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.
Targeted genome editing technologies are being leveraged across many sectors including in the development of novel therapeutics. NIST and FDA are convening a public workshop with stakeholders across industry, academia, non-profit, and government to define a path forward for developing pre-competitive measurement and standards solutions to address the wet lab, dry lab and terminology needs for confident use of genome editing technologies, particularly for the development of human therapeutic products. The outcomes of this workshop will help clarify current regulatory perspectives and supply additional information to the newly launched NIST Genome Editing consortium (now accepting members) towards the path forward for developing solutions. The workshop will be organized into both general session talks with discussion as well as breakout sessions to get detailed feedback and engagement.