Description: There is a need for improved measurements and standards for the field of regenerative medicine and cell therapy products. A survey of 16 big pharma by Alliance for Regenerative Medicine (http://alliancerm.org/) found that "product consistency & lack of standards is possibly the single greatest challenge facing the field" of regenerative medicine . Likewise, a survey by Regenerative Medicine Foundation (http://regmedfoundation.org/) found that the "lack of reference materials to benchmark measurements and validation criteria for critical assays" are the biggest roadblocks for the field . Finally, a regenerative medicine roadmap identified "cell attribute measurements" as a primary need to enable reproducible manufacturing of high-quality cells . In order to examine approaches for improving confidence in the measurements that are necessary for bringing cell therapy products to market, a NIST Workshop was convened.
Link to Workshop Webpage: "Strategies to Achieve Measurement Assurance for Cell Therapy Products" (includes pdfs of the agenda, speaker slides & breakout session templates)
Workshop Attendee Demographics: 94 registrants comprised of 46% industry, 41% government, 5% non-profit & 7% academic.
Workshop Report: Simon Jr CG, Lin-Gibson S, Elliott JT, Sarkar S, Plant AL (2016) Strategies for achieving measurement assurance for cell therapy products. Stem Cells Translational Medicine 5, 705-708. https://doi.org/10.5966/sctm.2015-0269
Contributors: Carl Simon, Sheng Lin-Gibson, Anne Plant, Sumona Sarkar, John Elliott