Washington, D.C. (October 25, 2017) – On September 27, 2017, the U.S. Food and Drug Administration (FDA) awarded a one-year contract to Nexight Group to engage with experts to recommend processes and outline a strategic plan for developing standards in regenerative medicine and advanced therapies. The Standards Coordinating Body for Gene, Cell, and Regenerative Medicines and Cell-based Drug Discovery (SCB) has partnered with Nexight to provide subject matter technical support for this effort. This work will create a foundation that allows industry, regulatory authorities, and other stakeholders to reduce barriers to regenerative medicine research and product development and accelerate the market readiness of these life-changing medical treatments.

The 21st Century Cures Act, signed into law December 2016, directs the FDA, National Institutes of Standards and Technology (NIST), and industry stakeholders to “coordinate and prioritize the development of standards and consensus definition of terms… [that] support, through regulatory predictability, the development, evaluation, and review of regenerative medicine therapies and regenerative advanced therapies.” Jiwen Zhang, SCB’s President, commented, “This provision in the Act is consistent with the mission of the SCB to improve product development, manufacturing, and analytical techniques to help bring innovative regenerative medicine products to market to help patients. Therefore, SCB is pleased to have the opportunity to partner with Nexight in implementation of this provision.”

Regenerative medicine therapies present unique challenges related to product testing, scientific protocols, product quality and specifications, performance characteristics, and compliance criteria. Thus, advancing the development and use of standards has the potential to:

  • Transform product development by inspiring innovation and focusing expertise where it is needed most;
  • Contribute to regulatory predictability so that investment and research is catalyzed and safe therapies are brought to market in a timely manner; and
  • Facilitate the overall development of promising therapies that can cure or treat many conditions and diseases that are not currently easily treatable through conventional means.

Ross Brindle, Nexight Group’s Chief Executive Officer said, “Nexight Group is honored to be selected by FDA to conduct this important work. Engaging the regenerative medicine scientific community to inform standards development has great potential to get novel, life-changing therapies to patients who need them both quickly and safely.”

Between now and September 2018, Nexight Group and the SCB will work together to engage the community to gain a clear picture of the current regenerative medicine standards landscape and recommend an efficient standards development process that incorporates stakeholder input. As part of this work, the Nexight-SCB team will:

  • Develop a landscape report that outlines business needs, gaps in standards, and promising therapy areas for standards application in regenerative medicine therapies.
  • Host three webinars for community stakeholders, including researchers, product developers, academic institutions, clinicians, professional societies, and government agencies on standards development. Stand by for information on the first of the webinars in December 2017.
  • Recommend processes and criteria for identifying and prioritizing standards that will have a high impact on the quality and safety of regenerative medicine therapies, and identify those factors that affect the feasibility and cost-benefit of certain standards.

With Nexight Group’s proven processes for engaging diverse experts in discussions about gaps and needed solutions to advance scientific fields, and the technical acumen and industry involvement of the SCB, the Nexight-SCB team provides both an unparalleled understanding of the work required and the highly developed technical approach necessary to successfully support this promising industry. While working with key regenerative medicine stakeholders throughout this project, we aim to help lay the foundation for a compliance environment that encourages growth and innovation in a safe and consistent manner.

The Nexight-SCB team will be engaging with community members throughout the project to provide input and validate perspectives. If you are not already engaged in this field as a member of the SCB, please contact kchappell@nexightgroup.com and agetz@regenmedscb.org to be included in the outreach.

About Nexight Group
Nexight Group, LLC is a small business based in Silver Spring, Maryland, with extensive experience engaging stakeholders, establishing new collaborative organizations, developing roadmaps and strategic plans, establishing new business processes, and supporting technical education and outreach efforts for experts in diverse industries, including energy, materials and manufacturing, infrastructure security and resilience, and health and development. In collaboration with Georgia Tech and the Georgia Research Alliance, Nexight Group led the coordination and development of Achieving Large-Scale, Cost-Effective, Reproducible Manufacturing of High-Quality Cells: A Technology Roadmap to 2025, a roadmap that aims to facilitate widespread access to life-changing cell therapies, engineered tissues, medical devices, and drug discovery and testing platforms through collaborative research and development. For more information on Nexight Group, visit nexightgroup.com

 About the Standards Coordinating Body
The Standards Coordinating Body (SCB) is a non-profit consortium of non-government stakeholders that operates through public-private partnerships with government agencies, regulatory bodies, and other government organizations involved in establishing consensus standards for regenerative medicine and other advanced therapy products. The SCB’s members include industry representatives, professional societies, and government and academic entities working together to support standards development. The SCB’s mission is to efficiently and effectively support and improve the cost, time, and resources used in regenerative medicine product development by creating a more harmonized compliance environment. For more information on the SCB, visit standardscoordinatingbody.org.