Sector Call Summaries: Cell Therapy (2020)
1) SCB Updates
Staff shared key SCB accomplishments from the past year
2) Landscape and Needed Standards Report feedback
Landscape Report feedback:
Add information on which standards are formally/informally FDA-recognized
Include more about framework of how SDOs are involved with SCB
Add more about implementation—how to do so, include links to relevant publications beyond the standards themselves
Add new sorting methods: types of products, processes, materials, equipment, quality/testing issues, supply chain
Capture search results for a pull-down menu of common terms
Include links to relevant documents, places standards can be purchased
Needed Standards Report feedback:
The Cell Therapy Sector identified several ways to revise this report to make it more user-friendly and valuable, including adding standards needs related to:
Cell-based imaging and single-cell analysis standards
Certificate of analysis for raw materials and electronic formatting (e.g. ASTM standards)
Management of metadata
Participants also suggested increased communication of when standards move from the Needed Standards Report to the Landscape Report.
3) SCB Project Updates
Shared project updates specific to the cell therapy sector
4) Communications Feedback
Invited feedback on ways to improve communication with stakeholders
5) Workshop/Courses
SCB is planning future workshop opportunities focused around standards for cell therapy. Possible topics include:
Needs, quality testing, and reporting of ancillary materials
Validation and fit-for-purpose for rapid microbial testing methods (RMTM) and incorporating these methods into the manufacturing process
Inventory of existing standards
How to understand and incorporate standards into an approval process
The new open ballots page was also shared.
6) Other Business
1) COVID-19 Updates
Staff provided an update on plans to reschedule in-person SCB-hosted events from summer/fall to later in winter/spring
Shared updates from major standards developing organizations (SDOs), including virtual events and free access to standards relevant to COVID-19
2) SCB Updates
Staff shared key SCB accomplishments from the past year
3) PROJECT UPDATES
Shared project updates specific to the cell therapy sector
4) IN-DEVELOPMENT STANDARDS
Provided updates on current in-development standards in need of expert input
5) STANDARDS IMPLEMENTATION COURSES
SCB is planning future workshop opportunities focused on implementation of standards. Initial offerings will focus on standards for ancillary materials and cell counting.
Participant discussion feedback:
The initial course topics are good choices; they are both major issues in the community
The field needs guidance on how to adapt ancillary materials designed for laboratories to the needs of therapeutic manufacturing
Case studies would help people dig into issues better than lectures
It is important to increase transparency between suppliers and users
1) SCB News
Staff shared news about upcoming offerings, including standards implementation courses, planned feasibility reports, planned updates to the Regenerative Medicine Standards Landscape report, and a rapid microbial testing article that will be published in Cytotherapy journal.
2) Cell Therapy Standards Updates
Shared project updates specific to the cell therapy sector
3) Identification and Prioritization of Needed Standards
Participants looked at Impact/Urgency ratings of standards from the Community Perspectives: Needed Standards in Regenerative Medicine report and provided suggested changes.
Participants also suggested additional standards needs to add to the report.
SCB will distribute a survey to gather additional feedback on these topics.
4) Upcoming Annual Meeting and SDO Forum
SCB is planning an annual meeting for January 2021 to inform the public about published and in-development standards, increase engagement with standards, and solicit input on standards needs.
There will be a meeting among SDO representatives in November to discuss current standards efforts under way and harmonize efforts, as well as focus on next steps for addressing community-identified needs.
1) SCB UPdates
Staff shared recent updates, including:
Upcoming projects including feasibility assessments, training for regenerative medicine standards implementation, and updating the Regenerative Medicine Standards Landscape report to be an interactive, searchable portal
Plans to hire additional staff to help with upcoming initiatives
2) Cell Therapy Standards Updates
Shared project updates specific to the cell therapy sector
3) Identification and Prioritization of Needed Standards
Participants provided feedback on:
The functional areas with the greatest impact and urgency in the field
The standards areas with the greatest impact and urgency in the field
Which standards areas have the greatest community support
Which standards areas have the greatest scientific consensus
Participants also suggested additional standards needs to add to the report.
SCB will distribute a survey to gather additional feedback on these topics.
4) Upcoming Annual Meeting and SDO Forum
SCB is planning an annual meeting for January 2021 to:
Inform the public about published and in-development standards
Identify and prioritize needed standards
Increase engagement with standards
Answer questions on standards implementation