SCB Perspectives: BioFabUSA Fall Summit Preview

Richard McFarland, SCB Secretary and Chief Regulatory Officer at the Advanced Regenerative Manufacturing Institute (ARMI)

September 18, 2018

As we strive to bring innovative new regenerative medicine therapies to the patients, I believe our community should thoughtfully leverage the lessons learned from others who have had success accelerating adjacent product areas toward commercialization.

My colleagues at BioFabUSA agree: our Fall Summit on September 19–20 will focus on operational strategies for transitioning engineered tissues and organs from research and clinical trials to commercialization and patient adoption learned from the successes and best practices of pioneers in the biofabrication community. The summit will open with a keynote by Sandeep Patel, the HHS Open Innovation Manager on the HHS Kidney X Innovation Accelerator to focus the community on the ultimate goal of engineered organ replacements. Subsequent talks and discussions will delve into the details of many areas needed for the community to make this goal a reality, including topics such as government collaborations, public-private partnerships, and innovations in education and workforce development. As Secretary of the SCB, I’m particularly pleased to say that standards also have a prominent place in the agenda as a critical facilitator of tissue engineering product availability.

At SCB, accelerating the development of regenerative medicine therapies through the identification of needed standards and the coordination of their advancement is the heart of our mission. We’re coordinating and participating in a wide range of projects to this end, some of which will have direct impacts on tissue engineering, such as a project with ASTM International to develop standard Rapid Microbial Testing Methods (RMTM) requirements for therapeutic preparations involving scaffolds, which will help identify and validate efficient, reliable measurement and testing methods that manufacturers can employ to better assess product quality and safety. We’re also working on a project with NIST, BioFabUSA, and ASTM International to advance standards for characterizing the properties of fiber-based scaffolds.

In addition to getting the chance to chat with my colleagues at the Summit about new advances in tissue engineering as part of my role with ARMI/BioFabUSA, I’m thrilled to have the opportunity to speak on SCB’s behalf on a panel about the work SCB has done to define the current standards landscape for regenerative medicine, as well as needs for future standards advancement. SCB’s Regenerative Medicine Standards Landscape Report provides the community with an updatable tool to aid the collective understanding of what standards are already out there and help identify what’s needed. I’m curious to hear what my colleagues at the Summit have to say about the challenges they’re facing that future standards could help address.

If you’re unable to join us at the Summit, we welcome you to send us your input on the standards landscape report or get involved with the RMTM project, the fiber-based scaffolds project, or other standards projects that can benefit the tissue engineering sector.

But if you’ll be in New Hampshire this week, I hope to see you at the Summit!