SCB Regenerative Medicine Focus Areas
With hundreds of potentially lifesaving regenerative medicine products poised to move toward commercialization in the coming years, standards are more critical than ever.
SCB is dedicated to advancing and promoting the use of standards, but we need additional community support to respond to the interrelated challenges facing the regenerative medicine field:
Workers in regenerative medicine need vital training now to implement new standards
Current funding is insufficient to support the level of education and training needed to to help industry efficiently and effectively adopt and correctly use standards.
Regenerative medicine is fast-paced and requires a rapid response
Structured funding from partners (FDA, NIST, and ARMI | BioFabUSA) has been crucial to our success but only focuses on subsets of needs and priorities identified up to a year in advance.
Inaugural FOCUS AREAs
1) STANDARDS IMPLEMENTATION EDUCATION AND WORKFORCE DEVELOPMENT
KEY CHALLENGE: Standards can only benefit the community if there is broad understanding of how to implement them to meet regulatory expectations.
FOCUS AREA SOLUTIONS: Develop courses on how to use specific regenerative medicine standards to demonstrate regulatory compliance, improve workforce performance, and improve the efficiency and repeatability of internal processes.
STATUS: Pending full funding
2) DATA MANAGEMENT
KEY CHALLENGE: Variability in data management practices is a common pain point for treatment centers, manufacturers, and suppliers. The variance in data management practices and communication create opportunities for manufacturing error and overburden staff. This can result in limiting capacity to support clinical trials of potentially lifesaving therapies.
FOCUS AREA SOLUTIONS: Identify common data needs and approaches to streamline data management practices.
STATUS: Pending full funding
DONOR BENEFITS
Formal recognition of your contribution
At SCB-hosted workshops and meetings
On the SCB website
In SCB publications (newsletter, social media)
A seat on the Focus Area’s Steering Committee
Advise on opportunities within the focus area
Provide input on workshops and meeting agendas
Participate in course development for standards implementation support
Focus Area reports or courses
Help shape public reports about the Focus Area
Discounted course registration for your employees
SCB ACTIVITIES ENABLED BY YOUR DONATION
Depending on total funding received for each Focus Area, SCB will:
Assess the Focus Area landscape in a publicly available report summarizing:
Standards-related projects under way in the community
Critical gaps in standards development or adoption and potential solutions
Organize a public workshop
Bring together stakeholders to discuss common Focus Area needs and challenges not being fully addressed by existing projects
Champion new projects
Respond to gaps or opportunities identified by the community (e.g., feasibility studies, standards development, standards education)
Host quarterly public Focus Area meetings
Discuss ongoing opportunities and challenges
Share updates on Focus Area progress and achievements and publish meeting highlights in the SCB newsletter
Act as a liaison for existing efforts
Ensure harmonization across efforts led by different organizations
Develop relevant courses
Improve understanding and implementation of specific standards in the Focus Area for leaders and employees
HELP ACCELERATE THE REGENERATIVE MEDICINE FIELD
Your donation to support a Focus Area will help us rally the community to address the most critical issues limiting progress in regenerative medicine.
To donate or discuss donor opportunities, contact Justin Barch, CAE, SCB Executive Director.