Regenerative Medicine Community Perspectives on the Realizing the Benefit of 21st Century Cures through Standards Development Workshop
Washington, DC (March 25, 2019) — The Realizing the Benefit of 21st Century Cures through Standards Development workshop — co-hosted by FDA, NIST, SCB, and Nexight Group on March 18–19, 2019 — brought together members of the regenerative medicine community from key stakeholder groups, including industry, government agencies, standards developing organizations, and academia. We sat down with a few participants to hear their feedback on the workshop and how they believe it will help the regenerative medicine community.
Regulatory Perspective: Judy Arcidiacono, U.S. Food and Drug Administration
Q: What topic of the workshop were you most excited about?
I’m most excited about the breakout groups on specific standards under development, where we expect to hear perspectives we haven’t heard before that can help these standards initiatives better reflect the needs of the community.
Q: How was the workshop significant to you as a regulator?
This workshop will help connect the pieces in implementing the 21st Century Cures Act. The educational topics and discussions throughout the event will raise awareness of standards and help regenerative medicine product developers meet regulatory requirements for safety, data analysis, and product characterization.
Industry Perspective: Chris Wiwi, Celgene
Q: What topic of the workshop were you most excited about?
I appreciated the case studies as a way of making the process more tangible and showing what is needed to pull off creation of a standard.
Q: How was the workshop significant to you as a member of industry?
In industry, we tend to be product-specific. Industry can provide suggestions for standards, but we are often very time constrained, so it’s valuable to have an organization like SCB to help facilitate the process and funnel ideas and needs to working groups that can make standards a reality. Standards also provide an educational component on the best ways to do things, which industry can both contribute to and benefit from.
Academia/Industry Perspective: Barbara Boyan, VCU College of Engineering
Q: What topic of the workshop were you most excited about?
I think the discussions about the challenge of variability in regenerative medicine are valuable. Every medical center is doing regenerative medicine, but defining it is hard. It has so many aspects—how do you make sure it is safe and effective? Someone has to start talking about the complexity, and we have to address the sources of variability that keep it from working reliably.
Q: How was the workshop significant to you as a member of the regenerative medicine community?
I work across both academia and industry; I have built multiple regenerative medicine companies. Both sides are plagued by the same issue: they are innovators. We keep innovating, but we struggle to bring cell-based products to market because they are in flux—alive and changing over time. How do you tell a patient that their treatment will be the same every time when cells have inherent variability? How can you bring innovation into an entity that can actually make it to market? This event provided a forum for discussion of some of the real challenges we face.
Academia Perspective: Tony Burand, University of Iowa Student
Q: What topic of the workshop were you most excited about?
The key note about clinical translation was very interesting. Standards knowledge in academia is often lacking, and students can end up at a disadvantage when they come out of that environment into industry without an understanding of standards.
Q: What is the most interesting thing you learned during the workshop?
How easy it is to participate in standards development. Before coming, I didn’t know what was involved, but now I see the burden is quite low and you don’t need full-time involvement.
patient-facing organization/advocacy perspective: Amy hines, be the match biotherapies
Q: What topic of the workshop were you most excited about?
The workshop provided a collaborative and engaging platform to both share with and learn from multi-disciplinary experts in the regenerative medicine community. If I had to select one topic, it would be the prioritization of standards — where should we begin? This particular workshop breakout session was impressive as it provided thoughtful discussion and consideration of areas in which standardization will be beneficial, and honest and respectful feedback related to areas in which standardization might not be feasible or warranted.
Q: How was the workshop significant to you as a member of the regenerative community?
The workshop was both inspiring and energizing! Inspiring in that, as a community, there is strong alignment to improve access to therapies, increase starting material quality and consistency, and decrease the variability of process and procedures. Energizing in that Be The Match BioTherapies is excited to continue participating in the development of standards that will contribute to this incredibly important work!
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