“Regenerative medicine offers great promise to the patients who need these types of new therapies,” said Allison Getz, Sr. Operations Program Manager for the Standards Coordinating Body (SCB). She continued, “But along with great promise, comes great challenges related to product testing, scientific protocols, product quality and specifications, performance characteristics and compliance criteria.”
“The field of regenerative medicine also faces challenges common to emerging industries, including fragmentation of knowledge, insufficient communication and coordination, and unpredictable advancement of innovation,” also noted Dawn Henke, Sr. Technical Program Manager for SCB.
To help address these challenges, the Standards Coordinating Body for Gene, Cell, Regenerative Medicines and Cell-Based Drug Discovery (SCB) was established in late 2016 by regenerative medicine stakeholders and industry, including the Alliance for Regenerative Medicine to coordinate the development of standards for the regenerative medicine community. To that end, SCB has a contract from the Food and Drug Administration (FDA) to develop a process to identify and prioritize standards gaps, facilitate the development of standards, and implement existing standards for the field of regenerative medicine.
“SCB occupies a unique niche within the regenerative medicine ecosystem – it has no vested interest in a particular scientific, commercial, clinical, or policy approach, and is focused on facilitating the use and development of standards in response to demonstrated need expressed by a range of stakeholders,” commented Richard McFarland, ARMI | BioFabUSA’s Chief Regulatory Officer and SCB Secretary.
This niche allows SCB to catalyze the development of standards amongst multiple standards development organizations. For example, over the course of the next two months, SCB will be a key player in two different efforts within regenerative medicine: ASTM F04 meeting in Washington D.C., and ISO TC276 in Gaithersburg, MD and Potsdam, Germany.
In order to achieve its overall mission, SCB needs participation from the entire community to be engaged to ensure a broad range of perspectives and expertise are incorporated. An opportunity for individuals to engage is at the upcoming workshop, convened by FDA, NIST, SCB and Nexight Group. “Realizing the Benefit of 21st Century Cures through Standards Development” will take place January 14-15, 2019 in Gaithersburg, MD. For more information on this event, visit their event page!
To get involved in standards needs identification, prioritization, or the development process, or to receive regular updates on SCB’s progress, please contact Allison Getz at email@example.com. Visit SCB’s website at them on LinkedIn to find a number of events, webinars and other materials relating to standards.