Archived Webinars and Workshops
SCB both coordinates and is involved in a variety of activities that support regenerative medicine standards development, including the webinars and workshops listed below.
Please see the Events page for a list of current community events and activities.
Webinars
8/24/2022: SCB Webinar: FDA/CBER's Consensus Standards Recognition Program - Draft Guidance
SCB hosted a webinar to discuss the FDA guidance on CBER's Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies, which will help regenerative medicine stakeholders identify standards FDA will accept in regulatory submissions.
In this webinar, SCB explained the draft guidance document, answered participant questions, and collected and coordinated participant comments for submission to the FDA.
2/10/2021: STANDARDS DEVELOPMENT FORUM PUBLIC WEBINAR
In this webinar, SCB shares the outcomes of the Standards Development Forum. For the Forum, SCB invited representatives from professional organizations, SDOs, accreditation bodies, government agencies, and pharmacopeias to discuss issues and opportunities within the regenerative medicine community. The meeting resulted in several new upcoming resources for the regenerative medicine community:
A public standards development resource with information on current standards efforts, the status of standards efforts, needed subject matter experts, and most importantly, how to get involved.
A comprehensive open ballot update system to notify stakeholders of open ballots/comment periods for standards, the timeline for responses, and how to get involved in the next steps.
Other key discussions included challenges faced by the regenerative medicine community, standards needs, and opportunities for collaboration. The webinar provides more detail on the major initiatives and discussions from the meeting.
6/26/2018: THE REGENERATIVE MEDICINE STANDARDS DEVELOPMENT PROCESS
Featured: Dawn Henke, SCB Technical Program Manager (how SCB proposes to complement existing standards development processes to improve coordination, increase community engagement, and enhance regenerative medicine standards awareness across the community) and Claudia Zylberberg, CEO of Akron Biotech; Judith Arcidiacono, International Regulatory Expert and Standards Liaison, Office of Tissue and Advanced Therapies, Center for Biologics Evaluation and Research, USFDA; and Sumona Sarkar, Biomedical Engineer, NIST (case studies/testimonials about the benefits of becoming engaged in the standards development process)
3/13/2018: OVERVIEW OF STANDARDS FOR THE REGENERATIVE MEDICINE LANDSCAPE
Featured: Dawn Henke, SCB Senior Technical Program Manager (highlights from a recent study of the regenerative medicine standards landscape) and Jacqueline Wolfrum, Assistant Director at the MIT Center for Biomedical Innovation (case study illustrating how an effort to advance rapid microbial testing can inform development of a potential standard)
Overview of Existing Standards and Standards Needs (Dawn Henke)
Case Study on Rapid Microbial Test Methods for Sterility Testing of Regenerative Medicine Products (Jacqueline Wolfrum)
12/12/2017: THE NEED FOR STANDARDS IN REGENERATIVE MEDICINE
Featured: Allison Getz, SCB Senior Operations Program Manager (overview of standards types); Heidi Hagen, Chief Strategy Officer at Vineti, and Anthony Ratcliffe, Chief Executive Officer of Synthasome (how the development of standards influenced the work in their fields of regenerative medicine)
Standards Types (Allison Getz)
Labeling and Standards in Tissue and Cell Therapy (Heidi Hagen)
Labeling and Standards in Articular Cartilage Repair and Regeneration (Anthony Ratcliffe)
11/16-17/2023: IDENTIFICATION AND STANDARDIZATION OF METHODS FOR ASSESSING GENE THERAPY PRODUCT ACTIVITY AND COMPARABILITY AND THE EVALUATION OF T-CELL THERAPIES: A WORKSHOP CONVENED BY FDA, NIST, SCB, USP, AND NEXIGHT GROUP
This hybrid 2-day workshop centered on the identification of standards needs for gene and cell therapy product assessment. The workshop was attended by more than 50 in-person stakeholders and 180 virtual stakeholders from industry, academia, standards development organizations (SDOs), and government agencies, among other regenerative medicine stakeholder groups. In addition to discussions on standards needs, it included presentations by regulatory and industry representatives on the challenges and best practices in assessing cell and gene therapy products for quality, safety, and efficacy, and areas where it would be most valuable to focus attention for standardization, as well as information on standards and the standards development process. A full workshop summary report is available
3/18-19/2019: REALIZING THE BENEFIT OF 21st CENTURY CURES THROUGH STANDARDS DEVELOPMENT: A Workshop Convened by FDA, NIST, SCB, and Nexight Group
This two-day workshop featured updates from SDO representatives and industry organizations on the benefits of standards and of participating in the standards development processes. Participants also had the opportunity to learn about current regenerative medicine standards efforts that need community support and participate in discussions to support their advancement. A full workshop summary report and other accompanying materials are available.
8/10/2018: CHARACTERIZATION OF FIBER-BASED SCAFFOLDS WORKSHOP
SCB, along with NIST, BioFabUSA, and ASTM International hosted a workshop to gather input from the regenerative medicine community on standards needs related to the characterization of fiber-based scaffolds. Please see the detailed summary of the workshop, which includes the agenda and other accompanying materials.
Other Strategic Activities
Identifying Processes and Criteria to Strengthen Regenerative Medicine Standards Development
On September 27, 2017, the U.S. Food and Drug Administration (FDA) awarded a one-year contract to Nexight Group and SCB. The purpose of this contract is to identify existing and needed standards relevant to regenerative medicine and to engage with experts to develop recommendations and outline a plan to improve the processes and criteria used to identify, prioritize, and assess promising regenerative medicine standards. As part of this effort, the Nexight-SCB team developed The Regenerative Medicine Standards Landscape report and hosted three webinars (see above) for community stakeholders on the need for standards in regenerative medicine, existing and in-development standards, and the standards development process.
This work will create a foundation that allows industry, regulatory authorities, and other stakeholders to reduce barriers to regenerative medicine research and product development and accelerate the market readiness of these life-changing medical treatments.
Project Duration: September 2017-September 2018