SCB both coordinates and is involved in a variety of activities that support regenerative medicine standards development, including the webinars and workshops listed below. Also see the Events page for a list of other community events and activities.
There are no webinars scheduled at this time. Please check the Events page for other related activities.
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)
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)
FDA, NIST, SCB, and Nexight Group will host a workshop at the National Cybersecurity Center of Excellence (NCCoE) in Rockville, Maryland. The workshop will feature updates from Standards Development Organization (SDO) representatives and industry organizations on the benefits of standards and participating in the standards development processes. Targeted stakeholders include: RM manufacturers, clinical trial sponsors, contract manufacturers, academic institutions, raw material providers, and logistics delivery providers. See the workshop event page for more information.
Please check the Events page for other related activities.
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