Sector Call Summaries: Gene Therapy (2021)
1) SCB Updates
Staff shared recent updates, including:
Completion of multiple feasibility reports and ongoing work on a standard implementation course curriculum
Upcoming annual meeting
Plans to hire additional staff to help with upcoming initiatives
2) Gene Therapy Standards Updates
Shared new projects and project updates specific to the gene therapy sector
3) Landscape and Needed Standards Report Update
SCB recently updated the Community Perspectives: Needed Standards in Regenerative Medicine report and plans to integrate both the needed standards report and the Regenerative Medicine Standards Landscape report into a new web-based interactive standards portal.
4) Standards Development Forum
SCB held a standards development forum for representatives from standards developing organizations (SDOs), professional organizations, government agencies, and pharmacopoeias, which resulted in plans for the following new resources:
A public standards development resource
A comprehensive open ballot update system
1) SCB Updates
Staff shared recent updates, including:
Summary of SCB-coordinated standards advanced in Q1
Launch of the SCB Regenerative Medicine Standards Portal
Update to the Needed Standards report content to incorporate input from community surveys
2) Gene Therapy Standards Updates
Shared new projects and project updates specific to the gene therapy sector
3) Feasibility Assessments
Three feasibility assessments have been published and are accepting new working group members to join the standard advancement effort:
Chain of Identity
Pre-existing Immunity to AAVs
Lentiviral Vector Standards
Two ongoing feasibility assessments:
Cell Viability
Framework for Gene Delivery Methods and Gene Editing Tools
4) Upcoming Events
Cell counting curriculum feedback webinar upcoming on April 27
Annual SCB meeting upcoming in September 2021
Other upcoming regenerative medicine events:
5/10: The ASGCT pre-meeting workshop
5/14: ASFA 2021
5/25: SCB Standards Development Forum
5/27: ISCT: Traceability and Labeling for Cell-based Therapies and Regenerated Tissues
Q3: JULY 22, 2021
1) SCB UPDATES
Staff shared recent updates, including:
Overview of the new SCB Regenerative Medicine Standards Portal
Recently released and upcoming ANSI standards packages
Upcoming Standards Development Forum resource to help users navigate existing regenerative medicine terminology
Updates on rapid microbial testing method (RMTM) and flow cytometry consortia activities under SCB’s new NIST Contract
2) SECTOR-SPECIFIC STANDARDS UPDATES
Introduced new initiatives
Reviewed calls for subject matter experts to join standard project working groups
Shared project updates, including newly published standards
3) NEEDED STANDARDS SURVEY AND FEASIBILITY STUDIES
Discussed Needed Standards Prioritization Survey (open until September 15)
Invited suggestions for additional needed standards and feasibility assessment topics
4) UPCOMING EVENTS
Discussed standards implementation courses
Solicited topic suggestions for:
Standards development webinar series
September 2021 workshop
Q4: OCTOBER 28, 2021
1) SECTOR-SPECIFIC STANDARDS UPDATES
Staff shared project updates, including newly published standards and advancement of in-development standards
Reviewed calls for subject matter experts to join standard project working groups
Shared case studies describing project details and needed expertise for specific projects:
Patient Data Management
ASTM WK70143, Sampling Methods of TEMPs for Sterility Testing
Called for stakeholders to join upcoming feasibility studies:
Product potency and functionality measurement methods
Cell morphology considerations and measurement
Methods and processes for assessing cell identity
2) SCB REGENERATIVE MEDICINE PORTAL
Gave an overview of the SCB Regenerative Medicine Standards Portal
Invited participants to fill out the Portal Feedback Survey
3) STRATEGIC COMMITMENTS AND OPPORTUNITIES
Standards Development Forum working group developing a resource for navigating varying definitions for regenerative medicine terminology
Educational web series on standards under development
SCB supporting NIST in managing three consortia and their working groups for rapid microbial testing methods (RMTM), flow cytometry, and viral vectors
Upcoming standards implementation courses
Introduced new ANSI standards packages curated by SCB
4) REQUEST FOR FEEDBACK
Invited input via survey on standards package topics and regenerative medicine terms