The Executive Director’s Corner

Happy New Year to our SCB extended family! It’s hard to believe that 2020 is already here. The new year promises exciting new initiatives, projects, and standards, some of which began in 2019 and some that will be new for 2020. Before looking forward, let’s take a minute to reflect on the incredible accomplishments from 2019:  

• SCB attended 4 national and 3 international meetings and conferences since our last newsletter alone. These included presentations and standards development meetings for ASTM and ISO.  

• Two SCB-coordinated standards were published: 

  • ISO/TS 20399: Ancillary materials present during the production of cellular therapeutic products (Parts 1, 2, 3)

  • ISO 20391-2: Cell counting — Part 2: Experimental design and statistical analysis to quantify counting method performance

• A total of 31 step advances were accomplished in 2019 for SCB-coordinated standards projects. Step advances are counted whenever a standard moves to a new standards advancement stage such as community prioritization, voting, and drafting. 

• SCB co-hosted the Realizing the Benefit of 21st Century Cures Through Standards Development Workshop with FDA, NIST, and Nexight Group.

• Five new standards advancement projects were launched: 

  • Specifications for Bioinks and Bioprinters (including bioink printability test method, bioprinter software and data governance, and bioprinter hardware standard efforts)

  • Cryopreservation of Cells

  • Base Labeling Requirements for Apheresis Products for Regenerative Medicine Manufacturing

• SCB’s standards coordination efforts were recognized in the U.S. Senate and House of Representatives reports accompanying a 2020 appropriations bill.

• SCB’s 2018 Characterization of Fiber‐Based Scaffolds workshop was featured in the December 2019 issue of the Journal of Biomedical Materials Research.

• SCB was listed as a key regenerative medicine stakeholder in the Medicines & Healthcare Products Regulatory Agency (MHRA) Strategy for Pharmacopoeial Public Quality Standards for Biological Medicines.

• The SCB staff grew to twice its 2018 size with the addition of a third Technical Program Manager, Catherine (Katie) Zander, PhD, and Program Administrative Assistant Sakeenah Muwwakkil.

• Communication of SCB activities continued to expand, with:

  • Publication of updated versions of our Community Perspectives: Needed Standards in Regenerative Medicine report and the Regenerative Medicine Standards Landscape

  • Expansion of our website with additional available resources, including new case studies and “Standards 101”

  • A modified approach to communicating updates to make it easier for stakeholders to keep abreast of new developments and opportunities and to participate in their sectors of interest. New sector pages now include consolidated monthly summaries of scheduled sector calls, calls to action, open ballots, standards updates, and relevant events for the gene therapy, cell therapy, and tissue engineering sectors.

Looking ahead, SCB is working to advance more than 18 standards advancement projects, with at least two new standards projected for publication during the coming year. As requests for SCB presentations at national and international meetings accelerate, we’ll be increasing our reach and influence through seminars, presentations, and workshops. And finally, SCB will work to extend its outreach efforts through improved digital communications and content that are relevant for our stakeholders.

To accomplish these objectives and continue our progress, SCB needs to expand its funding efforts. The Executive Committee is currently reviewing a number of initiatives, many suggested by our stakeholders, that will address the long-term financial health of SCB. In addition, SCB is considering several new initiatives to attract additional funding from other sources. As SCB works to identify and implement these suggestions, I’ll keep you up to date in future editions of our newsletter.

SCB will continue to represent your interests in a proactive and highly professional way in 2020. We invite all our friends to join us as we reach for the next level.

Wishing everyone a safe, healthy, and prosperous new year—and be sure to watch for our newly re-designed SCB logo, coming soon!

—Peter Reczek, January 2020

Note: An abbreviated version of this post appears in the Q4 2019 Newsletter.