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

The education and workforce development focus area will involve current SCB projects, non-SCB-led projects, and other efforts as needed.

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

The data management focus area will involve current SCB projects, non-SCB-led projects, and other efforts as needed.

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

Recognition of your contribution

Formal recognition of your contribution

 

A seat on the focus area's steering committee

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

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:

Focus area landscape assessment report

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

Champion new projects

Host meetings

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

Existing effort liaison

Act as a liaison for existing efforts

  • Ensure harmonization across efforts led by different organizations

Course development

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.