SCB Perspectives: Looking Ahead to SCB’s Important Work in 2021
Executive Director Bob Shaw shares his thoughts on SCB’s areas of focus for the coming year.
Hello, all. This is my first time reaching out to you since joining SCB in October. I am very excited to work with the SCB staff to develop this world-class organization that addresses standards and standardization in regenerative medicine. It is an amazing field and an amazing time to be associated with regenerative medicine—for example, recent advancements in gene therapy and gene editing technologies are providing patients with renewed hope that some primary genetic diseases may be treatable or even curable.
About SCB
Our job at SCB is to coordinate and facilitate the standards process. We work to accelerate standards development so that industry can make use of those standards for easier regulatory review and approval of their new products. We have a dedicated and committed staff who are passionate about regenerative medicine and the mission of SCB.
2021 Areas of Focus
As we wind down from a challenging but successful 2020, we're excited about our plans for 2021. One of SCB’s unique advantages that we have direct contact with the U.S. Food and Drug Administration (FDA) to help us identify and address priorities they feel are important for the field to progress. Together, we identified several areas of focus for this coming year:
Conducting feasibility assessments to help identify potential barriers to standardization for high-priority standards identified in the Community Perspectives: Needed Standards in Regenerative Medicine report:
Lentiviral vectors (aligned with G7 in the needed standards report)
Cell collection for apheresis products (aligned with C2 in the needed standards report)
Chain-of-identity/chain-of-custody recording (aligned with C17 in the needed standards report)
Prioritizing standards for coordination—SCB is coordinating working groups to advance more than 14 standard advancement projects. We have identified five standards in particular that could benefit from SCB’s increased coordination support in 2021:
Microphysiological systems (proposed work item submitted to ASTM)
ASTM F2312, Standard Terminology Relating to Tissue Engineered Medical Products
ISO/DW TS 23565, General Requirements and Considerations for Equipment Systems Used in Manufacturing of Cellular Therapeutic Products
ISO/CD 23511, General Requirements for Cell Line Authentication
ISO/WD 20688-2, Nucleic Acid synthesis — Part 2: General Definitions and Requirements for the Production and Quality Control of Synthesized Gene Fragment, Gene, and Genome
Continuing collaborative standards advancement:
We will continue to work with standards developing organizations (SDOs) such as ASTM and the International Organization for Standardization (ISO) to ensure that standards are finalized and published in a timely manner.
Planning educational courses for standards implementation
We are developing a pilot curriculum to help the community implement recently published cell counting standards.
Get Involved
If you work in regenerative medicine and want to get involved in our activities to help influence the industry, help the field advance, and help patients, please contact us. We want to be your partner in identifying priority areas for standards and implementing standards within your organization. Join us to help accelerate the path for new treatments.