Sector Call Summaries (2022)
Q3 2022
1) SCB Overview
Reviewed SCB’s purpose and history
2) SCB News
New All About Standards web series
Request for feedback on areas of standards need in the regenerative medicine standards needs in the SCB Regenerative Medicine Standards Portal
Two new in-progress feasibility assessments on:
Regenerative medicine software and equipment interoperability
Biological evaluation of tissues and extracellular matrices used in tissue engineering for in vivo studies
SCB will hold an informational webinar on FDA’s recognition program for voluntary consensus standards within CBER
3) Sector-Specific Standards Updates
Shared project updates, including newly published standards
Reviewed calls for subject matter experts to join standard project working groups
4) Other Updates
Reminder about the NIST cell counting statistical tool
Workforce development updates:
Developed pilot curricula for implementation of ISO cell counting standards part 1 and 2
Seeking volunteers to help develop content for an ISO ancillary materials course
Launching two new SCB focus areas to address key interrelated challenges:
Standards Implementation Education and Workforce Development
Data Management
Q2 2022
1) SCB Overview
Reviewed SCB’s purpose and history
2) SCB News
New Executive Director, Justin Barch
Launched All About Standards web series
Posted a draft standard on implementation of a chain identity identifier, open for comments through May 27
Updated regenerative medicine standards needs in the SCB Regenerative Medicine Standards Portal
Completed new feasibility assessments on product potency, cell morphology, and cell identity
3) FDA News
FDA plans to develop a recognition program for voluntary consensus standards within CBER
New guidance documents relevant to regenerative medicine:
Considerations for the Development of CAR-T Cell Products
Human Gene Therapy Products Incorporating Human Genome Editing
4) Sector-Specific Standards Updates
Shared project updates, including newly published standards
Reviewed calls for subject matter experts to join standard project working groups
5) Other Updates
Announced launch of new NIST cell counting statistical tool
Updates on workforce development
Developed pilot curricula for implementation of ISO standards on cell counting and nucleic acid synthesis
Designing and implementing a pilot training program with ARMI | BioFabUSA on the regenerative medicine manufacturing process
Q1 2022
1) SCB Updates
Reviewed SCB’s purpose, history, and recent achievements
Standards Development Forum
Three new feasibility studies on product potency, cell morphology, and cell identity
Presentations at community events
2) SECTOR-SPECIFIC STANDARDS UPDATES
Shared project updates, including newly published standards
Reviewed calls for subject matter experts to join standard project working groups
3) Standards Implementation Curricula and Workforce Development
Developing pilot curricula for:
ISO Cell Counting Standards Part 1 and 2
ISO Nucleic Acid Synthesis
Developing pilot training program for standards
4) SCB-curated ANSI Standards Packages
Invited input on topics for additional, more specific packages
5) PLANS FOR 2022
Upcoming initiatives
Educational standards series
Ancillary materials standards curriculum
Launch ANSI-accredited certificate program on cell counting standards
Community events SCB will attend
6) Q&A
Group discussion on potential opportunities to offset cost of standards for academia and small businesses