Project Proposal Process

 

The SCB reviews and accepts projects that span the priorities of the SCB consortium under the 4 working groups: cell therapy, gene therapy, cell-based drug discovery, and tissue engineering. Each working group seeks to assess and identify issues that need to be addressed to effectively develop, evaluate, and implement standards that will support enabling technologies and infrastructure, clinical development, and commercialization.

Our project proposal process is initiated when interested stakeholders submit a one-page proposal (with overview of the potential project) for consideration. The interested party appoints a project “Chair” or “Lead” to serve as a liaison with the SCB. Lastly, the interested stakeholder completes a “Letter of Commitment” to the SCB to demonstrate an understanding of the SCB’s principles to organize efforts as part of a consortium of non-government stakeholders that operates through public-private partnerships with government regulatory agencies and other government organizations involved in helping to establish consensus standards for regenerative medicine products.

 

In turn, when the SCB has approved the project proposal, we will appoint a dedicated project manager. The SCB will then establish a budget for the project according to the following:

a.     SCB resource commitment as 20% of the aggregate project budget, or;
b.     A minimum for yearly G&A

 

Support from the SCB includes numerous resources for the advancement of the project. The project manager serves as administrative and operational support, including the development and advancement of project awareness, education, and alliance relationship management with network/agency stakeholders. The SCB staff will manage the development of a standards framework, a work plan, timelines, and the process architecture. The SCB also ensures the appropriate production of webinars, white papers and other publications, website project support, and grant writing. Through SCB involvement, the associated stakeholder will gain access to landscape analysis and review of current international consensus standards and initiatives through SDOs and other stakeholders, such as ISO, ATCC, and ASTM. An example of an ongoing project with SCB support is the Cell Transportation Project

 

Projects supported by the SCB drive collective efforts to create standards to support therapeutic development of regenerative medicine tools and products, which will ultimately holds significant value for industry participants. Organizations participating in sector- and project-specific initiatives have an unique opportunity to partner with the SCB during the critical formative stages of the organization and gain in-depth knowledge of how standards development and implementation will influence both research and development and subsequent commercialization of regenerative medicine therapies. If you are interested in submitting a project proposal to the SCB, please submit the project agreement form to Elena Kfoury (ekfoury@regenmedscb.org) and Alexa Machikas (amachikas@regenmedscb.org). If you would like more information about the project proposal process, please contact us