, FDA issues in clinical care and research, and general federal and state regulatory compliance. Most recently, she has lectured on legal issues in health care and research at Stanford, University of California - Berkeley Law School, Public Responsibility in Medicine and Research, and the American Health Lawyers Association. Her recent writings have appeared in publications such as BNA's Medical Research Law and Policy Report, The Stanford Journal of Law, Science & Policy, The Boston Health Law Reporter, and the Massachusetts Health and Hospital Law Manual. Susan received her Bachelor of Arts from Harvard College and her J.D. from Columbia University School of Law.