Feedback Needed on the Community Perspectives: Needed Standards in Regenerative Medicine Report

SCB, in partnership with Nexight Group, has created a new report to help inspire and align community action around advancing the standards that could make the greatest difference to the regenerative medicine field. A draft version of the Community Perspectives: Needed Standards in Regenerative Medicine report is now available and open for comments through June 19, 2019.

When SCB first began assessing the regenerative medicine landscape to create The Regenerative Medicine Standards Landscape report, many stakeholders reported a pressing need for more standards specific to the field. In response, we have developed this new report highlighting more than 30 standards needs identified by the regenerative medicine community that could improve the safety and quality of regenerative medicine products.

The report provides an overview of needs specific to each regenerative medicine sector, followed by detailed descriptions of standards needs by functional area. It provides a 1–2-page description of each standards need, including:

• A description of the topic area and challenge

• The main objective of advancing standards in this area

• Potential areas to standardize (e.g., specific tests or processes)

• Related efforts in the community that could be leveraged to advance a standard

• Suggested next steps for stakeholders interested in addressing the standards need

The report draws on community feedback we gathered from more than 250 regenerative medicine stakeholders throughout 2018 and 2019 through expert interviews, a community-wide survey, and community prioritization exercises at the Realizing the Benefit of 21st Century Cures through Standards Development Workshop and several other smaller-scale workshops held in conjunction with other industry events.

One of SCB’s goals since its inception has been to strengthen the identification and prioritization process for advancing regenerative medicine standards through greater community engagement, a goal we outlined in Realizing the Promise of Regenerative Medicine Therapies: Strengthening the Standards Development Process. The methodology we used to create the report on needed standards allowed us to implement many of these process improvements.

We invite you to read the report and provide feedback to improve its usefulness to the regenerative medicine field. Feedback can include:

• Suggested additions or corrections to report content

• Additional related efforts you are aware of

• Suggestions for next steps you would like to see included

• Corrections to applicable sectors or functional areas for standards needs

• Ways to better organize or structure report content

• Any other feedback you feel would improve the report

Please send your feedback to slichtner@nexightgroup.com by June 19, 2019.