NIST Organizers: Sheng Lin-Gibson, Sumona Sarkar, Clare Allocca
FDA Organizers: Judith A. Arcidiacono, Steven S. Oh, Steven Bauer
NIST and FDA are actively collaborating on projects that address regulatory and measurement challenges for regenerative medicine products and advanced therapies. These collaborations leverage NIST expertise in measurement sciences to address specific analytical scientific challenges as well as FDA regulatory science, research and review expertise in regenerative medicine products to ensure that the science and standards developed address significant regulatory challenges that recur across the field. One of the fundamental challenges for manufacturers of regenerative medicine products is the counting of cells for manufacturing and dosing purposes. This workshop will focus on approaches for selecting appropriate cell counting methods and overcoming gaps in obtaining sufficient measurement assurance for cell counting. The expected outcome of the workshop is a Workshop Summary/Whitepaper to be published in a peer reviewed journal as well as input into standards for cell characterization.
The maximum capacity of this workshop is 50 persons. Meeting participants are expected to actively contribute to the discussions (see Requirements for Meeting Participation). Spaces for meeting observers will be allotted based on availability. This one-day public workshop will be followed by the meetings of the US TAG to ISO/TC 276: Biotechnology.