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NCCN Policy Summit Explores Challenges in Tissue Allocation

By Jessica K. DeMartino, PhD, Manager, Health Policy Programs, NCCN

On Monday, June 8, 2015, as part of its Oncology Policy Program, the National Comprehensive Cancer Network® (NCCN®) hosted its Policy Summit: Emerging Issues in Tissue Allocation, at the National Press Club in Washington, DC.

The policy summit was held in response to growing issues of concern for many researchers due, in part, to expanding research interests in precision medicine. The increased demand by pharmaceutical and biotech companies for patient tissue specimens collected for clinical care and trials presents clinical, ethical, and legal issues.

The summit commenced with findings from the NCCN Tissue Allocation Work Group, convened in March 2015 to address areas of concern and establish best practices to address emerging issues around tissue allocation. Daniel Sullivan, MD, Moffitt Cancer Center, and Judith Carrithers, JD, MPA, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, presented the findings of the Work Group. Dr. Sullivan highlighted the shared goals of stakeholders, which include high quality samples to serve both diagnostic and research purposes; consistent and standard practices for sample collection, processing, storage and release; and sufficient quantity of tumor sample for all planned uses. Ms. Carrithers emphasized the role of institutional review boards and institutional policies in deciding how tissue gets allocated to different stakeholders. The Tissue Allocation Work Group represented clinicians, pathologists, clinical and translational investigators, industry, patient advocacy groups, and institutional review boards.

Following presentation of the Work Group’s findings, Kenneth Bloom, MD, GE Healthcare, further discussed the need to establish pre-analytic standards. Dr. Bloom highlighted the impact biospecimen quality has on both clinical and research outcomes. He went on to describe the National Biomarker Development Alliance’s efforts to establish pre-analytical standards and work with the College of American Pathologists (CAP) to implement these standards into CAP accreditation.

Tom Flotte, MD, Mayo Clinic Cancer Center, and Veronique Neumeister, MD, Yale School of Medicine, discussed the tissue practices at their respective academic cancer centers. Dr. Flotte focused on the unique features of Mayo Clinic Cancer Center's pathology department and the frozen section laboratory – every sample is frozen, and the well-designed work flow that allows for very high quality pathology work to be completed in a controlled time frame. Dr. Neumeister described the organizational structure of the Yale Pathology Tissue Services and emphasized Yale’s development of tissue microarrays.

Following the expert presentations, the summit featured two roundtable discussions, moderated by Clifford Goodman, PhD, The Lewin Group, the first of which facilitated deliberation about diagnostic, clinical, and research concerns. Panelists for the first roundtable included Carlos Arteaga, MD, American Association for Cancer Research; Phil Branton, MD, College of American Pathologists; Jeffrey W. Clark, MD, Massachusetts General Hospital Cancer Center; Marisa Dolled-Filhart, PhD, Merck; Dr. Flotte; and Roslyn Meyer, PhD, Yale University School of Medicine. Key takeaways from this discussion included the concept that poor quality of biospecimens can hinder innovation, pre-analytic standards are highly desirable for all stakeholders, and cost will be the major hindrance to implementing pre-analytic standards across both community and academic centers.

During the second and final panel discussion, Ms. Carrithers; Anitra Engebretson, Pancreatic Cancer Action Network; Hank Greely, JD, Stanford Law School; and Nadia Haque, PhD, Genentech, analyzed regulatory, policy, ethical, and patient concerns around tissue allocation. The group touched on the informed consent process and whether it is meeting the needs of patients, researchers, or industry partners. The overall consensus was that there is room for improvement. Specimen ownership, intellectual property ownership, and financial benefit of discoveries were all points of discussion for the group.

Recommendations for best practices and standards in tissue allocation, based on findings from the Work Group and policy summit, will be formulated and published as a white paper in JNCCN – Journal of the National Comprehensive Cancer Network in Fall 2015. A full summary of the policy summit will be available in six to eight weeks on

For more information about the NCCN Oncology Policy Program, visit